Egyptian Drug Formulary

Central Administration of Pharmaceutical Care

General Administration For Drug Utilization and pharmacy Practice

Egyptian National Antimicrobial Formulary

2023

Code: EDREX: GL.CAP.Care.018

Version No:1
Issue Date: 2023

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Table of Contents
Content Page
Preface III
Egyptian Antimicrobial drug formulary manual IV
Acknowledgment VI
Contributors VII
List of Contents (Pharmacologically) VIII
List of content (Alphabetically) i
List of Antibiotics in Formulary according to WHO AWaRe list iv
References v

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Preface

The Egyptian Antimicrobial Drug Formulary is published under the authority of the
General Administration of Drug Utilization and Pharmacy Practice, Central Administration
of Pharmaceutical Care, Egyptian Drug Authority. It has been discussed within the
National Rational Antimicrobial Use Committee

The Egyptian Drug Formulary aims to provide pharmacists and other healthcare
professionals with accessible reliable information about the available medications in the
Egyptian database for making the right clinical decisions.

The Egyptian Drug Formulary is a guide that should be interpreted in light of

professional knowledge. The developers work to ensure that the information is as accurate
and up-to-date as possible at the date of publication but knowledge and best practice
change regularly. No responsibility on the work team for errors or omissions.

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Egyptian Antimicrobial drug formulary manual

The Egyptian Antimicrobial Drug Formulary contains a list of medicines that are
registered in the Egyptian database. It is designed as drug monographs classified
pharmacologically and arranged alphabetically. There is a pharmacologically classified
drug index at the beginning of the document and another alphabetically classified index
at the end of the document.

Egyptian drug formulary presents detailed practical information for health care
providers about each medicine.

Each monograph includes:

1. Generic name
2. Dosage form/strengths available in Egypt from the EDA database
3. Route of administration
4. Pharmacological category and ATC code
5. Indications: labeled indications
6. For antibiotics: includes category from AWaRe list:
• Acess: This group includes antibiotics that have activity against a wide range of
commonly encountered susceptible pathogens while also showing lower
resistance potential than antibiotics in the other groups.
• Watch: This group includes antibiotic classes with higher resistance potential and
includes most of the highest priority agents among the Critically Important
Antimicrobials for Human Medicine and/or antibiotics at relatively high risk of
selection of bacterial resistance. These medicines should be prioritized as key
targets of stewardship programs and monitoring.

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• Reserve: This group includes antibiotics and antibiotic classes that should be
reserved for the treatment of confirmed or suspected infections due to multi-
drug-resistant organisms. Reserve group antibiotics should be treated as “last
resort” options.
7. Dosage regimens for adults and children
8. Dosage adjustments if needed.
9. Contraindications
10. Adverse drug reaction
11. Monitoring parameters
12. Drug Interactions: that imply avoidance or considering modifications.
13. Pregnancy and lactation
14. Administration: detailed administration information for all routes [parenteral
(preparation concentrations, compatibility with diluents, infusion rate, precautions
during administration), Oral (food correlation)].
Refer to the manufacturer PIL (Patient Information Leaflet) if there are other
specific considerations.
15. Warnings/Precautions
16. Storage:
➢ For reconstituted vials, apply mentioned storage conditions only if prepared in
aseptic techniques and ISO-controlled conditions according to USP standards,
otherwise discard immediately if not used.
➢ USP develops standards for compounding medications to help ensure the patient
benefit and reduce risks such as contamination, infection, or incorrect dosing.
Refer to manufacturer PIL (Patient Information Leaflet) and SPC (Summary
of product characteristics) if there are other specific consideraions.

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Acknowledgment
Great efforts of work, research and dedication have been exerted for the
development of "The Egyptian Drug Formulary". It would not be ever possible except with
the devotion and dedication of many experts and affiliated organizations in this field.

We are extremely grateful to:

Prof Dr. Tamer Essam, chairman of the Egyptian Drug Authority (EDA) for
encouraging and supporting this work.
Dr. Shereen Abdelgawad, head of the Central Administration of Pharmaceutical
Care for her support and efforts.

We would like to sincerely express deep thanks to the multidisciplinary task force
members who devoted their time, knowledge, and valuable comments to the development
of the Egyptian National Drug Formulary.

Moreover, Sincere gratitude is expressed to all experts who participated in developing

the Egyptian Drug Formulary and who were so generously helping make this work come
true.

Disclaimer

Any information about drugs contained within this formulary is general in nature, and does
not cover all data on the medicines mentioned. The Content is not intended as medical
advice for individual problems or for evaluating the risks and benefits of taking a particular
drug. Refer to the product insert if there are specific considerations. Authors of the Content
disclaim all responsibility for any consequence, directly or indirectly, of the use and
application of any of the content on this formulary.

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Contributors
Chief editor
Dr. Nesma Atef
Head of Egyptian Drug Formulary unit at Drug Utilization and Pharmacy Practice General Administration-EDA
Editorial Board
Dr. Shimaa Nasr Dr. Eman Zakaria
Head of Rational Drug Use unit at Drug Utilization and Head of National drug lists unit at Drug Utilization and
Pharmacy Practice General Administration-EDA Pharmacy Practice General Administration-EDA
Dr. Abeer Elbehairy Dr. Lobna Sami
Head of Pharmacy development administration at Drug Head of Pharmaceutical care initiative unit, at Drug
Utilization and Pharmacy Practice General Utilization and Pharmacy Practice General Administration-
Administration-EDA EDA
Members of the National Rational Antimicrobial Use Committee
(Ordered Alphabetically)

Dr. Ahmed Motawea Prof. Dr. Hossam Arafa

Chief of medical supply dept. Consultant of the General Authority of Healthcare (GAH
Armed Forces Medical Services Authority Representative)
Dr. Asaad Sadek Prof. Dr. Maha Abdel Aziz El-touny
Acting Director IPC General Directorate Prof. Internal medicine ASU.
(MOHP Representative) IPC consultant Ministry of Interior
Dr. Elizabeth Tayler Dr. Mohammed Abdelfattah
Senior technical officer-AMR Consultant at WHO Head of the central administration for preventive affairs
Country Office (MOHP Representative)
Dr. Eman Nadim Prof. Dr. Nirmeen Ahmed Sabry
Clinical pharmacist at the central administration for Professor of clinical pharmacy
unified procurement Cairo University
(The Egyptian Authority for unified procurement Medication management consultant
Representative)
Prof. Dr. Ghada Esmail Dr. Omar Abdel Aziz
Prof. of Clinical Pathology (Microbiology) at Faculty of World Health Organization Technical Officer –
Medicine Ain Shams University. Surveillance, Preparedness, and Response
Head of IPC University Hospitals
(University Hospitals representative)
Dr. Ghada Ali Younis Dr. Sherif Kamal
Former General Manager of the Drug Utilization and Chief pharmacist
Pharmacy Practice General Administration at the Clinical pharmacy programs director
Egyptian Drug Authority. Children’s cancer hospital Egypt

Dr. Hema Soliman Dr. Shereen Abdel Gawad

Quality and Patient Safety Consultant Head of Pharmaceutical Care Central Administration –
(GAHAR Representative) Head of National Rational Antimicrobial Use Committee-
EDA.

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List of Contents (Pharmacologically)

AMINOGLYCOSIDES 1

1. AMIKACIN 1
2. GENTAMICIN 4
3. NEOMYCIN 10
4. STREPTOMYCIN 13
5. TOBRAMYCIN 17

ANTHELMINTIC 20

1. ALBENDAZOLE 20
2. DIETHYLCARBAMAZINE 22
3. IVERMECTIN 24
4. LEVAMISOLE 27
5. MEBENDAZOLE 29
6. NICLOSAMIDE 30
7. PRAZIQUANTEL 32
8. PYRANTEL 34
9. TRICLABENDAZOLE 35

ANTIFUNGAL 36

1. AMPHOTERICIN B 36
2. ANIDULAFUNGIN 39
3. CASPOFUNGIN 41
4. FLUBENDAZOLE 44
5. FLUCONAZOLE 45
6. GRISEOFULVIN 49
7. ITRACONAZOLE 51
8. KETOCONAZOLE 55
9. MICAFUNGIN 59
10. NYSTATIN 62
11. VORICONAZOLE 64
12. POSACONAZOLE 70

ANTIMALARIAL AGENTS 75

1. ARTEMETHER AND LUMEFANTRINE 75

2. ARTESUNATE 78
3. ARTESUNATE AND AMODIAQUINE 81
4. CHLOROQUINE 83
5. HYDROXYCHLOROQUINE 87
6. MEFLOQUINE 90
7. PYRIMETHAMINE 93
8. SULFADOXINE AND PYRIMETHAMINE 95

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ANTIRETROVIRALS 98

A) NUCLEOSIDE/NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS 98

1. ABACAVIR (ABC) 98
2. LAMIVUDINE (3TC) 101
3. TENOFOVIR DISOPROXIL FUMARATE (TDF) 105
4. ZIDOVUDINE 108
B) NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS 110
5. NEVIRAPINE (NVP) 110
6. EFAVIRENZ (EFV) 112
C) PROTEASE INHIBITORS 115
7. ATAZANAVIR (ATV) 115
8. LOPINAVIR AND RITONAVIR 117
9. DARUNAVIR AND RITONAVIR (DRV/R) 120
D) INTEGRASE INHIBITORS 123
10. DOLUTEGRAVIR (DTG) 123
11. RALTEGRAVIR 125

ANTITUBERCULAR AGENT 127

1. ETHAMBUTOL 127
2. ETHAMBUTOL, ISONIAZID, RIFAMPICIN, AND PYRAZINAMIDE 130
3. ISONIAZID 132
4. PYRAZINAMIDE 135
5. RIFAMPICIN 137
6. RIFAMPICIN AND ISONIAZID 141

ANTIVIRAL 144

1. ACYCLOVIR 144
2. ADEFOVIR DIPIVOXIL 151
3. DACLATASVIR 154
4. ENTECAVIR 157
5. FAMCICLOVIR 160
6. FAVIPIRAVIR 163
7. GANCICLOVIR 164
8. LAMIVUDINE AND ZIDOVUDINE 167
9. LEDIPASVIR AND SOFOSBUVIR 169
10. OMBITASVIR, PAPRITAPREVIR AND RITONAVIR 173
11. OSELTAMIVIR 176
12. RIBAVIRIN 180
13. SIMEPREVIR 186
14. SOFOSBUVIR 189
15. SOFOSBUVIR AND VELPATASVIR 192
16. SOFOSBUVIR, VELPATASVIR AND VOXILAPREVIR 195
17. TENOFOVIR ALAFENAMIDE 198
18. VALACYCLOVIR 200
19. VALGANCICLOVIR 204

CARBAPENENEMS 208

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1. ERTAPENEM 208
2. IMIPENEM AND CILASTATIN 213
3. MEROPENEM 217

CEPHALOSPORINS 220

A) FIRST GENERATION CEPHALOSPORINS 220

1. CEFADROXIL 220
2. CEFAZOLIN 222
3. CEPHALEXIN 226
4. CEPHRADINE 229
B) SECOND GENERATION CEPHALOSPORINS 231
1. CEFACLOR 231
2. CEFOXITIN 234
3. CEFPROZIL 237
4. CEFUROXIME 239
C) THIRD GENERATION CEPHALOSPORINS 242
1. CEFDINIR242
2. CEFIXIME 244
3. CEFPODOXIME 246
4. CEFOPERAZONE 250
5. CEFOPERAZONE AND SULBACTAM 253
6. CEFOTAXIME 255
7. CEFTAZIDIME 258
8. CEFTAZIDIME AND AVIBACTAM 261
9. CEFTRIAXONE 264
D) FOURTH GENERATION CEPHALOSPORINS 268
1. CEFEPIME 268
E) FIFTH GENERATION CEPHALOSPORINS 271
1. CEFTAROLINE FOSAMIL 271
2. CEFTOLOZANE AND TAZOBACTAM 275

MACROLIDE 278

1. AZITHROMYCIN 278
2. CLARITHROMYCIN 281
3. ERYTHROMYCIN, 285
4. ROXITHROMYCIN 288
5. SPIRAMYCIN 290

MISCELLANEOUS 292

1. AZTREONAM 292
2. CHLORAMPHENICOL 295
3. CLINDAMYCIN 298
4. COLISTIMETHATE 302
5. DAPSONE 305
6. DILOXANIDE 308
7. DOXYCYCLINE 309
8. FOSFOMYCIN 313

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9. LINCOMYCIN 315
10. LINEZOLID 317
11. METRONIDAZOLE 321
12. NITROFURANTOIN 324
13. OXYTETRACYCLINE 327
14. RIFAXIMIN 329
15. SECNIDAZOLE 332
16. SULFAMETHOXAZOLE AND TRIMETHOPRIM 334
17. TEDIZOLID 337
18. TEICOPLANIN 339
19. TETRACYCLINE 341
20. THIAMPHENICOL 345
21. TIGECYCLINE 347
22. VANCOMYCIN 351

PENICILLINS 357

1. AMOXICILLIN 357
2. AMOXICILLIN AND CLAVULANIC ACID 361
3. AMPICILLIN 366
4. AMPICILLIN AND SULBACTAM 370
5. BENZYLPENICILLIN [PENICILLIN G] 373
6. CLOXACILLIN 378
7. FLUCLOXACILLIN 380
8. PENICILLIN G BENZATHINE 382
9. PHENOXYMETHYLPENICILLIN 386
10. PIPERACILLIN AND TAZOBACTAM 388
11. SULTAMICILLIN 391

QUINOLONES 393

1. CIPROFLOXACIN 393
2. GATIFLOXACIN 400
3. LEVOFLOXACIN 402
4. LOMEFLOXACIN 407
5. MOXIFLOXACIN 409
6. NORFLOXACIN 413
7. OFLOXACIN 415

TOPICAL 420

1. BENZYL BENZOATE 420

2. CLOTRIMAZOLE 422
3. ECONAZOLE 425
4. ERYTHROMYCIN AND ZINC ACETATE 427
5. ISOCONAZOLE 428
6. MICONAZOLE 429
7. MUPIROCIN 431
8. NEOMYCIN, POLYMYXIN B, AND DEXAMETHASONE 433
9. NATAMYCIN 435

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10. TERBINAFINE 436
11. SELENIUM SULFIDE 439
12. SILVER SULFADIAZINE 441
13. SODIUM FUSIDATE/ FUSIDIC ACID 443
14. PERMETHRIN 445
LIST OF CONTENT I
REFERENCES: V

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Amino Aminoglycosides Access Group
glycosides
1. Amikacin
Generic Name Amikacin

Dosage Vial 100mg, 250mg, 500mg, 1000mg

form/strengths
Route of IV, IM
administration
Pharmacologic Antibiotic, Aminoglycoside
category ATC: J01GB06
Indications Serious infections: Treatment of serious infections (eg, bone infections, respiratory tract
infections, endocarditis, septicemia) due to gram-negative organisms

Dosage Individualization is critical because of the low therapeutic index.

Regimen In underweight and nonobese patients, use total body weight (TBW) instead of ideal body
weight.
For obese patients (ie, TBW >1.25 × IBW), use 40% adjusted body weight ([0.4 × (TBW - IBW)]
+ IBW) for initial weight-based dosing
Therapeutic drug monitoring: Monitoring of serum concentrations is recommended to
ensure efficacy and avoid toxicity, particularly in critically ill patients with serious infections
or in disease states known to significantly alter aminoglycoside pharmacokinetics (eg, cystic
fibrosis, burns, major surgery). Timing and frequency of concentration monitoring are
individualized based on dosing and monitoring strategy
Dosing: Adult
Usual dosage range:
Injectable aminoglycoside dosing is highly variable and dependent on several factors.
Maximum doses are:
IM, IV: 5 mg/kg every 8 hours or 7.5 mg/kg every 12 hours. Target peak concentration
depends on the indication, site of infection, and minimum inhibitory concentration (MIC) of
the pathogen; in general, adjust dose to achieve the peak of 20 to 40 mg/L. Target trough
concentrations should be <8 mg/L; the ideal target trough is 1 to 4 mg/L.
Note: Some clinicians suggest a daily dose of 15 to 20 mg/kg once daily for patients with
normal renal function.
Dosing: Pediatric
General dosing, severe, susceptible infections: Infants, Children, and Adolescents:
IM, IV: 15-20 mg/kg/day divided every 12 or 8 hours or 15 to 20 mg/kg/dose every 24 hours.
Dosage • Dosing: Renal impairment Adult:
adjustment If the usual indication-specific dose is 7.5
CrCl mg/kg every 12 hours or 5 mg/kg every 8
hours
≥60 mL/minute No dosage adjustment necessary.
40 to <60 mL/minute 5 to 7.5 mg/kg every 12 hours.
20 to <40 mL/minute 5 to 7.5 mg/kg every 24 hours.

Serum concentrations of the drug should be monitored in dialysis patients and

dosage adjusted to maintain desired serum concentrations.
• Dosing: Altered Kidney Function: Pediatric

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Infants, Children, and Adolescents: IM, IV:
Note: Renally adjusted dose recommendations are based on doses of 5 to 7.5
mg/kg/dose every 8 hours:
GFR >50 mL/minute/1.73 m2: No adjustment is required.
GFR 30 to 50 mL/minute/1.73 m2: Administer every 12 to 18 hours.
GFR 10 to 29 mL/minute/1.73 m2: Administer every 18 to 24 hours.
GFR <10 mL/minute/1.73 m2: Administer every 48 to 72 hours.
Intermittent hemodialysis: 5 mg/kg/dose; readjust dose as indicated by serum
concentrations.
Peritoneal dialysis (PD): 5 mg/kg/dose; readjust dose as indicated by serum
concentrations.
Continuous renal replacement therapy (CRRT): 7.5 mg/kg/dose every 12 hours,
monitor serum concentrations.
• Dosing: Hepatic Impairment:
There are no dosage adjustments needed.
Contra- Hypersensitivity to amikacin, other aminoglycosides, or any component of the formulation
indications
Adverse Drug Frequency not defined:
Reactions Nervous system: Neurotoxicity (including muscle twitching, numbness, seizure, tingling of
skin)
Otic: Auditory ototoxicity, vestibular ototoxicity
Renal: Nephrotoxicity
Respiratory: Respiratory paralysis
Monitoring • Urinalysis, BUN, serum creatinine, appropriately timed peak and trough concentrations,
Parameters vital signs, temperature, weight, hearing parameters
• Initial and periodic peak and trough plasma drug levels should be determined,
particularly in critically ill patients with serious infections or in disease states known to
significantly alter aminoglycoside pharmacokinetics (eg, cystic fibrosis, burns, or major
surgery).
• Close monitoring of aminoglycoside levels in case of combination therapy with penicillin
and aminoglycoside is needed in patients with significant renal impairment
Reference Range
Traditional dosing:
Target concentrations: Peak: 20 to 40 mg/L; trough: <8 mg/L (ideal target 1 to 4 mg/L)
Timing of serum samples: Draw peak 30 minutes after completion of 30-minute infusion or at
1 hour following initiation of infusion or IM injection; draw trough within 30 minutes prior to
next dose
Drug • Risk X: Avoid combination
Interactions Aminoglycosides Ataluren BCG (Intravesical) Bacitracin (Systemic) Cholera Vaccine Cisplatin
Foscarnet Mannitol Mecamylamine Methoxyflurane Netilmicin (Ophthalmic) Polymyxin B
• Risk D: Consider therapy modification
Bacillus clausii Colistimethate Sodium Picosulfate Typhoid Vaccine Vancomycin
Pregnancy and Pregnancy risk factor D.
Lactation A decision should be made to discontinue breastfeeding or discontinue the drug, taking into
account the importance of the drug to the mother. Patients with multidrug-resistant
tuberculosis and a sputum smear-positive test should avoid breastfeeding when possible
The effects on the nursing infant are unknown.
-Breastfed infants should be monitored for antibiotic-associated colitis, diarrhea, and/or
candidiasis.

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Administration Administration: IM injection in large muscle mass.
Administration: IV
Infuse over 30 to 60 minutes. In infants, infusion over 1 to 2 hours is recommended.
Preparation for Administration:
For intravenous administration, dilute in a compatible solution (eg, NS, D5W) to a final
concentration of 0.25 to 5 mg/mL
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Hypersensitivity: Cross-sensitivity to other aminoglycosides may occur.
• Nephrotoxicity: [US Boxed Warning]: May cause nephrotoxicity; usual risk factors include
preexisting renal impairment, concomitant nephrotoxic medications, advanced age and
dehydration. Discontinue treatment if signs of nephrotoxicity occur; renal damage is usually
reversible.
• Neuromuscular blockade and respiratory paralysis: [US Boxed Warning]: May cause
neuromuscular blockade and respiratory paralysis; especially when given soon after
anesthesia or muscle relaxants.
• Neurotoxicity: [US Boxed Warning]: May cause neurotoxicity; usual risk factors include
preexisting renal impairment, concomitant neuro-/nephrotoxic medications, advanced age
and dehydration. Ototoxicity is proportional to the amount of drug given and the duration of
treatment. Tinnitus or vertigo may be indications of vestibular injury and impending bilateral
irreversible damage. Discontinue treatment if signs of ototoxicity occur.
• Superinfection: Prolonged use
Disease-related concerns:
• Hearing impairment: Use with caution in patients with preexisting vertigo, tinnitus, or
hearing loss.
• Hypocalcemia: Use with caution in patients with hypocalcemia.
• Neuromuscular disorders: Use with caution in patients with neuromuscular disorders,
including myasthenia gravis or parkinsonism.
• Renal impairment: Use with caution in patients with preexisting renal insufficiency; dosage
modification required.
Concurrent drug therapy issues:
• Neurotoxic and/or nephrotoxic drugs: [US Boxed Warning]: Avoid concomitant or
sequential use of other neurotoxic and/or nephrotoxic drugs (eg, bacitracin, cisplatin,
amphotericin B, paromomycin, polymyxin B, colistin, vancomycin, other aminoglycosides).
• Potent diuretics: [US Boxed Warning]: Avoid concomitant use with potent diuretics (eg,
ethacrynic acid, furosemide) since diuretics themselves may cause ototoxicity and may
enhance aminoglycoside toxicity.
Dosage form specific issues:
• Sulfites: May contain sulfites which may cause allergic reactions
Other warnings/precautions:
• Surgical irrigation: Irreversible deafness, renal failure, and death due to neuromuscular
blockade have been reported following use of aminoglycosides as surgical irrigation
Storage Store intact vials at 20°C to 25°C.
Following admixture, amikacin is stable for 24 hours at room temperature, 60 days at 4°C, or
30 days at -15°C. Previously refrigerated solutions are stable for 24 hours at 25°C.
Refer to manufacturer PIL if there are specific considerations.

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2. Gentamicin
Access Group

Generic Name Gentamicin

Dosage Ampoule 20mg, 40mg, 80mg

form/strengths Topical cream or ointment 0.1%, 0.3%
Eye/ear Drops 0.3%, 5mg/ml,
Eye/ Ear Ointment: 3mg/gm, 5mg/gm
Route of IV, IM, Topical, Opthalmic
administration
Pharmacologic Antibiotic, Aminoglycoside
category Systemic ATC: J01GB03
Ophthalmic ATC: S01AA11
Topical: D06AX07

Indications IV, IM: Serious infections:

Treatment of serious infections (eg, sepsis, meningitis, urinary tract infections, respiratory tract
infections, peritonitis, bone infections, skin and soft tissue infections) caused by susceptible
strains
Treatment of infective endocarditis caused by enterococci, in combination with other antibiotics.
Dermatologic infections: Topical treatment of superficial dermatologic infections
Ophthalmic infections: Topical treatment of ocular bacterial infections, including conjunctivitis,
keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivitis, acute
meibomianitis, and dacryocystitis
Dosage Note: Aminoglycoside dosing weight: For obese patients (ie, TBW >1.25 x IBW), use 40% adjusted
Regimen body weight ([0.4 x {TBW-IBW}] + IBW) for initial weight-based dosing.
Therapeutic drug monitoring: Monitoring of serum concentrations is recommended to ensure
efficacy and avoid toxicity.
Note: High-dose, extended-interval dosing is generally preferred for treatment of gram-negative
infections. Conventional/traditional dosing is typically used for synergy dosing or non-CNS, gram-
positive infections.

Dosing: Adult
Gram-negative infections:
Conventional dosing: IV, IM: 3 to 5 mg/kg/day in divided doses every 8 hours
High-dose extended-interval dosing (once-daily dosing): IV: 5 to 7 mg/kg once daily; use with
caution in patients with CrCl <40 mL/minute
Synergy dosing for non-CNS gram-positive infections:
IV, IM: 3 mg/kg/day in 1 to 3 divided doses in combination with a gram-positive active agent
Endocarditis, treatment:
Enterococcus spp. (native or prosthetic valve, without high-level gentamicin resistance): IV, IM: 1
mg/kg every 8 hours as part of an appropriate combination regimen.
Urinary tract infection, complicated (pyelonephritis or urinary tract infection with systemic
signs/symptoms) (alternative agent):

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Inpatients: IV, IM: 5 mg/kg once daily. Switch to an appropriate oral regimen once symptoms
improve, if culture and susceptibility results allow. Total duration of therapy ranges from 5 to 14
days and depends on clinical response and the antimicrobial chosen to complete the regimen.
Outpatients: IV, IM: 5 mg/kg once, followed by 5 to 14 days of appropriate oral therapy
Meningitis, bacterial:
Enterococcus spp.: IV: 5 mg/kg/day in 1 or 3 divided doses; give as part of an appropriate
combination regimen and individualize duration based on clinical response
Listeria monocytogenes: IV: 5 mg/kg/day in 3 divided doses in combination with ampicillin or
penicillin. Gentamicin is given until clinical improvement
Dosing: Pediatric
IV or IM:
Premature or full-term neonates ≤1 week of age: 2.5 mg/kg every 12 hours
Conventional dosing: Infants, Children, and Adolescents: IM, IV: 2 to 2.5 mg/kg/dose every 8
hours
Endocarditis, treatment:
Synergy dosing (eg, gram-positive bacteria): Children and Adolescents: IV: 3 to 6
mg/kg/day divided every 8 hours; use in combination with other antibiotics dependent on
pathogen and source of infection (ie, valve type).
Treatment dosing (eg, gram-negative bacteria): Children and Adolescents: IV: 7.5
mg/kg/day divided every 8 hours; use in combination with other antibiotics
Intra-abdominal infection, complicated: Infants, Children, and Adolescents: IV: 3 to 7.5
mg/kg/day divided every 8 to 24 hours; use in combination with other antibiotics
Surgical prophylaxis: Infants, Children, and Adolescents: IV: 2.5 mg/kg as a single dose; administer
within 60 minutes prior to surgical incision with or without other antibiotics (procedure
dependent)
Urinary tract infection (UTI):
Conventional dosing: Infants, Children, and Adolescents: IV: 7.5 mg/kg/day divided every 8 hours
until clinical improvement and ability to oral intake; complete course with oral antibiotics;
duration should be individualized based upon age, severity, and degree of urinary tract
involvement
Dermatologic infections: Adult/pediatric: Topical: Apply 3 to 4 times daily to affected area
Ophthalmic infections: Adult/pediatric: Ophthalmic:
Ointment: Instill (1.25 cm) 2 to 3 times daily
Solution: Instill 1 to 2 drops every 4 hours, up to 2 drops every hour for severe infections

Dosage Dosing: Renal Impairment: Adult

adjustment High-dose, extended-interval dosing:
Note: Use with caution in patients with CrCl <40 mL/minute; high-dose, extended-interval dosing
may still be considered, especially in patients with severe sepsis/shock or those infected with
multidrug-resistant gram-negative organisms (expert opinion).
IV: Initial dose: 5 to 7 mg/kg. Subsequent doses and frequency of administration should be
determined based on therapeutic drug monitoring; regimens may vary. The following
recommendations may serve as a general guideline after the initial dose:
CrCl ≥60 mL/minute: IV: Administer every 24 hours; adjust dose and/or interval based on
gentamicin serum concentrations.
CrCl 40 to <60 mL/minute: IV: Administer every 36 hours; adjust dose and/or interval based on
gentamicin serum concentrations.
CrCl 20 to <40 mL/minute: IV: Administer every 48 hours; adjust dose and/or interval based on
gentamicin serum concentrations.

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CrCl <20 mL/minute: IV: Administer usual dose once, then determine subsequent dose and
interval based on serum concentration monitoring.
Conventional/traditional dosing:
Regimens may vary based on individualized pharmacokinetic calculations and pharmacodynamic
targets; also refer to institutional-specific policies.
Note: The following recommendations are expert opinion and based on a usual dosage range of 3
to 5 mg/kg/day:
CrCl ≥60 mL/minute: IM, IV: No dosage adjustment necessary.
CrCl ≥40 to <60 mL/minute: IM, IV: Administer usual dose every 12 hours; adjust dose and/or
interval based on gentamicin serum concentrations.
CrCl 20 to <40 mL/minute: IM, IV: Administer usual dose every 24 hours; adjust dose and/or
interval based on gentamicin serum concentrations.
CrCl <20 mL/minute: IM, IV: Administer usual dose every 36 to 48 hours; adjust dose and/or
interval based on gentamicin serum concentrations.
Dosing: Renal Impairment: Pediatric
Parenteral: Note: Gentamicin serum concentrations should be monitored in patients with kidney
impairment; following the initial dose, subsequent doses may be determined based on
therapeutic monitoring.
Infants, Children, and Adolescents: IM, IV:
The following adjustments have been recommended: Note: Renaly adjusted dose
recommendations are based on doses of 2.5 mg/kg/dose every 8 hours:
GFR >50 mL/minute/1.73 m2: No dosage adjustment necessary.
GFR 30 to 50 mL/minute/1.73 m2: Administer every 12 to 18 hours.
GFR 10 to 29 mL/minute/1.73 m2: Administer every 18 to 24 hours.
GFR <10 mL/minute/1.73 m2: Administer every 48 to 72 hours.
Intermittent hemodialysis: 2 mg/kg/dose; readjust dose as indicated by serum concentration.
Peritoneal dialysis (PD): 2 mg/kg/dose; readjust dose as indicated by serum concentration.
Continuous renal replacement therapy (CRRT): 2 to 2.5 mg/kg/dose every 12 to 24 hours, monitor
serum concentrations.

Dosing: Hepatic Impairment:

No dosage adjustment is needed
Contra- Hypersensitivity to gentamicin, other aminoglycosides, or any component of the formulation
indications
Adverse Drug Frequency not defined.
Reactions Cardiovascular: Edema, hypertension, hypotension, phlebitis, thrombophlebitis
Central nervous system: Abnormal gait, ataxia, brain disease, confusion, depression, dizziness,
drowsiness, headache, lethargy, myasthenia, numbness, paresthesia, peripheral neuropathy,
pseudomotor cerebri, seizure, vertigo
Dermatologic: Alopecia, erythema, pruritus, skin rash, urticaria
Endocrine & metabolic: Hypocalcemia, hypokalemia, hypomagnesemia, hyponatremia, weight
loss
Gastrointestinal: Anorexia, Clostridioides difficile-associated diarrhea, decreased appetite,
enterocolitis, nausea, sialorrhea, stomatitis, vomiting
Genitourinary: Casts in urine (hyaline, granular), Fanconi-like syndrome (infants and adults; high
dose, prolonged course), oliguria, proteinuria
Hematologic & oncologic: Agranulocytosis, anemia, eosinophilia, granulocytopenia, leukopenia,
purpura, reticulocytopenia, reticulocytosis, splenomegaly, thrombocytopenia
Hepatic: Hepatomegaly, increased liver enzymes
Hypersensitivity: Anaphylaxis, anaphylactoid reaction, hypersensitivity reaction

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Local: Injection site reaction, pain at injection site
Neuromuscular & skeletal: Arthralgia, muscle cramps, muscle fatigue (myasthenia gravis-like
syndrome), muscle twitching, tremor, weakness
Ophthalmic: Visual disturbance
Otic: Auditory impairment, hearing loss (associated with persistently increased serum
concentrations; early toxicity usually affects high-pitched sound), tinnitus
Renal: Decreased creatinine clearance, decreased urine specific gravity, increased blood urea
nitrogen, increased serum creatinine, polyuria, renal failure (high trough serum concentrations),
renal tubular necrosis
Respiratory: Dyspnea, laryngeal edema, pulmonary fibrosis, respiratory depression
Miscellaneous: Fever

Monitoring • Urinalysis, urine output, BUN, serum creatinine, plasma gentamicin levels (as appropriate to
Parameters dosing method). Levels are typically obtained before and after the third dose in conventional
dosing. Hearing should be tested before, during, and after treatment; particularly in those at
risk for ototoxicity or who will be receiving prolonged therapy (>2 weeks)
• Close monitoring of aminoglycoside levels is warranted in case of combination therapy with
penicillin derivatives.

Reference range: Conventional dosing:

Timing of serum samples: Draw peak 30 minutes after the 30-minute infusion has been completed
or 1 hour after IM injection; draw trough immediately before the next dose is due.

Therapeutic levels:
Peak:
Sepsis, pneumonia, and other serious infections (including life-threatening infections): 7 to 10
mcg/mL
Urinary tract infections, including pyelonephritis: 4 to 6 mcg/mL

Synergy against gram-positive organisms: 3 to 4 mcg/mL

Trough:
Gram-negative infections: <2 mcg/mL (ideal target <1 mcg/mL)
Synergy against gram-positive organisms: <1 mcg/mL

Obtain drug levels after the third dose unless renal dysfunction/toxicity suspected
Drug • Risk X: Avoid combination
Interactions Agalsidase Alfa Aminoglycosides Ataluren Bacitracin (Systemic) BCG (Intravesical) Cholera
Vaccine Cisplatin Foscarnet Mannitol (Systemic) Mecamylamine Methoxyflurane Netilmicin
(Ophthalmic) Polymyxin B
• Risk D: Consider therapy modification
Agalsidase Beta Bacillus clausii Colistimethate Sodium Picosulfate Typhoid Vaccine
Vancomycin
• Risk C: Monitor therapy
Amphotericin B Arbekacin Bisphosphonate Derivatives Botulinum Toxin-Containing
Products Capreomycin Carboplatin Cardiac Glycosides Cephalosporins
Cyclosporine Cyclizine Distigmine Lactobacillus And Estriol Loop Diuretics Neuromuscular-
Blocking Agents Nonsteroidal Anti-Inflammatory Agents Oxatomide Penicillins
Tacrolimus (systemic) Tenofovir Products

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Pregnancy and Pregnancy risk factor D
Lactation Aminoglycosides may cause fetal harm if administered to a pregnant woman.
The World Health Organization (WHO) considers gentamicin to be compatible with breastfeeding.
Infants should be monitored for thrush and diarrhea
Administration IM: Administer undiluted. Gentamicin in NS is not intended for IM administration.; in paralyzed
patients, suggest the IV route.
IV: Administer as a diluted solution by slow intermittent infusion over 30 to 120 minutes; usual
infusion time is 30 to 60 minutes; consider longer infusion time (60 to 120 minutes) with high
doses. Shorter infusion times (≤5 minutes) have been reported in pediatric patients, including
preterm and term neonates, receiving ≤4 mg/kg/dose. Avoid infusing concomitantly with
penicillins or cephalosporins if feasible; Consult drug interactions database for more information.
Preparation for Administration:
IV: May dilute in NS or D5W. In adults, dilution in 50 to 200 mL is recommended; the
concentration of the pediatric-specific product is 10 mg/mL.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Hypersensitivity: Cross-sensitivity to other aminoglycosides may occur.
• Nephrotoxicity: [US Boxed Warning]: May cause nephrotoxicity; usual risk factors include
preexisting renal impairment, concomitant nephrotoxic medications, advanced age and
dehydration. Discontinue treatment if signs of nephrotoxicity occur; renal damage is usually
reversible.
• Neuromuscular blockade and respiratory paralysis: especially when given soon after
anesthesia or neuromuscular blockers.
• Neurotoxicity: May cause neurotoxicity; usual risk factors include preexisting renal
impairment, concomitant neuro-/nephrotoxic medications, advanced age and dehydration.
Tinnitus or vertigo may be indications of vestibular injury and impending bilateral irreversible
damage. Discontinue treatment if signs of ototoxicity occur.
• Superinfection: Prolonged use.
• Corneal healing: May delay corneal healing in ophthalmic administration.
Disease-related concerns:
• Electrolyte abnormalities: Use with caution in patients with hypocalcemia, hypokalemia, or
hypomagnesemia.
• Hearing impairment: Use with caution in patients with preexisting vertigo, tinnitus, or hearing
loss.
• Neuromuscular disorders: Use with caution in patients with neuromuscular disorders, including
myasthenia gravis.
• Renal impairment: Use with caution in patients with preexisting renal insufficiency; dosage
modification is required.
Special populations:
• Pregnancy: Aminoglycosides may cause fetal harm if administered to a pregnant woman.
Concurrent drug therapy issues:
• Neurotoxic and/or nephrotoxic drugs: [US Boxed Warning]: Avoid concomitant or sequential
use of other neurotoxic and/or nephrotoxic drugs (eg, cisplatin, polymyxin B, colistin,
vancomycin, other aminoglycosides).
• Potent diuretics: Avoid concomitant use with potent diuretics (eg, ethacrynic acid, furosemide)
since diuretics themselves may cause ototoxicity and may enhance aminoglycoside toxicity.
Other warnings/precautions:
• Long-term use: Risk of toxicity is increased; additional monitoring may be required with long-
term use.
• Surgical irrigation: May be almost completely systemically absorbed after local irrigation

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and/or topical application (except to the urinary bladder) during surgical procedures.
Consider potential for nephrotoxicity, neuromuscular blockade, ototoxicity, and respiratory
paralysis.
Storage • Intact vials: Store at 20°C to 25°C. Protect from freezing.
• IV infusion solutions mixed in NS or D5W are stable for 48 hours at room temperature and
refrigeration.
• Cream/ Ointments: Store at controlled room temperature of 20°C to 25°C
• Refer to manufacturer PIL if there are specific considerations.

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3. Neomycin
Watch Group

Generic name Neomycin

Dosage Tablets 350.000 I. U, 500 mg

form/strengths Ophthalmic and topical preparations in combinations
Route of Oral
administration
Pharmacologic Ammonium Detoxicant; Antibiotic, Aminoglycoside
category ATC: A07AA01
Indications Hepatic coma (portal-systemic encephalopathy): Adjunctive therapy in hepatic coma.
Surgical (perioperative) prophylaxis: Adjunctive therapy as part of a regimen for the
suppression of the normal bacterial bowel flora (eg, preoperative bowel preparation)
Oral:
Dosage Dosing: Adult
Regimen To minimize risk of toxicity, use lowest possible dosage and shortest duration of therapy.
Closely monitor patients for aminoglycoside toxicity.
Treatment duration >2 weeks is not recommended.
Surgical (perioperative) prophylaxis: Oral: 1 g at 19, 18 and 9 hours before the time of
surgery as an adjunct to mechanical cleansing of the intestine, followed by an appropriate IV
antibiotic prophylaxis regimen.
Hepatic encephalopathy: 4 to 12 g daily divided every 4 to 6 hours for 5 to 6 days
Chronic hepatic insufficiency: 4 g daily
Dosing: Pediatric
General Pediatric Dosage
If neomycin is considered necessary in children <18 years of age, duration of therapy should
not exceed 2 weeks.
Hepatic Encephalopathy
Children: 50-100 mg/kg daily given in 4 divided doses for ≤7 days.
Prior to initiation of neomycin, withdraw protein from the diet and avoid diuretics;
incrementally return protein back to the diet during treatment. Monitor closely; give
supportive therapy (including blood products) as indicated
Preoperative intestinal antisepsis: Infants, Children, and Adolescents: Oral: 15 mg/kg/dose
for 3 doses administered over 10 hours the day before surgery; maximum dose: 1,000
mg/dose; used in combination with other oral antimicrobial (eg, erythromycin or
metronidazole) and with/or without adjunct to mechanical cleansing of the intestine
Dosage Dosing: Renal Impairment:
adjustment Dosage reduction or discontinuation of therapy should be considered if a patient develops
renal insufficiency. The risk of nephro- and/or ototoxicity is increased in patients with renal
impairment.
Dosing: Hepatic Impairment:
There are no dosage adjustments needed. Caution in severe cases.
Contra- Hypersensitivity to the neomycin or any component of the formulation; intestinal
indications obstruction; patients with inflammatory or ulcerative GI disease. Patients with a history of
hypersensitivity or serious toxic reactions to other aminoglycosides may have a cross-
sensitivity to neomycin.
Adverse Drug >10%: Central nervous system: Sore mouth
Reactions Gastrointestinal: Anorectal pain, diarrhea, mouth irritation, nausea, rectal irritation, vomiting

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Monitoring Serum creatinine/BUN at baseline and periodically during chronic therapy; audiometry in
Parameters symptomatic patients
Drug Risk X: Avoid combination
Interactions Aminoglycosides Ataluren Bacitracin BCG (Intravesical) Cholera Vaccine Cisplatin Foscarnet
Mannitol Mecamylamine Methoxyflurane Netilmicin (Ophthalmic) Polymyxin B Sorafenib
Risk D: Consider therapy modification
Bacillus clausii Sodium Picosulfate Colistimethate Typhoid Vaccine Vancomycin
Pregnancy and Pregnancy Risk Factor D
Lactation It is not known if neomycin is excreted into breast milk. Due to the potential for serious adverse
reactions in the nursing infant, It is recommended a decision be made whether to discontinue
nursing or to discontinue the drug, taking into account the importance of treatment to the
mother.
As a class, aminoglycosides are expected to be poorly distributed into breast milk, limiting
systemic exposure to a nursing infant. In general, modification of bowel flora may occur with
any antibiotic exposure
Administration Oral: Administer without regard to meals; for preoperative intestinal antisepsis, administer at
prescribed dosing times.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Systemic:
Precautions Concerns related to adverse effects:
• Hypersensitivity: Cross-sensitivity to other aminoglycosides may occur.
• Malabsorption: Small amounts of neomycin are absorbed through intact intestinal mucosa;
increases in fecal bile acid excretion and reduction of intestinal lactase activity may occur.
Oral doses of >12 g/day produce malabsorption of fats, nitrogen, cholesterol, carotene,
glucose, xylose, lactose, sodium, calcium, cyanocobalamin and iron.
• Nephrotoxicity: [US Boxed Warning]: May cause nephrotoxicity; usual risk factors include
preexisting renal impairment, concomitant nephrotoxic medications, advanced age and
dehydration. Discontinue treatment if signs of nephrotoxicity occur; renal damage is usually
reversible.
• Neuromuscular blockade and respiratory paralysis: [US Boxed Warning]: May cause
neuromuscular blockade and respiratory paralysis; especially when given soon after
anesthesia or muscle relaxants.
• Neurotoxicity: [US Boxed Warning]: May cause neurotoxicity; symptoms also include
numbness, skin tingling, muscle twitching and seizures.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C.
difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been
observed >2 months postantibiotic treatment.
Disease-related concerns:
• Hearing impairment: Use with caution in patients with preexisting vertigo, tinnitus, or
hearing loss.
• Neuromuscular disorders: Use with caution in patients with neuromuscular disorders,
including myasthenia gravis and Parkinson’s disease.
• Renal impairment: Use with caution in patients with preexisting renal insufficiency; dosage
modification required.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or
frequency adjustment, additional monitoring, and/or selection of alternative therapy.
Consult drug interactions database for more detailed information.
other warnings/precautions:
• Parenteral administration: More toxic than other aminoglycosides when given

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parenterally; do not administer parenterally.
• Surgical irrigation: Do not use as surgical irrigation due to significant systemic absorption
of the drug.
Storage Store at 20ºC to 25ºC
Refer to manufacturer PIL if there are specific considerations.

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4. Streptomycin
Watch Group

Generic Name Streptomycin

Dosage Vial (or Powder for injection): 1gm

form/strengths
Route of IM
administration Or oral in combinations
Pharmacologic Antibiotic, Aminoglycoside; Antitubercular Agent
category ATC: Parentral: J01GA01
Oral: A07AA04
Indications Tuberculosis:
Treatment of tuberculosis, in combination with other appropriate antituberculosis agents,
when the primary agents are contraindicated because of toxicity or intolerance.
Nontuberculosis infections:
Treatment of infections caused by susceptible bacteria that are not amenable to therapy
with less potentially toxic agents.
Dosage Dosing: Adult
Regimen Aminoglycoside dosing weight:
For underweight patients (ie, total body weight [TBW] < ideal body weight [IBW]), calculate
the dose based on TBW.
For obese patients (ie, TBW > 1.25 × IBW), calculate the dose based on 40% adjusted body
weight (IBW + [0.4 × (TBW-IBW)]).
Therapeutic drug monitoring: Monitoring of serum concentrations is recommended to
ensure efficacy and avoid toxicity; confirm availability of rapid streptomycin serum
concentrations. Timing and frequency of concentration monitoring are individualized based
on dosing and monitoring strategy
Note IV is offlabel use
Usual dosage range: IM, IV: 15 to 30 mg/kg/day or 1 to 2 g daily
Indication-specific dosing:
Brucellosis: IM, IV: 1 g once daily in combination with doxycycline. Duration depends on
extent of disease; streptomycin is usually given for the first 14 to 21 days of therapy,
followed by doxycycline monotherapy
Endocarditis (alternate agent):
Enterococcus spp. (native or prosthetic valve, susceptible to penicillin and
streptomycin/resistant to gentamicin): IM, IV: 7.5 mg/kg every 12 hours in combination with
ampicillin or penicillin
Plague: IM: 1 g every 12 hours for 7 to 14 days and for at least a few days after clinical
resolution
Tuberculosis (alternative agent): IM, IV: 15 mg/kg once daily or 25 mg/kg 3 times weekly
Tularemia (alternative agent): IM: 1 g twice daily for ≥10 days depending on severity
Pediatric Patients
General Dosage for Infants and Children
IM
20–40 mg/kg daily given in divided doses every 6–12 hours, maximum dose: 1,000 mg/dose;
maximum daily dose: 2,000 mg/day. maximum daily dose: 2,000 mg/day

Dosage Dosing: Renal Impairment: Adult

adjustment The following adjustments have been recommended:

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CrCl more than 50 mL/minute: Administer the dose every 24 hours.
CrCl 10 to 50 mL/minute: Administer the dose every 24 to 72 hours.
CrCl less than 10 mL/minute: Administer the dose every 72 to 96 hours.

ATS/CDC/IDSA: Tuberculosis:
CrCl ≥30 mL/minute: No dosage adjustment is necessary.
CrCl <30 mL/minute: 15 mg/kg/dose 2 to 3 times weekly.
ESRD on IHD: 15 mg/kg/dose 2 to 3 times weekly. Give after dialysis if given on day of
dialysis.
Dosing: Renal Impairment: Pediatric
Infants, Children, and Adolescents: Note: Renally adjusted dose recommendations are based
on doses of 20 to 40 mg/kg/day every 24 hours. Monitor serum concentrations.
GFR 30 to 50 mL/minute/1.73 m2: Administer 7.5 mg/kg/dose every 24 hours
GFR 10 to 29 mL/minute/1.73 m2: Administer 7.5 mg/kg/dose every 48 hours
GFR <10 mL/minute/1.73 m2: Administer 7.5 mg/kg/dose every 72 to 96 hours
Intermittent hemodialysis (IHD): Administer 7.5 mg/kg/dose every 72 to 96 hours
Peritoneal dialysis (PD): Administer 7.5 mg/kg/dose every 72 to 96 hours
Dosing: Hepatic Impairment:
There are no dosage adjustments needed
Dosing: Geriatric
Dose reductions are recommended in patients >60 years of age.

Contra- Hypersensitivity to streptomycin, other aminoglycosides, or any component of the

indications formulation

Adverse Drug Frequency not defined.

Reactions Cardiovascular: Hypotension
Central nervous system: Drug fever, facial paresthesia, headache, neurotoxicity
Dermatologic: Exfoliative dermatitis, skin rash, urticaria
Gastrointestinal: Nausea, vomiting
Genitourinary: Azotemia, nephrotoxicity
Hematologic & oncologic: Eosinophilia, hemolytic anemia, leukopenia, pancytopenia,
thrombocytopenia
Hypersensitivity: Anaphylaxis, angioedema
Neuromuscular & skeletal: Arthralgia, tremor, weakness
Ophthalmic: Amblyopia
Otic: Auditory ototoxicity, vestibular ototoxicity
Respiratory: Dyspnea
Monitoring Baseline and periodic hearing tests (audiograms), clinical assessment for vertigo and tinnitus,
Parameters BUN, creatinine, serum electrolytes; serum drug concentrations should be monitored in all
patients
Drug Risk X: Avoid combination
Interactions Aminoglycosides Ataluren Bacitracin (Systemic) BCG (Intravesical) Cholera Vaccine Foscarnet
Mannitol Mecamylamine Methoxyflurane Netilmicin (Ophthalmic) Polymyxin B Cisplatin
Risk D: Consider therapy modification
Bacillus clausii Typhoid Vaccine Sodium Picosulfate Colistimethate Vancomycin

Pregnancy and Pregnancy Risk Factor D

Lactation Aminoglycosides have poor oral bioavailability, which may limit systemic absorption via

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breast milk. Streptomycin is considered compatible with breastfeeding. In general, antibiotics
that are present in breast milk may cause non-dose-related modification of bowel flora.
Monitor infants for GI disturbances, such as thrush and diarrhea
Administration Administration:
Parenteral:
IM: Inject deep IM into a large muscle mass; rotate injection sites
IV (off-label route): After further dilution, infuse over 30 to 60 minutes
Preparation for Administration:
IM: Reconstitute vial with 4.2 mL, 3.2 mL, or 1.8 mL sterile water for injection (SWFI) to yield
a final concentration of ~ 200 mg/mL, 250 mg/mL, or 400 mg/mL, respectively
IV: Further dilute dose to concentration of 5 to 10 mg/mL in D5W or NS
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Neuromuscular blockade and respiratory paralysis: [US Boxed Warning]: May cause
neuromuscular blockade and respiratory paralysis; especially when given soon after
anesthesia or muscle relaxants.
• Neurotoxicity: [US Boxed Warning]: May cause neurotoxicity, including disturbances of
vestibular and cochlear function, optic nerve dysfunction, peripheral neuritis, arachnoiditis,
and encephalopathy; usual risk factors include pre-existing renal impairment, concomitant
neuro-/nephrotoxic medications. Ototoxicity is proportional to the amount of drug given and
the duration of treatment. Tinnitus or vertigo may be indications of vestibular injury and
impending bilateral irreversible damage. Baseline and periodic caloric stimulation and
audiometric tests are recommended with prolonged therapy. Discontinue treatment if signs
of ototoxicity occur.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C.
difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been
observed >2 months postantibiotic treatment.
Disease-related concerns:
• Hearing impairment: Use with caution in patients with pre-existing vertigo, tinnitus, or
hearing loss.
• Neuromuscular disorders: Use with caution in patients with neuromuscular disorders,
including myasthenia gravis.
• Renal impairment: [US Boxed Warning]: May cause nephrotoxicity. Use with caution in
patients with renal impairment; dose adjustment is necessary in patients with renal
impairment and/or nitrogen retention. Monitor renal function closely; peak serum
concentrations should not surpass 20 to 25 mcg/mL in patients with renal impairment.
Concurrent drug therapy issues:
• Neurotoxic and/or nephrotoxic drugs: [US Boxed Warning]: Avoid concomitant or
sequential use with other neurotoxic and/or nephrotoxic drugs (eg, neomycin, kanamycin,
gentamicin, paromomycin, polymyxin B, colistin, tobramycin, cyclosporine).
Dosage form specific issues:
• Sulfite sensitivity: Some formulations may contain sodium metabisulfite; may cause allergic
reactions including anaphylaxis or asthma exacerbations (some life-threatening) in
susceptible patients.
Other warnings/precautions:
• Appropriate use: [US Boxed Warning]: Parenteral form should be used only where
appropriate audiometric and laboratory testing facilities are available. IM injections should
be administered in a large muscle well within the body to avoid peripheral nerve damage and
local skin reactions

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Storage Store intact vials at 20°C to 25°C. Protect from light.
Reconstituted solution remains stable for 24 hours at room temperature. Exposure to light
causes darkening of solution without apparent loss of potency.
Refer to manufacturer PIL if there are specific considerations.

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5. Tobramycin
Watch Group
Generic Name Tobramycin

Dosage Ophthalmic ointment 0.3% (3 mg/gm)

form/strengths Ophthalmic solution 0.3%
Inhalation Solution 300 mg/5ml
Route of Ophthalmic, Inhalation
administration
Pharmacologic Antibiotic, Aminoglycoside
category Ophthalmic ATC: S01AA12
Inhalation ATC: J01GB01
Indications Inhalation:
Cystic fibrosis: Management of cystic fibrosis in adults and pediatric patients ≥6 years
of age with Pseudomonas aeruginosa.

Ophthalmic:
Ocular infections: Treatment of external infections of the eye and its adnexa caused by
susceptible bacteria.
Dosage Inhalation:
Regimen Dosing: Adult
Cystic fibrosis: Inhalation:
300 mg every 12 hours (do not administer doses <6 hours apart); administer in repeated
cycles of 28 days on drug followed by 28 days off drug.
Dosing: Pediatric
Eradication of new or initial Pseudomonas aeruginosa airway culture in patients with cystic
fibrosis: Limited data available: Infants ≥6 months, Children, and Adolescents: Inhalation: 300
mg every 12 hours for 28 days.
Pseudomonas aeruginosa colonization; chronic lung maintenance:
Patients with cystic fibrosis:
Children and Adolescents (limited data in children <6 years): Inhalation: 300 mg every 12
hours; administer in repeated cycles of 28 days on drug followed by 28 days off drug

Ophthalmic:
Dosing: Adult, Pediatric
Ocular infections: Ophthalmic:
Ointment: Apply half-inch ribbon into affected eye(s) 2 or 3 times daily for mild to moderate
infections; for severe infections, apply every 3 to 4 hours until improvement (then reduce
before discontinuation).
Solution: Instill 1 to 2 drops into affected eye(s) every 4 hours for mild to moderate
infections; for severe infections, instill 2 drops every hour until improvement (then reduce
prior to discontinuation).
Dosage Dosing: Renal Impairment: Adult
adjustment It is recommended either maintain the standard dose and increase the interval between
doses or decrease the dose while maintaining every 8-hour dosing interval. should be
individualized
Dosing: Hepatic Impairment: Adult
There are no dosage adjustments needed

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Contra- Hypersensitivity to tobramycin, other aminoglycosides, or any component of the formulation
indications
Adverse Drug Inhalation:
Reactions >10%:
Central nervous system: Voice disorder (4% to 14%), headache (11%)
Respiratory: Cough (31%), rhinitis (11% to 35%), pulmonary disease (30% to 34%; includes
pulmonary or cystic fibrosis exacerbations), reduced forced expiratory volume (1% to 31%),
discoloration of sputum (21%), productive cough (18% to 20%), rales (6% to 19%), dyspnea
(12% to 16%), decreased lung function (7% to 16%), oropharyngeal pain (11% to 14%),
hemoptysis (12% to 13%), pharyngolaryngeal pain (3%)
Miscellaneous: Fever (12% to 16%)
1% to 10%:
Cardiovascular: Chest discomfort (3% to 7%)
Central nervous system: Malaise (6%)
Dermatologic: Skin rash (2%)
Gastrointestinal: Nausea (8% to 10%), dysgeusia (<1%), vomiting (6%), diarrhea (2% to 4%)
Hematologic & oncologic: Increased erythrocyte sedimentation rate (8%), eosinophilia (2%),
increased serum immunoglobulins (2%)
Neuromuscular & skeletal: Musculoskeletal chest pain (<1% to 5%), myalgia (≤5%)
Otic: Hypoacusis (powder: 10%), tinnitus (2% to 3%), deafness (≤1%; including unilateral
deafness, reported as mild to moderate hearing loss or increased hearing loss)
Respiratory: Upper respiratory tract infection (7% to 9%), nasal congestion (7% to 8%),
wheezing (5% to 7%), throat irritation (2% to 5%), bronchospasm (≤1% to 5%), laryngitis
(≤5%) bronchitis (3%), epistaxis (2% to 3%), tonsillitis (2%)
Monitoring Monitor serum tobramycin concentrations in patients with a known history of auditory
Parameters dysfunction, renal dysfunction, and/or concomitant use of nephrotoxic drugs. One hour after
inhalation, serum concentrations of 1 to 2 mcg/mL have been observed.

Urinalysis, urine output, BUN, serum creatinine, peak, and trough plasma tobramycin levels.
Levels are typically obtained after the third dose in conventional dosing. Be alert to
ototoxicity; hearing should be tested before and during treatment
Drug Risk X: Avoid combination:
Interactions Mannitol (Systemic): May enhance the nephrotoxic effect of Tobramycin (Oral Inhalation).
Pregnancy and Pregnancy Category D
Lactation The amount of tobramycin available systemically following topical application of the
ophthalmic drops is undetectable
Systemic absorption following oral inhalation is expected to be low compared to IV
administration. Infants should be monitored for loose or bloody stools and candidiasis.
The amount of tobramycin available systemically following topical application of the
ophthalmic drops is undetectable. If ophthalmic agents are needed in lactating women, the
minimum effective dose should be used to decrease systemic absorption
Administration Administration: Inhalation
To be orally inhaled over ~15 minutes. If multiple different nebulizer treatments are
required, administer bronchodilator first, followed by chest physiotherapy, any other
nebulized medications, and then tobramycin last. Do not mix with other nebulizer
medications.
Administration: Ophthalmic
For topical ophthalmic use only; not for injection into the eye. Contact lenses should not be
worn during treatment of ophthalmic infections. Avoid contact of tube or bottle tip with skin
or eye.

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Ointment: Apply into conjunctival sac(s) of eye; the patient should look downward before
closing eye
Solution: Apply gentle pressure to lacrimal sac during and immediately following instillation
(1 minute) or instruct patient to gently close eyelid after administration, to decrease systemic
absorption of ophthalmic drops
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Inhalation:
Precautions Concerns related to adverse effects:
• Bronchospasm: Bronchospasm may occur; bronchospasm or wheezing should be treated
appropriately if either arise.
• Nephrotoxicity: Nephrotoxicity was not observed during tobramycin inhalation clinical
studies, but has been associated with aminoglycosides. Patients with known or suspected
renal dysfunction or taking concomitant nephrotoxic drugs should be closely monitored
(renal function tests and serum tobramycin concentrations) as clinically indicated. If
nephrotoxicity occurs, discontinue therapy until serum concentrations fall below 2 mcg/mL.
• Neuromuscular disorders: Use with caution in patients with neuromuscular disorders,
including myasthenia gravis and Parkinson’s disease; neuromuscular blockade, respiratory
failure, and prolonged respiratory paralysis may occur. Concomitant neuromuscular blocking
agents may also increase the risk of prolonged respiratory paralysis.
• Ototoxicity: Ototoxicity, as measured by complaints of hearing loss or tinnitus, has been
reported. Tinnitus may be a sentinel symptom of ototoxicity, and therefore, the onset of this
symptom warrants further investigation. Ototoxicity, manifested as both auditory and
vestibular toxicity, has been reported with parenteral aminoglycosides. Vestibular toxicity
may be manifested by vertigo, ataxia, or dizziness. Patients with known or suspected
auditory or vestibular dysfunction should be closely monitored (audiometric evaluations and
serum tobramycin concentrations). A baseline audiogram should be considered for patients
at increased risk of auditory dysfunction. Use with caution in patients with preexisting
vertigo, tinnitus, or hearing loss.
Ophthalmic:
Concerns related to adverse effects:
• Hypersensitivity reactions: Sensitivity varying from local to generalized effects (eg,
erythema, pruritus, urticaria, skin rash, anaphylaxis, anaphylactoid reaction, bullous reaction)
to topically applied aminoglycosides and cross-sensitivity to other aminoglycosides
antibiotics may occur; discontinue use if hypersensitivity develops.
• Superinfection: Prolonged use may lead to overgrowth of nonsusceptible organisms,
including fungi. If superinfection is suspected, institute appropriate alternative therapy.
Special populations:
• Contact lens wearers: Some products may contain benzalkonium chloride or
benzododecinium bromide which may be absorbed by soft contact lenses; contact lenses
should not be worn during treatment of ophthalmologic infections.
Other warnings/precautions:
• Appropriate use: For topical application to the eye only; not for injection. To avoid
contamination, do not touch tip of container to any surface.
Storage Inhalation: Store in original package at 25°C
Ophthalmic: Store at 2°C to 25°C
Refer to manufacturer PIL if there are specific considerations.

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Anthelmintic
1. Albendazole

Generic Name Albendazole

Dosage Suspension 200mg/5ml, 2 gm/100ml

form/strengths Tablets 400mg
Route of Oral
administration
Pharmacologic Anthelmintic
category ATC: P02CA03
Indications Treatment of cystic hydatid disease of the liver, lung, and peritoneum caused by the larval form of
the dog tapeworm, E. granulosus.
Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the
pork tapeworm, T. solium.
Dosage Dosing: Adult
Regimen Hydatid disease (Echinococcus granulosis, dog tapeworm): Oral:
<60 kg: 15 mg/kg/day in 2 divided doses (maximum: 800 mg/day).
≥60 kg: 800 mg/day in 2 divided doses.
Duration: Optimal duration uncertain; 1 to 6 months based on clinical factors
Neurocysticercosis (Taenia solium, pork tapeworm), parenchymal disease: Oral: 15 mg/kg/day in
2 divided doses (maximum: 1.2 g/day) for 10 to 14 days; may be repeated if persistent viable
lesions on 6-month follow-up imaging.
Note: Concomitant therapy with praziquantel is recommended if >2 viable cysts present.
Initiate adjunctive corticosteroid therapy prior to initiation of albendazole.

Dosing: Pediatric
Hydatid disease (E. granulosus, dog tapeworm): Children and Adolescents: Oral: 5 to 7.5
mg/kg/dose twice daily for 1 to 6 months; maximum dose: 400 mg/dose
Neurocysticercosis (T. solium, pork tapeworm), parenchymal disease:
Children and Adolescents: Oral: 7.5 mg/kg/dose twice daily for 8 to 30 days; maximum dose: 600
mg/dose.
Note: Patients should receive concurrent corticosteroid for the first week of albendazole therapy
and anticonvulsant therapy as required.

Dosage Dosing: Renal Impairment:

adjustment There are no dosage adjustments needed.
Dosing: Hepatic Impairment:
Consider discontinuing therapy if hepatic enzymes increase to twice the ULN while on therapy.
Contra- Hypersensitivity to albendazole, benzimidazoles, or any component of the formulation
indications
Adverse Drug >10%:
Reactions Central nervous system: Headache (neurocysticercosis: 11%; hydatid: 1%)
Hepatic: Increased liver enzymes (hydatid: 16%; neurocysticercosis: <1%)
1% to 10%:
Central nervous system: Increased intracranial pressure, dizziness, vertigo, meningism
Dermatologic: Alopecia
Gastrointestinal: Abdominal pain, nausea and vomiting
Miscellaneous: Fever

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Monitoring LFTs and CBC with differential at start of each 28-day cycle and every 2 weeks during therapy
Parameters (more frequent monitoring for patients with liver disease); pregnancy test
Patients with neurocysticercosis: Ophthalmic exam for retinal lesions prior to therapy initiation;
MRI every 6 months after completing therapy until resolution of cystic lesion
Drug Risk C: Monitor therapy
Interactions Carbamazepine Grapefruit Juice Phenobarbital Phenytoin Ritonavir
Pregnancy and Pregnancy Category C
Lactation Use during the first trimester of pregnancy is not recommended.
albendazole is generally considered compatible with breastfeeding
Administration Administration: Oral
Administer with a high-fat meal if treating a systemic infection (to increase absorption).
Administration on an empty stomach may be appropriate for treating an intraluminal infection
with no systemic involvement.
If patients have difficulty swallowing, tablets may be crushed or chewed, then swallowed with a
drink of water.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Bone marrow suppression: rare; use with caution in patients with hepatic impairment (more
susceptible to hematologic toxicity). Discontinue therapy in all patients who develop
clinically significant decreases in blood cell counts.
• Transaminase elevations: Reversible elevations in hepatic enzymes have been reported.
Patients with abnormal LFTs and hepatic echinococcosis are at an increased risk of
hepatotoxicity.
Disease-related concerns:
• Neurocysticercosis: Appropriate use: Antiparasitic therapy may worsen symptoms of
neurocysticercosis by inducing an inflammatory response; adjunctive corticosteroid therapy
should be started before initiation of albendazole. Antiparasitic therapy should not be
initiated in patients with untreated hydrocephalus, calcified lesions, or cysticercal
encephalitis. Perform funduscopic exam prior to initiation of antiparasitic therapy to exclude
intraocular cysticerci; antiparasitic therapy may lead to blindness in some cases with
unsuspected intraocular parasites.
Storage Store between 20°C and 25°C
Refer to manufacturer PIL if there are specific considerations.

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2. Diethylcarbamazine
Generic Name Diethylcarbamazine

Dosage Tablets: 50mg, 100 mg

form/strengths
Route of Oral
administration
Pharmacologic Anthelmintic
category ATC: P02CB02
Indications Loiasis: Treatment and prophylaxis of loiasis

Lymphatic filariasis: Treatment of lymphatic filariasis

Dosage Loiasis: Oral:
Regimen Treatment:
CDC recommendations: 8 to 10 mg/kg/day in 3 divided doses for 21 days; Note: For patients with
microfilaria in the blood, some clinicians recommend the following dose-escalating regimen: 50
mg as a single dose on day 1; 50 mg 3 times daily on day 2; 100 mg 3 times daily on day 3; 9
mg/kg/day in 3 divided doses on day 4 to end of treatment course. Repeat courses of treatment
may be needed to achieve cure
Prophylaxis: 300 mg once weekly; continue as long as exposure occurs.
Lymphatic filariasis: Oral:
Oral: 6 mg/kg/day for 1 or 12 days (14 to 21 days in patients with tropical pulmonary
eosinophilia); daily dose may be given as a single dose or in 3 divided doses. Note: For patients
with microfilaria in the blood, some clinicians recommend the following dose-escalating
regimen: 50 mg as a single dose on day 1; 50 mg 3 times daily on day 2; 100 mg 3 times daily on
day 3; 6 mg/kg/day in 3 divided doses on day 4 to end of treatment course
Dosing: Pediatric
Loiasis: Children and Adolescents: Oral: 8 to 10 mg/kg/day in 3 divided doses for 21 days;
patients with symptomatic loiasis and microfilarial loads ≥8,000 microfilariae/mL should receive
apheresis or treatment with albendazole prior to treatment with diethylcarbamazine. For
patients with microfilaria in the blood, some clinicians recommend starting with a lower dosage
(eg, 50 mg/day) with gradual increase over 3 days to 9 mg/kg/day in 3 divided doses on day 4 to
end of treatment course.
Lymphatic filariasis: Oral:
CDC recommendations: Children ≥18 months and Adolescents: 6 mg/kg/day as a single dose or 6
mg/kg/day in 3 divided doses for 12 days (14 to 21 days in patients with tropical pulmonary
eosinophilia). For patients with microfilaria in the blood, some clinicians recommend starting
with a lower dosage (eg 50 mg/day) with gradual increase over 3 days to 6 mg/kg/day in 3
divided doses on day 4 to end of treatment course.

Dosage Dosing: Altered Kidney Function: Adult

adjustment Reduce dose in moderate to severe impairment (no specific adjustment is provided)

Contra- Patients with onchocerciasis

indications
Adverse Drug Frequency not defined:
Reactions Cardiovascular: Collapse, orthostatic hypotension, tachycardia
Central nervous system: Brain disease, coma, dizziness, drowsiness, encephalitis (allergic),
fatigue, headache, lethargy, malaise, meningoencephalitis (helminthic), vertigo

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Dermatologic: Dermatitis, Mazzotti reaction, pruritus, urticaria
Endocrine & metabolic: Adenitis
Gastrointestinal: Abdominal pain, decreased appetite, diarrhea, nausea, vomiting
Genitourinary: Proteinuria (may be reversible)
Hematologic & oncologic: Lymphadenitis, lymphangitis
Local: Skin edema
Neuromuscular & skeletal: Arthralgia, myalgia
Ophthalmic: Conjunctivitis, corneal edema, eye disease (inflammatory and degenerative changes
of optic nerve and retina with prolonged use), eye pain, increased intraocular pressure,
iridocyclitis, lacrimation, optic neuritis, photophobia, punctate keratitis, visual field defect
Respiratory: Asthma, respiratory distress
Miscellaneous: Fever
Monitoring Renal function at baseline and periodically during treatment; in patients with loiasis, measure
Parameters microfilarial load prior to treatment; patients with microfilarial loads ≥8,000 microfilariae/mL
treated with albendazole to reduce microfilarial load should have close, frequent monitoring of
microfilarial load to confirm reduction before initiation of treatment with diethylcarbamazine
Drug There are no known significant interactions.
Interactions
Pregnancy and Use of diethylcarbamazine during pregnancy is not recommended
Lactation It is not known if diethylcarbamazine is present in breast milk; breastfeeding is not
recommended.
Administration Oral: Administer after meals
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Encephalopathy: When treating loiasis, encephalopathy (sometimes fatal), and other severe
neurologic adverse reactions may occur; the risk is related to the microfilarial load. Microfilarial
load must be tested prior to treatment. Use caution if microfilarial load >2,500 microfilariae/mL;
patients with microfilarial loads ≥8,000 microfilariae/mL should have the load reduced through
apheresis or treatment with albendazole before initiation of treatment with diethylcarbamazine.
Corticosteroid use and/or slow dose escalation has not been shown to decrease the risk of fatal
encephalopathy.
• Inflammatory reactions: Use in patients with onchocerciasis may precipitate Mazzotti reaction
(pruritus, fever, arthralgia). Inflammatory response occurring in the cornea and retina can result
in permanent visual damage. Use is contraindicated in patients with onchocerciasis; possibility of
co-infection with onchocerciasis should be excluded prior to initiation of treatment with
diethylcarbamazine
• Skin reactions: In patients treated for loiasis, some symptoms of loiasis (eg, Calabar swelling,
pruritus) may increase briefly during treatment; concomitant use of antihistamines and
corticosteroids during the first week of treatment may decrease these symptoms.
Disease-related concerns:
• Cardiac disorders: Use with caution in patients with cardiac disorders.
• Renal impairment: Use with caution; dosage reduction recommended.
Other warnings/precaution:
• Alkaline urine: Elimination half-life is prolonged and AUC is increased in alkaline urine; dose
reductions may be needed in patients with diets that promote urinary alkalinization
Storage Store at room temperature.
Refer to manufacturer PIL if there are specific considerations.

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3. Ivermectin
Generic Name Ivermectin
Dosage Tablet 3mg, 6mg
form/strengths Topical Lotion 5mg/gm, 10mg/1gm
Topical cream 10mg/1gm
Route of Oral, Topical
administration
Pharmacologic Anthelmintic
category ATC:
D11AX22 (Dermatologic)
P02CF01 (Oral)
Indications Systemic:
Onchocerciasis: Treatment of onchocerciasis due to the immature form of Onchocerca
volvulus.
Strongyloidiasis, intestinal: Treatment of intestinal (eg, nondisseminated) strongyloidiasis
due to Strongyloides stercoralis.

Topical:
Head lice (Pediculus capitis) (Sklice lotion): Treatment of head lice infestations in patients 6
months and older.
Rosacea (cream): Treatment of inflammatory lesions of rosacea in adult patients.
Dosage Dosing: Children ≥15 kg, Adolescents and Adult
Regimen Onchocerciasis: Oral: 150 mcg/kg as a single dose; retreatment may be required every 3 to
12 months until asymptomatic
Strongyloidiasis, intestinal: Oral: 200 mcg/kg/day for 1 to 2 days.
Topical:
Rosacea: Apply once daily. Head lice: Single dose use only
Dosage Dosing: Renal Impairment:
adjustment There are no dosage adjustments needed
Dosing: Hepatic Impairment:
Although not extensively studied, ivermectin plasma concentrations can be expected to
increase significantly in patients with hepatic disease.
Contra- Hypersensitivity to ivermectin or any component of the formulation
indications
Major Adverse Adverse Reactions (Significant): Considerations
Drug Reactions CNS effects
Hypersensitivity reactions (delayed)
Immunologic post-treatment reaction (Mazzoti reaction)

≥10%:
Miscellaneous: Mazzotti reaction (associated with onchocerciasis: pruritus: 28%; fever: 23%;
skin edema, papular rash, pustular rash, and urticaria: ≤23%; arthralgia and synovitis: ≤9%;
lymphadenitis [axillary node: 4% to 11%, cervical node: 1% to 5%, inguinal node: 13% to
14%, other lymph node: 2% to 3%])
1% to 10%:
Cardiovascular: Orthostatic hypotension (1%), peripheral edema (3%), tachycardia (4%)
Dermatologic: Pruritus (associated with strongyloidiasis: 3%)

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Gastrointestinal: Diarrhea (2%), nausea (2%)
Hematologic & oncologic: Decreased white blood cell count (3%), eosinophilia (3%),
increased hemoglobin (1%)
Hepatic: Increased serum alanine aminotransferase (2%), increased serum aspartate
aminotransferase (2%)
Hypersensitivity: Facial edema (1%)
Nervous system: Dizziness (3%)
Ophthalmic: Inflammation of limbus of eyes (5%), punctate cataract (2%)
Topical:
1% to 10%:
Central nervous system: Localized burning (≤1%)
Dermatologic: Skin irritation (≤1%)
Monitoring Skin and eye microfilarial count, periodic ophthalmologic exams; follow up stool
Parameters examinations
Drug • Risk X: Avoid combination
Interactions BCG (Intravesical), Cholera Vaccine
• Risk D: Consider therapy modification
Sodium Picosulfate, Typhoid Vaccine
Pregnancy and Pregnancy category C
Lactation Although use in pregnancy is likely low risk, other agents are currently recommended for
the treatment of pediculosis pubis or scabies in pregnant patient.
Ivermectin is present in breast milk. Although use is likely low risk, other agents are
currently recommended for the treatment of pediculosis pubis or scabies in patients who
are breastfeeding
Administration Administer on an empty stomach with water. Some experts recommend administering with
food to increase absorption.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Ivermectin may cause an immunologic post-treatment reaction, also known as a Mazzoti
reaction, which is associated with pruritus, skin rash, fever, fatigue, lymphadenopathy,
arthralgia, tachycardia, hypotension (including orthostatic hypotension), edema,
and abdominal pain. Most cases have been reported in association with the treatment of
onchocerciasis, but cases have also been reported in association with the treatment of
other infections (eg, scabies). Symptoms are mostly mild and usually resolve in 4 days;
however, cases of coma and death have been reported, although these deaths are often
attributed to Loa loa-associated encephalopathy. Serious Mazzoti reactions are estimated
to occur in 19% to 81% of patients exposed to ivermectin for the treatment of filarial
parasites, which is disproportionality more than other antinematodal drugs.
Onset: Varied; within 1 to 7 days of therapy initiation
Special populations:
• Immunocompromised patients: Repeated treatment may be required in
immunocompromised patients (eg, HIV); control of extraintestinal strongyloidiasis may
necessitate suppressive (once monthly) therapy.
Other warnings/precautions:
• Appropriate use: Onchocerca volvulus: Ivermectin has no activity against adult O.
volvulus parasites.
Warnings: Additional Pediatric Considerations

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Avoid use or use with extreme caution in pediatric patients <2 years or <15 kg; due to a less
developed blood-brain barrier compared to older pediatric patients and an increased risk
for CNS effects (ie, encephalopathy); monitor patients closely.
Storage Store at temperatures below 30°C.
Refer to manufacturer PIL if there are specific considerations.

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4. Levamisole
Generic Name Levamisole

Dosage Syrup: 0.8% (40mg/5ml)

form/strengths Tablet: 40mg
Route of Oral
administration
Pharmacologic Anthelmintic
category ATC: P02CE01

Indications Treatment of ascariasis and mixed ascariasis/hookworm infections

Dosage Dosage Range

Regimen Oral: Infants, Children, and Adults:
Weight-based dosing: 2.5 mg/kg (maximum: 150 mg/dose) as a single dose.
Age-based dosing:
1 month to <1 year: 40 mg as a single dose.
1 to 7 years: 80 mg as a single dose.
>7 years: 150 mg as a single dose
Dosage No data available
adjustment
Contra- Hypersenesitivity to any component of the formulation.
indications
Adverse Drug Hematologic: (sometimes fatal) agranulocytosis, Leukopenia, thrombocytopenia
Reactions Cardiovascular: edema and chest pain
Dermatologic: include dermatitis, alopecia, pruritus and urticaria
Gastrointestinal: nausea, diarrhea, vomiting, stomatitis, anorexia, abdominal pain
and constipation. Flatulence and dyspepsia.
Musculoskeletal arthralgia and myalgia
Nervous system: dizziness, headache, paresthesia, taste perversion, an altered sense of smell
Psychiatric: somnolence, depression, nervousness, insomnia, and anxiety. Confusion,
hallucinations, impaired concentration, nightmares, and an encephalopathy-like syndrome
Ocular side effects including blurred vision conjunctivitis, Periorbital edema
Hepatic: Hyperbilirubinemia and increased alkaline phosphatase
Renal: Renal failure, elevated serum creatinine rarely.
Other: vaginal bleeding, anaphylaxis, Fever, Flu-like symptoms including fatigue, fever, rigors,
myalgia, and malaise
Monitoring No data available
Parameters
Drug • Albendazole: The bioavailability of Albendazole can be increased when combined with
Interactions Levamisole.
• Ivermectin: The bioavailability of Ivermectin can be increased when combined with
Levamisole.
Pregnancy and Pregnancy category C
Lactation WHO recommends against breastfeeding with maternal levamisole therapy.
Administration Take on an empty stomach. Refer to manufacturer PIL if there are specific considerations.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ No data available
Precautions

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Storage Store at room temperature and keep away from moisture and sunlight
Refer to manufacturer PIL if there are specific considerations.

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5. Mebendazole
Generic Name Mebendazole

Dosage Oral suspension: 100mg/5ml

form/strengths Tablets: 100mg, 500mg
Route of Oral
administration
Pharmacologic Anthelmintic
category ATC: P02CA01
Indications Intestinal nematode infection: Treatment of patients ≥2 years of age with GI infections.

Dosage Dosing: Adult, Adolescents and children ˃ 2 years

Regimen Ancylostoma duodenale or Necator americanus (hookworm) or Ascariasis (roundworm):
Oral: 100 mg twice daily for 3 days or 500 mg as a single dose. Repeat in 3 weeks if not cured
with initial treatment.
Trichuriasis (whipworm): Oral: 100 mg twice daily for 3 days; repeat in 3 weeks if not cured with
initial treatment.
Enterobiasis (pinworm):
Oral: 100 mg as a single dose; repeat in 2 weeks
Dosage Dosing: Renal Impairment:
adjustment There are no dosage adjustments needed
Dosing: Hepatic Impairment:
Mebendazole undergoes extensive hepatic metabolism; use with caution as systemic exposure
may be increased.
Contra- Hypersensitivity to mebendazole or any component of the formulation
indications
Adverse Drug Gastrointestinal: Abdominal pain, anorexia, diarrhea, flatulence, nausea, vomiting
Reactions Hepatic: Hepatitis
Monitoring Periodic hematologic, hepatic, and renal function; check for helminth ova in feces within 3-4
Parameters weeks following the initial therapy
Drug Risk X: Avoid combination
Interactions Metronidazole (Systemic)
Pregnancy and pregnancy category C
Lactation Mebendazole is poorly excreted into breastmilk and poorly absorbed orally. Reports on the use
of mebendazole during breastfeeding have found no adverse reactions in breastfed infants.
Administration Administer with or without food. Tablets may be chewed, swallowed whole, or crushed and
mixed with food. Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Bone marrow suppression: Neutropenia and agranulocytosis have been reported with high
doses and prolonged use. Monitor CBC if used at higher doses or for a prolonged duration.
Disease-related concerns:
• Hepatic impairment: Use with caution; systemic exposure may be increased.
Special populations:
• Pediatric: Experience with use in children <2 years of age is limited; convulsions have been
reported postmarketing in pediatric patients <1 year.
Storage Store at 20°C to 25°C. Refer to manufacturer PIL if there are specific considerations.

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6. Niclosamide
Generic Name Niclosamide

Dosage Chewable Tablets 500mg

form/strengths
Route of Oral
administration
Pharmacologic Anthelmintic
category ATC: P02DA01
Indications Tapeworm infections: Treatment of intestinal tapeworm infections caused by Taenia saginata
(beef tapeworm), Taenia solium (pork tapeworm), Diphyllobothrium latum (fish tapeworm), and
Hymenolepis nana (dwarf tapeworm)
Dosage Dosing: Adult
Regimen • Taenia saginata (beef tapeworm), Taenia solium (pork tapeworm), Diphyllobothrium latum
(fish tapeworm): 2 g as a single dose.
• Hymenolepis nana (dwarf tapeworm): Initial: 2 g as a single dose on day 1, followed by 1
g/day for 6 days.
Dosing: Pediatric
Taenia saginata (beef tapeworm), Taenia solium (pork tapeworm), Diphyllobothrium latum (fish
tapeworm):
Children <2 years: 500 mg as a single dose.
Children 2 to 6 years: 1 g as a single dose.
Children >6 years and Adolescents: 2 g as a single dose.

Hymenolepis nana (dwarf tapeworm):

Children <2 years: Initial: 500 mg as a single dose on day 1, followed by 250 mg/day for 6 days.
Children 2 to 6 years: Initial: 1 g as a single dose on day 1, followed by 500 mg/day for 6 days.
Children >6 years and Adolescents: Initial: 2 g as a single dose on day 1, followed by 1 g/day for 6
days.
Dosage Dosing: Renal Impairment: Adult
adjustment There are no dosage adjustments needed.
Dosing: Hepatic Impairment: Adult
There are no dosage adjustments needed.
Contra- Hypersensitivity to niclosamide or any component of the formulation
indications
Adverse Drug Gastrointestinal: Abdominal pain, nausea, retching
Reactions other: Hypersensitivity reaction
Monitoring Stool cultures
Parameters
Drug Alcohol (Ethyl): Niclosamide may increase the absorption of Alcohol (Ethyl).
Interactions
Pregnancy and pregnancy category B
Lactation The World Health Organization (WHO) classifies niclosamide as compatible with breastfeeding,
although data on the use of niclosamide during lactation are limited. The safety of niclosamide in
children has not been established, although niclosamide is not thought to be systemically
absorbed.
Administration Chew or crush tablets into a fine pulp and swallow with a little water or disintegrate tablet in a
little water; administer dose after breakfast. A strong saline laxative may be administered 2

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hours after the daily dose to aid in worm elimination (strongly recommended for pork tapeworm
infections). Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • CNS depression: May cause CNS depression, which may impair physical or mental abilities;
patients must be cautioned about performing tasks which require mental alertness (eg,
operating machinery or driving).
Disease-related concerns:
• Constipation: Restore regular bowel movements in patients who are constipated prior to
niclosamide treatment.
Other warnings/precautions:
• Appropriate use: A strong saline laxative may be administered 2 hours after the daily dose to
aid in worm elimination. The laxative is strongly recommended for pork tapeworm (Taenia
solium) infections to decrease the risk of cysticercosis by rapid excretion of lower tapeworm
segments containing ripe eggs.

Storage Store below 25°C

Refer to manufacturer PIL if there are specific considerations.

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7. Praziquantel
Generic Name Praziquantel

Dosage Tablet 600mg

form/strengths Suspension 1.8gm/15ml
Route of Oral
administration
Pharmacologic Anthelmintic
category ATC: P02BA01
Indications Helminths: Treatment of infections in patients ≥1 year caused by the following: All species
of Schistosoma and the liver flukes Clonorchis sinensis/Opisthorchis viverrini
Dosage Dosing: Adult
Regimen Clonorchiasis/opisthorchiasis: Oral: 25 mg/kg/dose 3 times daily for 1 to 2 days.
Schistosomiasis: Note: Repeat treatment may be needed in 2 to 4 weeks to increase
effectiveness.
− S. haematobium, Schistosoma intercalatum, or S. mansoni: Oral: 40 mg/kg/day as a
single dose or in 2 divided doses for 1 day.
− S. japonicum or S. mekongi: Oral: 60 mg/kg/day in 2 -3 divided doses for 1 day.
Dosing: Pediatric
Flukes:
Clonorchiasis; Opisthorchiasis: Children and Adolescents:
Oral: 25 mg/kg/dose 3 times daily at 4- to 6-hour intervals for 1 to 2 days
Schistosomiasis (Bilharziasis):
Note: Repeat treatment may be needed in 2 to 4 weeks to increase effectiveness
Children and Adolescents: Oral: 20 mg/kg/dose2- 3 times daily for 1 day

Dosage Dosing: Renal Impairment: Adult

adjustment No dosage adjustment necessary.
Dosing: Hepatic Impairment: Adult
Total drug exposure in moderate-to-severe impairment is increased. use with caution.
Contra- Hypersensitivity to praziquantel or any component of the formulation; ocular cysticercosis;
indications concomitant administration with strong cytochrome P450 (CYP450) inducers, such as
rifampin
Adverse Drug Frequency not defined
Reactions Central nervous system: Dizziness, headache, malaise
Dermatologic: Urticaria
Gastrointestinal: Abdominal distress, nausea
Miscellaneous: Fever

Monitoring Liver function tests; monitor patients with cardiac irregularities during treatment; monitor
Parameters for seizures; culture urine or feces for ova prior to instituting therapy

Drug Risk X: Avoid combination

Interactions Conivaptan Fexinidazole Fusidic Acid (Systemic) Rifampin
Risk D: Consider therapy modification
Barbiturates (phenobarbital) Carbamazepine Corticosteroids Phenytoin Rifampicin St John’s
wort
Pregnancy and Pregnancy class B

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Lactation Use during breastfeeding is considered acceptable.

Administration Oral: Administer tablets with water during meals

Tablets should be promptly swallowed whole (do not chew) to avoid bitter taste that may
cause gagging or vomiting; tablets are scored and may be halved or quartered.
Tablets may be crushed or disintegrated and mixed with semi-solid food or liquid (eg,
orange juice, honey) to reduce the bitter taste; use within 1 hour of mixing.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Disease-related concerns:
Precautions • Cardiac arrhythmias: Bradycardia, ectopic rhythms, ventricular fibrillation, and AV blocks
have been observed with praziquantel administration.
• Central nervous system effects: Praziquantel may exacerbate central nervous system
pathology due to schistosomiasis, paragonimiasis, or Taenia solium cysticercosis. Assess
whether the potential benefit justifies the potential risk in patients with a history of seizures
and/or other signs of potential central nervous system involvement such as subcutaneous
nodules suggestive of cysticercosis.
• Hepatic impairment: Use with caution in patients with moderate to severe hepatic
impairment; reduced liver drug metabolism may result in higher and longer lasting plasma
concentrations of unmetabolized praziquantel.
• Neurocysticercosis: Appropriate use: Antiparasitic therapy may worsen symptoms of
neurocysticercosis by inducing an inflammatory response; adjunctive corticosteroid therapy
should be started before initiation of antiparasitic therapy. Antiparasitic therapy should not
be initiated in patients with untreated hydrocephalus, calcified lesions, or cysticercal
encephalitis. Perform funduscopic exam prior to initiation of antiparasitic therapy to
exclude intraocular cysticerci; antiparasitic therapy may lead to blindness in some cases
with unsuspected intraocular parasites.
• Schistosomiasis: Praziquantel may not be effective against migrating schistosomulae;
observational data indicate that praziquantel treatment in the acute phase of the infection
may not prevent progression from asymptomatic to acute schistosomiasis, or from
asymptomatic/acute disease to chronic disease. In addition, use in patients with
schistosomiasis may be associated with clinical deterioration such as paradoxical reactions
or serum sickness Jarisch-Herxheimer-like reactions, which is a sudden inflammatory
immune response likely caused by the release of schistosomal antigens. Such reactions
typically occur during the acute disease phase, and may lead to life-threatening events such
as respiratory failure, encephalopathy, papilledema, and/or cerebral vasculitis.
Concurrent drug therapy issues:
• Drug/drug interactions: Potentially significant interactions may exist, requiring dose or
frequency adjustment, additional monitoring, and/or selection of alternative therapy.
Therapeutic levels of praziquantel may not be achieved with concurrent administration of
strong inducers of cytochrome P450 (eg, rifampin); concurrent use is contraindicated.

Other warnings/precautions:
• Patient information: Patients should be instructed to not drive or operate machinery on
the day of treatment and the day after treatment.
Storage Store below 30°C
Refer to manufacturer PIL if there are specific considerations.

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8. Pyrantel
Generic Name Pyrantel

Dosage Oral Suspension: 250 mg/5ml

form/strengths
Route of Oral
administration
Pharmacologic Anthelmintic
category ATC: P02CC01
Indications Enterobiasis (pinworm): Treatment of pinworms caused by Enterobius vermicularis
Dosage Dosing Adult and pediatrics:
Regimen Enterobiasis (pinworm): Oral: 11 mg/kg (maximum: 1 g/dose) as a single dose; repeat dose in 2
weeks to prevent reinfection.
Note: It is recommended to treat the entire household to prevent reinfection
Dosage Dosing: Altered Kidney Function:
adjustment There are no dosage adjustments needed
Dosing: Hepatic Impairment:
Use with caution.
Contra- Hypersensitivity to pyrantel or any component of the formulation
indications
Adverse Drug Central nervous system: Dizziness, headache
Reactions Gastrointestinal: Abdominal cramps, diarrhea, nausea, vomiting
Monitoring Stool for presence of eggs, worms, and occult blood
Parameters
Drug There are no known significant interactions.
Interactions
Pregnancy and Pregnancy category C.
Lactation No information is available on the use of pyrantel pamoate during breastfeeding. It is poorly
absorbed orally, so excretion into breastmilk and absorption by the breastfed infant is unlikely.
Administration Administration: Oral
May be administered without regard to meals; may be taken with water, milk, or fruit juice. The
use of a laxative is not required prior to, during, or after use.
Suspension: Shake well before use.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Disease-related concerns:
Precautions • Hepatic impairment: Use with caution in patients with hepatic impairment.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic
acid;which is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day)
have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates.
• Phenylalanine: Some products may contain phenylalanine.
Other warnings/precautions:
• Household contacts: Since pinworm infections are easily spread to others, treat all family
members in close contact with the patient.
Storage Store at 15°C to 30°C. Refer to manufacturer PIL if there are specific considerations.

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9. Triclabendazole
Generic Name Triclabendazole
Dosage Scored Tablets 250mg
form/strengths
Route of Oral
administration
Pharmacologic Anthelmintic
category ATC: P02BX04
Indications Fascioliasis: Treatment of fascioliasis in patients ≥6 years of age

Dosage Fascioliasis dosing: Children ≥6 years, Adolescents and Adult

Regimen Oral: 10 mg/kg every 12 hours for 2 doses
Note: Round dose up to the nearest half (125 mg) or whole tablet (250 mg).
Dosage Dosing: Renal Impairment:
adjustment There are no dosage adjustments have not been studied
Dosing: Hepatic Impairment:
There are no dosage adjustments have not been studied
Contra- Hypersensitivity to triclabendazole, other benzimidazoles, or any component of formulation
indications
Adverse Drug >10%:
Reactions Central nervous system: Headache (14%)
Dermatologic: Hyperhidrosis (25%), urticaria (11%)
Gastrointestinal: Abdominal pain (93%), decreased appetite (18%), nausea (18%)
1% to 10%:
Dermatologic: Pruritus (4%)
Gastrointestinal: Diarrhea (7%), vomiting (7%)
Hepatic: Increased serum bilirubin (7%), increased serum aspartate aminotransferase (5%),
increased serum alkaline phosphatase (4%), increased serum alanine aminotransferase (3%)
Neuromuscular & skeletal: Musculoskeletal chest pain (4%)
Monitoring Monitor ECG in patients with a history of known or suspected QT prolongation or when used with
Parameters concomitant QTc-prolonging drugs.
Drug Risk C: Monitor therapy
Interactions Haloperidol QT-prolonging Agents (Highest Risk)
Pregnancy and Adverse events were not observed in animal reproduction studies. Human data is limited.
Lactation Lactation: Limited data. Because of protein binding of the drug and metabolites, exposure of the
breastfed infant is likely to be low.
Administration Oral: Administer with food and water; tablet may be swallowed whole, divided in half, or crushed
and sprinkled over a small amount of applesauce; administer within 4 hours; round dose up to the
nearest whole or half tablet. Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Hepatic toxicity: Transient increases in liver enzymes and total bilirubin have been reported in
patients receiving triclabendazole.
• QTc Prolongation: Transient QTc interval prolongation has been observed in animals; monitor
ECG in patients with a history of known or suspected QTc prolongation or when used with
concomitant QTc-prolonging drugs.
Storage Store below 30°C in the original container.
Refer to manufacturer PIL if there are specific considerations.

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Antifungal
1. Amphotericin B

Generic Name Amphotericin B

Dosage Vial 50 mg/15ml
form/strengths
Route of IV
administration
Pharmacologic Antifungal Agent, Parenteral
category ATC: J02AA01
Indications Fungal infection, invasive: Treatment of patients with progressive, potentially life-threatening
fungal infections

Leishmaniasis
Dosage Adult:
Regimen • Test dose: A test dose of 1 mg in 20 mL D5W administered over 20 to 30 minutes may be
considered.
• Usual dosage range: IV: 0.5 to 1 mg/kg/day (range: 0.3 to 1.5 mg/kg/day); maximum dose:
1.5 mg/kg/day. Note: Lipid-based formulations of amphotericin B are generally preferred for
treatment of systemic infections because they demonstrate comparable efficacy and better
tolerability
• Duration of therapy depends on the initial severity of the infection and the clinical response
of the patient. In some infections, a satisfactory response is only obtained after several
months of continuous treatment
Pediatrics: Infants, Children, and Adolescents
• Test dose: Infants, Children, and Adolescents: IV: 0.1 mg/kg/dose to a maximum of 1 mg;
infuse over 20 to 60 minutes;
• Initial test dose: 0.25-0.5 mg/kg/dose to a maximum of 1 mg; infuse over 20 to 60 minutes;
gradually increase daily, usually in 0.25 mg/kg increments (except in critically ill patients) until
the desired daily dose is reached (maximum daily dose: 1.5 mg/kg/day);
• Maintenance dose: 0.25 to 1 mg/kg/dose once daily;
doses up to 1.5 mg/kg/day may be used for rapidly progressing disease for short-term use; once
therapy has been established; amphotericin B may be administered on an every-other-day basis at
1 to 1.5 mg/kg/dose in some cases
Dosage Dosing: Renal Impairment: Adult, Pediatric
adjustment Altered kidney function: IV: No dosage adjustment necessary for any degree of kidney
impairment (only 2% to 5% excreted in biologically active form). However, a dosage interval of 24
to 36 hours has been recommended in patients with a GFR < 10 mL/min
Nephrotoxicity during treatment: Consider switching to an alternative antifungal agent or a lipid-
based amphotericin formulation
Renal replacement therapy: Poorly dialyzed; no supplemental dose or dosage adjustment
necessary, including patients on intermittent hemodialysis or CRRT.
Hepatic Impairment:
There are no dosage adjustments needed.
Contra- Hypersensitivity to amphotericin or any component of the formulation
indications

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Adverse Drug Systemic: >10%
Reactions Cardiovascular: Hypotension
Central nervous system: Chills, headache, malaise, pain
Endocrine & metabolic: Hypokalemia, hypomagnesemia
Gastrointestinal: Anorexia, diarrhea, epigastric pain, heartburn, nausea, vomiting
Hematologic & oncologic: Anemia (normochromic-normocytic)
Local: Pain at injection site (with or without phlebitis or thrombophlebitis [incidence may increase
with peripheral infusion of admixtures])
Renal: Renal function abnormality (including azotemia, renal tubular acidosis, nephrocalcinosis
[>0.1 mg/ml]), renal insufficiency
Respiratory: Tachypnea
Miscellaneous: Fever
1% to 10%:
Cardiovascular: Flushing, hypertension
Central nervous system: Arachnoiditis, delirium, neuralgia (lumbar; especially with intrathecal
therapy), paresthesia (especially with intrathecal therapy)
Genitourinary: Urinary retention
Hematologic & oncologic: Leukocytosis
Monitoring BUN and serum creatinine levels should be determined every other day when therapy is increased
Parameters and at least weekly thereafter. Renal function (monitor frequently during therapy), electrolytes
(especially potassium and magnesium), LFTs, temperature, PT/PTT, CBC; fluid input and output;
signs of hypokalemia (muscle weakness, cramping, drowsiness, ECG changes, etc);
signs/symptoms of infusion-related reaction (fever, shaking chills, hypotension, anorexia, nausea,
vomiting, headache, tachypnea)
Drug Risk X: Avoid combination
Interactions Bromperidol Foscarnet Methoxyflurane Saccharomyces boulardii
Risk D: Consider therapy modification:
Amifostine, Arsenic Trioxide, Colistimethate, Obinutuzumab, Sodium Stibogluconate
Pregnancy and Pregnancy Risk Factor: B
Lactation It is not known if amphotericin is excreted into breast milk. Due to its poor oral absorption,
systemic exposure to the nursing infant is expected to be decreased; however, because of the
potential for toxicity, breast-feeding is not recommended.
Administration Administration: IV
May be infused over 2 to 6 hours; an inline filter (≥1 micron mean pore diameter) may be used
for administration. To minimize infusion-related immediate reactions, premedicate with the
following 30 to 60 minutes prior to drug administration: acetaminophen, diphenhydramine,
and/or hydrocortisone. Preinfusion administration of 1 L of NS appears to reduce the risk of
nephrotoxicity during treatment
Preparation for Administration:
IV: Add 10 mL of SWFI (without a bacteriostatic agent) to each vial of amphotericin B. Further
dilute with 250 to 500 mL D5W; final concentration should not exceed 0.1 mg/mL (peripheral
infusion) or 0.25 mg/mL (central infusion).
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Anaphylaxis: Has been reported with amphotericin B-containing drugs; facilities for
cardiopulmonary resuscitation should be available during administration due to the possibility
of anaphylactic reaction. If severe respiratory distress occurs, the infusion should be
immediately discontinued; during the initial dosing, the drug should be administered under
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• Infusion reactions: Acute reactions (eg, fever, rigors, hypotension, anorexia, nausea,
vomiting, headache, tachypnea) may occur 1 to 3 hours after starting an intravenous infusion.
These reactions are usually more common with the first few doses and generally diminish with
subsequent doses. Avoid rapid infusion to prevent hypotension, hypokalemia, arrhythmias, and
shock.
• Leukoencephalopathy: Has been reported following administration of amphotericin B. Total
body irradiation has been reported to be a possible predisposition.
• Nephrotoxicity: May cause nephrotoxicity; risk factors include underlying renal disease,
concomitant nephrotoxic medications and daily and/or cumulative dosing of amphotericin.
Avoid use with other nephrotoxic drugs; drug-induced renal toxicity usually improves with
interrupting therapy, decreasing dosage, or increasing dosing interval. However permanent
impairment may occur, especially in patients receiving a large cumulative dose (eg, >5 g) and in
those also receiving other nephrotoxic drugs. Hydration and sodium repletion prior to
administration may reduce the risk of developing nephrotoxicity. Frequent monitoring of renal
function is recommended.
Disease-related concerns:
• Heart failure: In a scientific statement from the American Heart Association, amphotericin
has been determined to be an agent that may cause direct myocardial toxicity (magnitude:
moderate/major).
• Renal impairment: Use with caution in patients with renal impairment.
Special populations:
• Patients with neutropenia: Pulmonary reactions may occur in patients with neutropenia
receiving leukocyte transfusions; separation of the infusions as much as possible is advised.
Other warnings/precautions:
• Therapy interruption: If therapy is stopped for >7 days, restart at the lowest dose
recommended and increase gradually.
Storage • Store intact vials under refrigeration. Protect from light.
• Reconstituted vials are stable, protected from light, for 24 hours at room temperature and 1
week when refrigerated.
• Parenteral admixtures in D5W should be used promptly after preparation and protected from
light during administration.
Refer to manufacturer PIL if there are specific considerations.

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2. Anidulafungin
Generic Name Anidulafungin

Dosage Vial 100mg

form/strengths
Route of IV
administration
Pharmacologic Antifungal Agent, Parenteral; Echinocandin
category ATC: J02AX06
Indications Candidemia, intra-abdominal or peritoneal candidiasis: Treatment of candidemia and other
forms of Candida infections (intra-abdominal abscess and peritonitis) in adults and pediatric
patients ≥1 month of age.
Candidiasis, esophageal refractory disease: Treatment of esophageal candidiasis in adults.
Limitations of use: Dosage for the treatment of disseminated CNS or eye Candida infections
has not been established. High relapse rates have occurred in patients treated for esophageal
candidiasis.
Dosage Dosing: Adult
Regimen Candidemia, intra-abdominal or peritoneal candidiasis:
IV: Initial dose: 200 mg on day 1; subsequent dosing: 100 mg once daily; treatment should
continue until 14 days after last positive culture.
Candidiasis, esophageal (alternative agent):
IV: 200 mg daily; may transition to oral fluconazole therapy once oral intake tolerable.
Transition to an oral antifungal once patient tolerates oral intake if susceptibility allows; total
antifungal duration is 14 to 28 days
Dosage Dosing: Renal Impairment: Adult
adjustment No dosage adjustment necessary, including dialysis patients.
Dosing: Hepatic Impairment: Adult
No dosage adjustment necessary.
Contra- Hypersensitivity to anidulafungin, other echinocandins, or any component of the formulation;
indications known or suspected hereditary fructose intolerance.
Adverse Drug >10%:
Reactions Cardiovascular: Hypotension (15%), hypertension (12%), peripheral edema (11%)
Central nervous system: Insomnia (15%)
Endocrine & metabolic: Hypokalemia (≤25%), hypomagnesemia (12%)
Gastrointestinal: Nausea (7% to 24%), diarrhea (9% to 18%), vomiting (7% to 18%)
Genitourinary: Urinary tract infection (15%)
Hepatic: Increased serum alkaline phosphatase (12%)
Infection: Bacteremia (18%)
Respiratory: Dyspnea (12%)
Miscellaneous: Fever (9% to 18%)
2% to 10%:
Cardiovascular: Deep vein thrombosis (10%), chest pain (5%)
Central nervous system: Confusion (8%), headache (8%), depression (6%)
Dermatologic: Decubitus ulcer (5%)
Endocrine & metabolic: Hypoglycemia (7%), dehydration (6%), hyperglycemia (6%),
hyperkalemia (6%)
Gastrointestinal: Constipation (8%), dyspepsia (7%), abdominal pain (6%), oral candidiasis (5%)
Hematologic & oncologic: Anemia (8% to 9%), leukocytosis (5% to 8%), thrombocythemia (6%)
Hepatic: Increased serum transaminases (≤5%)

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Infection: Sepsis (7%)
Neuromuscular & skeletal: Back pain (5%)
Renal: Increased serum creatinine (5%)
Respiratory: Pleural effusion (10%), cough (7%), pneumonia (6%), respiratory distress (6%)
Monitoring LFTs; anaphylaxis or infusion reactions (eg, bronchospasm, dyspnea, flushing, hypotension,
Parameters pruritus, rash, urticaria).
Drug Saccharomyces boulardii: Antifungal Agents (Systemic, Oral) may diminish the therapeutic
Interactions effect of Saccharomyces boulardii. Risk X: Avoid combination
Pregnancy and US FDA pregnancy category: Not assigned.
Lactation Risk summary: Based on results from animal studies, this drug may cause fetal harm when
used during pregnancy; no data available on use of this drug in pregnant women to inform a
drug-related risk.
It is not known if anidulafungin is present in breast milk. Use is not recommended unless the
benefit outweighs the risk.
Administration Administration: IV
For IV use only; infusion rate should not exceed 1.1 mg/minute (1.4 mL/minute or 84
mL/hour). Do not concurrently infuse with other medications or electrolytes.
Preparation for Administration:
Parenteral: IV: Reconstitute vials using SWFI; reconstitute the 100 mg vial with 30 mL;
concentration after reconstitution is 3.33 mg/mL. Further dilute in D5W or NS to a final
concentration of 0.77 mg/mL.
Warnings/ Concerns related to adverse effects:
Precautions • Anaphylactic reactions: Immediate treatment for hypersensitivity reactions should be
available. Discontinue treatment immediately if reactions occur.
• Hepatic effects: Elevated LFTs, hepatitis, and hepatic failure have been reported; monitor for
progressive hepatic impairment if increased transaminase enzymes noted.
• Infusion reactions: Infusion reactions (eg, bronchospasm, dyspnea, flushing, hypotension,
pruritus, rash, urticaria) may occur; do not exceed recommended rate of infusion.
Special populations:
• Obesity: Data suggest that clearance increases as a function of body weight. Based on data
from another echinocandin, higher doses may be necessary in obese patients.
Dosage form specific issues:
• Fructose: Some dosage forms may contain fructose; may precipitate a metabolic crisis (eg,
life-threatening hepatic failure, hypoglycemia, hypophosphatemia, lactic acidosis) in patients
with hereditary fructose intolerance. Obtain history of hereditary fructose intolerance prior to
therapy.
• Polysorbate 80 (Tweens): Some dosage forms may contain Tweens. Hypersensitivity
reactions, usually a delayed reaction, have been reported. Thrombocytopenia, ascites,
pulmonary deterioration, and renal and hepatic failure have been reported in premature
neonates after receiving parenteral products containing polysorbate 80.
Storage • Store intact vials at 2°C to 8°C; excursions at 25°C are permitted for 96 hours and the vial
may be returned to storage at 2°C to 8°C. Do not freeze.
• The reconstituted solution can be stored for up to 24 hours at temperatures up to 25°C
prior to dilution.
• The infusion solution may be stored for up to 48 hours at temperatures up to 25°C prior to
administration; do not freeze.
• Refer to manufacturer PIL if there are specific considerations.

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3. Caspofungin
Generic Name Caspofungin

Dosage Vial 50mg, 70mg

form/strengths
Route of IV
administration
Pharmacological Antifungal Agent, Parenteral; Echinocandin
category ATC: J02AX04
Indications Aspergillosis, invasive: Treatment of invasive aspergillosis in patients ≥3 months of age who are
refractory to or intolerant of other therapies (eg, amphotericin B, lipid formulations of
amphotericin B, itraconazole).
Limitations of use: Has not been studied as initial therapy for invasive aspergillosis.
Candidemia and other Candida infections: Treatment of candidemia and the
following Candida infections in patients ≥3 months of age: Intra-abdominal abscesses, peritonitis,
and pleural space infections.
Limitations of use: Has not been studied in endocarditis, osteomyelitis, and meningitis due
to Candida.
Candidiasis, esophageal: Treatment of esophageal candidiasis in patients ≥3 months of age.
Limitations of use: Not approved for the treatment of oropharyngeal candidiasis (OPC).
Neutropenic fever, empiric antifungal therapy: Empiric therapy for presumed fungal infections in
febrile, neutropenic patients ≥3 months of age.
Dosage Regimen Dosing: Adult
Note: Duration of caspofungin treatment should be determined by patient status and clinical
response.
Aspergillosis, invasive (salvage therapy): IV: Initial dose: 70 mg on day 1; subsequent dosing: 50
mg once daily. Duration of therapy should be a minimum of 6 to 12 weeks and depends on site of
infection, extent of disease, and level/duration of immunosuppression.
Candidemia and other Candida infections: IV: Initial dose: 70 mg on day 1; subsequent dosing: 50
mg once daily; generally, continue for at least 14 days after the last positive culture or longer if
neutropenia warrants. Higher doses (150 mg once daily infused over ~2 hours) compared to the
standard adult dosing regimen (50 mg once daily) have not demonstrated additional benefit or
toxicity in patients with invasive candidiasis.
Note: IDSA Candidiasis guidelines recommend transition to fluconazole (usually after 5 to 7 days
in non-neutropenic patients) in clinically stable patients with fluconazole-susceptible isolates and
negative repeat cultures.
Candidiasis, esophageal (alternative agent): IV:
50 mg once daily; some experts favor a loading dose of 70 mg on day 1. May transition to oral
fluconazole therapy once oral intake tolerable. In patients with fluconazole-refractory disease,
continue caspofungin for 14 to 21 days. Note: Among patients with HIV, a higher relapse rate has
been reported with echinocandins than with fluconazole
Fungal infections, empiric therapy (neutropenic patients): IV: Initial dose: 70 mg on day 1;
subsequent dosing: 50 mg once daily; continue until resolution of neutropenia; if fungal infection
confirmed, continue for a minimum of 14 days (continue for at least 7 days after resolution of
both neutropenia and clinical symptoms); if clinical response inadequate, may increase up to 70
mg once daily if tolerated
Dosage Dosing: Renal Impairment: Adult
adjustment No dosage adjustment necessary.

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Dosing: Hepatic Impairment: Adult
Mild impairment (Child-Pugh class A): No dosage adjustment necessary.
Severe and Moderate impairment (Child-Pugh class B, C): 70 mg on day 1 (where recommended),
followed by 35 mg once daily; however, pharmacokinetic data suggest that this dose reduction
may result in suboptimal drug exposure

Contra- Hypersensitivity to caspofungin or any component of the formulation

indications Documentation of allergenic cross-reactivity for echinocandin antifungals is limited. However,
because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-
sensitivity cannot be ruled out with certainty

Adverse Drug >10%:

Reactions Cardiovascular: Hypotension, peripheral edema, tachycardia
Central nervous system: Chills, headache
Dermatologic: Skin rash
Gastrointestinal: Diarrhea, vomiting, nausea
Hematologic & oncologic: Decreased hemoglobin, decreased hematocrit, decreased white blood
cell count, anemia
Hepatic: Increased serum alkaline phosphatase, increased serum ALT, increased serum AST,
increased serum bilirubin
Local: Localized phlebitis
Renal: Increased serum creatinine
Respiratory: Respiratory failure, cough, pneumonia
Miscellaneous: Infusion related reaction, fever, septic shock
1% to 10%:
Cardiovascular: Hypertension, atrial fibrillation, bradycardia, cardiac arrhythmia, edema, flushing,
myocardial infarction
Central nervous system: Anxiety, confusion, depression, dizziness, drowsiness, fatigue, insomnia,
seizure
Dermatologic: Erythema, pruritus, skin lesion, urticaria, decubitus ulcer
Endocrine & metabolic: Hypomagnesemia, hyperglycemia, hypokalemia, hypercalcemia,
hypervolemia
Gastrointestinal: Abdominal pain, mucosal inflammation, abdominal distention, anorexia,
constipation, decreased appetite, dyspepsia, upper abdominal pain
Genitourinary: Urinary tract infection, nephrotoxicity
Hematologic & oncologic: Blood coagulation disorder, febrile neutropenia, neutropenia, petechia,
thrombocytopenia
Hepatic: Decreased serum albumin, hepatic failure, hepatomegaly, hepatotoxicity,
hyperbilirubinemia, jaundice
Infection: Sepsis, bacteremia
Local: Catheter infection, infusion site reaction (pain/pruritus/swelling)
Neuromuscular & skeletal: Arthralgia, back pain, limb pain, tremor, weakness
Renal: Hematuria, increased blood urea nitrogen, renal failure
Respiratory: Dyspnea, pleural effusion, respiratory distress, rales, epistaxis, hypoxia, tachypnea
Monitoring Liver function; anaphylaxis, skin rash, or histamine-related reactions (eg, facial swelling,
Parameters bronchospasm, sensation of warmth)
Drug Risk X: Avoid combination
Interactions Saccharomyces
Risk D: Consider therapy modification
Rifampin Cyclosporine

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Pregnancy Pregnancy Category C
No information is available on the use of caspofungin during breastfeeding. Because caspofungin
has poor oral bioavailability, it is unlikely to reach the milk and be absorbed by the infant.
Administration Parenteral: IV: Administer by slow IV infusion over 1 hour (manufacturer); higher doses (eg, 150
mg) have been infused over ~2 hours. Do not administer by IV bolus
Preparation for Administration:
Bring intact vial to room temperature. Reconstitute vials using 10.8 mL NS for injection, SWFI, or
bacteriostatic water for injection, resulting in a concentration of 5 mg/mL for the 50 mg vial,
and 7 mg/mL for the 70 mg vial (vials contain overfill). Mix gently to dissolve until clear
solution is formed; do not use if cloudy or contains particles. Solution should be further
diluted with 0.9%, sodium chloride or LR (do not exceed final concentration of 0.5 mg/mL).
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Hepatic effects: Increased transaminases and rare cases of clinically significant hepatic
dysfunction (including failure and hepatitis) have been reported in pediatric and adult patients.
Monitor liver function tests during therapy; if tests become abnormal or worsen, consider
discontinuation.
• Hypersensitivity: Anaphylaxis, other hypersensitivity reactions, histamine-related reactions have
been reported.
Disease-related concerns:
• Hepatic impairment: Use with caution in patients with hepatic impairment. Dosage reduction
may be necessary in adults with moderate impairment (Child-Pugh class B); safety and efficacy
have not been established in children with any degree of hepatic impairment and adults with
severe impairment (Child-Pugh class C).
Storage • Store intact vials at 2°C to 8°C.
• Reconstituted solution may be stored at ≤25°C for up to 1 hour prior to dilution.
• Solutions diluted in NS, or LR for infusion should be used within 24 hours when stored at
≤25°C or within 48 hours when stored at 2°C to 8°C.
• Refer to manufacturer PIL if there are specific considerations.

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4. Flubendazole
Generic Name Flubendazole

Dosage Tablets 100mg

form/strengths Oral suspension: 100mg/5ml
Route of Oral
administration
Pharmacologic Anthelmintics
category ATC: P02CA05
Indications For treatment of enterobiasis

For ascariasis, hookworm infections, and trichuriasis

Dosage in adults and children:
Regimen For the treatment of enterobiasis 100 mg is given as a single oral dose, repeated after 2 to 3
weeks.
For ascariasis, hookworm infections, and trichuriasis 100 mg is given twice daily for 3 days.
Dosage No information
adjustment
Contra- Pregnancy.
indications
Adverse Drug GI disturbances: nausea, abdominal pain and rumbling, soft/loose stools, and dyspepsia
Reactions fatigue and breathlessness

Monitoring Lactation. Monitor blood counts and liver function tests regularly during treatment.
Parameters
Drug Methotrexate The excretion of Methotrexate can be decreased when combined with
Interactions Flubendazole.
Pregnancy and Pregnancy category C
Lactation No clear data about lactation safety
Administration Oral Administration with food.
Refer to manufacturer PIL if there are specific considerations.
Warnings/Prec If side effects are severe, flubendazole may have to be withdrawn.
autions
Storage store at temperature not exceeding 30oC
Refer to manufacturer PIL if there are specific considerations.

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5. Fluconazole
Generic Name Fluconazole

Dosage Capsule 50mg, 150mg, 200mg

form/strengths Oral Syrup (or powder for oral suspension) 25mg/5ml, 50mg/5ml, 200mg/5ml
Vial (2mg/ml) 50mg, 100mg, 200mg
Route of IV, Oral
administration
Pharmacologic Antifungal Agent, Azole Derivative
category ATC : J02AC01
Indications Treatment of candidiasis (esophageal, oropharyngeal, peritoneal, urinary tract, vaginal);
Systemic candida infections (eg, candidemia, disseminated candidiasis, pneumonia);
Cryptococcal meningitis;
antifungal prophylaxis in allogeneic hematopoietic cell transplant recipients
Dosage Dosing: Adult
Regimen Conventional dose:
IV, Oral: 400 to 800 mg (6 to 12 mg/kg) once daily
Candidiasis, treatment
• Urinary tract infection: Oral: 200 to 400 mg (3 to 6 mg/kg) once daily
• Vaginal/Vulvovaginal: Oral: 150 mg as a single dose or every 72 hours according to
complications
• Oropharyngeal (moderate to severe): IV, Oral: Loading dose of 200 mg on day 1, then 100 to
200 mg once daily
• Oropharyngeal, chronic suppression for recurrent infection:
Note: Reserve for immunocompromised patients (eg, with HIV and low CD4 count).
Oral: 100 mg once daily. May discontinue once immune reconstitution occurs
• Candidemia (neutropenic and non-neutropenic patients):
Initial therapy (alternative agent):
Note: For use in non-neutropenic patients that are not critically ill and not at high risk of
fluconazole-resistant isolate. For use in neutropenic patients that are not critically ill and
have had no prior azole exposure.
IV, Oral: Loading dose of 800 mg (or 12 mg/kg) on day 1, then 400 mg (or 6 mg/kg) once
daily; if fluconazole-susceptible Candida glabrata isolated, transition to 800 mg (or 12
mg/kg) once daily
• Esophageal, treatment: IV, Oral: 400 mg (or 6 mg/kg) on day 1, then 200 to 400 mg (or 3 to
6 mg/kg) once daily for 14 to 21 days
• Intra-abdominal infection, acute, including peritonitis and/or abscess (alternative agent): IV,
Oral: 800 mg (or 12 mg/kg) on day 1, then 400 mg (or 6 mg/kg) once daily. Total antifungal
duration is ≥14 days based on source control and clinical response
• Osteoarticular (osteomyelitis or septic arthritis) (fluconazole-susceptible isolates): Initial or
step-down therapy: IV, Oral: 400 mg (or 6 mg/kg) once daily. Duration for osteomyelitis is 6
to 12 months and for septic arthritis is 6 weeks.
• Peritonitis, associated with peritoneal dialysis: Note: Use for empiric treatment if no prior
azole exposure or for directed therapy against fluconazole-susceptible isolates:
IV, Oral: 200 mg on day 1, then 100 to 200 mg once daily for 2 to 4 weeks
Tinea:
Oral: 150 to 300 mg once weekly

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Cryptococcal meningitis: Note: Treatment involves induction, consolidation, and maintenance
phases of therapy.
Induction (alternative regimens): Oral: 800 mg once daily in combination with
amphotericin B for 2 weeks
Consolidation: Oral: 400 to 800 mg once daily for 8 weeks (800 mg once daily preferred for
patients who receive a 2-week induction course)
Maintenance (suppression): Oral: 200 to 400 mg once daily for 6 to 12 months

Dosing: Pediatric
General dosing, susceptible infection: Infants, Children, and Adolescents: IV, Oral: Initial: 6 to 12
mg/kg/dose, followed by 3 to 12 mg/kg/dose once daily; duration and dosage depends on
severity of infection; Limiting dose to 600 mg/dose.
Dosage Dosing: Renal Impairment:
adjustment No adjustment for vaginal candidiasis single-dose therapy.
For multiple dosing: administer 100% of the loading/initial dose, then adjust daily doses as
follows: IV, Oral:
CrCl >50 mL/minute: No dosage adjustment necessary.
CrCl ≤50 mL/minute: Reduce maintenance dose by 50%.
CrCl less than 10 mL/minute/1.73 m2: for pediatrics, administer usual loading dose, then reduce
maintenance dose by 50% and administer every 48 hours.
Hemodialysis, intermittent (thrice weekly): IV, Oral: only administer maintenance doses 3
times/week (on dialysis days) after the hemodialysis session; while in pediatrics approximately
50% after a 3-hour session.
Peritoneal dialysis:
IV, Oral: Initial: reduce maintenance doses by 50%. Administer 50% of recommended dose every
48 hours in pediatrics

Dosing: Hepatic Impairment:

There are no dosage adjustments needed; use with caution
Dosing: Obesity: Adult
body weight dosing:
a loading dose of 12 mg/kg, followed by a maintenance dose of 6 mg/kg
Contra- Hypersensitivity to fluconazole or any component of the formulation coadministration of
indications terfenadine in adult patients receiving multiple doses of 400 mg or higher or with CYP3A4
substrates which may lead to QTc prolongation (eg, astemizole, cisapride, erythromycin,
pimozide, or quinidine)
Adverse Drug Adverse Reactions (Significant): Considerations
Reactions Cardiovascular effects
Dermatologic reactions
Hepatotoxicity
>10%: Central nervous system: Headache
1% to 10%:
Central nervous system: Dizziness
Dermatologic: Skin rash
Gastrointestinal: Nausea, abdominal pain, vomiting, diarrhea, dysgeusia, dyspepsia
Frequency not defined: Hepatic: Fulminant hepatitis, hepatitis, increased serum alkaline
phosphatase, increased serum aspartate aminotransferase, increased serum transaminases,
jaundice
Monitoring Periodic liver function tests (AST, ALT, alkaline phosphatase) and renal function tests, potassium
Parameters

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Drug • Risk X: Avoid combination
Interactions Aprepitant Astemizole Asunaprevir Bosentan Bosutinib Budesonide (Topical) Cisapride
Domperidone Erythromycin Fedratinib Fexinidazole Flibanserin Fosaprepitant Ivabradine
Lemborexant Lomitapide Lumateperone Mizolastine Ospemifene Pimozide Quinidine
Saccharomyces Boulardii Simeprevir Siponimod Ulipristal Voriconazole
• Risk D: Consider therapy modification
Acalabrutinib Alfentanil Alitretinoin (Systemic) Alprazolam Amiodarone Avanafil Avapritinib
Avatrombopag Brigatinib Bromocriptine Budesonide (Systemic) Cilostazol Citalopram
Clopidogrel Cobimetinib Colchicine Deflazacort Dronedarone Eliglustat Encorafenib
Eplerenone Erdafitinib Fentanyl Fexinidazole Fluvastatin Guanfacine Ibrutinib Ivacaftor
Ivosidenib Lorlatinib Lurasidone Lurbinectedin Methadone Midazolam Mobocertinib
Naloxegol Olaparib Parecoxib Pemigatinib Pexidartinib QT-Prolonging Class IA
Antiarrhythmics QT-Prolonging Class III Antiarrhythmics QT-Prolonging Kinase Inhibitors QT-
Prolonging Miscellaneous Agents Ranolazine Rifampin Rimegepant Ruxolitinib (Systemic)
Selpercatinib Selumetinib Sirolimus Sonidegib Suvorexant Tacrolimus (Systemic) Tazemetostat
Terfenadine Tezacaftor And Ivacaftor Tipranavir Tofacitinib Tolvaptan Triazolam Ubrogepant
Vardenafil Venetoclax Vitamin K Antagonists (Eg, Warfarin) Voclosporin Voxelotor
Zanubrutinib
Pregnancy pregnancy category D
WHO recommendations state that fluconazole is considered compatible with breastfeeding
when used in usual recommended doses.
Administration Administration: IV
Do not use if cloudy or precipitated. Infuse over ~1 to 2 hours; do not exceed 200 mg/hour
Administration: Oral
May be administered without regard to meals.
Refer to manufacturer PIL if there are specific considerations
Warnings/ Concerns related to adverse effects:
Precautions • Hazardous agent (NIOSH 2016 [group 3]).
• Arrhythmias: Cases of QTc prolongation and torsade de pointes associated with fluconazole use
have been reported (usually high dose or in combination with agents known to prolong the QT
interval); use caution in patients with concomitant medications or conditions which are
arrhythmogenic.
• CNS effects: May occasionally cause dizziness or seizures; use caution driving or operating
machinery.
• Hepatotoxicity: Serious (and sometimes fatal) hepatic toxicity (eg, hepatitis, cholestasis,
fulminant hepatic failure) has been observed. Monitor patients who develop abnormal liver
function tests for the development of more severe hepatic injury; discontinue fluconazole if signs
and symptoms consistent with liver disease develop.
• Hypersensitivity reactions: Anaphylaxis has been reported rarely; use with caution in patients
with hypersensitivity to other azoles.
• Skin reactions: Rare exfoliative skin disorders have been observed; fatal outcomes have been
reported in patients with serious concomitant diseases.
Disease-related concerns:
• Hepatic impairment: Use with caution in patients with preexisting hepatic impairment; monitor
liver function closely and discontinue if symptoms consistent with liver disease develop.
• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment may
be necessary.
Dosage form specific issues:
• Sucrose: Oral suspension contains sucrose; avoid use in patients with fructose intolerance,

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glucose-galactose malabsorption, or sucrase-isomaltase insufficiency.

Storage • Tablet, Powder for oral suspension: Store at <30°C.

• Following reconstitution, store at 5°C to 30°C. Discard unused portion after 2 weeks. Don’t
freeze.
• Injection: Store injection in glass at 5°C to 30°C.
• Store injection in plastic flexible containers with overwrap at 20°C to 25°C. Do not freeze. Do
not unwrap unit until ready for use.
• Refer to manufacturer PIL if there are specific considerations.

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6. Griseofulvin
Generic Name Griseofulvin

Dosage Oral Suspension 125mg/5ml

form/strengths Tablets 125mg
Topical Suspension 2.5gm/100ml
Route of Oral, Topical
administration
Pharmacologic Antifungal Agent
category ATC (oral): D01BA01
ATC (Systemic): D01AA08
Indications Dermatophyte infections: Treatment of the following dermatophyte infections of the skin,
hair, and nails not adequately treated by topical therapy: inea corporis, tinea pedis, tinea
cruris, tinea barbae, tinea capitis, tinea unguium (onychomycosis)

Limitations of use: Use for the prophylaxis of fungal infections has not been established; not
effective for the treatment of tinea versicolor.
Dosage Dosing: Adult
Regimen Dermatophyte infections: Oral:
Microsize: 500 mg/day in single or divided doses; for more widespread lesions initial doses of
750 to 1,000 mg/day in single or divided doses may be needed; may decrease gradually to 500
mg/day or less if patient responds to higher dose.
Ultramicrosize: 375 mg daily in single or divided doses; doses up to 750 mg/day in divided
doses have been used for infections more difficult to eradicate such as tinea unguium and
tinea pedis
Duration of therapy depends on the site of infection
Dosage and duration of treatment should be individualized according to the requirements and
response of the patient
Dosing: Pediatric
General dosing; susceptible infection: Children >2 years and Adolescents:
Microsize: Oral: 20 to 25 mg/kg/day in single or 2 divided doses; maximum daily dose: 1,000
mg/day
Ultramicrosize: Oral: 10 to 15 mg/kg/day once daily; maximum daily dose: 750 mg/day

Dosage Dosing: Renal Impairment:

adjustment There are no dosage adjustments needed
Dosing: Hepatic Impairment:
Use is contraindicated in hepatic failure.

Contra- Hypersensitivity to griseofulvin or any component of the formulation; hepatic failure;

indications porphyria; pregnancy

Adverse Drug Frequency not defined

Reactions Central nervous system: Confusion, dizziness, fatigue, headache, insomnia
Dermatologic: Dermatological reaction (erythema multiforme-like drug reaction), skin
photosensitivity, skin rash (most common), urticaria (most common)
Gastrointestinal: Diarrhea, epigastric distress, gastrointestinal hemorrhage, nausea, oral
candidiasis, vomiting

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Genitourinary: Nephrosis
Hematologic & oncologic: Granulocytopenia
Hepatic: Hepatotoxicity
Monitoring Periodic renal, hepatic, and hematopoietic function tests especially with long-term use
Parameters
Drug Risk X: Avoid combination
Interactions Progestins (Contraceptive), Ulipristal
Risk D: Consider therapy modification
Estrogen Derivatives (Contraceptive)
Risk C: Monitor therapy
Alcohol, Barbiturates (Except: Methohexital; Thiopental), Carbocisteine,
Cyclosporine, Verteporfin, Vitamin K Antagonists (eg, Warfarin)
Pregnancy and Pregnancy Risk Factor X
Lactation It is not known if griseofulvin is excreted in breast milk. Due to the potential for serious
adverse reactions in the nursing infant, breastfeeding is not recommended.

Administration Administration: Oral:

• Oral suspension, tablets: Administer with a fatty meal (eg, whole milk, ice cream, peanut
butter) to increase absorption; shake suspension well before use.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Hematologic effects: Leukopenia has been reported (rare); discontinue therapy if
granulocytopenia occurs.
• Hepatic effects: May cause jaundice and elevated liver function tests or bilirubin (may be
serious or even fatal); monitor hepatic function and discontinue therapy if necessary.
• Penicillin allergy: Hypersensitivity cross reaction between penicillins and griseofulvin is
possible, however, known penicillin-sensitive patients have been treated successfully without
complications.
• Photosensitivity: Avoid exposure to intense sunlight to prevent photosensitivity reactions.
• Skin reactions: Severe skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal
necrolysis, erythema multiforme) have been reported (may be serious or even fatal);
discontinue use if severe skin reactions occur.
Disease-related concerns:
• Lupus erythematosus: Development of lupus erythematosus, lupus-like syndromes or
exacerbation of existing lupus erythematosus has been reported.
Other warnings/precautions:
• Appropriate use: Use for the prophylaxis of fungal infections has not been established; not
effective for the treatment of tinea versicolor
Storage Store at 20°C to 25°C. Protect from light.
Refer to manufacturer PIL if there are specific considerations.

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7. Itraconazole
Generic Name Itraconazole
Dosage form/ Capsules 100mg,
strengths Syrup 10mg/ml
Route of Oral
administration
Pharmacologic Antifungal Agent, Azole Derivative
category ATC: J02AC02
Indications Aspergillosis (100 mg capsules): Treatment of pulmonary and extrapulmonary aspergillosis in
immunocompromised and nonimmunocompromised patients who are intolerant of or
refractory to amphotericin B therapy.

Blastomycosis (100 mg capsules): Treatment of pulmonary and extrapulmonary

blastomycosis in immunocompromised and nonimmunocompromised patients.

Candidiasis, esophageal and oropharyngeal (oral solution): Treatment of oropharyngeal and

esophageal candidiasis.

Histoplasmosis (100 mg capsules): Treatment of histoplasmosis, including chronic cavitary

pulmonary disease and disseminated, nonmeningeal histoplasmosis in immunocompromised
and nonimmunocompromised patients.

Onychomycosis: Capsules (100 mg): Treatment of onychomycosis of the toenail, with or

without fingernail involvement, and onychomycosis of the fingernail caused by
dermatophytes (tinea unguium) in nonimmunocompromised patients.
Dosage Note: Formulations: Due to differences in bioavailability, itraconazole formulations are not
Regimen interchangeable. Generally, the oral solution is preferred because of improved absorption.
Therapeutic drug monitoring: For most indications, adjust dose based on trough serum
concentration to ensure efficacy and avoid toxicity. Timing and frequency of concentration
monitoring is individualized. Safety: Use with caution in patients with heart failure with
reduced ejection fraction; discontinue itraconazole if signs or symptoms of heart failure occur
Adults
General Adult Dosage
Aspergillosis: Oral: Solution or capsule (100 mg): 200 mg twice daily
Duration: Minimum of 6 to 12 weeks, depending on degree/duration of immunosuppression,
disease site, and response to therapy
Blastomycosis:
Note: For initial treatment of mild to moderate disease or step-down therapy after
amphotericin B for more severe infection
Oral: Solution or capsule (100 mg):
Loading dose: 200 mg 3 times daily for 3 days.
Maintenance dose:
Mild to moderate disease in immunocompetent patients: 200 mg once to twice daily.
Moderately severe to severe disease and immunocompromised patients: 200 mg twice daily.
CNS infection (alternative agent): 200 mg 2 to 3 times daily
Candidiasis:
Note: Generally reserved for fluconazole-refractory disease or as an alternative initial agent.
Capsule formulation is not recommended.

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Oral: Solution: 200 mg once daily
Histoplasmosis:
Treatment, initial therapy for mild to moderate disease or step-down therapy after
amphotericin B for more severe infection: Oral:
Solution or capsule (100 mg):
Loading dose: 200 mg 3 times daily for 3 days.
Maintenance dose:
Mild to moderate disease in immunocompetent patients: 200 mg once to twice daily.
Moderately severe to severe or disseminated disease and immunocompromised patients: 200
mg twice daily.
CNS infection: 200 mg 2 to 3 times daily.
Onychomycosis:
Note: Other agents are preferred for dermatophyte onychomycosis.
Oral: Capsule or tablet:
Continuous dosing: 200 mg once daily for 6 weeks or 12 weeks.
Pulsed dosing: 200 mg twice daily for 1 week; repeat every 4 weeks for 2 months or 3 months
Dosing: Pediatric
General dosing, susceptible infection: Limited data available: Infants, Children, and
Adolescents: Oral: 5 mg/kg/dose every 12 hours for treatment; usual maximum daily dose:
200 mg/day; some infections may require up to 400 mg/day
Dosage Dosing: Renal Impairment:
adjustment Use with caution in patients with renal impairment; dosage adjustment may be needed.
Limited data available.
Dosing: Hepatic Impairment:
Use caution and monitor closely for signs/symptoms of toxicity.
Contra- Hypersensitivity to itraconazole or any component of the formulation; treatment of
indications onychomycosis (or other non-life-threatening indications) in patients with evidence of
ventricular dysfunction, such as congestive heart failure (CHF) or a history of CHF; treatment
of onychomycosis in women who are pregnant or contemplating pregnancy
Adverse Drug >10%: Gastrointestinal: Diarrhea, nausea
Reactions 1% to 10%:
Cardiovascular: Edema, chest pain, hypertension,
Central nervous system: Headache, dizziness, anxiety, depression, fatigue, pain, malaise,
abnormal dreams
Dermatologic: Skin rash, pruritus, diaphoresis
Endocrine & metabolic: Hypertriglyceridemia, hypokalemia
Gastrointestinal: Vomiting, abdominal pain, dyspepsia, flatulence, gastrointestinal disease,
gingivitis, aphthous stomatitis, constipation, gastritis, gastroenteritis, increased appetite
Respiratory: Rhinitis, upper respiratory tract infection, sinusitis
Miscellaneous: Fever
Monitoring Obtain liver function tests in patients with preexisting disease and in all patients on
Parameters prolonged therapy (>1 month). Obtain renal function tests and serum concentrations (when
clinically indicated). Assess other medicines patient may be taking; alternate therapy or
dosage adjustments may be needed. Assess for signs and symptoms of heart or liver toxicity
Drug Risk X: Avoid combination
Interactions Acalabrutinib Alfuzosin Aliskiren Alprazolam Aprepitant Astemizole Asunaprevir Avanafil
Avapritinib Barnidipine Bilastine Blonanserin Bosutinib Budesonide (Topical) Cisapride
Clobetasone Cobimetinib Conivaptan CYP3A4 Inducers Dabrafenib Dapoxetine
Dihydroergotamine Disopyramide Dofetilide Domperidone Dronedarone Efavirenz Elagolix,

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Estradiol, And Norethindrone Eletriptan Eplerenone Ergoloid Mesylates Ergonovine
Ergotamine Estazolam Everolimus Felodipine Flibanserin Fluticasone Fosaprepitant Fusidic
Acid (Systemic) Halofantrine Ibrutinib Irinotecan Products Savuconazonium Sulfate Ivabradine
Lefamulin Lemborexant Lercanidipine Lomitapide Lovastatin Lumateperone Lurbinectedin
Macitentan Methadone Methylergonovine Midazolam Mizolastine Naloxegol Netupitant
Nimodipine Nisoldipine Pazopanib Piperaquine Quinidine Radotinib Ranolazine Rimegepant
Rivaroxaban Rupatadine Salmeterol Silodosin Simeprevir Simvastatin Sonidegib Suvorexant
Tamsulosin Tazemetostat Telithromycin Temsirolimus Terfenadine Ticagrelor Tolvaptan
Topotecan Trabectedin Triazolam Ubrogepant Udenafil Ulipristal Vincristine Vinflunine
Vorapaxar
Risk D: Consider therapy modification
Abemaciclib Ado-Trastuzumab Emtansine Afatinib Alfentanil Alitretinoin (Systemic)
Almotriptan Amiodarone Antacids Apixaban Aripiprazole Aripiprazole Lauroxil Atogepant
Atorvastatin Avacopan Axitinib Bedaquiline Berotralstat Betrixaban Brexpiprazole Brigatinib
Bromocriptine Budesonide (Oral Inhalation) (Systemic) Buspirone Cabazitaxel Cabozantinib
Cardiac Glycosides Cariprazine Ceritinib Cilostazol Cobicistat Colchicine Copanlisib Crizotinib
Cyclosporine Dabrafenib Daclatasvir Darifenacin Darunavir Dasatinib Deflazacort Delamanid
Didanosine Docetaxel Duvelisib Edoxaban Elagolix Elbasvir And Grazoprevir Elexacaftor,
Tezacaftor, And Ivacaftor Eliglustat Encorafenib Entrectinib Erdafitinib Erlotinib Eszopiclone
Fedratinib Fentanyl Fesoterodine Fexinidazole Fluticasone (Oral Inhalation) Fosamprenavir
Gilteritinib Glasdegib Guanfacine Halofantrine Histamine H2 Receptor Antagonists
Ibrexafungerp Idelalisib Iloperidone Indinavir Ppis And Pcabs Istradefylline Ivacaftor
Ixabepilone Lapatinib Larotrectinib Lopinavir Lorlatinib Manidipine Maraviroc Midostaurin
Mifepristone Mirodenafil Nifedipine Nilotinib Olaparib Osilodrostat Palbociclib Panobinostat
Pemigatinib Pexidartinib Pimavanserin Ponatinib Pralsetinib Quetiapine Relugolix Ribociclib
Riociguat Ritonavir Rivaroxaban Ruxolitinib Saquinavir Saxagliptin Selpercatinib Selumetinib
Sildenafil Sirolimus Solifenacin Sufentanil Sunitinib Tacrolimus (Systemic) Tadalafil Talazoparib
Temsirolimus Tezacaftor And Ivacaftor Thiotepa Tipranavir Tofacitinib Tolterodine Toremifene
Trazodone Triamcinolone (Systemic) Valbenazine Vardenafil Vemurafenib Venetoclax
Vilazodone Vincristine Voxelotor Zanubrutinib Zopiclone
Pregnancy and Pregnancy Category C
Lactation Itraconazole is present in breast milk. No information is available on the clinical use of
itraconazole during breastfeeding. Until more data become available, an alternate drug may
be preferred, especially while nursing a newborn or preterm infant.
Administration • Oral bioavailability varies depending on whether the drug is administered as capsules or
the oral solution; these preparations should not be used interchangeably. Do not
administer with antacids.
• Only the oral solution (not capsules) is indicated for treatment of oropharyngeal or
esophageal candidiasis.
• The capsules absorption is best if taken with food; therefore, it is best to administer
itraconazole after meals at the same time each day. Capsules should be swallowed whole.
• The oral solution should be administered without food to ensure maximal absorption of
the drug
• Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • CNS depression: May cause CNS depression, which may impair physical or mental abilities;
patients must be cautioned about performing tasks that require mental alertness (eg,
operating machinery, driving)
• Hearing loss: Transient or permanent hearing loss has been reported. Quinidine (a
contraindicated drug) was used concurrently in several of these cases. Hearing loss usually

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resolves after discontinuation, but may persist in some patients.
• Heart failure: [US Boxed Warning]: Itraconazole can cause or exacerbate heart failure (HF).
Negative inotropic effects have been observed following intravenous administration. Use with
caution in patients with risk factors for HF (COPD, renal failure, edematous disorders,
ischemic or valvular disease). If signs or symptoms of HF occur or worsen during
administration of itraconazole, discontinue use or reassess the risk-benefit of continuing
treatment.
• Hepatotoxicity: Rare cases of serious hepatotoxicity (including liver failure and death) have
been reported (including some cases occurring within the first week of therapy
• Hypersensitivity: Hypersensitivity reactions have been reported; discontinue use and
institute appropriate supportive care if a hypersensitivity reaction occurs. Use with caution in
patients with a history of hypersensitivity to other azoles.
• Neuropathy: Cases of peripheral neuropathy have occurred in patients on long-term
itraconazole. Monitor for and discontinue if signs or symptoms of neuropathy occur during
treatment.
Disease-related concerns:
• Cystic fibrosis: Large differences in itraconazole pharmacokinetic parameters have been
observed in cystic fibrosis patients receiving the oral solution; if a patient with cystic fibrosis
does not respond to therapy, alternate therapies should be considered.
• Hepatic impairment: Use with caution in patients with hepatic impairment; monitor liver
function closely. Not recommended for use in patients with active liver disease, elevated liver
enzymes, or prior hepatotoxic reactions to other drugs unless the expected benefit exceeds
the risk of hepatotoxicity.
• Renal impairment: Use with caution in patients with renal impairment; limited information
is available; dosage adjustment may be needed.
Concurrent drug therapy issues:
• High potential for interactions: Life-threatening cardiac dysrhythmias and/or sudden death
have occurred in patients taking CYP 3A inhibitors such as cisapride, pimozide, methadone or
quinidine. [US Boxed Warning]: Coadministration with itraconazole can cause elevated plasma
concentrations of certain drugs and can lead to QT prolongation and ventricular
tachyarrhythmias, including torsades de pointes. Coadministration with methadone,
disopyramide, dofetilide, dronedarone, quinidine, isavuconazole, ergot alkaloids, irinotecan,
lurasidone, oral midazolam, pimozide, triazolam, felodipine, nisoldipine, ivabradine,
ranolazine, eplerenone, cisapride, naloxegol, lomitapide, lovastatin, simvastatin, avanafil,
ticagrelor and, in subjects with varying degrees of renal or hepatic impairment, colchicine,
fesoterodine, and solifenacin is contraindicated. Coadministration with eliglustat is
contraindicated in poor or intermediate metabolizers of CYP2D6 and in patients taking strong
or moderate CYP2D6 inhibitors.
Other warnings/precautions:
• Appropriate use: Itraconazole should NOT be used for voriconazole-refractory aspergillosis
because the same antifungal and/or resistance mechanism(s) may be shared by both agents.
Storage • Capsule: Store at room temperature of 15°C to 25°C. Protect from light and moisture.
• Oral solution: Store at ≤25°C; do not freeze.
• Refer to manufacturer PIL if there are specific considerations.

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8. Ketoconazole
Generic Name Ketoconazole

Dosage Oral tablets 200 mg

form/strengths Topical Cream/ointment: 2 gm/100g
Route of Oral
administration
Pharmacologic Antifungal Agent, Imidazole Derivative
category ATC (topical): D01AC08
ATC (systemic): J02AB02
Indications Fungal infections (systemic):
Treatment of susceptible systemic fungal infections, including blastomycosis, histoplasmosis,
paracoccidioidomycosis, coccidioidomycosis, and chromomycosis in patients who have failed or
who are intolerant to other antifungal therapies
Dosage Dosing: Adult
Regimen Fungal infections (systemic): Oral: 200 mg once daily; may increase to 400 mg once daily if
response is insufficient. Continue until active fungal infection is resolved; some infections may
require a treatment duration of up to 6 months.
Dosing: Pediatric
Fungal infections (systemic): Children ≥2 years and Adolescents: Oral: 3.3 to 6.6 mg/kg/day
once daily; maximum daily dose: 400 mg/day; duration of therapy variable based on pathogen,
patient, and disease-specific factors.

Dosage Dosing: Renal Impairment:

adjustment Mild to severe impairment: No dosage adjustment.
Hemodialysis: Minimally dialyzable: No dosage adjustment necessary
Dosing: Hepatic Impairment:
Use is contraindicated in acute or chronic liver disease.
Hepatotoxicity during treatment:
If ALT >ULN or 30% above baseline (or if patient is symptomatic), interrupt therapy and obtain
full hepatic function panel. Upon normalization of liver function, may consider resuming
therapy if benefit outweighs risk (hepatotoxicity has been reported on rechallenge).
Contra- Hypersensitivity to ketoconazole or any component of the formulation; acute or chronic liver
indications disease; coadministration with alprazolam, cisapride, colchicine, disopyramide, dofetilide,
dronedarone, eplerenone, ergot alkaloids (eg, dihydroergotamine, ergometrine, ergotamine,
methylergometrine), felodipine, HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin),
irinotecan, lurasidone, methadone, oral midazolam, nisoldipine, pimozide, quinidine,
ranolazine, tolvaptan, triazolam
Adverse Drug Frequency not defined.
Reactions Cardiovascular: Orthostatic hypotension, peripheral edema
Central nervous system: Fatigue, insomnia, malaise, nervousness, paresthesia
Dermatologic: Pruritus (2%), alopecia, dermatitis, erythema, erythema multiforme, skin rash,
urticaria, xeroderma
Endocrine & metabolic: Hot flash, hyperlipidemia, menstrual disease
Gastrointestinal: Nausea (3%), vomiting (3%), abdominal pain (1%), anorexia, constipation,
dysgeusia, dyspepsia, flatulence, increased appetite, tongue discoloration, upper abdominal
pain, xerostomia
Hematologic & oncologic: Decreased platelet count
Hepatic: Jaundice

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Hypersensitivity: Anaphylactoid reaction
Neuromuscular & skeletal: Myalgia, weakness
Respiratory: Epistaxis
Miscellaneous: Alcohol intolerance
Monitoring Hepatic function tests (baseline and frequently during therapy), including weekly ALT for the
Parameters duration of treatment; Canadian labeling recommends monitoring hepatic function at baseline,
at weeks 2 and 4, and monthly thereafter; calcium and phosphorous (periodically with long-
term use); adrenal function as clinically necessary
Drug Risk X: Avoid combination
Interactions Abametapir Abemaciclib Acalabrutinib Alfuzosin Alprazolam Aprepitant Astemizole
Asunaprevir Avanafil Avapritinib Barnidipine Bilastine Blonanserin Bosutinib Budesonide
(Topical) Cisapride Cobimetinib Conivaptan Dapoxetine Disopyramide Dofetilide
Doxorubicin Dronedarone Elbasvir And Grazoprevir Elagolix, Estradiol, And Norethindrone
Eletriptan Eplerenone Ergot Derivatives Estazolam Everolimus Felodipine Fexinidazole
Flibanserin Fluticasone (Nasal) Fosaprepitant Fusidic Acid (Systemic) Ibrutinib Infigratinib
Irinotecan Products Isavuconazonium Sulfate Ivabradine Ivosidenib Lemborexant
Lercanidipine Lomitapide Lonafarnib Lovastatin Lumateperone Lurasidone Lurbinectedin
Macitentan Mefloquine Methadone Midazolam Mizolastine Mobocertinib Naloxegol
Neratinib Nevirapine Nimodipine Nisoldipine Pazopanib Pimozide Quinidine Radotinib
Ranolazine Regorafenib Rimegepant Rivaroxaban Rupatadine Ruxolitinib (Topical)
Saccharomyces Boulardii Salmeterol Silodosin Simeprevir Simvastatin Sirolimus Sonidegib
Suvorexant Tamsulosin Tazemetostat Telithromycin Tepotinib Terfenadine Ticagrelor
Tolvaptan Trabectedin Triazolam Ubrogepant Udenafil Vincristine (Liposomal) Vinflunine
Voclosporin Vorapaxar
Risk D: Consider therapy modification
Ado-Trastuzumab Emtansine Afatinib Alcohol (Ethyl) Alfentanil Alitretinoin (Systemic)
Almotriptan Amiodarone Antacids Antihepaciviral Combination Products Apixaban
Aripiprazole Aripiprazole Lauroxil Atogepant Avacopan Axitinib Bedaquiline Berotralstat
Betrixaban Brexpiprazole Brigatinib Bromocriptine Budesonide (Oral Inhalation) Budesonide
(Systemic) Buspirone Cabazitaxel Cabozantinib Carbocisteine Cariprazine Ceritinib Cilostazol
Cobicistat Colchicine Copanlisib Crizotinib Cyclosporine CYP3A4 Inducers Dabigatran Etexilate
Dabrafenib Daclatasvir Darifenacin Darunavir Dasatinib Deflazacort Delamanid Didanosine
Docetaxel Duvelisib Edoxaban Efavirenz Elagolix Elexacaftor, Tezacaftor, And Ivacaftor
Eliglustat Encorafenib Entrectinib Erdafitinib Erlotinib Eszopiclone Fedratinib Fentanyl
Fesoterodine Fluticasone (Oral Inhalation) Fosamprenavir Gilteritinib Glasdegib Guanfacine
Halofantrine Histamine H2 Receptor Antagonists Hyoscyamine Ibrexafungerp Idelalisib
Iloperidone Indinavir Inhibitors Of The Proton Pump (Ppis And Pcabs) Istradefylline Ivacaftor
Ixabepilone Lapatinib Larotrectinib Levomilnacipran Lopinavir Lorlatinib Lumacaftor And
Ivacaftor Manidipine Maraviroc Midostaurin Mifepristone Mirodenafil Nifedipine Nilotinib
Olaparib Osilodrostat Palbociclib Panobinostat Pemigatinib Pexidartinib Piflufolastat F18
Pimavanserin Ponatinib Pralsetinib Quetiapine Relugolix Relugolix, Estradiol, And
Norethindrone Ribociclib Rifabutin Riociguat Ritonavir Ruxolitinib (Systemic) Saquinavir
Saxagliptin Selpercatinib Selumetinib Sildenafil Sirolimus Solifenacin Sufentanil Sunitinib
Tacrolimus Tadalafil Temsirolimus Tezacaftor And Ivacaftor Tipranavir Tofacitinib Tolterodine
Toremifene Trazodone Triamcinolone Valbenazine Vardenafil Vemurafenib Venetoclax
Vilazodone Vincristine Voxelotor Zanubrutinib Zopiclone
Pregnancy and Due to the teratogenicity reported in animal reproduction studies and its antiandrogenic
Lactation effects, ketoconazole is not recommended for the treatment of systemic fungal infections in
pregnant women.
Systemically: Breastfeeding is not recommended.

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Tpically: Use is generally considered acceptable; caution is recommended. a decision should
be made to discontinue breastfeeding or discontinue the drug, taking into account the
importance of the drug to the mother.
Administration Administer oral tablets 2 hours prior to antacids to prevent decreased absorption due to the
high pH of gastric contents.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ • Adrenal suppression: High doses of ketoconazole may depress adrenocortical function;
Precautions returns to baseline upon discontinuation of therapy. Recommended maximum dosing should
not be exceeded. Monitor adrenal function as clinically necessary, particularly in patients with
adrenal insufficiency and in patients under prolonged stress (eg, intensive care, major
surgery).
• Bone fragility: In animal studies, increased long bone fragility with cases of fracture has been
observed with high-dose ketoconazole. Careful dose selection may be advisable for patients
susceptible to bone fragility (eg, postmenopausal women, elderly).
• Hypersensitivity reactions: Cases of hypersensitivity reactions (including rare cases of
anaphylaxis) have been reported; some reactions occurred after the initial dose.
• Myopathy: Coadministration with HMG-CoA reductase inhibitors (eg, lovastatin, simvastatin)
may increase the risk of myopathy. Concomitant use is contraindicated.
• Sedation: Coadministration with midazolam, triazolam, and alprazolam may result in elevated
plasma concentrations of the benzodiazepines, leading to prolonged hypnotic and sedative
effects. Concomitant use is contraindicated.
Disease-related concerns:
• Achlorhydria: Absorption is reduced in patients with achlorhydria; administer with acidic
liquids (eg, soda pop). Avoid concomitant use of drugs that decrease gastric acidity (eg, proton
pump inhibitors, antacids, H2-blockers).
• CNS infections: Ketoconazole has poor penetration into cerebral-spinal fluid and should not
be used to treat fungal meningitis.
• Hepatic impairment: [US Boxed Warning]: Ketoconazole has been associated with
hepatotoxicity, including fatal cases and cases requiring liver transplantation; some patients
had no apparent risk factors for hepatic disease. Patients should be advised of the
hepatotoxicity risks and monitored closely. Toxicity was observed after a median duration of
therapy of ~4 weeks, but has also been noted after as little as 3 days; may occur when patients
receive high doses for short durations or low doses for long durations. Cases have been
reported in patients treated with ketoconazole for onychomycosis, cutaneous dermatophyte
infections, or Candida infections. Use with caution in patients with preexisting hepatic
impairment, those on prolonged therapy and/or taking other hepatotoxic drugs concurrently.
Hepatic dysfunction is typically (but not always) reversible upon discontinuation. Obtain liver
function tests at baseline and frequently throughout therapy; serum ALT should be monitored
weekly throughout therapy. Discontinue therapy for elevated hepatic enzymes that persist or
worsen or if accompanied by signs/symptoms (eg, jaundice, nausea/vomiting, dark urine) of
hepatic injury.
• Prostate cancer: In European clinical trials of men with metastatic prostate cancer, fatalities
were reported in a small number of study participants within 14 days of initiating high-dose
ketoconazole (1,200 mg daily); a causal effect has not been established.
Concurrent drug therapy issues:
• QT prolongation: [US Boxed Warning]: Concomitant use with cisapride, disopyramide,
dofetilide, dronedarone, methadone, pimozide, quinidine, and ranolazine is contraindicated
due to the possible occurrence of life-threatening ventricular arrhythmias such as torsade de
pointes.
Other warnings/precautions:

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• Appropriate use: [US Boxed Warning]: Ketoconazole tablets are not indicated for the
treatment of onychomycosis, cutaneous dermatophyte infections, or Candida infections. Use
only when other effective antifungal therapy is unavailable or not tolerated and the benefits of
ketoconazole treatment are considered to outweigh the risks. Ketoconazole oral tablets are
only approved to treat systemic fungal infections.
Storage Store at 20°C to 25°C
Refer to manufacturer PIL if there are specific considerations.

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9. Micafungin
Generic Name Micafungin

Dosage Powder for Solution for I.V Infusion: 50mg

form/strengths
Route of I.V infusion
administration
Pharmacologic Antifungal Agent, Parenteral; Echinocandin
category ATC: J02AX05
Indications -Treatment of candidemia, acute disseminated candidiasis, and Candida peritonitis and
abscesses in adults and pediatric patients ≥4 months of age or in pediatric patients ≤4 months
of age without meningoencephalitis and/or ocular dissemination

-Treatment of esophageal candidiasis in adults and pediatric patients ≥4 months of age.

-Prophylaxis against invasive fungal infections (hematopoietic cell transplant recipients):

Prophylaxis of Candida infections in adults and pediatric patients ≥4 months of age undergoing
hematopoietic cell transplantation
Dosage -Adult:
Regimen 1-Candidiasis:
-Candidemia (neutropenic and nonneutropenic patients), including disseminated candidiasis:
IV: 100 mg once daily for ≥14 days. Discontinued after first negative blood culture and
continues until signs/symptoms of candidemia and neutropenia, if present, have resolved
2-Esophageal, refractory disease (alternative agent):
-Intra-abdominal infection (eg, peritonitis, abdominal abscess): IV: 100 mg once daily for ≥14
days and continues until source control and clinical resolution.
3-Prophylaxis against invasive fungal infections:
-Hematologic malignancy or hematopoietic cell transplant (alternative agent): IV: 50 to 100
mg once daily. Duration is at least until resolution of neutropenia and varies based on degree
and duration of immunosuppression

-Pediatric:
1-Aspergillosis, treatment, invasive (salvage therapy):
Infants, Children, and Adolescents:
-≤40 kg: IV: 2 to 3 mg/kg/dose once daily; higher doses of 4 to 6 mg/kg/dose once daily have
also been described
->40 kg: IV: 100 mg/dose once daily; may increase to 150 mg/dose if clinically indicated;
maximum daily dose: 150 mg/day

2-Candidiasis, esophageal (alternative agent in patients who cannot tolerate oral therapy):
-Non-HIV-exposed/-infected:
-Infants ≥4 months, Children, and Adolescents:
-≤30 kg: IV: 3 mg/kg/dose once daily.
->30 kg: IV: 2.5 mg/kg/dose once daily; maximum dose: 150 mg/dose.
-HIV-exposed/-infected:
-Children 2 to 8 years and ≤40 kg: IV: 3 to 4 mg/kg/dose once daily.
-Children ≥9 years:
-≤40 kg: IV: 2 to 3 mg/kg/dose once daily.
->40 kg: IV: 100 mg/dose once daily.
-Adolescents: IV: 150 mg/dose once daily.

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3-Candidiasis, systemic (including candidemia and invasive candidiasis):
-Infants <4 months: IV: 10 mg/kg/dose once daily
-Infants ≥4 months, Children, and Adolescents: IV: Initial: 2 mg/kg/dose once daily; usual
maximum dose: 100 mg/dose
4-Empiric antifungal therapy (neutropenic fever):
-Infants ≥4 months, Children, and Adolescents: IV: 2 to 3 mg/kg/dose once daily; maximum
dose: 200 mg/dose
5-Fungal infection, prophylaxis in hematopoietic stem cell transplant (HSCT) recipients:
-Infants <4 months: Limited data available: IV: 2 mg/kg/dose once daily
-Infants ≥4 months, Children, and Adolescents: IV: 1 mg/kg/dose once daily; maximum dose: 50
mg/dose
Dosage -Renal Impairment:
adjustment -No dosage adjustment necessary for any degree of kidney dysfunction
-Hepatic impairment:
-No dosage adjustment necessary.
Contra- -Hypersensitivity to micafungin, other echinocandins, or any component of the formulation
indications
Adverse Drug If used in Candidiasis treatment:
Reactions >10%:
-Cardiovascular: Phlebitis (19%)
-Gastrointestinal: Diarrhea (7% to 11%), vomiting (7% to 18%)
-Hematologic & oncologic: Anemia (infants, children, and adolescents: 18%)
-Hepatic: Abnormal hepatic function tests (4%; infants, children, and adolescents: <15%),
hyperbilirubinemia (infants, children, and adolescents: <15%)
-Renal: Renal failure syndrome (infants, children, and adolescents: <15%)
-Miscellaneous: Fever (9% to 13%)
1 – 10%:
-Cardiovascular: Atrial fibrillation (adults: 3%), tachycardia (infants, children, & adolescents: 4%)
-Dermatologic: Skin rash (2% to 5%)
-Endocrine & metabolic: Abnormal aspartate transaminase (3%), hyperkalemia (adults: 5%),
hypoglycemia (adults: 6%)
-Gastrointestinal: Abdominal distention (infants, children, and adolescents: 2%), abdominal
pain (infants, children, and adolescents: 4%), nausea (7% to 10%)
-Hematologic & oncologic: Neutropenia (infants, children, and adolescents: 5%),
thrombocytopenia (infants, children, and adolescents: 9%)
-Hepatic: Increased serum alkaline phosphatase (3% to 6%)
-Nervous system: Headache (adults: 9%)
Candidiasis prophylaxis in hematopoietic stem cell transplantation:
>10%:
Cardiovascular: Tachycardia (16% to 26%)
Dermatologic: Pruritus (infants, children, and adolescents: 33%), skin rash (25% to 30%),
urticaria (<5%; infants, children, and adolescents: 19%)
Gastrointestinal: Abdominal distention (infants, children, and adolescents: 19%), abdominal
pain (26% to 35%), diarrhea (77%; infants, children, and adolescents: 51%), nausea (70% to
71%), vomiting (65% to 66%)
Genitourinary: Decreased urine output (infants, children, and adolescents: 23%), hematuria
(infants, children, and adolescents: 23%)
Hematologic & oncologic: Anemia (infants, children, and adolescents: 51%), febrile neutropenia
(infants, children, and adolescents: 16%), neutropenia (75% to 77%), thrombocytopenia (72% to
75%)

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Hepatic: Abnormal hepatic function tests (infants, children, and adolescents: <15%),
hyperbilirubinemia (infants, children, and adolescents: <15%), increased serum alanine
aminotransferase (16%)
Nervous system: Anxiety (22% to 23%), headache (adults: 44%), insomnia (adults: 37%)
Renal: Renal failure syndrome (infants, children, and adolescents: <15%)
Miscellaneous: Fever (infants, children, and adolescents: 61%), infusion-related reaction
(infants, children, and adolescents: 16%)
Monitoring -Periodic liver function tests
Parameters -Serum creatinine, BUN
-CBC
-Infusion reactions including rash, pruritus, facial swelling, and vasodilatation
Drug Risk X: Avoid combination
Interactions Saccharomyces boulardii
Pregnancy and Pregnancy Category C
Lactation Caution is recommended during lactation. No information is available on the use of micafungin
during breastfeeding. Because micafungin is >99% bound to plasma proteins and has poor oral
bioavailability, it is unlikely to reach the milk and be absorbed by the infant.
Administration -Aseptically add 5 mL of NS (preservative free) or D5W to each 50 or 100 mg vial. To minimize
foaming, gently swirl to dissolve; do not shake. Further dilute 50 to 150 mg in 100 mL NS or
D5W. Protect infusion solution from light (it is not necessary to protect the drip chamber or
tubing from light).
-Administer as I.V Infusion over 1 hour; may reduce infusion rate for infusion reaction (eg, rash,
pruritus, facial swelling, vasodilatation). Flush line with NS prior to administration.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ -Use with caution in patients that develop worsening renal function during treatment and
Precautions monitor closely.
-Data suggest that micafungin clearance increases as a function of weight; higher doses may be
necessary in patients with obesity
Storage -Store at 25°C; excursions permitted to 15°C to 30°C.
-Reconstituted and diluted solutions in D5W or NS are stable for 24 hours at room temperature.
Protect infusion solution from light (it is not necessary to protect the drip chamber or tubing
from light).
Refer to manufacturer PIL if there are specific considerations.

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10. Nystatin
Generic Name Nystatin

Dosage form/ Oral drops (suspension): 100000IU/ml

strengths Cream 10MIU
Vaginal suppository 100000IU
Route of Oral Topical
administration
Pharmacologic Antifungal Agent, Oral Nonabsorbed/Partially Absorbed
action ATC (oral): A07AA02
ATC (Topical): D01AA01
ATC (Vaginal): G01AA01
Indications Oral: Treatment of susceptible cutaneous, mucocutaneous, and oral cavity fungal infections
normally caused by the Candida species

Topical: Fungal infections (cutaneous and mucocutaneous): Treatment of cutaneous and

mucocutaneous fungal infections caused by Candida albicans and other
susceptible Candida species.
Dosage Dosing: Adult
Regimen Intestinal infections: Oral tablets: 500,000-1,000,000 units every 8 hours
Oral candidiasis, mild disease (alternative agent): Suspension (swish and swallow):
400,000-600,000 units 4 times/day; swish in the mouth and retain for as long as possible
(several minutes) before swallowing
Cream, ointment: Apply to the affected areas twice daily or as indicated until healing is
complete
Dosing: Pediatric
Oral candidiasis: Oral suspension:
Children and Adolescents: Oral: 400,000 to 600,000 units 4 times daily; administer half of
dose to each side of mouth; swish and retain in the mouth for as long as possible before
swallowing.
Peritonitis (Peritoneal dialysis), prophylaxis for high risk situations (eg, during antibiotic
therapy or PEG placement): Oral Suspension: Infants, Children, and Adolescents: 10,000
units/kg once daily
Topical: Mucocutaneous candidal infections: Infants, Children, and Adolescents:
Manufacturer's labeling:
Cream/ointment: Topical: Apply to affected area twice daily

Dosage Dosing: Renal Impairment:

adjustment There are no dosage adjustments needed.
Dosing: Hepatic Impairment:
There are no dosage adjustments needed.

Contra- Hypersensitivity to nystatin or any component of the formulation

indications
Adverse Drug Oral: 1% to 10%: Gastrointestinal: Diarrhea, nausea, stomach pain, vomiting
Reactions Topical: Frequency not defined: Dermatologic: Contact dermatitis, Stevens-Johnson
syndrome
Monitoring Determine that cause of infection is fungal. Avoid skin contact when applying.
Parameters

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Drug Oral: Saccharomyces boulardii: Antifungal Agents (Systemic, Oral) may diminish the
Interactions therapeutic effect of Saccharomyces boulardii. Risk X: Avoid combination
Topical: Progesterone: Antifungal Agents (Vaginal) may diminish the therapeutic effect of
Progesterone. Risk X: Avoid combination
Pregnancy and Pregnancy Risk Factor C
Lactation Excretion into breast milk is not known; however, absorption following oral use is poor.
Administration Oral:
Suspension: Shake well before using. Should be swished about the mouth and retained in
the mouth for as long as possible (several minutes) before swallowing.
Topical:
For topical external use only; not for systemic, oral, intravaginal, or ophthalmic use. Apply
liberally to clean/dry skin. For fungal infection of the feet, the powder should be dusted in
all footwear
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Hypersensitivity: May occur; immediately discontinue if signs of a hypersensitivity
reaction occur.
• Irritation: Discontinue if irritation occurs.

Storage • Suspension: Store at controlled room temperature of 15°C to 25°C

• Cream: Store at room temperature.
• Refer to manufacturer PIL if there are specific considerations.

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11. Voriconazole
Generic Name Voriconazole

Dosage Tablets 50mg, 200mg

form/strengths Vial 200mg
Oral suspension 40mg
Route of Oral, IV
administration
Pharmacologic Antifungal Agent, Azole Derivative;
category ATC: J02AC03
Indications Treatment of fungal infections in patients ≥2 years of age: Treatment of invasive aspergillosis;
treatment of esophageal candidiasis; treatment of candidemia (in non-neutropenic patients);
treatment of disseminated Candida infections of the skin and abdomen, kidney, bladder wall, and
wounds; treatment of serious fungal infections caused by Scedosporium
apiospermum and Fusarium spp. (including Fusarium solani) in patients intolerant of, or refractory
to, other therapy
Dosage Dosing: Adult
Regimen Aspergillosis, invasive, including disseminated and extrapulmonary infection; treatment:
IV:
Initial: 6 mg/kg every 12 hours for 2 doses
Maintenance dose: 4 mg/kg every 12 hours
Oral: 200 to 300 mg twice daily or weight-based dosing (3 to 4 mg/kg twice daily)
Candidiasis, treatment:
Candidemia (neutropenic and non-neutropenic patients), including disseminated candidiasis
(alternative agent):
Initial therapy: IV: 400 mg twice daily for 2 doses, then 200 to 300 mg IV or orally twice
daily or weight-based dosing (6 mg/kg IV twice daily for 2 doses, then 3 to 4 mg/kg IV or
orally twice daily)
Step-down therapy (for clinically stable patients who have responded to initial therapy with
negative repeat cultures)
Oral: 200 mg twice daily; for susceptible isolates of Candida glabrata, use 200 to 300 mg
twice daily or weight-based dosing (3 to 4 mg/kg twice daily)
Duration: Treat for ≥14 days after first negative blood culture and resolution of signs/symptoms;
continue until resolution of neutropenia,
Fusariosis (alternative agent):
Invasive:
IV: 6 mg/kg twice daily for 2 doses, then 4 mg/kg twice daily
Oral, following improvement with initial IV therapy: 200 mg twice daily.
Duration: Often prolonged and depends on site of infection, severity, immune status, and response
to therapy
Scedosporiosis:
IV: 6 mg/kg twice daily for 2 doses, then 4 mg/kg twice daily.
Oral: 400 mg twice daily for 2 doses, then 200 to 300 mg twice daily.
Duration: Often prolonged and varies based on clinical response and patient immune status
Dosing: Pediatric
Note: In pediatric patients <12 years, bioequivalence between the oral tablet and suspension has
not been determined; due to possible shortened gastric transit time in infants and children,
absorption of tablets may be different than adults; dosing recommendations for infants and
children are based on studies with the oral suspension. Data suggests higher doses (mg/kg) than
adults are required in patients <15 years and weighing <50 kg.

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General dosing, susceptible infection: Note: Dosage adjustment may be required if patient does
not have adequate response, cannot tolerate dose, or adequate trough concentrations are not
achieved; monitor trough concentrations closely.
Children 2 to <12 years: Note: Monitor serum concentrations to maintain trough concentrations of
2 to 6 mcg/mL.
Loading dose: IV: 9 mg/kg/dose every 12 hours for 2 doses on day 1.
Maintenance:
IV: 8 mg/kg/dose every 12 hours.
Oral: Oral suspension: 9 mg/kg/dose every 12 hours; maximum dose: 350 mg/dose;
Note: In most patients, oral therapy is not recommended as initial therapy for treatment; it is
recommended to convert from parenteral to oral therapy only after significant clinical
improvement has been observed.
Children ≥12 years and Adolescents ≤14 years: Note: In this age group, body weight is more
important than age in predicting pharmacokinetics.
IV:
<50 kg: Loading dose: 9 mg/kg/dose every 12 hours for 2 doses; followed by maintenance dose
of 4 to 8 mg/kg/dose every 12 hours.
≥50 kg: Loading dose: 6 mg/kg/dose every 12 hours for 2 doses; followed by maintenance dose
of 3 to 4 mg/kg/dose every 12 hours.
Oral:
<50 kg: 9 mg/kg/dose every 12 hours; maximum dose: 350 mg/dose.
≥50 kg: 200 mg every 12 hours.
Adolescents ≥15 years:
IV: Loading dose: 6 mg/kg/dose every 12 hours for 2 doses; followed by a maintenance dose of
3 to 4 mg/kg/dose every 12 hours.
Oral:
<40 kg: 100 mg every 12 hours.
≥40 kg: 200 mg every 12 hours.
Dosage Dosing: Renal Impairment: Adult
adjustment Oral:
Mild to severe impairment: No dosage adjustment necessary
IV:
CrCl ≥50 mL/minute: There are no dosage adjustments needed.
CrCl <50 mL/minute: There are no specific dosage adjustments necessary while it is recommended
to use oral voriconazole in these patients unless an assessment of the benefit: risk justifies the use
of IV voriconazole; if IV therapy is used, closely monitor serum creatinine and change to oral
voriconazole when possible. IV therapy has been used in select patients with CrCl <50 mL/minute
using varying doses (median duration of treatment 7 to 10 days).
Dosing: Hepatic Impairment: Adult & Pediatrics
Mild to moderate impairment (Child-Pugh class A or B): Following standard loading dose, reduce
maintenance dosage by 50%
Severe impairment (Child-Pugh class C): There are no dosage adjustments provided (has not been
studied). Should only be used if benefit outweighs risk; monitor closely for toxicity
Dosing: Obesity: Adult
Use ideal body weight (IBW) for most obese patients in weight-based dosing calculations; consider
using an adjusted body weight (adjusted body weight=0.4 [total body weight – IBW] + IBW) in
obese patients with life-threatening invasive fungal infections. Confirm selection of an appropriate
dose with therapeutic drug monitoring
Dosing: Renal impairment: Pediatric
Oral: Children ≥2 years and Adolescents:

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Mild to severe impairment: There are no pediatric dosage adjustments necessary.
Dialysis: Poorly dialyzed; no supplemental dose or dosage adjustment necessary.
Continuous renal replacement therapy (CRRT): Drug clearance is highly dependent on the method
of renal replacement, filter type, and flow rate. Appropriate dosing requires close monitoring of
pharmacologic response, signs of adverse reactions due to drug accumulation, as well as drug
concentrations in relation to target trough (if appropriate).
Parenteral: IV: Children ≥2 years and Adolescents:
CrCl ≥50 mL/minute: There are no dosage adjustments provided needed.
CrCl <50 mL/minute: There are no pediatric-specific dosage adjustments provided; has not been
studied. Due to accumulation of the intravenous vehicle (cyclodextrin), It is recommended the use
of oral voriconazole unless an assessment of risk benefit justifies the use of IV voriconazole; if IV
therapy is used, closely monitor serum creatinine and change to oral voriconazole when possible.
Contra- Hypersensitivity to voriconazole or any component of the formulation; coadministration with
indications astemizole, barbiturates (long acting), carbamazepine, cisapride, efavirenz (≥400 mg daily), ergot
derivatives (ergotamine and dihydroergotamine), pimozide, quinidine, rifampin, rifabutin, ritonavir
(≥800 mg daily; also avoid low dose [eg, 200 mg daily] dosing if possible), sirolimus, St John’s wort,
terfenadine
Adverse Drug Adverse Reactions (Significant): Considerations
Reactions Acute kidney injury
Cardiovascular effects
Dermatologic reactions
Hepatotoxicity
Ocular and neurological effects
Skeletal effects
>10%:
Cardiovascular: Hypertension (children, adolescents: 11%; adults: <2%)
Dermatologic: Skin rash (children, adolescents: 13%; adults: 2% to 4%) (See Table 1)
Endocrine & metabolic: Hyperkalemia (≤17%), hypokalemia (children, adolescents: 11%; adults:
<1%)
Gastrointestinal: Abdominal pain (children, adolescents: 12%; adults: <2%), diarrhea (children,
adolescents: 11%; adults: <2%), nausea (children, adolescents: 13%; adults: 1% to 4%), vomiting
(children, adolescents: 20%; adults: 1% to 3%)
Hepatic: Increased serum alanine aminotransferase (children, adolescents, adults: 2% to 23%),
increased serum alkaline phosphatase (children, adolescents, adults: 4% to 23% (See Table 2)),
increased serum aspartate aminotransferase (children, adolescents, adults: 2% to 20%)
Ophthalmic: Visual disturbance (children, adolescents: 26%, adults: 14% to 16%; likely serum
concentration dependent
Renal: Increased serum creatinine (children, adolescents: <5%; adults: ≤21%)
Respiratory: Epistaxis (children, adolescents: 16%; adults: <2%)
Miscellaneous: Fever (children, adolescents: 25%; adults: 2%)

Monitoring • Hepatic function at initiation, weekly during the first month and monthly during course of
Parameters treatment; renal function; serum electrolytes (particularly calcium, magnesium and potassium)
prior to initiation and during therapy; visual function (visual acuity, visual field and color
perception) if treatment course continues >28 days; phototoxic reactions (especially in
pediatric patients); pancreatic function (in patients at risk for acute pancreatitis); total body
skin examination yearly (more frequently if lesions noted).
• Monitoring of serum trough concentrations is recommended in the following infections:
invasive aspergillosis treatment (and prolonged prophylaxis) and endophthalmitis. For other

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infections, consider obtaining voriconazole trough level to assure therapeutics serum
concentrations in patients failing therapy or in those exhibiting signs of toxicity.
• For invasive aspergillosis, the Infectious Diseases Society of America recommends monitoring
trough serum concentrations after steady state has been reached (4 to 7 days after therapy
initiation); the need for continued or repeat monitoring is a patient specific decision influenced
by many factors (eg, infection severity, cost, assay availability).
Reference Range
Trough recommendations in adult patients:
Invasive aspergillosis (non-CNS infection)
Efficacy: >1 to 1.5 mcg/mL
Minimize toxicity: <5 to 6 mcg/mL
CNS aspergillosis (meningitis, ventriculitis):
Goal: Trough levels between 2 and 5 mcg/mL
Endophthalmitis:
Goal: Trough levels between 2 and 5 mcg/mL
Other infections
Efficacy: >1.0 mcg/mL
Minimize toxicity: <4.0 mcg/mL
Therapeutic range in adult patients: 1 to 5 mcg/mL
Drug Risk X: Avoid combination
Interactions Amiodarone, Aprepitant, Atazanavir, Barbiturates, Carbamazepine, Cisapride, Conivaptan,
Darunavir, Domperidone, Dronedarone, Eplerenone, Ergotamine, Fluconazole, Fluticasone
(Nasal), Fosaprepitant, Ivabradine, Lovastatin, Nimodipine, Rifampin, Ritonavir, Simeprevir,
Simvastatin, Sirolimus, Tamsulosin, Terfenadine, Ticagrelor, Triazolam

Risk D: Consider therapy modification

Alprazolam, Aripiprazole, Atorvastatin, Bromocriptine, Budesonide (Systemic), Buspirone,
Calcium Channel Blockers, Cilostazol, Citalopram, Colchicine, Cyclosporine (Systemic),
Doxorubicin (Conventional), Efavirenz, Everolimus, Fluticasone (Oral Inhalation), Guanfacine,
Tacrolimus(Systemic), Vincristine
Pregnancy and pregnancy category D
Lactation Breastfeeding must be stopped on initiation of therapy.
It is not known if voriconazole is excreted in breast milk. Due to the potential for serious adverse
reactions in the nursing infant, It is recommended a decision be made whether to discontinue
nursing or to discontinue the drug, taking into account the importance of treatment to the mother.
Administration Preparation for Administration as IV:
Reconstitute 200 mg vial with 19 mL of SWFI resulting in a concentration of 10 mg/mL; use of
automated syringe during reconstitution is not recommended.
Further dilute reconstituted solution with NS, LR, D5WLR, D5W1/2NS, D5W, D5W with KCl 20
mEq/L, 1/2NS, or D5WNS to a final concentration of 0.5 to 5 mg/mL. Do not dilute with 4.2%
sodium bicarbonate infusion
Administration: IV
Infuse over 1 to 3 hours (rate not to exceed 3 mg/kg/hour). Do not administer as an IV bolus
injection. Do not infuse concomitantly into same line or cannula with other drug infusions. Do not
infuse concomitantly even in separate lines or cannulas with concentrated electrolyte solutions or
blood products. May be infused simultaneously with nonconcentrated electrolytes or TPN through
a separate IV line. If TPN is infused through a multiple lumen catheter, use a different port than
used for voriconazole.
Administration: Oral

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Administer 1 hour before or 1 hour after a meal. Shake oral suspension for approximately 10
seconds before each use. Enteral tube feedings may decrease oral absorption; may hold tube
feedings for 1 hour before and 1 hour after a voriconazole dose
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Hazardous agent (NIOSH 2016 [group 3]).
• Arrhythmias/QT prolongation: QT interval prolongation has been associated with voriconazole
use; rare cases of arrhythmia (including torsade de pointes), cardiac arrest, and sudden death have
been reported, usually in seriously ill patients with comorbidities and/or risk factors (eg, prior
cardiotoxic chemotherapy, cardiomyopathy [especially with concomitant heart failure], electrolyte
imbalance, or concomitant QTc-prolonging drugs). Also use with caution in patients with
potentially proarrhythmic conditions (eg, congenital or acquired QT syndrome, sinus bradycardia,
or preexisting symptomatic arrhythmias); correct electrolyte abnormalities (eg, hypokalemia,
hypomagnesemia, hypocalcemia) prior to initiating and during therapy.
• Dermatologic reactions: Rare cases of malignancy (melanoma, squamous cell carcinoma [SCC])
have been reported in patients with prior onset of severe photosensitivity reactions or exposure to
standard dose long-term voriconazole therapy (in lung transplant recipients, SCC increased by ~6%
per 60 days with a 28% absolute risk increase at 5 years.
• Hepatic toxicity: Serious (and rarely fatal) hepatic reactions (eg, hepatitis, cholestasis, fulminant
failure) have been observed with voriconazole.
• Infusion-related reactions Stop infusion for severe reactions or as clinical presentation indicates.
• Ocular effects: Visual changes, including blurred vision, changes in visual acuity, color perception,
and photophobia, are commonly associated with treatment.
• Renal toxicity: Acute renal failure has been observed; use with caution in patients receiving
concomitant nephrotoxic medications. Evaluate renal function (particularly serum creatinine) at
baseline and periodically during therapy.
• Skeletal effects: Fluorosis and/or periostitis may occur during long-term therapy. If patient
develops skeletal pain and radiologic findings of fluorosis or periostitis, discontinue therapy.
• Toxicity symptoms: Voriconazole demonstrates nonlinear pharmacokinetics.
Disease-related concerns:
• Electrolyte abnormalities: Correct electrolyte abnormalities (eg, hypokalemia, hypomagnesemia,
hypocalcemia) prior to initiating and during therapy.
• Hepatic impairment: Use with caution; elevated liver function tests and clinical signs of liver
damage, such as jaundice, have been associated with voriconazole. Adjustments to maintenance
dosing is required in mild to moderate hepatic cirrhosis (Child-Pugh class A and B). In patients with
severe hepatic insufficiency use only if the benefit outweighs the potential risk. Evaluate hepatic
function (particularly liver function tests and bilirubin) at baseline and periodically during therapy.
• Lactose intolerance: Tablets contain lactose and should not be given to patients with rare
hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose
malabsorption.
• Pancreatitis: Monitor pancreatic function in patients (children and adults) at risk for acute
pancreatitis (eg, recent chemotherapy or hematopoietic stem cell transplantation). Pancreatitis
has been observed during therapy.
• Renal impairment: Avoid the use of IV voriconazole in patients with renal impairment. See
"Dosage forms specific issues: Injection: formulation." Evaluate renal function (particularly serum
creatinine) at baseline and periodically during therapy.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency
adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug
interactions database for more detailed information.

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Special populations:
• Pediatric pharmacokinetics: In pediatric patients, voriconazole pharmacokinetics are complex. In
patients >14 years of age or 12 to 14 years and weighing >50 kg, data suggest that
pharmacokinetics are similar to adults. In patients <12 years of age, the full pharmacokinetic
profile for voriconazole is not completely defined and for patients <2 years, the data are sparse. In
children 2 to <12 years, current data suggest voriconazole undergoes a high degree of variability in
exposure with linear elimination at lower doses and nonlinear elimination at higher doses;
therefore, to achieve similar AUC as adults, increased dosage is necessary in children.
• Pediatric dermatologic reactions: Frequency of phototoxic reactions is higher in pediatric
patients. Stringent photoprotective measures are necessary in children due to the risk of
squamous cell carcinoma. In children experiencing photoaging injuries (eg, lentigines or ephelides),
avoidance of sun and dermatologic follow-up are warranted even after treatment is discontinued.
• Pediatric hepatic reactions: Frequency of hepatotoxic reactions is higher in pediatric patients.
Close monitoring of liver function tests is recommended; if tests become markedly elevated from
baseline, consider discontinuation.

Storage Powder for injection: Store vials between 15°C to 30°C. Reconstituted solutions are stable for up
to 24 hours under refrigeration at 2°C to 8°C.
Powder for oral suspension: Store at 2°C to 8°C. Reconstituted oral suspension is stable for up to
14 days if stored at 15°C to 30°C Do not refrigerate or freeze.
Tablets: Store at 15°C to 30°C
Refer to manufacturer PIL if there are specific considerations.

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12. Posaconazole
Generic Name Posaconazole

Dosage Oral Suspension: 200 mg/5ml

form/strengths Solution for slow I.V. Infusion: 300 mg/16.7ml
Route of Oral, IV
administration
Pharmacologic Antifungal Agent, Azole Derivative
al category ATC: J02AC04
Indications Aspergillosis, invasive: injection (patients ≥13 years of age): Treatment of invasive aspergillosis.
Candidiasis, oropharyngeal: IR oral suspension (patients ≥13 years of age): Treatment of
oropharyngeal candidiasis (including patients refractory to itraconazole and/or fluconazole).
Prophylaxis against invasive fungal infections, severely immunocompromised patients: IR oral
suspension (patients ≥13 years of age): Prophylaxis of invasive Aspergillus and Candida infections
in patients who are at high risk of developing these infections due to being severely
immunocompromised (eg, hematopoietic stem cell transplant with graft-versus-host disease,
hematologic malignancy with prolonged neutropenia due to chemotherapy).
Dosage Dosing: Adult
Regimen Note: Therapeutic drug monitoring: Adjust dose based on trough serum concentration to ensure
efficacy and avoid toxicity. Timing and frequency of concentration monitoring is individualized.
Aspergillosis
Invasive (including disseminated and extrapulmonary) (alternative agent for patients who are
refractory to or intolerant of first-line agents):
IV: 300 mg twice daily for 2 doses, then 300 mg once daily.
Duration: Minimum of 6 to 12 weeks; total duration depends on degree/duration of
immunosuppression, disease site, and response to therapy; immunosuppressed patients may
require more prolonged treatment.
Candidiasis: Note: Generally reserved for fluconazole-refractory disease or as an alternative initial
agent for patients with HIV or solid organ transplantation.
Oropharyngeal: Oral:
Initial episode (alternative agent): IR suspension: 400 mg twice daily for 1 to 3 days, then 400 mg
once daily for a total duration of 7 to 14 days.
Fluconazole-refractory disease: IR suspension: 400 mg twice daily or 400 mg twice daily for 3 days,
then 400 mg once daily. Duration is up to 28 days.
Prophylaxis against invasive fungal infections:
Hematology malignancy or hematopoietic cell transplant:
Oral:IR suspension: 200 mg 3 times daily.
IV: 300 mg twice daily for 2 doses, then 300 mg once daily.
Duration: Varies based on degree and duration of immunosuppression
Dosing: Pediatric
Aspergillosis, invasive; prophylaxis: Note: Duration of therapy is based on recovery from
neutropenia or immunosuppression.
Oral:
Immediate-release suspension: Adolescents ≥13 years: Oral: 200 mg 3 times daily.
IV:
Children ≥2 years and Adolescents <18 years: IV: 6 mg/kg/dose twice daily for 2 doses, followed by
6 mg/kg/dose once daily; maximum dose: 300 mg/dose.
Adolescents ≥18 years: IV: 300 mg twice daily for 2 doses, followed by 300 mg once daily.

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Aspergillosis, invasive; treatment (salvage): Note: Duration of therapy is highly dependent on
degree/duration of immunosuppression, disease site, and evidence of disease improvement;
minimum of 6 to 12 weeks of therapy is recommended.
Oral: Adolescents:
Immediate-release suspension: Limited data available: Oral: 200 mg 3 times daily or 400 mg twice
daily.
IV: Adolescents: 300 mg twice daily for 2 doses, followed by 300 mg once daily.
Candidiasis, oropharyngeal; treatment:
Non-HIV-infected: Adolescents:
Initial episode: Immediate-release suspension: Oral: 100 mg twice daily for 2 doses, followed by
100 mg once daily for 13 days.
Refractory infection: Immediate-release suspension: Oral: 400 mg twice daily; duration of therapy
is based on underlying disease and clinical response.
HIV-infected: Adolescents:
Initial episode (alternative to fluconazole): Immediate-release suspension: Oral: 400 mg twice daily
for 2 doses, followed by 400 mg once daily for 7 to 14 days.
Refractory infection: Immediate-release suspension: Oral: 400 mg twice daily for 28 days.
Candidiasis, esophageal (azole-refractory); treatment: Adolescents (HIV-infected): Oral
immediate-release suspension: 400 mg twice daily for 28 days.
Candidiasis, invasive; prophylaxis: Note: Duration of therapy is based on recovery from
neutropenia or immunosuppression.
Oral:
Immediate-release suspension: Adolescents ≥13 years: Oral: 200 mg 3 times daily.
IV:
Children ≥2 years and Adolescents <18 years: IV: 6 mg/kg/dose twice daily for 2 doses, followed by
6 mg/kg/dose once daily; maximum dose: 300 mg/dose.
Adolescents ≥18 years: IV: 300 mg twice daily for 2 doses, followed by 300 mg once daily.

Dosage Dosing: Renal Impairment:

adjustment IV:
eGFR ≥50 mL/minute/1.73 m2: No dosage adjustment recommended.
eGFR <50 mL/minute/1.73 m2: Avoid use unless risk/benefit assessment warrants use; the
intravenous vehicle (cyclodextrin) may accumulate. Monitor serum creatinine levels; if increases
occur, consider oral therapy.
Oral: Immediate-release suspension:
eGFR ≥20 mL/minute/1.73 m2: No dosage adjustment necessary.
eGFR <20 mL/minute/1.73 m2: No dosage adjustment necessary; however, monitor for
breakthrough fungal infections due to variability in posaconazole exposure.
Hemodialysis: Not removed by dialysis.
Dosing: Hepatic Impairment:
Hepatotoxicity prior to initiating therapy (mild to severe): No dosage adjustment available. Hepatic
dysfunction alters the pharmacokinetic parameters of posaconazole.
Hepatotoxicity during treatment: Consider discontinuing therapy if signs and symptoms consistent
with liver disease that may be attributable to posaconazole develop.
Contra- Coadministration with sirolimus, ergot alkaloids (eg, ergotamine, dihydroergotamine), HMG-CoA
indications reductase inhibitors that are primarily metabolized through CYP3A4 (eg, atorvastatin, lovastatin,
simvastatin), or CYP3A4 substrates that prolong the QT interval (eg, pimozide, quinidine);
hypersensitivity to posaconazole, other azole antifungal agents, or any component of the
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Adverse Drug >10%:
Reactions Cardiovascular: Hypertension (8% to 20%), hypotension (oral: 14%), lower extremity edema (oral:
15%), peripheral edema (11% to 16%), tachycardia (oral: 12%), thrombophlebitis (IV via peripheral
venous catheter: 60%)
Dermatologic: Pruritus (11% to 22%), skin rash (3% to 24%)
Endocrine & metabolic: Dehydration (oral: 1% to 11%), hyperglycemia (oral: 11%), hypokalemia
(14% to 30%), hypomagnesemia (10% to 18%), weight loss (oral: 1% to 14%)
Gastrointestinal: Abdominal pain (5% to 27%), anorexia (oral: 2% to 19%), constipation (8% to
21%), decreased appetite (10% to 15%), diarrhea (10% to 42%), nausea (9% to 38%), oral
candidiasis (oral: 1% to 12%), stomatitis (11% to 20%), upper abdominal pain (6% to 11%), vomiting
(7% to 29%)
Hematologic & oncologic: Anemia (2% to 25%), febrile neutropenia (15% to 31%), neutropenia
(oral: 4% to 23%; severe neutropenia: 10%), petechia (8% to 11%), thrombocytopenia (7% to 29%)
Hepatic: Increased serum alanine aminotransferase (3% to 17%), increased serum alkaline
phosphatase (1% to 13%), increased serum aspartate aminotransferase (3% to 17%)
Infection: Herpes simplex infection (oral: 3% to 11%)
Nervous system: Chills (10% to 16%), dizziness (oral: 11%), fatigue (3% to 17%), headache (8% to
28%), insomnia (oral: 1% to 17%), pain (oral: 1% to 11%), rigors (oral: ≤20%)
Neuromuscular & skeletal: Arthralgia (oral: 11%), asthenia (oral: 2% to 13%), musculoskeletal pain
(oral: 16%)
Respiratory: Cough (3% to 25%), dyspnea (1% to 20%), epistaxis (11% to 17%), pharyngitis (oral:
12%), pneumonia (3% to 13%)
Miscellaneous: Fever (6% to 45%), inflammation (mucosal: 14% to 28%)
1% to 10%:
Cardiovascular: Edema (oral: 9%), pulmonary embolism (<5%), torsades de pointes (<5%)
Dermatologic: Diaphoresis (oral: 2%)
Endocrine & metabolic: Adrenocortical insufficiency (<5%), hypocalcemia (oral: 9%)
Gastrointestinal: Dyspepsia (oral: 10%), pancreatitis (<5%)
Genitourinary: Vaginal hemorrhage (oral: 10%)
Hematologic & oncologic: Hemolytic-uremic syndrome (<5%), thrombotic thrombocytopenic
purpura (<5%)
Hepatic: Hepatic insufficiency (<5%), hepatitis (<5%), hepatomegaly (<5%), increased liver enzymes
(<5%), increased serum bilirubin (3% to 10%), jaundice (<5%)
Hypersensitivity: Hypersensitivity reaction (<5%)
Nervous system: Paresthesia (<5%)
Neuromuscular & skeletal: Back pain (oral: 10%)
Renal: Acute kidney injury (<5%)
Monitoring • blood pressure
Parameters • Monitoring of hepatic function Liver function tests should be evaluated at the start of and
during the course of posaconazole therapy
• serum creatinine
• serum electrolytes
Drug Risk X: Avoid Combination
Interactions Acalabrutinib Alcohol (Ethyl) Alfuzosin Alprazolam Aprepitant Astemizole Asunaprevir Atorvastatin
Avanafil Avapritinib Barnidipine Blonanserin Bosutinib Budesonide (Topical) Cisapride Cobimetinib
Conivaptan Dapoxetine Domperidone Doxorubicin (Conventional) Dronedarone Efavirenz Elagolix,
Estradiol, And Norethindrone Eletriptan Eplerenone Ergot Derivatives (Vasoconstrictive CYP3A4
Substrates) Finerenone Flibanserin Fluticasone (Nasal) Fosaprepitant Infigratinib Isavuconazonium
Sulfate Ivabradine Lefamulin Lemborexant Lercanidipine Lomitapide Lonafarnib Lovastatin
Lumateperone Lurasidone Lurbinectedin Macitentan Mizolastine Naloxegol Neratinib Nimodipine

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Nisoldipine Pimozide Pralsetinib QT-Prolonging CYP3A4 Substrates Quinidine Radotinib Ranolazine
Regorafenib Rimegepant Rupatadine Ruxolitinib Salmeterol Silodosin Simeprevir Simvastatin
Sirolimus Sonidegib Suvorexant Tamsulosin Tazemetostat Terfenadine Ticagrelor Tolvaptan
Trabectedin Triazolam Ubrogepant Udenafil Vincristine (Liposomal) Vinflunine Voclosporin
Vorapaxar
Risk D: Consider Therapy Modification
Abemaciclib Ado-Trastuzumab Emtansine Alfentanil Alitretinoin (Systemic) Almotriptan
Aripiprazole Aripiprazole Lauroxil Atogepant Avacopan Axitinib Brexpiprazole Brigatinib
Bromocriptine Budesonide (Oral Inhalation) (Systemic) Buspirone Cabazitaxel Cabozantinib
Cariprazine Cilostazol Colchicine Copanlisib Cyclosporine (Systemic) Dabrafenib Daclatasvir
Darifenacin Deflazacort Docetaxel Duvelisib Elagolix Elbasvir And Grazoprevir Eliglustat Erdafitinib
Erlotinib Eszopiclone Everolimus Fedratinib Felodipine Fentanyl Fesoterodine Fexinidazole
Fluticasone (Oral Inhalation) Fosphenytoin-Phenytoin Glasdegib Guanfacine Histamine H2
Receptor Antagonists Ibrexafungerp Ibrutinib Idelalisib Iloperidone Inhibitors Of The Proton Pump
(Ppis And Pcabs) Irinotecan Products Istradefylline Ivacaftor Ixabepilone Lapatinib Larotrectinib
Lorlatinib Lumacaftor And Ivacaftor Manidipine Maraviroc Midazolam Mifepristone Mirodenafil
Nifedipine Olaparib Palbociclib Panobinostat Pazopanib Pemigatinib Pexidartinib Pimavanserin
Ponatinib Rifabutin Ruxolitinib (Systemic) Saxagliptin Selpercatinib Selumetinib Sildenafil
Solifenacin Sufentanil Sunitinib Tacrolimus (Systemic) Tadalafil Temsirolimus Tezacaftor And
Ivacaftor Thiotepa Tofacitinib Tolterodine Trazodone Triamcinolone (Systemic) Valbenazine
Vardenafil Vemurafenib Venetoclax Vilazodone Vincristine Voxelotor Zanubrutinib Zopiclone
Pregnancy and Pregnancy Category C
Lactation Breastfeeding is not recommended during use of this drug; breastfeeding should be discontinued
upon initiation of this drug.
Administration Oral (suspension):
•Take this drug with a full meal. If you are not able to eat a full meal, take this drug with a
liquid nutrition supplement or an acidic carbonated drink like ginger ale. If you are not able to
drink these drinks, talk with your doctor.
•Shake well before use. Measure liquid doses carefully
Administration: IV
Infuse over 90 minutes via a central venous line. Do not administer IV push or bolus. Must be
infused through an in-line filter (0.22 micron polyethersulfone [PES] or polyvinylidene
difluoride [PVDF]). Infusion through a peripheral line should only be used as a one-time
infusion over 30 minutes in a patient who will be receiving a central venous line for
subsequent doses, or to bridge a period during which a central venous line is to be replaced
or is in use for another infusion. May be an irritant.
Preparation for Administration: Pediatric
IV: Equilibrate the refrigerated vial to room temperature. Contents of vial should be
withdrawn and admixed with D5W, D5W with KCl 20 mEq, D5NS, D51/2NS, 1/2NS, or NS to
achieve a concentration of 1 to 2 mg/mL. The admixed solution may be colorless to yellow.
Color variations in this range do not affect potency. Admixture should be used immediately.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Hepatic effects: Hepatic dysfunction has occurred, ranging from mild/moderate increases of ALT,
AST, alkaline phosphatase, total bilirubin, and/or clinical hepatitis to severe reactions (cholestasis,
hepatic failure including death). Elevations in LFTs have been generally reversible after
posaconazole has been discontinued; some cases resolved without drug interruption. More severe
reactions have been observed in patients with underlying serious medical conditions (eg,
hematologic malignancy) and primarily with IR oral suspension total daily doses of 800 mg.
Monitor LFTs at baseline and periodically during therapy. If increases occur, monitor for severe

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hepatic injury development. Consider discontinuation of therapy in patients who develop clinical
evidence of liver disease that may be secondary to posaconazole.
Disease-related concerns:
• Arrhythmias: Use caution in patients with an increased risk of arrhythmia (long QT syndrome,
concurrent QTc-prolonging drugs metabolized through CYP3A4, hypokalemia). Development of
QTc prolongation, including torsades de pointes, has been reported.
• Electrolyte abnormalities: Correct electrolyte abnormalities (eg, hypokalemia, hypomagnesemia,
hypocalcemia) prior to initiating and during therapy.
• Renal impairment: Do not use injection in patients with eGFR <50 mL/minute/1.73 m2, unless
risk/benefit has been assessed. See "Dosage Forms Specific Issues: Injection Formulation."
Evaluate renal function (particularly serum creatinine) at baseline and periodically during therapy.
If increases occur, consider oral therapy. Monitor closely for breakthrough fungal infections in
patients with severe renal impairment taking delayed-release oral suspension, delayed-release
tablets, or IR oral suspension due to variability in posaconazole exposure.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid;
benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99
mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in
neonates; See manufacturer's labeling.
• Injection formulation: Do not give as an IV bolus injection. Avoid/limit use of IV formulation in
patients with eGFR <50 mL/minute/1.73 m2; injection contains excipient cyclodextrin (sulfobutyl
ether beta-cyclodextrin [SBECD]), which may accumulate although the clinical significance of this
finding is uncertain; consider using oral posaconazole in these patients unless benefit of injection
outweighs the risk. If injection is used in patients with eGFR <50 mL/minute, monitor serum
creatinine closely; if increases occur, consider changing therapy to oral posaconazole.
• Oral formulations: The delayed-release tablet, delayed-release oral suspension, and IR oral
suspension are not to be used interchangeably due to dosing differences for each formulation.
Monitor patients taking oral formulations who experience severe diarrhea or vomiting for
breakthrough fungal infections.
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens).
Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to
pharmaceutical products containing polysorbate 80 in certain individuals.
• Sorbitol: Some dosage forms may contain sorbitol.
Special populations:
• Obesity: Patients weighing >120 kg may have lower plasma drug exposure; monitor closely for
breakthrough fungal infections.
Other warnings/precautions:
• Appropriate use: For patients prescribed posaconazole IR oral suspension who are unable to eat,
take with a high-fat meal, or tolerate nutritional supplements or acidic carbonated beverages (eg,
ginger ale) and do not have the option of taking the delayed-release tablet, delayed-release
suspension, or injection, consider alternative antifungal therapy or closely monitor for
breakthrough fungal infections. Delayed-release suspension is not recommended in adults or
pediatric patients >40 kg; recommended dosage cannot be achieved.
Storage • Suspension: Store at room temperature in a dry place.
• Injection: Store intact vials at 2°C to 8°C. Diluted solution for infusion may be stored for ≤24
hours at 2°C to 8°C
• Refer to manufacturer PIL if there are specific considerations.

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Antimalarial agents
1. Artemether and lumefantrine
Generic Name Artemether and lumefantrine

Dosage Tablet: 20 mg + 120 mg

form/strengths
Route of Oral
administration
Pharmacological Antimalarial Agent
category ATC: P01BF01
Indications Malaria, treatment: Treatment of acute, uncomplicated malaria infections due to
Plasmodium falciparum, including geographical regions where chloroquine resistance has
been reported.
Dosage Regimen -Adult Dosing:
-Malaria, treatment: 3-day schedule: Oral:
Patients ≥35 kg: 4 tablets at hour 0 and hour 8 on the first day, then 4 tablets twice daily on
day 2 and day 3 (total of 24 tablets per treatment course).

-Pediatric Dosing:
Infants ≥2 months, Children, and Adolescents: Oral

-5 kg to <15 kg: One tablet at hour 0 and at hour 8 on the first day and then one tablet twice
daily (in the morning and evening) on days 2 and 3 (total of 6 tablets per treatment course).

-15 kg to <25 kg: Two tablets at hour 0 and at hour 8 on the first day and then two tablets
twice daily (in the morning and evening) on days 2 and 3 (total of 12 tablets per treatment
course).

-25 kg to <35 kg: Three tablets at hour 0 and at hour 8 on the first day and then three
tablets twice daily (in the morning and evening) on day 2 and 3 (total of 18 tablets per
treatment course).

-≥35 kg: Four tablets at hour 0 and at hour 8 on the first day and then four tablets twice
daily (in the morning and evening) on days 2 and 3 (total of 24 tablets per treatment
course).
Dosage -Renal Impairment:
adjustment -Mild or moderate impairment: Dosage adjustments are not recommended
- Severe impairment: Use with caution (has not been studied).

-Hepatic Impairment:
-Mild or moderate impairment: Dosage adjustments are not recommended
-Severe impairment : Use with caution (has not been studied).

Contra- -Hypersensitivity to artemether, lumefantrine, or any component of the formulation

indications -Concurrent use with strong CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin, St
John’s wort)
Adverse Drug ->10%:
Reactions -Cardiovascular: Palpitation (adults: 18%)
-Central nervous system: Headache (adults 56%; children 13%), dizziness (adults 39%;

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children 4%), fever (25% to 29%), chills (adults 23%; children 5%), sleep disorder (adults:
22%), fatigue (adults 17%; children 3%)
-Gastrointestinal: Anorexia (adults 40%; children 13%), nausea (adults 26%; children 5%),
vomiting (17% to 18%), abdominal pain (8% to 17%)
-Infection: Plasmodium falciparum (exacerbation: children: 17%)
-Neuromuscular & skeletal: Weakness (adults 38%; children 5%), arthralgia (adults 34%;
children 3%), myalgia (adults 32%; children 3%)
-Respiratory: Cough (adults 6%; children 23%)
-Miscellaneous: Fever (25% to 29%)
-3% to 10%:
-Central nervous system: Insomnia (adults: 5%), malaise (adults: 3%), vertigo (adults: 3%)
-Dermatologic: Pruritus (adults: 4%), skin rash (3%)
-Gastrointestinal: Diarrhea (7% to 8%)
-Hematologic & oncologic: Anemia (4% to 9%)
-Hepatic: Hepatomegaly (6% to 9%), increased serum AST (≤4%)
-Infection: Malaria (≤3%)
-Respiratory: Rhinitis (4%), nasopharyngitis (≤3%)
Monitoring -Adequate food consumption (to ensure absorption and efficacy)
Parameters -ECG monitoring if concomitant use of other agents that prolong the QT interval is
medically required
Drug Risk X: Avoid combination
Interactions CYP3A4 Inducers (Strong) Fexinidazole Halofantrine St John's Wort
Risk D: Consider therapy modification
Antimalarial Agents Dapsone Hormonal Contraceptives Mequitazine Ubrogepant
Pregnancy and Category C
Lactation Artemether/lumefantrine may be used to treat chloroquine resistant uncomplicated
malaria during the second and third trimesters. Artemether/lumefantrine also may be used
as an alternative treatment during the first trimester when preferred agents are not
available. In pregnant patients with severe malaria, artemether/lumefantrine is the
preferred interim oral therapy when the preferred IV agent is not readily available
(discontinue once IV treatment is initiated). Dosing is the same as nonpregnant patients

Estimates of its excretion into breastmilk indicate that amounts in milk are very low. The
Centers for Disease Control and Prevention consider the drug combination acceptable for
use in mothers nursing an infant weighing at least 5 kg.
Administration -Oral:
Administer with a full meal for best absorption.
- For patients unable to swallow tablets: Crush tablet and mix with 5-10 mL of water.
Administer to patient. Rinse container with water and administer contents to the patient.
The crushed mixture should be followed with food/drink if possible.
-Repeat dose if vomiting occurs within 2 hours of administration; for persistent vomiting,
explore alternative therapy.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ • Drugs that prolong the QT interval: Avoid use in patients receiving other agents that
Precautions prolong the QT interval; consider alternative therapy. ECG monitoring is advised if
concomitant use of agents that prolong the QT interval is medically required.
-Avoid use in patients at risk for QT prolongation,
- Not indicated for the treatment of severe or complicated malaria or for the prevention of
malaria.

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- In the event of disease reappearance after a quiescent period, patients should be treated
with a different antimalarial drug.
Storage Store at 25°C, excursions permitted to 15°C to 30°C
Refer to manufacturer PIL if there are specific considerations.

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2. Artesunate

Generic Name Artesunate

Dosage -Tablet: 50 mg
form/strengths
Route of Oral
administration
Pharmacologic -Antimalarial Agent
category -Artemisinin Derivative
ATC: P01BE03
Indications Malaria (severe), treatment: Initial treatment of severe malaria in adult and pediatric
patients.
Dosage -Ault or Pediatric Dosing:
Regimen -Malaria (uncomplicated), treatment:

Artesunate- Body weight (kg) Dose administered orally once daily for
amodiaquin 3 days:
e
4.5 to <9 25 mg plus 67.5 mg

9 to <18 50 mg plus 135 mg

18 to <36 100 mg plus 270 mg

≥36 200 mg plus 540 mg

Artesunate- Body weight (kg) Dose administered orally once daily for
mefloquine 3 days:

5 to <9 25 mg plus 55 mg

9 to <18 50 mg plus 110 mg

18 to <30 100 mg plus 220 mg

≥30 200 mg plus 440 mg

Artesunate- Body weight (kg) Artesunate (single dose orally on

sulfadoxine (orally once day 1 of
- daily for 3 (500 mg sulfadoxine
pyrimetham days): and 25 mg
ine pyrimethamine):

5 to <10 25 mg 250 mg plus 12.5

mg

10 to <25 50 mg 500 mg plus 25 mg

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25 to <50 100 mg 1000 mg plus 50
mg

≥50 200 mg 1500 mg plus 75

mg

if used alone (via the parenteral, rectal, or oral route), artesunate must be administered for
five to seven days.
Dosage -Adult:
adjustment -Renal Impairment:
No dosage adjustment necessary.

-Hepatic Impairment:
No dosage adjustment necessary.
Contra- - Hypersensitivity to artesunate or any component of the formulation.
indications
Adverse Drug -1% to 10%:
Reactions -Genitourinary: Hemoglobinuria (7%)
-Hepatic: Jaundice (2%)
-Nervous system: Neurological signs and symptoms (1%)
-Renal: Acute renal failure (9%)
Monitoring - Signs/symptoms of hypersensitivity
Parameters -Hb, reticulocyte count, haptoglobin, lactate dehydrogenase, and total bilirubin once weekly
for up to 4 weeks after artesunate initiation
Drug - Risk D: Consider therapy modification
Interactions Artemether and Lumefantrine, Dapsone

Pregnancy and -An increased risk of adverse pregnancy outcomes has not been observed following maternal
Lactation use of artesunate.
-Severe malaria is especially hazardous during pregnancy, therefore full dose parenteral
antimalarial treatment should be administered without delay.
Limited information indicates that a maternal dose of 200 mg orally produced low levels in
milk and would not be expected to cause any adverse effects in breastfed infants, especially
if the infant is older than 2 months. Withholding breastfeeding for 6 hours after a dose
should markedly reduce the dose the infant receives.
Administration Administration: Oral
Tablets should be swallowed with water. Do not administer with a high fat meal. If patient
vomits within 30 minutes of administration, re-administer the dose.
Warnings/ - Artesunate has not been evaluated in the treatment of severe malaria due to Plasmodium
Precautions vivax, Plasmodium malariae or Plasmodium ovale.
Switching to oral treatment regimen
-Acute treatment of severe falciparum malaria with should always be followed by a complete
treatment course of an appropriate oral combination antimalarial regimen
Storage • Store intact vials and diluent at 20°C to 25°C; excursions permitted to 15°C to 30°C.
Protect from light.
• Refer to manufacturer PIL if there are specific considerations.

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3. Artesunate and amodiaquine

Generic Name Artesunate and amodiaquine

Dosage Tablets 50mg/200mg

form/strengths
Route of Oral
administration
Pharmacologic Aminoquinoline (Antimalarial); Antimalarial Agent; Artemisinin Derivative
category ATC: P01BF03
Indications Malaria: Treatment of uncomplicated malaria due to susceptible strains of Plasmodium
falciparum.
Dosage Dosing: Adult
Regimen Malaria: Oral: Artesunate 4 mg/kg (range 2 to 10 mg/kg) and amodiaquine 10 mg/kg (range
7.5 to 15 mg/kg) once daily for 3 days.
Dosing: Pediatric
Malaria: Oral: Infants ≥2 months, Children, and Adolescents:
Dosing recommendation based on the following weight-based dosing: Artesunate 4 mg/kg
(range 2 to 10 mg/kg) and amodiaquine 10 mg/kg (range 7.5 to 15 mg/kg) once daily for 3
days

Dosage Dosing: Renal Impairment:

adjustment There are no dosage adjustments provided; use with caution.
Dosing: Hepatic Impairment:
There are no dosage adjustments provided; use with caution.

Contra- Hypersensitivity to artesunate, amodiaquine, or any component of the formulation; hepatic

indications injury or hematologic abnormality with previous amodiaquine treatment; retinopathy; use
for malaria prophylaxis

Adverse Drug 1% to 10%:

Reactions Central nervous system: Dizziness, drowsiness, headache, insomnia, shivering
Gastrointestinal: Abdominal pain, anorexia, nausea, sore throat
Hematologic & oncologic: Leukopenia, neutropenia
Hepatic: Increased serum transaminases
Infection: Common cold, influenza
Neuromuscular & skeletal: Asthenia
Respiratory: Bronchitis, cough, rhinitis

Monitoring Liver function in patients with symptoms of hepatitis; CBC in patients with symptoms of
Parameters immunosuppression (fever, tonsillitis, mouth ulcers)

Drug Risk X: Avoid combination

Interactions CYP2C8 Inhibitors (Moderate) or (strong) Efavirenz Trimethoprim Zidovudine
Risk D: Consider therapy modification
Artemether and Lumefantrine Dapsone (Systemic) Dapsone (Topical) Sulfamethoxazole

Pregnancy and Adverse events were observed in some animal reproduction studies using this combination.

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Lactation Agents other than artesunate/amodiaquine are recommended during the first trimester;
use later in pregnancy may be considered, although information related to this combination
is limited. Also refer to the Artesunate monograph for additional information.
Small amounts of artesunate and amodiaquine are present in breast milk. Adverse events in
the nursing infant would not be expected.
When treatment for malaria is needed, this combination may be used in breastfeeding
women.
Administration Administration: Oral
Administer at the same time each day with water. Avoid administration with high fat meals.
If patient vomits within 30 minutes of administration, repeat full dose.
Refer to manufacturer PIL if there are specific considerations.

Warnings/ Concerns related to adverse effects:

Precautions • Cardiovascular effects: Cardiovascular effects have been reported with amino-4-quinolone
derivatives. Due to the potential of QT prolongation, use caution
• CNS depression: May cause CNS depression, which may impair physical or mental abilities;
patients must be cautioned about performing tasks that require mental alertness (eg,
operating machinery or driving).
• Extrapyramidal symptoms (EPS): May cause extrapyramidal symptoms; can occur after
one dose. Symptoms should resolve with discontinuation of therapy; an alternative
antimalarial treatment should be initiated.
• Hematologic effects: Rare hematologic reactions including anemia, agranulocytosis, and
neutropenia have been reported; monitor CBC if signs/symptoms of infection occur.
Discontinue treatment if signs/symptoms of severe blood disorder not attributable to
underlying disease occur. Use for malaria prophylaxis is contraindicated due to risk of
agranulocytosis.
Disease-related concerns:
• Hepatic impairment: Use with caution in patients with hepatic impairment; has not been
studied. Monitor for signs/symptoms of hepatitis.
• Renal impairment: Use with caution in patients with renal impairment; has not been
studied.
Other warnings/precautions:
• Appropriate use: Artesunate/amodiaquine should not be used to treat complicated
malaria or other strains of Plasmodium malaria. Artesunate/amodiaquine should not be
administered in areas with known resistance to amodiaquine due to an increased risk of
treatment failure and development of resistance to artesunate. Use for malaria prophylaxis
is contraindicated

Storage • Store at ≤30°C

• Refer to manufacturer PIL if there are specific considerations.

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4. Chloroquine

Generic Name Chloroquine

Dosage Suspension: 80 mg/5 ml

form/strengths Tablet: 250 mg
Injection: 200 mg/5ml
Route of Oral
administration
Pharmacologic Antimalarial Agent, Aminoquinoline (Antimalarial)
category ATC: P01BA01
Indications -Malaria Treatment: treatment of uncomplicated malaria due to susceptible strains of
Plasmodium vivax, Plasmodium malariae, Plasmodium ovale, and Plasmodium falciparum
-Prophylaxis of malaria (in geographic areas where chloroquine resistance is not present)
- Extraintestinal amebiasis
Dosage -Adult Dosing:
Regimen Note: Each 250 mg of chloroquine phosphate is equivalent to 150 mg of chloroquine base.
-Malaria, uncomplicated, treatment:
Oral: 1 g (600 mg base) on day 1, followed by 500 mg (300 mg base) 6-, 24-, and 48 hours
after first dose
-Prophylaxis:
Oral: 500 mg (300 mg base) weekly on the same day each week; begin 1 to 2 weeks prior to
exposure; continue while in endemic area and for 4 weeks after leaving endemic area.
Extraintestinal amebiasis: Oral: 1 g (600 mg base) daily for 2 days followed by 500 mg daily
(300 mg base) for at least 2 to 3 weeks; may be combined with an intestinal amebicide.
-Pediatric Dosing:
-Malaria:
-Treatment, acute attack, uncomplicated:
Infants, Children, and Adolescents: Oral: Initial 16.7 mg/kg chloroquine phosphate
(maximum initial dose: 1,000 mg chloroquine phosphate); followed by 8.3 mg/kg
chloroquine phosphate (maximum dose: 500 mg chloroquine phosphate/dose)
administered at 6, 24, and 48 hours after initial dose for a total of 4 doses
-Chemoprophylaxis:
Infants, Children, and Adolescents: Oral: 8.3 mg/kg chloroquine phosphate once weekly on
the same day each week; maximum dose: 500 mg chloroquine phosphate/dose. Begin 1 to
2 weeks prior to exposure; continue while in endemic area and continue for at least 4
weeks after leaving endemic area

Dosage -Adult:
adjustment -Renal Impairment:
-GFR ≥10 mL/minute: No dosage adjustment necessary.
-GFR <10 mL/minute: in prolonged use: administer 50% of dose
-Hepatic Impairment:
Chloroquine concentrates in the liver. However, no specific dosage adjustment guidelines
are available for patients with hepatic impairmentaution.
Contra- -Hypersensitivity to chloroquine, 4-aminoquinoline compounds, or any component of the
indications formulation
-Presence of retinal or visual field changes of any etiology (when used for indications other
than acute malaria)

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Adverse Drug Frequency not defined:
Reactions -Cardiovascular: Atrioventricular block, bundle branch block, cardiac arrhythmia, cardiac
failure, cardiomyopathy, ECG changes (including flattened T wave on ECG, inversion T wave
on ECG, prolonged QT interval on ECG, widened QRS complex on ECG), hypotension,
torsades de pointes, ventricular fibrillation, ventricular tachycardia
-Dermatologic: Alopecia, bleaching of hair, blue-gray skin pigmentation (oral mucosa and
hard palate, nails, and, erythema multiforme, exacerbation of psoriasis, exfoliative
dermatitis, lichen planus, pleomorphic rash, pruritus, skin photosensitivity, Stevens-Johnson
syndrome, toxic epidermal necrolysis, urticaria
-Endocrine & metabolic: Exacerbation of porphyria, severe hypoglycemia
-Gastrointestinal: Abdominal cramps, anorexia, diarrhea, nausea, vomiting
-Hematologic & oncologic: Agranulocytosis (reversible), aplastic anemia, hemolytic anemia
(in G6PD-deficient patients), neutropenia, pancytopenia, thrombocytopenia
Hepatic: Hepatitis, increased liver enzymes
Hypersensitivity: Anaphylaxis, angioedema
Immunologic: Drug reaction with eosinophilia and systemic symptoms
Nervous system: Agitation, anxiety, confusion, decreased deep tendon reflex, delirium,
depression, extrapyramidal reaction (dystonia, dyskinesia, protrusion of the tongue,
torticollis), hallucination, headache, insomnia, personality changes, polyneuropathy,
psychosis, seizure, sensorimotor neuropathy, sensorineural hearing loss, suicidal tendencies
-Neuromuscular & skeletal: Asthenia, myopathy, neuromuscular disease, proximal
myopathy
-Ophthalmic: Accommodation disturbances, blurred vision, corneal opacity (reversible),
macular degeneration (may be irreversible), maculopathy (may be irreversible), night
blindness, retinal pigment changes (bull’s eye appearance), retinopathy (including
irreversible changes in long-term or high-dose therapy), transient scotomata, visual field
defect (paracentral scotomas)
-Otic: Hearing loss (risk increased in patients with preexisting auditory damage), tinnitus

Monitoring - CBC (with differential), liver function, and renal function at baseline and periodically
Parameters during therapy
-Blood glucose (if symptoms of hypoglycemia occur)
-Muscle strength
-ECG at baseline and as clinically indicated: in patients at elevated risk of QTc prolongation
-Ophthalmologic exam at baseline to screen for retinal toxicity, followed by annual
screening beginning after 5 years of use (or sooner if major risk factors are present).
Drug Risk X: Avoid combination
Interactions Agalsidase Alfa, Artemether, Cimetidine, Fexinidazole, Lumefantrine, Mefloquine, Pimozide
QT-prolonging Strong Aprepitant Cimetidine Ciprofloxacin Clarithromycin Diltiazem
Erythromycin Fluconazole Grapefruit juice Itraconazole Ketoconazole Posaconazole
Voriconazole Verapamil, Remdesivir
Risk D: Consider therapy modification
Agalsidase Beta, Ampicillin, Antacids, Cholera Vaccine, Dapsone, Domperidone, Lanthanum,
Rabies Vaccine

Pregnancy and Category C

Lactataion Chloroquine may be used in all trimesters of pregnancy according to guidelines. Dose
adjustments could be needed, but data are not sufficient to determine what an appropriate
dosing change is when chloroquine is used for the treatment or prophylaxis of malaria
during pregnancy. According to WHO Pregnant patients should be closely monitored for

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response to treatment.
Very small amounts of chloroquine are excreted in breast milk; when given once weekly,
the amount of drug is not sufficient to harm the infant nor is the quantity sufficient to
protect the child from malaria. Because no information is available on the daily use of
chloroquine during breastfeeding, hydroxychloroquine or another agent may be preferred
in this situation, especially while nursing a newborn or preterm infant.
Administration Oral: Administer with food to decrease GI adverse effects.
Refer to manufacturer PIL if there are specific considerations.

Warnings/ Concerns related to adverse effects:

Precautions • Cardiovascular effects: Cases of cardiomyopathy resulting in cardiac failure (sometimes
fatal) have been reported during long term therapy at high doses. Monitor for signs and
symptoms of cardiomyopathy; discontinue if cardiomyopathy develops.
• Extrapyramidal effects: Acute extrapyramidal disorders may occur, usually resolving after
discontinuation of therapy and/or symptomatic treatment.
• Hematologic effects: Rare hematologic reactions including reversible agranulocytosis,
aplastic anemia, neutropenia, pancytopenia, and thrombocytopenia have been reported;
monitor CBC during prolonged therapy. Consider discontinuation if severe blood disorders
occur that are unrelated to disease.
• Hypoglycemia: Severe hypoglycemia, including loss of consciousness, has been reported in
patients treated with or without antidiabetic agents. Counsel patients about risk of
hypoglycemia and associated signs and symptoms.
• Neuromuscular effects: Skeletal muscle myopathy or neuromyopathy, leading to
progressive weakness and atrophy of proximal muscle groups have been reported; muscle
strength (especially proximal muscles) should be assessed periodically during prolonged
therapy; discontinue therapy if weakness occurs.
• Retinal toxicity: Retinal toxicity, potentially causing irreversible retinopathy, is
predominantly associated with high daily doses and a duration of >5 years of use of
chloroquine or hydroxychloroquine in the treatment of rheumatic diseases.
Disease-related concerns:
• Auditory damage: Use with caution in patients with preexisting auditory damage;
discontinue immediately if hearing defects are noted.
• G6PD deficiency: Use chloroquine with caution in patients with these conditions. Blood
monitoring for hemolytic anemia in G6PD deficiency patients may be necessary, particularly
with concomitant use of other medications associated with hemolysis
• Hepatic impairment: Use with caution in patients with hepatic impairment, alcoholism, or
concurrent therapy with hepatotoxic agents.
• Myasthenia gravis: Use may worsen or precipitate new myasthenia gravis (MG); use only
if necessary and monitor for worsening MG.
• Porphyria: Use with caution in patients with porphyria; may exacerbate disease
symptoms.
• Psoriasis: Use with caution in patients with psoriasis; may exacerbate disease symptoms.
• Seizure disorder: Use with caution in patients with a history of seizure disorder; may
cause seizures.
Other warnings/precautions:
• Appropriate use: Chloroquine does not prevent relapses in patients with vivax or ovale
malaria (not effective against exoerythrocytic forms); additional treatment with an
antimalarial effective against these forms (eg, an 8-aminoquinoline) is required for the
treatment of infections with P. vivax and P. ovale. Do not use for the treatment of
complicated malaria (high-grade parasitemia and/or complications [eg, cerebral malaria,

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acute renal failure]).
• Chloroquine resistance: Chloroquine is not effective against chloroquine- or
hydroxychloroquine-resistant strains of Plasmodium species. Chloroquine resistance is
widespread in P. falciparum and is reported in P. vivax. Prior to initiation of chloroquine for
prophylaxis, it should be determined if chloroquine is appropriate for use in the region to be
visited; do not use for malaria prophylaxis in areas where chloroquine resistance occurs.
Storage -Store at 25°C, excursions are permitted between 15°C and 30°C.
-Protect from light.
Refer to manufacturer PIL if there are specific considerations.

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5. Hydroxychloroquine

Generic Name Hydroxychloroquine

Dosage Tablets 200mg

form/strengths
Route of Oral
administration
Pharmacologic Aminoquinoline (Antimalarial); Antimalarial Agent
category ATC: P01BA02
Indications Lupus erythematosus: Treatment of chronic discoid erythematosus and systemic lupus
erythematosus in adults.

Malaria: Treatment of uncomplicated malaria caused by susceptible strains of Plasmodium

vivax, Plasmodium malariae, Plasmodium ovale, and Plasmodium falciparum; prophylaxis of
malaria in geographic areas where chloroquine resistance is not reported. Note: The CDC
guidelines also recommend hydroxychloroquine for chloroquine-sensitive Plasmodium
knowlesi malaria.

Rheumatoid arthritis: Treatment of acute and chronic rheumatoid arthritis in adults.

Dosage Note: All doses below expressed as hydroxychloroquine sulfate. Hydroxychloroquine sulfate
Regimen 200 mg is equivalent to 155 mg hydroxychloroquine base
Adult Dosing:
Note: Due to the risk of retinal toxicity, most patients should not receive a daily dose >5
mg/kg/day using actual body weight or 400 mg, whichever is lower.
Lupus erythematosus:
Systemic lupus erythematosus:
Oral: 200 to 400 mg daily as a single daily dose or in 2 divided doses.
Discoid lupus erythematosus and subacute cutaneous lupus erythematosus:
Oral: 200 to 400 mg daily as a single daily dose or in 2 divided doses.
Malaria (alternative agent):
Prophylaxis:
Oral: 400 mg once weekly on the same day each week; begin 1 to 2 weeks before travel to
malarious area; continue therapy while in malarious area and for 4 weeks after leaving the
area.
Treatment, uncomplicated:
Oral: 800 mg once, followed by 400 mg at 6, 24, and 48 hours after initial dose
(total dose: 2 g).
Rheumatoid arthritis:
Oral: 200 to 400 mg daily as a single daily dose or in 2 divided doses.
Pediatric dosing:
Malaria:
Chemoprophylaxis:
Infants, Children, and Adolescents: Oral: 6.5 mg/kg hydroxychloroquine sulfate once weekly
on the same day each week; maximum dose: 400 mg/dose hydroxychloroquine sulfate; begin
1 to 2 weeks before travel to malarious area; continue while in malarious area and for 4
weeks after leaving the area.
Treatment, uncomplicated: Infants, Children, and Adolescents: Oral: Initial: 12.9 mg/kg/dose
hydroxychloroquine sulfate (maximum initial dose: 800 mg/dose hydroxychloroquine

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sulfate); followed by 6.5 mg/kg hydroxychloroquine sulfate at 6, 24, and 48 hours after initial
dose; maximum dose: 400 mg/dose hydroxychloroquine sulfate. For infection caused
by Plasmodium vivax or Plasmodium ovale, use in combination with appropriate antirelapse
treatment (ie, primaquine).
Dosage Dosing: Renal Impairment: Adult
adjustment Mild to severe impairment:
There is no dosage adjustment necessary with short-term use; however, dosage reduction
may be needed with prolonged use (eg, systemic lupus erythematosus); use with caution.
Dosing: Hepatic Impairment: Adult
There are no dosage adjustments provided in the manufacturer's labeling; use with caution.
Contra- Known hypersensitivity to hydroxychloroquine, 4-aminoquinoline derivatives, or any
indications component of the formulation.
Major Adverse Adverse Reactions (Significant): Considerations
Drug Reactions • Cardiomyopathy
• Hypersensitivity reactions (delayed)
• Hypoglycemia
• Neuromuscular effects
• Neuropsychiatric effects
• QT prolongation
• Retinal toxicity
1% to 10%: Ophthalmic: Retinopathy (4%; serum concentration dependent; early changes
reversible [may progress despite discontinuation if advanced])
Monitoring CBC (with differential) at baseline and periodically; liver function; renal function (in patients
Parameters at risk for ocular toxicity); blood glucose (if symptoms of hypoglycemia occur); muscle
strength (especially proximal) during long-term therapy; in patients at risk of torsades de
pointes, monitor ECG at baseline and periodically during therapy to assess for QTc
prolongation.
Ophthalmologic exam at baseline to screen for retinal toxicity, followed by annual screening
beginning after 5 years of use (or sooner if major risk factors are present). Consider annual
exams (without deferring 5 years) in patients with significant risk factors.
Common Drug Risk X: Avoid combination
Interactions Lumefantrine Mefloquine Remdesivir
Risk D: Consider therapy modification
Dapsone (Systemic) (Topical)
Pregnancy and This drug should not be used during pregnancy unless the benefit outweighs the risk to the
Lactation fetus. US FDA pregnancy category: Not formally assigned to a pregnancy category
International experts indicate that hydroxychloroquine is acceptable during breastfeeding
Administration Administration: Oral
Administer with food or milk. Do not crush or divide film-coated tablets; the tablets have a
bitter taste. In patients unable to swallow tablets, it has been recommended that
tablets may be crushed and mixed with a small amount of applesauce, chocolate
syrup, or jelly.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Cardiovascular effects: Cardiomyopathy resulting in cardiac failure, sometimes fatal, has
been reported (symptoms may present as atrioventricular block, pulmonary hypertension,
sick sinus syndrome, or as cardiac complications), and may appear during acute or chronic
therapy. Monitor for signs/symptoms of cardiac compromise; discontinue treatment
promptly if signs and symptoms of cardiomyopathy occur. May also be associated with QT

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interval prolongation; ventricular arrhythmia and torsades de pointes have been reported
(monitor QT-prolonging effects during therapy in at-risk patients or if used in combination
with other medications that prolong the QT interval).
• Dermatologic effects: Skin reactions to hydroxychloroquine may occur; use with caution in
patients on concomitant medications with a propensity to cause dermatitis.
• Hematologic effects: Bone marrow suppression (eg, agranulocytosis, anemia, aplastic
anemia, leukopenia, thrombocytopenia) have been reported; periodically monitor CBC during
prolonged therapy. Discontinue treatment if signs/symptoms of severe blood disorder not
attributable to the underlying disease occur.
• Hypoglycemia: Severe hypoglycemia, including life-threatening loss of consciousness, has
been reported in patients with and without concomitant use of antidiabetic agents. Advise
patients of risk of hypoglycemia and associated signs/symptoms; discontinue use in patients
who develop severe hypoglycemia.
• Neuromuscular effects: Proximal myopathy or neuromyopathy, leading to progressive
weakness, proximal muscle atrophy, depressed tendon reflexes, and abnormal nerve
conduction may occur, especially with long-term therapy. Curvilinear bodies and muscle fiber
atrophy with vacuolar changes have been noted on muscle or nerve biopsy. Muscle strength
(especially proximal muscles) and reflexes should be assessed periodically during long term
therapy.
• Psychiatric effects: Suicidal behavior has been reported rarely.
• Retinal toxicity: Retinal toxicity, potentially causing irreversible retinopathy, is
predominantly associated with high daily doses and a duration of >5 years of use of
chloroquine or hydroxychloroquine in the treatment of rheumatic diseases. If ocular toxicity
is suspected, discontinue and monitor closely; retinal changes and visual disturbances may
progress after discontinuation. A baseline ocular exam is recommended within the first year
of initiating hydroxychloroquine treatment.
Disease-related concerns:
• G6PD deficiency: use with caution due to a potential for hemolytic anemia.
• Gastrointestinal disorders: Use with caution in patients with gastrointestinal disorders.
• Hepatic impairment: Use with caution in patients with hepatic impairment, alcoholism, or
concurrent therapy with hepatotoxic agents.
• Myasthenia gravis: Use with caution in patients with myasthenia gravis; may exacerbate
condition.
• Porphyria: Use with extreme caution in patients with porphyria; may exacerbate or
precipitate disease.
• Psoriasis: Use with extreme caution in patients with psoriasis; may exacerbate or
precipitate disease.
• Renal impairment: Use with caution in patients with renal impairment; dosage reduction
may be needed.
Special populations:
• Pediatric: Pediatric patients have an increased sensitivity to aminoquinolines
Storage Store at 20°C to 25°C; excursions permitted to 15°C- 30°C. Protect from light.
Refer to manufacturer PIL if there are specific considerations.

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6. Mefloquine
Generic Name Mefloquine

Dosage Tablet: 250 mg

form/strengths
Route of Oral
administration
Pharmacologic Antimalarial Agent
category ATC: P01BC02
Indications -Malaria prophylaxis: Prophylaxis of Plasmodium falciparum and Plasmodium vivax malaria
infections, including prophylaxis of chloroquine-resistant strains of P. falciparum.

-Malaria treatment: Treatment of uncomplicated malaria caused by mefloquine-susceptible

strains of P. falciparum or by P. vivax.
Dosage -Adult Dosing:
Regimen -Malaria: Oral (dose expressed as mg of mefloquine hydrochloride):
-Uncomplicated malaria, treatment: 750 mg as initial dose, followed 6 to 12 hours later by
500 mg.
-Prophylaxis: 250 mg weekly starting ≥2 weeks before arrival in endemic area, continuing
weekly during travel and for 4 weeks after leaving endemic area

-Pediatric Dosing:
- Malaria, treatment; chloroquine-resistant (independent of HIV status):
Infants, Children, and Adolescents: Oral: 15 mg/kg once (maximum dose: 750 mg/dose)
followed in 6 to 12 hours with 10 mg/kg once (maximum dose: 500 mg/dose); use in
combination with other anti-malarial agents

- Malaria; chemoprophylaxis (independent of HIV status):

-Begin ≥2 weeks before arrival in endemic area, administer on the same day each week, and
continue weekly during travel and for 4 weeks after leaving endemic area
-Infants, Children, and Adolescents:
-Weight-based dosing: Oral: 5 mg/kg/dose once weekly; maximum dose: 250 mg/dose
Dosage -Renal Impairment:
adjustment No dosage adjustment necessary
-Hepatic impairment:
-No dosage adjustments available. Mefloquine should be used with caution in patients with
hepatic disease. The elimination of mefloquine may be prolonged, leading to higher plasma
drug concentrations
Contra- -Hypersensitivity to mefloquine, related compounds (eg, quinine and quinidine), or any
indications component of the formulation
-Prophylactic use in patients with a history of seizures or psychiatric disorder (including
active or recent history of depression, generalized anxiety disorder, psychosis,
schizophrenia, or other major psychiatric disorders)
Adverse Drug ->10%:
Reactions - Central nervous system: Abnormal dreams (14%)insomnia (13%)
-1% to 10%:
-Gastrointestinal: Vomiting (3%)
Monitoring On prolonged use, monitor:
Parameters -Liver function tests

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-Make evaluations for neuropsychiatric effects
-Ocular examinations
Drug -Category X: Avoid combination
Interactions Abametapir, Aminoquinolines, Artemether, Conivaptan, Halofantrine, Idelalisib,
Lumefantrine, Quinidine
-Category D: Consider therapy modification
Anticonvulsants, Clarithromycin Itraconazole Ketoconazole Posaconazole Barbiturates
(phenobarbital) Carbamazepine Phenytoin Rifampicin Dabrafenib, Dapsone, Enzalutamide,
Mifepristone, Stiripentol
Pregnancy and Category B. When other treatment options are not available, mefloquine may be used for
Lactation the treatment of chloroquine-resistant uncomplicated malaria in pregnancy.
Mefloquine concentrations in breast milk are ~3% to 4% of a 250 mg dose. Mefloquine is
considered acceptable for use in breastfeeding women. Use caution
Administration Oral:
-Administer with food and with at least 240 mL of water.
-When used for malaria prophylaxis, dose should be taken once weekly on the same day
each week.
-If vomiting occurs within 30 minutes after the dose, an additional full dose should be given
-If it occurs within 30 to 60 minutes after dose, an additional half-dose should be given.
-Tablets may be crushed and suspended in a small amount of water, milk, or another
beverage for persons unable to swallow tablets.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Agranulocytosis/aplastic anemia: Agranulocytosis and aplastic anemia have been
reported.
• Altered cardiac conduction: Mefloquine may cause alterations in the ECG including sinus
bradycardia, sinus arrhythmia, first-degree AV block, QT-interval prolongation, and
abnormal T waves. Use caution or avoid concomitant use of agents known to cause QT-
interval prolongation (eg, halofantrine, quinine, quinidine).
• Hypersensitivity reactions: Hypersensitivity reactions have occurred.
• Neuropsychiatric effects: [US Boxed Warning]: May cause neuropsychiatric adverse
effects that can persist after mefloquine has been discontinued. During prophylactic use, if
symptoms occur, discontinue therapy and substitute an alternative medication.
Disease-related concerns:
• Cardiovascular disease: Use with caution in patients with significant cardiac disease; ECG
changes (eg, sinus bradycardia, sinus arrhythmia, first-degree AV block, QT-interval
prolongation, abnormal T waves) have been reported.
• Hepatic impairment: Use with caution in patients with hepatic impairment; elimination
may be prolonged.
• Neuropsychiatric disorders: [US Boxed Warning]: Do not prescribe for prophylaxis in
patients with major psychiatric disorders including patients with active depression, a recent
history of depression, generalized anxiety disorder, psychosis, schizophrenia; use is
contraindicated in these patients. Use with caution in patients with a previous history of
depression.
• Ocular effects: Eye disorders (including optic neuropathy and retinal disorders) have been
reported during treatment. If visual symptoms develop during treatment, prompt
ophthalmologic evaluation is warranted; discontinuation of therapy may be necessary.
• Plasmodium falciparum infections: Appropriate use: In cases of life-threatening, serious,
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treated with intravenous antimalarial drug. Mefloquine may be given orally to complete the
course.
• Plasmodium vivax infections: Appropriate use: In cases of acute Plasmodium
vivax infection treated with mefloquine, patients should subsequently be treated with an 8-
aminoquinoline derivative (eg, primaquine) to avoid relapse.
• Seizure disorder: When using for treatment, use with caution in patients with a history of
seizures; may increase risk of seizures. Prophylactic use is contraindicated in patients with
seizure disorder.
Special populations:
• Pediatric: Early vomiting leading to treatment failure in children has been reported in
some studies; consider alternate therapy if a second dose is not tolerated.
Other warnings/precautions:
• Appropriate use: Not recommended for the treatment of malaria acquired in Southeast
Asia due to drug resistance.
• Prolonged use: If mefloquine is to be used for a prolonged period, liver function tests,
evaluations for neuropsychiatric effects, and ophthalmic examinations should be performed
periodically.
Storage Store at 20°C to 25°C. 15-30°C is permitted.
Refer to manufacturer PIL if there are specific considerations.

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7. Pyrimethamine
Generic Name Pyrimethamine

Dosage Pyrimethamine 25 mg tablets

form/strengths
Route of Oral
administration
Pharmacologic Antimalarial Agent
category ATC: P01BD01
Indications Toxoplasmosis (in combination with a sulfonamide).

Dosage -Adult Dosing:

Regimen Toxoplasmosis treatment: Oral: 50 to 75 mg/day for 1 to 3 weeks depending on patient's
tolerance and response, then may reduce dose by 50% and continue for 4 to 5 weeks; use
with a sulfonamide in combination with leucovorin calcium
-Pediatric Dosing:
- Toxoplasmosis, acquired infection (including encephalitis); treatment: Non-HIV-
exposed/-infected:
Use in combination with leucovorin (to prevent hematologic toxicity) and either
sulfadiazine or clindamycin.
Infants, Children, and Adolescents:
Oral: Initial: 2 mg/kg/day in divided doses twice daily for 2 days followed by 1 mg/kg/day
once daily (maximum dose: Chorioretinitis: 25 mg/dose; severe or CNS disease: 50
mg/dose). Continue therapy for 1 to 2 weeks after symptom resolution, for a total therapy
of 4 to 6 weeks.

-Toxoplasmosis, congenital infection (independent of HIV status); treatment:

In combination with sulfadiazine and leucovorin:
Infants: Oral: Initial: 2 mg/kg/day once daily or in 2 divided doses for 2 days, then 1
mg/kg/day once daily for 2 to 6 months, then 1 mg/kg/dose 3 times weekly ( maximum
dose: 25 mg/dose; total treatment duration: 12 months
Dosage -Renal Impairment:
adjustment No dosage adjustments needed.
-Hepatic Impairment:
Use cautiously in patients with hepatic impairment. Specific dosage recommendations are
not available.
Contra- -Hypersensitivity to pyrimethamine or any component of the formulation
indications -Megaloblastic anemia secondary to folate deficiency
Adverse Drug Frequency not defined.
Reactions Cardiovascular: Cardiac arrhythmia (large doses)
-Dermatologic: Erythema multiforme, skin rash, Stevens-Johnson syndrome, toxic epidermal
necrolysis
-Gastrointestinal: Anorexia, glossitis (atrophic), vomiting
-Hematologic & oncologic: Leukopenia, megaloblastic anemia, pancytopenia,
thrombocytopenia
-Genitourinary: Hematuria
-Hypersensitivity: Anaphylaxis
-Respiratory: Eosinophilic pneumonitis

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Monitoring -CBC, including platelet counts twice weekly with high-dose therapy
Parameters -Hepatic and renal function
Drug -Risk D: Consider therapy modification
Interactions Artemether and Lumefantrine, Dapsone , Folic Acid

Pregnancy and Category C

Lactation Pyrimethamine should be used with caution in patients with possible folate deficiency,
including pregnant women. If administered during pregnancy (ie, for toxoplasmosis),
supplementation of folate is strongly recommended.
During Breastfeeding, use is considered acceptable according to WHO.
Due to the potential for serious adverse reactions in the breastfed infant, It is
recommended a decision be made to discontinue breastfeeding or to discontinue the drug,
considering the importance of treatment to the mother, as well as use of concomitant
medications.
Administration Oral:
Administer with meals to minimize GI distress.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Hematologic: Megaloblastic anemia, leukopenia, thrombocytopenia, and pancytopenia
have been reported; most commonly with high doses. Monitor CBC and platelets twice
weekly in patients receiving high-dose therapy (eg, when used for toxoplasmosis
treatment).
Disease-related concerns:
• Folate deficiency: Use caution in patients with possible folate deficiency (eg,
malabsorption syndrome, alcoholism).
• G6PD deficiency: Use with caution in patients with possible G6PD deficiency.
• Hepatic impairment: Use with caution in patients with hepatic impairment.
• Renal impairment: Use with caution in patients with renal impairment.
• Seizure disorders: Use with caution in patients with a history of seizure disorders.
Other warnings/precautions:
• Leucovorin: Administer leucovorin to prevent hematologic complications due to
pyrimethamine-induced folic acid deficiency state; continue leucovorin during therapy and
for 1 week after therapy is discontinued (to account for long half-life of pyrimethamine)
Storage Store at 15°C to 25°C. Protect from light.
Refer to manufacturer PIL if there are specific considerations.

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8. Sulfadoxine and Pyrimethamine

Generic Name Sulfadoxine and Pyrimethamine

Dosage Tablet: Sulfadoxine 500 mg; Pyrimethamine 25 mg

form/strengths
Route of Oral
administration
Pharmacologic Antimalarial Agent
category ATC: P01BD51
Indications Short-term prophylaxis and treatment of uncomplicated Plasmodium falciparum malaria,
including areas where chloroquine resistance has been reported.
Dosage -Adult Dosing:
Regimen 1- Malaria prophylaxis: Start 1 to 2 weeks prior to entering a malaria-endemic area,
continue throughout the stay and for 4 weeks after returning.
- Semi-immune patients: Oral: Sulfadoxine 500 mg/pyrimethamine 25 mg per tablet: 2 or 3
tablets once every 4 weeks.
-Nonimmune patients: Oral: Sulfadoxine 500 mg/pyrimethamine 25 mg per tablet: 2 tablets
once every 2 weeks or 1 tablet once weekly.
2- Malaria (uncomplicated) treatment: Oral: Sulfadoxine 1,500 mg/pyrimethamine 75 mg (3
tablets) as a single dose.

-Pediatric Dosing:
1- Malaria prophylaxis: start 1 to 2 weeks prior to entering a malaria-endemic area, continue
throughout the stay and for 4 weeks after returning.
5-10 kg: 1/4 (0.25) tablet orally once a week
11-20 kg: 1/2 (0.5) tablet orally once a week
21-30 kg: 3/4 (0.75) tablet orally once a week
31-45 kg: 1 tablet orally once a week
>45 kg: 1.5 tablet orally once a week.

2- Malaria (uncomplicated) treatment: Oral: Administer the following weight-based

sulfadoxine/pyrimethamine dose on day 1. Monotherapy is not recommended. Do not use in
infants <2 months of age:
5-10 kg: One-half tablet orally one time
11-20 kg: 1 tablet orally one time
21-30 kg: 1.5 tablet orally one time
31-45 kg: 2 tablets orally one time
>45 kg: 3 tablets orally one time
Dosage -Renal impairment:
adjustment - Repeated prophylactic use of sulfadoxine; pyrimethamine is contraindicated in patients
with renal failure.
-Hepatic Impairment:
Repeated prophylactic use of sulfadoxine; pyrimethamine is contraindicated in patients with
hepatic failure.
Contra- Hypersensitivity to sulfadoxine, pyrimethamine, other sulfonamides, or any component of
indications the formulation
-Megaloblastic anemia due to folate deficiency
-Infants <2 months

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-Prophylactic use in patients with renal failure, hepatic failure, or blood dyscrasias

Adverse Drug -Cardiovascular: Allergic myocarditis

Reactions -Central nervous system: Apathy, ataxia, chills, depression, dizziness, drug fever (with toxic
necrosis), fatigue, hallucination, headache, insomnia, peripheral neuropathy,
polyneuropathy, seizure
-Dermatologic: Alopecia, erythema multiforme, exfoliative dermatitis, pruritus, skin
photosensitivity, skin rash, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria
-Gastrointestinal: Abdominal pain, diarrhea, gastrointestinal fullness, gastrointestinal
infection, glossitis, nausea, pancreatitis, stomatitis, vomiting
-Genitourinary: Anuria, urinary frequency
-Hematologic & oncologic: Agranulocytosis, aplastic anemia, eosinophilia, hemolytic anemia,
hypoprothrombinemia, leukopenia, megaloblastic anemia, methemoglobinemia,
pancytopenia, purpura, thrombocytopenia
Hepatic: Hepatic necrosis, hepatitis, increased liver enzymes (may be transient)
-Hypersensitivity: Anaphylactoid reaction
-Neuromuscular & skeletal: Arthralgia, lupus-like syndrome, myasthenia gravis
-Ophthalmic: Conjunctival hyperemia
-Otic: Tinnitus
-Respiratory: Pulmonary infiltrates
-Miscellaneous: Fever
Monitoring CBC and urinalysis periodically with prolonged administration of high doses
Parameters
Drug -Category X:
Interactions Aminolevulinic Acid, Artemether, BCG (Intravesical), Cholera Vaccine, Lumefantrine,
Methenamine, Procaine, Potassium P-Aminobenzoate
-Category D:
Chloroprocaine, Dapsone, Folic Acid, Methotrexate

Pregnancy and Category C

Lactation Because there is little published experience with sulfadoxine during breastfeeding, an
alternate drug may be preferred, especially while nursing a newborn or preterm infant.
Administration Oral:
Administer after a meal.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ -Use with caution in patients with:
Precautions -Hepatic impairment
-Renal impairment

Severe side effects including fatal Stevens-Johnson syndrome and toxic epidermal necrolysis
have occurred in patients taking pyrimethamine-sulfadoxine. Discontinue this medication at
the first sign of a skin rash or if a decrease in formed blood elements is noted, or upon the
occurrence of active bacterial or fungal infections.

Sulfadoxine-pyrimethamine is contraindicated in patients with blood dyscrasias,

megaloblastic anemia due to folate deficiency, and in infants less than 2 months of age..

Discontinue if folic acid deficiency develops.

Prophylaxis should not be continued for more than 2 years.

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Storage Store below 30oC
Refer to manufacturer PIL if there are specific considerations.

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Antiretrovirals

a) Nucleoside/Nucleotide reverse transcriptase inhibitors

1. Abacavir (ABC)
Generic Name Abacavir

Dosage Tablet: 300 mg

form/strengths
Route of oral
administration
Pharmacologic Nucleoside reverse transcriptase inhibitor(NRTI)
category ATC: J05AF06

Indications Used for Treatment of HIV-1 infection for children in the following situations:

• First line regimen in combination with lamivudine and dolutegravir

• alternative first line regimen in combination with lamivudine and lopinavir/ritonavir
• alternative first line regimen in combination with lamivudine and raltegravir
• second line regimen in combination with lamivudine and dolutegravir
Dosage Adult
Regimen HIV-1 infection, treatment: Oral: 300 mg twice daily or 600 mg once daily in combination with
other antiretroviral agents.
Infants ≥3 months, Children, and Adolescents: Oral:
Twice daily dose regimen
Oral solution: 8 mg/kg/dose twice daily; maximum dose: 300 mg/dose.
If body weight ≥14 kg
Tablets (scored 300 mg tablets), oral solution:
14 to <20 kg: 150 mg twice daily.
20 to <25 kg: 150 mg in the morning and 300 mg in the evening.
≥25 kg: 300 mg twice daily.
Once daily dose regimen
In clinically stable patients with undetectable viral load for more than 6 months (24 weeks)
on the liquid formulation of abacavir twice daily, the daily dose can be changed from twice
daily to once daily with liquid or tablet formulations. Initiation with once-daily dosing is
recommended for children who can be treated with tablet formulation
o If body weight ≤ 14 kg
Oral solution: 16 mg/kg/dose once daily; maximum dose: 600 mg/dose
o If body weight ≥14 kg
Tablets (scored 300 mg tablets), oral solution:
14 to <20 kg: 300 mg once daily.
20 to <25 kg: 450 mg once daily.
≥25 kg: 600 mg once daily.
Dosage Dosing: Renal Impairment
adjustment There are no dosage adjustments
Dosing: Hepatic Impairment Adults:
• Mild impairment (Child-Pugh class A): 200 mg twice daily (oral solution is
recommended).

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• Moderate to severe impairment (Child-Pugh class B or C): Use is contraindicated
Dosing: Hepatic Impairment Pediatrics:
• Mild impairment: Dosing adjustment is required; however, pediatric-specific
recommendations are not available
Moderate to severe hepatic impairment (Child-Pugh class B or C): Use is contraindicated.
Contra- • Hypersensitivity to abacavir or any component of the formulation
indications • moderate to severe hepatic impairment
• patients who are positive for the HLA-B*5701 allele
Major Adverse • Central nervous system: Headache (adults: ≤13%; infants, children, & adolescents:
Drug Reactions 1%), fatigue (≤12%), malaise (≤12%)
• Gastrointestinal: Nausea (7% to 19%)
• Endocrine & metabolic: Hypertriglyceridemia (2% to 6%)
• Hematologic & oncologic: Neutropenia (2% to 5%),
thrombocytopenia (1%)
• Hepatic: Increased serum alanine aminotransferase (6%), increased serum aspartate
aminotransferase (6%)
• Drug-induced hypersensitivity (9%)
• Respiratory: ENT infection (5%), viral respiratory tract infection (5%), bronchitis (4%),
pneumonia (infants, children, & adolescents: 4%)
• Miscellaneous: Fever (≤9%)
Monitoring CBC with differential, CD4 count, HIV RNA plasma levels, serum transaminases, fasting lipid
Parameters panel; serum creatine kinase, serum amylase (as clinically indicated); HLA-B*5701 genotype
status prior to initiation of therapy and prior to reinitiation of therapy in patients of
unknown HLA-B*5701 status; signs and symptoms of hypersensitivity
Drug Cladribine: Abacavir may diminish the therapeutic effect of Cladribine. Risk X: Avoid
Interactions combination
• Risk C: Monitor therapy
Cabozantinib Levomethadone Methadone Orlistat Riociguat
Pregnancy and • Pregnancy
Lactation Abacavir is a preferred (NRTI) for pregnant patients living with HIV who are antiretroviral
naive, who have had ART therapy in the past but are restarting, or who require a new ART
regimen (due to poor tolerance or poor virologic response of current regimen)
patients who become pregnant while taking abacavir may continue if viral suppression is
effective and the regimen is well tolerated.
• Lactation
Abacavir was detected in the serum of an infant following exposure via breast milk.
If a woman is receiving this drug while breastfeeding, her nursing infant should be monitored
for these effects : nausea, headache, malaise and fatigue, nausea, vomiting, and
dreams/sleep disorders
Administration Oral: May be administered without regard to food
Hazardous agent (NIOSH 2016 [group 2]).
Use appropriate precautions for receiving, handling, administration, and disposal. Gloves
(single) should be worn during receiving, unpacking, and placing in storage.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ • Hypersensitivity reactions: [US Boxed Warning]: Serious and sometimes fatal
Precautions hypersensitivity reactions have occurred. Patients who carry the HLA-B*5701 allele
are at a higher risk for a hypersensitivity reaction to abacavir
• Immune reconstitution syndrome: Patients may develop immune reconstitution

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syndrome resulting in the occurrence of an inflammatory response to an indolent or
residual opportunistic infection during initial HIV treatment or activation of
autoimmune disorders (eg, Graves disease, polymyositis, Guillain-Barré syndrome)
later in therapy; further evaluation and treatment may be required.
• Lactic acidosis/hepatomegaly
• Coronary heart disease: Use has been associated with an increased risk of MI in
some cohort studies. Consider using with caution in patients with risks for coronary
heart disease and minimizing modifiable risk factors (eg, hypertension,
hyperlipidemia, diabetes mellitus, smoking) prior to use.
• Hepatic impairment: Use with caution and adjust dosage in patients with mild hepatic
impairment (contraindicated in moderate to severe impairment).
May cause mild hyperglycemia; more common in pediatric patients.
Storage Store at 20°C to 25°C , Oral solution may be refrigerated; do not freeze
Refer to manufacturer PIL if there are specific considerations.

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2. Lamivudine (3TC)
Generic Name Lamivudine

Dosage Tablets 100mg, 150mg

form/strengths
Route of oral
administration
Pharmacologic Antihepadnaviral, Reverse Transcriptase Inhibitor, Nucleoside (Anti-HBV); Antiretroviral,
category Reverse Transcriptase Inhibitor, Nucleoside (Anti-HIV)
ATC: J05AF05
Indications Chronic hepatitis B: Treatment of chronic hepatitis B associated with evidence of hepatitis B
viral replication and active liver inflammation

Limitations of use: Use only when an alternative antiviral agent with a higher genetic barrier to
resistance is not available or appropriate. Lamivudine-HBV has not been evaluated in patients
coinfected with HIV, hepatitis C virus, or hepatitis delta virus; with decompensated liver
disease; or in liver transplant recipients.

HIV-1 infection, treatment: Treatment of HIV-1 in combination with other antiretroviral agents
Dosage Dosing: Adult
Regimen HIV-1 infection, treatment: Oral (use in combination with other antiretroviral agents): 150 mg
twice daily or 300 mg once daily
Treatment of hepatitis B (Epivir HBV, Heptovir [Canadian product]): Oral: 100 mg once daily
Treatment of hepatitis B/HIV coinfection (in patients with both infections requiring
treatment):
Oral: 150 mg twice daily or 300 mg once daily, in combination with tenofovir and other
appropriate antiretrovirals
Dosing: Pediatric:
HIV-1 infection, treatment
Twice-daily dosing
Children ≥3 years and Adolescents:
Oral tablet: Weight-band dosing for patients weighing ≥14 kg who are able to swallow tablets
(using scored 150 mg tablets):
14 to <20 kg: 75 mg (1/2 tablet) twice daily.
20 to <25 kg: 75 mg (1/2 tablet) in the morning and 150 mg (1 tablet) in the evening.
≥25 kg: 150 mg (1 tablet) twice daily.
Once-daily dosing: Oral: Note: Not recommended as initial therapy in children. Patients can be
transitioned to once daily treatment with the oral solution or tablet after stable on twice-daily
treatment for ≥36 weeks with an undetectable viral load and stable CD4 count
Oral solution: 10 mg/kg/dose once daily; maximum dose: 300 mg/dose.
Oral tablet: Weight-band dosing for patients ≥14 kg who are able to swallow tablets (scored
150 mg tablets)
14to <20 kg: 150 mg (1 tablet) once daily.
20to <25 kg: 225 mg (1 + 1/2 tablet) once daily.
≥25 kg: 300 mg (2 tablets) once daily
Hepatitis B, treatment (non-HIV-exposed/-infected):
Note: Use in HBV treatment is discouraged due to rapid resistance development; consider use
only if other anti-HBV antiviral regimens with more favorable resistance patterns cannot be
used.

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Adolescents ≥16 years: Oral: 100 mg once daily.

Dosage Renal Impairment: Adult in HIV treatment

adjustment CrCl ≥50 mL/minute: No dosage adjustment necessary.
CrCl 30 to 49 mL/minute: Administer 150 mg once daily.
CrCl 15 to 29 mL/minute: Administer 150 mg first dose, then 100 mg once daily.
CrCl 5 to 14 mL/minute: Administer 150 mg first dose, then 50 mg once daily.
CrCl <5 mL/minute: Administer 50 mg first dose, then 25 mg once daily.
Hemodialysis or Peritoneal dialysis: Administer 50 mg first dose, then 25 mg once daily, dosing
after hemodialysis is recommended, Supplemental dosing not needed after
Peritoneal dialysis
Treatment of hepatitis B patients:
CrCl ≥50 mL/minute: No dosage adjustment necessary.
CrCl 30 to 49 mL/minute: Administer 100 mg first dose, then 50 mg once daily.
CrCl 15 to 29 mL/minute: Administer 100 mg first dose, then 25 mg once daily.
CrCl 5 to 14 mL/minute: Administer 35 mg first dose, then 15 mg once daily.
CrCl <5 mL/minute: Administer 35 mg first dose, then 10 mg once daily.
Hemodialysis or Peritoneal dialysis: It is recommended to correct dosage for degree of renal
impairment; assuming CrCl <5 mL/minute, administer 35 mg first dose, then 10 mg once daily.

Renal Impairment: Pediatric

Infants, Children, and Adolescents <25 kg: There are no dosage adjustments consider reducing
the dose or increasing the dosing interval; use with caution; monitor closely.
Children and Adolescents ≥25 kg: the same as in adult
Dosing: Hepatic Impairment:
No dosage adjustment necessary. However, has not been studied in the setting of
decompensated liver disease.
Contra- Hypersensitivity to lamivudine or any component of the formulation
indications
Adverse Drug >10%:
Reactions Central nervous system: Headache (35%), fatigue (≤27%), malaise (≤27%), paresthesia (≤15%),
peripheral neuropathy (≤15%), neuropathy (12%), insomnia (≤11%), sleep disorder (≤11%)
Dermatologic: Skin rash (9% to 12%)
Gastrointestinal: Nausea (≤33%), diarrhea (adults: 14% to 18%, children: 8%), pancreatitis
(≤18%; higher percentage in pediatric patients), sore throat (13%), vomiting (≤13%)
Hematologic & oncologic: Neutropenia (7% to 15%)
Hepatic: Increased serum alanine aminotransferase (adults: 4% to 27%, children: 1%),
hepatomegaly (children: 11%, adults: <1%)
Infection: infection (25%; includes ear, nose, and throat)
Neuromuscular & skeletal: Musculoskeletal pain (12%)
Respiratory: Nasal signs and symptoms (8% to 20%), cough (15% to 18%)
Miscellaneous: Fever (children: 25%, adults: ≤10%)
1% to 10%:
Central nervous system: Dizziness (10%), chills (≤10%), depression (9%)
Gastrointestinal: Increased serum lipase (adults: 10%, children: 3%), anorexia (≤10%),
decreased appetite (≤10%), abdominal pain (9%), abdominal cramps (6%), stomatitis (children:
6%, adults: <1%), dyspepsia (5%)
Hematologic & oncologic: Lymphadenopathy (children: 9%), splenomegaly (children 5%, adults
<1%), thrombocytopenia (adults: 4%, children: 1%), decreased hemoglobin (2% to 4%)
Hepatic: Increased serum aspartate aminotransferase (2% to 4%)

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Neuromuscular & skeletal: Increased creatine phosphokinase (9%),
Otic: Ear disease (children: 7%)
Monitoring All patients: Hepatic function, signs/symptoms of lactic acidosis; signs/symptoms of
Parameters pancreatitis
HIV patients: Coinfection with HBV (prior to therapy); HIV viral load and CD4 count; immune
reconstitution syndrome
Hepatitis B patients: Coinfection with HIV (prior to therapy); following discontinuation, monitor
hepatic function closely with both clinical and laboratory follow/up for signs/symptoms of HBV
relapse/exacerbation (continue for at least several months after stopping treatment)
Drug Risk X: Avoid combination
Interactions Emtricitabine Cladribine
Risk D: Consider therapy modification
Sorbitol
Risk C: Monitor therapy
Cabozantinib Orlistat Trimethoprim
Pregnancy and pregnancy category C
Lactation lamivudine can be used; close fetal monitoring is recommended.
Lamivudine has been well studied in HIV-positive nursing mothers and appears to be well
tolerated by their breastfed infants.
Administration May be administered without regard to meals. Refer to manufacturer PIL if there are specific
considerations.
Warnings/ • Immune reconstitution syndrome: occurrence of an inflammatory response to an indolent or
Precautions residual opportunistic infection during initial HIV treatment or activation of autoimmune
disorders (eg, Graves disease, polymyositis, Guillain-Barré syndrome) later in therapy; further
evaluation and treatment may be required.
• Lactic acidosis/hepatomegaly: Lactic acidosis and severe hepatomegaly with steatosis have
been reported with nucleoside analogues, including fatal cases; suspend treatment in any
patient who develops clinical or laboratory findings suggestive of lactic acidosis or pronounced
hepatotoxicity. Use with caution in patients with risk factors for liver disease (risk may be
increased with female gender or obesity) (transaminase elevation may/may not accompany
hepatomegaly and steatosis).
• Pancreatitis: Has been reported, particularly in HIV-infected pediatric patients with a history
of nucleoside use. Discontinue treatment if signs of symptoms of pancreatitis occur.
Disease-related concerns:
• Chronic hepatitis B: [US Boxed Warning]: Severe acute exacerbations of hepatitis B (some
fatal) have been reported in patients with HBV or HIV/HBV coinfection who have discontinued
lamivudine; hepatic function should be monitored closely with both clinical and laboratory
follow-up for at least several months after discontinuation. Initiate antihepatitis B (HBV)
medications if clinically appropriate.
• Renal impairment: Use with caution in patients with renal impairment; dosage reduction
recommended.
• Resistance:
- HIV: [US Boxed Warning]: HIV-1 resistance may emerge in chronic hepatitis B-infection
patients with unrecognized or untreated HIV-1 infection. Counseling and HIV testing should be
offered to all patients before beginning treatment with lamivudine for hepatitis B and then
periodically during treatment. Lamivudine dosing for hepatitis B is subtherapeutic if used for
HIV-1 infection treatment. Lamivudine monotherapy is not appropriate for HIV-1 infection
treatment.
Special populations:

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• Pediatric: Use with caution in pediatric patients with a history of prior antiretroviral
nucleoside exposure or pancreatitis, or other significant risk factors for development of
pancreatitis.
Storage Tablet: Store at 25°C; excursions are permitted between 15°C and 30°C
Refer to manufacturer PIL if there are specific considerations.

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3. Tenofovir disoproxil fumarate (TDF)
Generic Name Tenofovir Disoproxil fumarate

Dosage Tablets 245 mg

form/strengths
Route of Oral
administration
Pharmacologic Reverse Transcriptase Inhibitor; Antihepadnaviral, Nucleotide (Anti-HBV); Antiretroviral,
al category Nucleotide (Anti-HIV)
ATC: J05AF07
Indications Chronic hepatitis B: Treatment of chronic hepatitis B virus (HBV) in patients ≥2 years of age
weighing ≥10 kg
HIV-1 infection, treatment: Treatment of HIV-1 infection in patients ≥2 years of age weighing
≥10 kg, in combination with other antiretroviral agents.

Dosage Dosing: Adult

Regimen Hepatitis B infection: Oral: 300 mg once daily
Note: Concurrent use with adefovir and/or tenofovir combination products should be avoided.
Treatment duration (AASLD practice guidelines): Treatment duration for nucleos(t)ide analog-
based therapy (eg, tenofovir) is variable and influenced by HBeAg status, duration of HBV
suppression, and presence of cirrhosis/decompensation
HIV-1 infection, treatment: Oral: 300 mg once daily (in combination with other
antiretrovirals).

Dosing: Pediatric
HIV-1 infection, treatment
Weight-directed dosing: Children ≥2 years weighing ≥10 kg and Adolescents: Oral: 8
mg/kg/dose once daily; maximum daily dose: 300 mg/day
Dosage form specific fixed dosing:
Oral tablets: Children ≥2 years weighing ≥17 kg and Adolescents: Oral:
17 to <22 kg: 150 mg once daily
22 to <28 kg: 200 mg once daily
28 to <35 kg: 250 mg once daily
≥35 kg: 300 mg once daily
HIV-1 nonoccupational postexposure prophylaxis (nPEP)
Children ≥2 years: Oral: Age- and weight-appropriate dosing (see HIV-1 infection, treatment
above) for 28 days in combination with other antiretroviral agents. Initiate therapy within 72
hours of exposure.
Adolescents: The combination product is recommended
Hepatitis B infection, chronic: Children ≥2 years weighing ≥10 kg and Adolescents: Oral: 8
mg/kg/dose once daily; maximum daily dose: 300 mg/day; see HIV treatment dosing for
product-specific dosing. In trials, oral antivirals were continued for 1 to 4 years; Hepatitis B e
antigen (HBeAg) seroconversion has been suggested as a therapeutic endpoint followed by an
additional 12 months of consolidation

Dosage Dosing: Renal Impairment: Adult

adjustment CrCl ≥50 mL/minute: No dosage adjustment necessary.
CrCl 30 to 49 mL/minute: 300 mg every 48 hours
CrCl 10 to 29 mL/minute: 300 mg every 72 to 96 hours (twice weekly)
CrCl <10 mL/minute: has not been studied. avoid use. If no alternative therapy is available,

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then may consider 300 mg every 7 days; use with caution and close monitoring.
Hemodialysis: 300 mg following dialysis every 7 days or after a total of ~12 hours of dialysis.
Dosing: Hepatic Impairment: Adult
No dosage adjustment necessary.
Dosing: Renal Impairment: Pediatric
Children ≥2 years and Adolescents: There are no dosage adjustments. Dosage should be
decreased in patients with CrCl <50 mL/minute
Dosing: Hepatic Impairment: Pediatric
Children ≥2 years and Adolescents: No dosage adjustment required.

Contra- Hypersensitivity to tenofovir or any component of the formulation

indications
Adverse Drug >10%:
Reactions Central nervous system: Insomnia (3% to 18%), headache (5% to 14%), pain (12% to 13%),
dizziness (8% to 13%), depression (4% to 11%)
Dermatologic: Skin rash (includes maculopapular, pustular, or vesiculobullous rash; pruritus; or
urticaria: 5% to 18%), pruritus (16%)
Endocrine & metabolic: Hypercholesterolemia (19% to 22%), increased serum triglycerides (1%
to 4%)
Gastrointestinal: Abdominal pain (4% to 22%), nausea (8% to 20%), diarrhea (9% to 16%),
vomiting (2% to 13%)
Neuromuscular & skeletal: Decreased bone mineral density (28%; ≥5% at spine or ≥7% at hip),
increased creatine phosphokinase (2% to 12%), weakness (6% to 11%)
Miscellaneous: Fever (4% to 11%)

Monitoring Patients with HIV: CBC with differential, reticulocyte count, creatine kinase, CD4 count, HIV
Parameters RNA plasma levels, serum phosphorus (baseline and as clinically indicated in patients with
chronic kidney disease); serum creatinine, urine glucose, urine protein (baseline and as
clinically indicated during therapy); hepatic function tests; bone density (patients with a
history of bone fracture or have risk factors for bone loss); testing for HBV is recommended
prior to the initiation of antiretroviral therapy; weight (children).
Patients with HBV: HIV status (prior to initiation of therapy); serum phosphorus (baseline and
as clinically indicated in patients with chronic kidney disease); serum creatinine, urine glucose,
urine protein (baseline and as clinically indicated during therapy); bone density (patients with
a history of bone fracture or have risk factors for bone loss); LFTs every 3 months during
therapy and for several months following discontinuation of tenofovir; signs/symptoms of HBV
relapse/exacerbation following discontinuation of therapy.
Drug Risk X: Avoid combination
Interactions Adefovir cladribine
Risk D: Consider therapy modification
Atazanavir Diclofenac Didanosine Ledipasvir Nonsteroidal Anti-Inflammatory Agents
Risk C: Monitor therapy
Voxilaprevir Velpatasvir Tipranavir Simeprevir Orlistat Lopinavir Ganciclovir-Valganciclovir
Darunavir Cidofovir Cabozantinib Aminoglycosides Acyclovir-Valacyclovir
Pregnancy and Pregnancy Category B
Lactation Tenofovir disoproxil fumarate is a recommended component of a regimen when acute HIV
infection is detected in patients who are breastfeeding. Breastfeeding should be interrupted if
acute HIV infection is suspected and not continued if infection is confirmed.
Administration Administration: Oral

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Tablets may be administered without regard to meals. Do not crush oral tablets
Consider calcium and vitamin D supplementation.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Decreased bone mineral density
• Immune reconstitution syndrome: Patients may develop immune reconstitution syndrome
resulting in the occurrence of an inflammatory response to an indolent or residual
opportunistic infection during initial HIV treatment or activation of autoimmune disorders (eg,
Graves’ disease, polymyositis, Guillain-Barré syndrome) later in therapy; further evaluation
and treatment may be required.
• Lactic acidosis/hepatomegaly
• Osteomalacia and renal dysfunction: May cause osteomalacia with proximal renal
tubulopathy. Bone pain, extremity pain, fractures, arthralgias, weakness and muscle pain have
been reported. In patients at risk for renal dysfunction, persistent or worsening bone or
muscle symptoms should be evaluated for hypophosphatemia and osteomalacia.
• Renal toxicity
Disease-related concerns:
• Chronic hepatitis B: [US Boxed Warning]: Severe, acute exacerbation of hepatitis B may occur
upon discontinuation. Monitor hepatic function several months after discontinuing treatment;
reinitiation of antihepatitis B therapy may be required.
• Hepatic impairment: Use with caution in patients with hepatic impairment.
• Renal impairment: Use with caution in patients with renal impairment (CrCl <50 mL/minute);
dosage adjustment required. IDSA guidelines recommend avoiding tenofovir in HIV patients
with preexisting kidney disease (CrCl <50 mL/minute and not on hemodialysis or GFR <60
mL/minute/1.73 m2) when other effective HIV treatment options exist because data suggest
risk of chronic kidney disease (CKD) is increased.
Concurrent drug therapy issues:
• Concomitant therapy: Do not use in combination with other tenofovir disoproxil fumarate or
tenofovir alafenamide products, or with adefovir.
Other warnings/precautions:
• Appropriate use: Hepatitis B coinfection: In patients coinfected with HIV and HBV, an
appropriate antiretroviral combination should be selected due to HIV resistance potential;
these patients should receive tenofovir dosed for HIV therapy.

Storage Store at 25°C, excursions are permitted between 15°C and 30°C. Dispense only in original
container.
Refer to manufacturer PIL if there are specific considerations.

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4. Zidovudine
Generic Name Zidovudine

Dosage Capsule 100 mg,250mg

form/strengths Tablet: 300 mg
Route of Oral
administration
Pharmacologic Antiretroviral, Reverse Transcriptase Inhibitor, Nucleoside (Anti-HIV)
category ATC: J05AF01
Indications Treatment of HIV-1 infection in combination with other antiretroviral agents

Perinatal HIV-1 transmission, prevention

Dosage Adults:
Regimen Prevention of perinatal HIV transmission: Zidovudine should be administered by continuous
IV infusion near delivery in women with known or suspected HIV RNA >1,000 copies/mL or
unknown HIV RNA status; use may be considered in women with HIV RNA between 50 and 999
copies/mL. If oral zidovudine was part of the antepartum regimen, discontinue during
intrapartum IV infusion and Other antiretroviral agents should be continued orally.
IV (preferred route): During labor and delivery: Loading dose: 2 mg/kg followed by a
continuous IV infusion of 1 mg/kg/hour until clamping of the umbilical cord. For scheduled
cesarean delivery, begin IV zidovudine 3 hours before surgery. Dosage based on total body
weight.
Oral (if IV not possible): Loading dose: 600 mg, then 400 mg every 3 hours
HIV-1 infection, treatment
Oral: 300 mg twice daily
IV: 1 mg/kg/dose administered every 4 hours around-the-clock (6 doses daily)

Pediatrics:
HIV-1 infection, treatment:
Infants (postconceptional age [PCA] ≥35 weeks and PNA ≥4 weeks), Children, and
Adolescents:
o Weight-directed dosing: Oral:
<9 kg: 12 mg/kg/dose twice daily.
9 to <30 kg: 9 mg/kg/dose twice daily.
≥30 kg: 300 mg twice daily.
o BSA-directed dosing: Oral: 240 mg/m2/dose every 12 hours,
o Range: 180 to 240mg/ m2/ dose every 12 hours (maximum dose: 300 mg/dose).

Dosing adjustment for hematologic toxicity: interruption of therapy for significant anemia
(Hgb <7.5 g/dL or >25% decrease from baseline) and/or significant neutropenia (ANC <750
cells/mm3 or >50% decrease from baseline) until evidence of bone marrow recovery occurs;
once bone marrow recovers, dose may be resumed using appropriate adjunctive therapy
Dosage Renal impairment in adults
adjustment CrCl ≥15 mL/minute: No dosage adjustment necessary.
CrCl <15 mL/minute: Oral: 100 mg 3 or 4 times daily or 300 mg once daily
End-stage renal disease on intermittent hemodialysis (administer dose after dialysis on dialysis
days): 100 mg 3 times daily or 300 mg once daily
Peritoneal dialysis: Oral: 100 mg every 6 to 8 hours.
Hepatic impairment in adults:

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There are no specific dosage adjustments available. However, adjustment may be necessary
due to extensive hepatic metabolism. Closely monitor patients for hematologic toxicities.

Contra- Potentially life-threatening hypersensitivity to zidovudine or any component of the

indications formulation
Neutrophil count <750/mm3 or hemoglobin <7.5 g/dL
Adverse Drug Central nervous system: Headache (63%), malaise (53%)
Reactions Dermatologic: Skin rash
Gastrointestinal: Nausea, anorexia (20%), vomiting
Hematologic & oncologic: Macrocytosis (infants, children, & adolescents: >50%), anemia
(neonates: 22%; infants, children, & adolescents: 4%; adults, grades 3/4: 1%),
Lymphadenopathy, neutropenia, splenomegaly, thrombocytopenia
Hepatic: Hepatomegaly increased ALT, AST
Respiratory: Cough (infants, children, & adolescents: 15%)
Fever (infants, children, & adolescents: 25%)
Cardiovascular: Cardiac failure (<6%), ECG abnormality, edema
Weight loss
Monitoring CBC with differential; LFTs; serum creatinine; HIV viral load and CD4 count.
Parameters
Drug Risk X: Avoid combination
Interactions Amodiaquine BCG (Intravesical) Cladribine Dipyrone Stavudine
Risk D: Consider therapy modification
Clarithromycin Deferiprone Doxorubicin (Conventional) Doxorubicin (Liposomal) Ribavirin
(Oral Inhalation) Ribavirin (Systemic)
Pregnancy and The Health and Human Services (HHS) perinatal HIV guidelines consider zidovudine an
Lactation alternative NRTI for pregnant females living with HIV who are antiretroviral-naive, who have
had ART therapy in the past but are restarting, or who require a new ART regimen (due to
poor tolerance or poor virologic response of current regimen). In addition, females who
become pregnant while taking zidovudine may continue if viral suppression is effective and
the regimen is well tolerated. The pharmacokinetics of zidovudine are not significantly altered
in pregnancy and dosing adjustment is not needed.
Zidovudine has been well studied during breastfeeding. Milk levels are low and most breastfed
infants do not have detectable blood levels. Some breastfed infants have developed anemia
during maternal therapy.
Administration May be administered without regard to meals. Refer to manufacturer PIL if there are
specific considerations.
Warnings/ Hematologic toxicity (neutropenia and severe anemia), Immune reconstitution syndrome,
Precautions Lactic acidosis/hepatomegaly, lipoatrophy, myopathy
Storage Store at 15°C to 25°C Protect capsules from moisture.
Refer to manufacturer PIL if there are specific considerations.

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b) Non-nucleoside reverse transcriptase inhibitors

5. Nevirapine (NVP)
Generic Name Nevirapine

Dosage Tablet:200 mg
form/strengths
Route of Oral
administration
Pharmacologic Antiretroviral, Reverse Transcriptase Inhibitor, Non-nucleoside (Anti-HIV)
category ATC: J05AG01
Indications Treatment of HIV-1, in combination therapy with other antiretroviral agents, in adults and
pediatric patients ≥15 days of age (immediate release) and ≥6 years of age with a BSA of ≥1.17
m2.

Not recommended as a component of initial therapy for the treatment of HIV, unless the
benefit outweighs the risk, in adult females with CD4+ cell counts >250 cells/mm3 or adult
males with CD4+ cell counts >400 cells/mm3.
Dosage HIV-1 infection, treatment: Oral, Adults:
Regimen Initial: Immediate release: 200 mg once daily for 14 days
Maintenance: Immediate release: 200 mg twice daily (in combination with additional
antiretroviral agents) if there is no rash or untoward effects during initial dosing period
HIV-1 infection, treatment: Oral, Pediatrics:
o Infants and Children <8 years:
With lead-in dosing: Initial: 200 mg/m2/dose once daily (maximum dose: 200 mg/dose) for the
first 14 days of therapy; increase to 200 mg/m2/dose twice daily (maximum dose: 200
mg/dose)
Without lead-in dosing: Infants and Children <2 years: 200 mg/m2/dose twice daily (maximum
dose: 200 mg/dose).
o Children ≥8 years:
Initial (lead-in dosing): 120 to 150 mg/m2/dose once daily (maximum dose: 200 mg/dose) for
the first 14 days of therapy; increase to 120 to 150 mg/m2/dose twice daily (maximum dose:
200 mg/dose) if no rash or other adverse effects occur.

o Adolescents:
Initial: 200 mg once daily for the first 14 days; increase to 200 mg every 12 hours if no rash or
other adverse effects occur; if patient able to swallow tablets whole, may convert
maintenance dose to the extended release formulation (400 mg once daily).

If nevirapine therapy is interrupted for ≤14 days (infants/children) or <7 days (adolescents),
restart at the full-dose due to mechanisms of nevirapine resistance
Dosage renal impairment
adjustment CrCl <20 mL/minute: There are no dosage adjustments (has not been studied).
Hemodialysis: An additional 200 mg immediate release dose is recommended following
dialysis
hepatic impairment
Permanently discontinue if symptomatic hepatic events occur.
Mild impairment (Child-Pugh class A): There are no dosage adjustments; use with caution.
Moderate to severe impairment (Child-Pugh class B or C): Use is contraindicated

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Contra- Moderate to severe hepatic impairment (Child-Pugh class B or C); use in occupational or
indications nonoccupational postexposure prophylaxis (PEP) regimens
hypersensitivity to nevirapine or any component of the formulation
Adverse Drug Endocrine & metabolic: Increased serum cholesterol (3% to 19%), increased LDL cholesterol
Reactions Hematologic & oncologic: Decreased serum phosphate (≤38%), neutropenia (1% to 13%)
Hepatic: Increased serum alanine aminotransferase (2% to 14%)

Monitoring Monitor CBC and viral load.

Parameters Intensive monitoring is required during the initial 18 weeks of therapy to detect potentially
life-threatening hepatic, dermatologic, and hypersensitivity reactions.
Baseline and repeat liver function tests.
Assess/evaluate AST/ALT immediately in any patients with a rash
Drug Risk X: Avoid combination
Interactions Atazanavir CarBAMazepine Dolutegravir Elvitegravir Ergonovine Itraconazole Ketoconazole
(Systemic) Letermovir Reverse Transcriptase Inhibitors (Non-Nucleoside) Saquinavir
Simeprevir St John's Wort Velpatasvir
Risk D: Consider therapy modification
Caspofungin Clarithromycin CYP3A4 Inducers (Strong) Daclatasvir Darunavir Fosamprenavir
Indinavir Lopinavir Ubrogepant
Pregnancy and The Health and Human Services (HHS) perinatal HIV guidelines do not recommend nevirapine
Lactation as an initial non-nucleoside reverse transcriptase inhibitor for use in antiretroviral-naive
pregnant patients because of the potential for adverse events, complex dosing, and low
barrier to resistance. Use is not recommended (except in special circumstances)
Severe, life-threatening, and in some cases fatal hepatotoxicity, particularly in the first 18
weeks, has been reported in patients treated with nevirapine
Administration May be administered with or without food. May be administered with an antacid.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Fat redistribution, hepatotoxicity, Severe, life-threatening skin reactions, Immune
Precautions reconstitution syndrome, Rhabdomyolysis.

Storage Store at 15°C to 30°C.

Refer to manufacturer PIL if there are specific considerations.

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6. Efavirenz (EFV)
Generic Name Efavirenz

Dosage Tablets , capsules : 200mg , 600 mg

form/strengths
Route of Oral
administration
Pharmacologic Antiretroviral, Reverse Transcriptase Inhibitor, Non-nucleoside (Anti-HIV)
category ATC: J05AG03
Indications HIV-1 infection: Treatment of HIV-1 infection in combination with other antiretroviral agents
in adults and pediatric patients at least 3 months old and weighing at least 3.5 kg.
Alternative first-line regimen in adults and adolescents in combination to tenofovir and
lamivudine
Dosage Dosing: Adult
Regimen HIV-1 infection, treatment:
Oral: 600 mg once daily, in combination with other appropriate agents; 400 mg once daily may
be used in combination with tenofovir and lamivudine
Dosing: Pediatric
HIV-1 infection, treatment: Use in combination with other antiretroviral agents:
Infants <3 months or <3 kg: Not recommended for use.
Infants ≥3 months weighing ≥3 kg and Children <3 years: Oral:
BSA-directed dosing: Oral: 367 mg/m2/dose once daily, maximum dose: 600 mg/dose;
recommended by some experts
Dosage Renal impairment:
adjustment No dosage adjustment necessary
hepatic impairment
Mild impairment (Child-Pugh class A): No dosage adjustment necessary; use with caution.
Moderate-to-severe impairment (Child-Pugh class B or C): Use is not recommended.
Contra- Hypersensitivity (eg, Stevens-Johnson syndrome) to efavirenz or any component of the
indications formulation
Adverse Drug Dermatologic: Skin rash (5% to 32%)
Reactions Endocrine & metabolic: Increased serum cholesterol (20% to 40%), increased HDL cholesterol
(25% to 35%), increased serum triglycerides (≥751 mg/dL: 6% to 11%)
Gastrointestinal: Diarrhea (3% to 14%)
Nervous system: Central nervous system toxicity (53%), dizziness (2% to 28%), depression (3%
to 19%), insomnia (7% to 16%), anxiety (2% to 13%), pain (1% to 13%)
Monitoring Serum transaminases; cholesterol and triglycerides (prior to therapy and periodically during);
Parameters signs and symptoms of infection; psychiatric effects
Drug Long list of interactions should be checked before administration, include:
Interactions Atazanavir: Efavirenz may decrease the serum concentration of Atazanavir. Management:
the adult atazanavir dose should be 400 mg daily, boosted with ritonavir 100 mg daily for
treatment-naive patients only; treatment-experienced patients should not use atazanavir
with efavirenz. Risk D: Consider therapy modification
Bromperidol: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid
combination
CarBAMazepine: May decrease the serum concentration of Efavirenz. Efavirenz may
decrease the serum concentration of CarBAMazepine. Risk X: Avoid combination
Caspofungin: efavirenz may decrease the serum concentration of Caspofungin.

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Management: Consider using an increased caspofungin dose of 70 mg daily in adults (or 70
mg/m2, up to a maximum of 70 mg, daily in pediatric patients) Risk D: Consider therapy
modification
Clarithromycin: Efavirenz may enhance the QTc-prolonging effect of Clarithromycin & may
decrease the serum concentration of Clarithromycin Management: Consider using an
alternative antibiotic in patients taking efavirenz or monitor for decreased therapeutic
effect of clarithromycin and for QT interval prolongation. Risk D: Consider therapy
modification
Darunavir: May increase the serum concentration of Efavirenz. Efavirenz may decrease the
serum concentration of Darunavir. Management: Monitor for decreased concentrations
and effects of darunavir and/or increased concentrations and effects of efavirenz Risk D:
Consider therapy modification
Itraconazole: Efavirenz may decrease the serum concentration of Itraconazole. Risk X: Avoid
combination
Maraviroc: Efavirenz may decrease the serum concentration of Maraviroc. Management:
Increase maraviroc adult dose to 600mg twice/day, but only in the absence of a concurrent
strong CYP3A4 inhibitor. Not recommended for pediatric patients not also receiving a
strong CYP3A4 inhibitor. Do not use in patients with CrCl less than 30 mL/min. Risk D:
Consider therapy modification
Nevirapine: May enhance the adverse/toxic effect of Efavirenz. Efavirenz may enhance the
adverse/toxic effect of Nevirapine. Nevirapine may decrease the serum concentration of
Efavirenz. Risk X: Avoid combination
Orphenadrine: CNS Depressants may enhance the CNS depressant effect of
Orphenadrine. Risk X: Avoid combination
Progestins (Contraceptive): Efavirenz may decrease the serum concentration of Progestins
(Contraceptive). Management: Use an alternative or additional method of contraception
Injected depot medroxyprogesterone acetate does not appear to participate in this
interaction. Risk D: Consider therapy modification
Simeprevir: CYP3A4 Inducers (Moderate) may decrease the serum concentration of
Simeprevir. Risk X: Avoid combination
Voriconazole: Efavirenz may decrease the serum concentration of Voriconazole.
Voriconazole may increase the serum concentration of Efavirenz. Management: The
voriconazole oral maintenance dose should be increased to 400 mg every 12 hours, and the
efavirenz dose should be reduced to 300 mg daily. Risk D: Consider therapy modification
Pregnancy and The Health and Human Services (HHS) perinatal HIV guidelines consider efavirenz an
lactation alternative ART for pregnant females living with HIV who are antiretroviral-naive, who have
had ART therapy in the past but are restarting, or who require a new ART regimen (due to
poor tolerance or poor virologic response of current regimen). Females who become pregnant
while taking efavirenz may continue if viral suppression is effective and the regimen is well
tolerated.
Efavirenz is present in breast milk. Treatment of mothers of HIV-positive mothers with
efavirenz does not appear to affect growth and development of their HIV-negative breastfed
infants.
Administration Administer on an empty stomach. Dosing at bedtime is recommended to limit central nervous
system effects. Refer to manufacturer PIL if there are specific considerations.
Warnings/ • May cause CNS effects (eg, abnormal dreams, insomnia, impaired concentration,
Precautions hallucinations, dizziness, drowsiness); symptoms usually begin within 1 to 2 days after

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starting efavirenz, and generally resolve within 2 to 4 weeks of continued therapy; dosing
at bedtime may improve tolerability
• Fat redistribution: May cause redistribution/accumulation of fat
• Hepatotoxicity: Hepatitis, including fulminant hepatitis progressing to hepatic failure
(sometimes fatal or requiring transplantation), has been reported, including patients with
no preexisting hepatic disease or other identifiable risk factors.
• Hypercholesterolemia
• Serious psychiatric side effects have been associated with use
• QT prolongation
• Use with caution in patients with a history of seizure disorder; dementia or hepatic
toxicity.
Storage 15°C to 30°C
Refer to manufacturer PIL if there are specific considerations.

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c) Protease inhibitors

7. Atazanavir (ATV)
Generic Name Atazanavir

Dosage Capsules: 100 mg, 150 mg, 200 mg.

form/strengths
Route of Oral
administration
Pharmacologic Antiretroviral, Protease Inhibitor (Anti-HIV)
category ATC: J05AE08
Indications Treatment of HIV-1 infections in combination with other antiviral drugs in patients ≥3 months
of age weighing ≥5 kg.
Dosage Adults:
Regimen 300 mg of atazanavir + 100 mg of ritonavir
or atazanavir 400 mg once daily in patients unable to tolerate ritonavir in antiretroviral-naïve
patients.
Note: Atazanavir without ritonavir is not recommended in antiretroviral-experienced patients
with prior virologic failure.
Pediatrics: (Boosted regimen (preferred regimen)
Oral powder: Infants ≥3 months, Children, and Adolescents: Oral:
5 to <15 kg: Atazanavir 200 mg once daily plus ritonavir 80 mg once daily.
In antiretroviral-naive patients weighing 5 to <10 kg unable to tolerate this dose, may use
atazanavir 150 mg once daily plus ritonavir 80 mg once daily with close HIV viral load
monitoring.
15 to <25 kg: Atazanavir 250 mg once daily plus ritonavir 80 mg once daily.
≥25 kg (who cannot swallow a capsule): Atazanavir 300 mg oncedaily plus ritonavir 100 mg
once daily.
Oral capsule: Children ≥6 years weighing ≥15 kg and Adolescents <18 years: Oral:
15 kg to <35 kg: Atazanavir 200 mg once daily plus ritonavir 100 mg once daily.
≥35 kg: Atazanavir 300 mg once daily plus ritonavir 100 mg once daily
Adolescents ≥18 years: Oral: Atazanavir 300 mg once daily plus ritonavir 100mg once daily
Unboosted regimen: Note: Boosted atazanavir dosing regimen is preferred; guidelines do
not recommend unboosted regimens unless patient is ≥13 years and not receiving concurrent
tenofovir; closely monitor plasma concentrations to ensure adequate concentrations are
achieved. Oral powder should not be used for unboosted regimens.

>6 to <13 years: Oral capsule: Oral: Atazanavir 520 mg/m2/dose once daily
13 to <18 years: Oral capsule: Oral: Atazanavir 620 mg/m2/dose once daily
Adolescents ≥18 years: Oral capsule: Oral: Atazanavir 400 mg once daily.

Dosage Renal Impairment

adjustment No change in patients with mild to severe impairment.
End-stage renal disease:
atazanavir is not appreciably removed during hemodialysis
Antiretroviral-naive patients: Atazanavir 300 mg plus ritonavir 100 mg once daily
Antiretroviral-experienced patients: Not recommended
Hepatic Impairment
Adult: Atazanavir without ritonavir in antiretroviral-naïvepatients:

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Mild impairment (Child-Pugh A): 400 mg daily.
Moderate impairment (Child-Pugh B): 300 mg daily.
Severe impairment (Child-Pugh C): not recommended.
Atammmmmzanavir with ritonavir is not recommended for hepatic patients (has not been
studied).

Pediatric :Boosted regimens (with ritonavir): Infants, Children, and Adolescents: Mild to
severe impairment: Use is not recommended
Contra- Hypersensitivity to atazanavir or other components of the formulation.
indications
Adverse Drug Skin rash – elevated serum cholesterol – elevated amylase – elevated serum bilirubin –
Reactions jaundice – cough – fever – elevated creatine phosphokinase, cough ( more in children), fever .
Monitoring Lipid profile – AST – ALT – Billirubin - Virologic response, hypersensitivity reaction,GIT
Parameters disturbance.
Drug Risk X: Avoid combination
Interactions Abametapir Acalabrutinib Alfuzosin Alprazolam Aprepitant Astemizole Asunaprevir Avanafil
Avapritinib Barnidipine Belinostat Blonanserin Bosutinib Budesonide (Topical) Buprenorphine
Cisapride Cobimetinib Conivaptan Dapoxetine Domperidone Doxorubicin Dronedarone
Elagolix Eletriptan Eplerenone Ergot Derivatives Flibanserin Fluticasone (Nasal) Fosaprepitant
Fusidic Acid (Systemic) Glecaprevir And Pibrentasvir Grazoprevir Ibrutinib Indinavir
Infigratinib Isavuconazonium Sulfate Ivabradine Lefamulin Lemborexant Lercanidipine
Lomitapide Lonafarnib Lovastatin Lumateperone Lurbinectedin Macitentan Midazolam
Naloxegol Neratinib Nevirapine Nimodipine Nisoldipine Ombitasvir, Paritaprevir, And
Ritonavir Paclitaxel Pazopanib Pimozide Pralsetinib Radotinib Ranolazine Red Yeast Rice
Regorafenib Repaglinide Revefenacin Rifampin Rimegepant Rupatadine Sacituzumab
Govitecan Salmeterol Saquinavir Silodosin Simeprevir Simvastatin Sonidegib St John's Wort
Suvorexant Tamsulosin Tazemetostat Terfenadine Ticagrelor Tipranavir Tolvaptan Topotecan
Trabectedin Triazolam Ubrogepant Udenafil Ulipristal Vincristine (Liposomal) Vinflunine
Voclosporin Vorapaxar Voriconazole Voxilaprevir

Pregnancy and Atazanavir crosses placental barrier in low amounts. Malformative risk with use of this drug in
Lactation pregnant women is unlikely.
The use of atazanavir in pregnancy without a booster is not recommended.
Breastfeeding is not recommended during use of this drug; if replacement feeding is not an
option, a different drug may be preferred.
Administration Administer with food.
Administer atazanavir 2 hours before or 1 hour after antacids. Administer atazanavir (with
ritonavir) simultaneously with, or at least 10hours after, H2-receptor antagonists, 12 hours
after proton pump inhibitor
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Elevated bilirubin - Fat redistribution - Hypersensitivity reactions - Immune reconstitution
Precautions syndrome - Nephrolithiasis/cholelithiasis
Caution in patients with diabetes, Hemophilia A or B, or patients with hepatic or renal
diseases
Storage Store between 15°C and 30°C.
Refer to manufacturer PIL if there are specific considerations.

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8. Lopinavir and Ritonavir
Generic Name Lopinavir/Ritonavir

Dosage Solution, oral: Lopinavir 80 mg and ritonavir 20 mg per 1 mL

form/strengths Tablet: Lopinavir 200 mg and ritonavir 50 mg
Route of Oral
administration
Pharmacologic Antiretroviral, Protease Inhibitor (Anti-HIV)
category
Indications Treatment of HIV-1 infection in adults and pediatric patients 14 days and older in combination
with other antiretroviral agents.

Not recommended as a component of initial therapy for the treatment of HIV.

Dosage HIV-1 infection, treatment (as a component of combination therapy): Oral,
Regimen Adults:
o Patients receiving concomitant antiretroviral therapy without efavirenz, nelfinavir,
or nevirapine:
Twice-daily dosing: Lopinavir 400 mg/ritonavir 100 mg twice daily.
Once-daily dosing: Therapy-naive or experienced patients with <3 lopinavir Resistance-
associated substitutions: Lopinavir 800 mg/ritonavir 200 mg once daily.
o Dosage adjustment for combination therapy with efavirenz, nelfinavir, or
nevirapine:
Oral: Solution: Lopinavir 520 mg/ritonavir 130 mg (6.5 mL) twice daily.
Tablet: Lopinavir 500 mg/ritonavir 125 mg twice daily
o Pregnant women: tablet, oral: Lopinavir 400 mg/ritonavir 100 mg twice, may
increasedose of lopinavir 600 mg/ritonavir 150 mg twice daily, or lopinavir 500
mg/ritonavir 125 mg twice daily, during the second and third trimesters of pregnancy
avoid use once daily or solution form.
HIV-1 infection, treatment (as a component of combination therapy): Oral
, Pediatrics: Use of tablets in patients <15 kg or <0.6 m2 is not recommended; oral solution
preferable. Once-daily dosing is not recommended in children <18 years of age.
o (Infants (≥42 weeks PMA):
Patients not receiving concomitant efavirenz, nelfinavir, or nevirapine:
Lopinavir 16mg/kg/dose or 300mg/ m2/dose, Twice daily.

Patients with concomitant efavirenz, nelfinavir, or nevirapine: lopinavir/ritonavir is not

recommended in infants who are receiving these agents.
o Children and Adolescents:
Patients not receiving concomitant efavirenz, nelfinavir, or nevirapine:
<15 kg: Lopinavir 12 mg/kg/dose twice daily.
15 to 40 kg: Lopinavir 10 mg/kg/dose twice daily.
>40 kg: Lopinavir 400 mg twice daily.

Patients with concomitant efavirenz, nelfinavir, or nevirapine:

<15 kg: Lopinavir 13 mg/kg/dose twice daily.
≥15 to 45 kg: Lopinavir 11 mg/kg/dose twice daily.
>45 kg: Adult dose
HIV-1 nonoccupational postexposure prophylaxis (nPEP): Initiate therapy within 72 hours of
exposure and continue for 28 days; use in combination with other antiretroviral agents. Oral:

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the same dose of HIV-1infection treatment in pediratric

Dosage renal impairment

adjustment No dosage adjustments provided.
Hemodialysis: Avoid once-daily dosing
hepatic impairment
• Mild to moderate impairment: There are no dosages adjustments use with caution.
• Severe impairment: There are no dosage adjustments (has not been studied); use with
caution
Contra- Hypersensitivity (eg, toxic epidermal necrolysis, Stevens-Johnson syndrome,) to lopinavir,
indications ritonavir, or any component of the formulation
Adverse Drug Dermatologic: Skin rash (children 12%; adults ≤5%)
Reactions Endocrine & metabolic: Hypercholesterolemia (3% to 39%), increased serum triglycerides (3%
to 36%), hyrglycemia
Gastrointestinal: Diarrhea (greater with once-daily dosing), dysgeusia, vomiting
Hepatic: Increased serum ALT (grade 3/4: 1% to 11%)
Respiratory: Upper respiratory tract infection (14%)
Cardiovascular: Vasodilation (≤3%)
Hematologic & oncologic: Thrombocytopenia ( 4% children), neutropenia (1% to 5%)
Monitoring Prior to therapy, consider genotypic or phenotypic testing for lopinavir resistance-associated
Parameters substitutions.
Triglycerides and cholesterol (prior to initiation then periodically thereafter), LFTs,
electrolytes, glucose
Drug Risk X: Avoid combination
Interactions Acalabrutinib Alfuzosin Alprazolam Antihepaciviral Combination Products Aprepitant
Astemizole Asunaprevir Avanafil Avapritinib Barnidipine Bilastine Blonanserin Bosutinib
Budesonide (Topical) Cabotegravir Cisapride Clobetasone Cobicistat Cobimetinib Conivaptan
Dapoxetine Darunavir Disulfiram Domperidone Doxorubicin (Conventional) Dronedarone
Elagolix Elagolix, Estradiol, And Norethindrone Eletriptan Eplerenone Everolimus Flecainide
Flibanserin Fosamprenavir Fosaprepitant Fusidic Acid (Systemic) Grazoprevir Ibrutinib
Infigratinib Isavuconazonium Sulfate Ivabradine Lefamulin Lemborexant Lercanidipine
Letermovir Lomitapide Lonafarnib Lovastatin Lumateperone Lurasidone Lurbinectedin
Macitentan Meptazinol Methotrimeprazine Metronidazole (Systemic) Midazolam Naloxegol
Neratinib Nimodipine Nisoldipine Pazopanib Pazopanib Pimozide Pralsetinib Propafenone
Quinidine Quinine Radotinib Ranolazinered Yeast Rice Regorafenib Revefenacin Rifampin
Rimegepantrivaroxabanrupatadinesacituzumab Govitecan Salmeterol Silodosin Simeprevir
Simvastatin Sonidegib St John's Wortsuvorexant Tamsulosin Tazemetostat Tepotinib Ticagrelor
Tipranavir Tolvaptan Topotecan Trabectedin Triazolam Ubrogepant Ulipristal Vardenafi
Lvincristine (Liposomal) Vinflunine Voclosporin Vorapaxar Voriconazole Voxilaprevir
Pregnancy and Lopinavir has a low level of transfer across the human placenta; fetal exposure is increased
Lactation with ritonavir. Based on information collected by the Antiretroviral Pregnancy Registry, an
increased risk of teratogenic effects has not been observed in humans.
Breastfeeding is not recommended during use of this drug.
Administration Solution: Must be administered with food
Tablet: May be taken with or without food. Swallow whole, do not break, crush, or chew.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ • Cardiovascular concerns: Possible higher risk of myocardial infarction associated with the
Precautions cumulative use of lopinavir/ritonavir; consider avoiding lopinavir/ritonavir-based
regimens in patients with high cardiac risk.

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• May alter cardiac conduction and prolong the QTc and/or PR interval.
• Fat redistribution.
• Hepatotoxicity, use with caution in patients with Hepatitis B or C and cirrhosis.
• Immune reconstitution syndrome.
• Increased cholesterol.
• Changes in glucose tolerance, hyperglycemia, exacerbation of diabetes, DKA,
• Use with caution in patients with hemophilia A or B
• Hepatic impairment: Use with caution; lopinavir concentrations may be increased.
• Pancreatitis: Use with caution in patients with increased triglycerides
Storage Oral solution: Store at 2°C to 8°C, Avoid exposure to excessive heat. If stored at 25°C use
within 2 months.
Tablet: Store at 15°C to 30°C. Exposure to high humidity outside of the original container
>2 weeks is not recommended
Refer to manufacturer PIL if there are specific considerations.

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9. Darunavir and ritonavir (DRV/r)
Generic Name Darunavir/ritonavir

Dosage Suspension, Oral: 100 mg/mL (200 mL)

form/strengths Tablet, Oral: 75 mg, 150 mg ,600 mg, 800 mg

Route of Oral
administration
Pharmacologic Antiretroviral, Protease Inhibitor (Anti-HIV). Binds to the site of HIV-1 protease activity. This
category results in the formation of immature, noninfectious viral particles.
ATC: J05AR26
Indications • Treatment of HIV-1 infection, coadministered with ritonavir and other antiretroviral
agents, in adults and pediatric patients 3 years and older
• Alternative second-line regimen in Adults, adolescents, Children and infants in
combination with zidovudine and lamivudine

HIV-1 infection, nonoccupational postexposure prophylaxisin combination with other

antiretroviral agents
Dosage Dosing: Adult
Regimen • Treatment naïve or experienced patients with no darunavir resistance-associated
substitutions:
Oral: 800 mg once daily; coadministrated with ritonavir 100 mg
• Treatment experiencedWith ≥1 darunavir resistance-associated substitution or If
genotypic testing is not possible:
600 mg twice daily; coadministrated with ritonavir 100 mg twice daily.
• Pregnant patients:
Oral: 600 mg twice daily, coadministered with ritonavir 100 mg twice daily.
• HIV-1 infection, nonoccupational postexposure prophylaxis: Oral: 800 mg plus ritonavir
100 mg once daily (in combination with other antiretroviral agents); initiate therapy
within 72 hours of exposure and continue for 28 days

Dosing: Pediatric
Children 3 to 11 years weighing ≥10 kg:
Treatment-naive patients or treatment-experienced patients without or with darunavir
resistance-testing results that demonstrate at least one mutation associated with resistance
Fixed-dosing: Tablets, Oral solution (darunavir: 100 mg/mL):
10 kg to <11 kg: Darunavir 200 mg (2 mL) twice daily plus ritonavir 32 mg twice daily.
11 kg to <12 kg: Darunavir 220 mg (2.2 mL) twice daily plus ritonavir 32 mg twice daily.
12 kg to <13 kg: Darunavir 240 mg (2.4 mL) twice daily plus ritonavir 40 mg twice daily.
13 kg to <14 kg: Darunavir 260 mg (2.6 mL) twice daily plus ritonavir 40 mg twice daily.
14 kg to <15 kg: Darunavir 280 mg (2.8 mL) twice daily plus ritonavir 48 mg twice daily.
15 kg to <30 kg: Darunavir 375 mg (tablets or 3.8 mL) twice daily plus ritonavir 48 mg twice
daily.
30 kg to <40 kg: Darunavir 450 mg (tablets or 4.6 mL) twice daily plus ritonavir 100 mg twice
daily.
≥40 kg: Darunavir 600 mg (tablet or 6 mL) twice daily plus ritonavir 100 mg twice daily.
Children ≥12 years and Adolescents weighing 30 to <40 kg: Treatment-naive patients or
treatment-experienced patients without or with mutations associated with darunavir
resistance:

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Twice-daily regimen: Darunavir 450 mg twice daily plus ritonavir 100 mg twice daily.
Once-daily regimen: Darunavir 675 mg (combination of tablets) once daily plus ritonavir 100
mg once daily;
Children ≥12 years and Adolescents weighing ≥40 kg: refere to adult dosing
Dosage Dosing: Renal Impairment
adjustment No dose adjustment in case of renal impairment
Dosing: Hepatic Impairment
• Mild to moderate impairment (Child-Pugh class A or B): No dosage adjustments
necessary
• Severe impairment (Child-Pugh class C): Use not recommended.

Contra- • Hypersensitivity to darunavir or any component of the formulation

indications • severe (Child-Pugh class C) hepatic impairment
coadministration with amiodarone, apixaban, lidocaine (systemic), rivaroxaban or drugs that
are highly dependent on CYP3A for clearance and drugs for which elevated plasma
concentrations are associated with serious and/or life-threatening events (narrow
therapeutic index).
Adverse Drug Dermatologic: Skin rash
Reactions Endocrine & metabolic: Increased serum cholesterol, increased LDL cholesterol), increased
serum glucose (≤11%)
Gastrointestinal: Vomiting, nausea, diarrhea (children & adolescents: 11% to 24%; adults: 9%
to 14%)

Monitoring Viral load, CD4, baseline genotypic and/or phenotypic testing in treatment-experienced
Parameters patients (if possible); serum glucose; transaminase levels prior to and during therapy
(increase monitoring in patients at risk for liver impairment), cholesterol, triglycerides,
glucose
Drug − Long list of interactions should be checked before administration, includes:
Interactions • Colchicine: ritonavir may increase the serum concentration of Colchicine.
Management: Colchicine is contraindicated in patients with impaired renal or hepatic
function who are also receiving darunavir/ritonavir. In those with normal renal and
hepatic function, reduce colchicine dose. Risk D: Consider therapy modification
• Domperidone: darunavir /ritonavir may increase the serum concentration of
Domperidone. Management: Drugs listed as exceptions to this monograph are
discussed in further detail in separate drug interaction monographs. Risk X: Avoid
combination
• Dronedarone: ritonavir may increase the serum concentration of Dronedarone.
Management: Risk X: Avoid combination
• Efavirenz: ritonavir may increase the serum concentration of Efavirenz. Efavirenz may
decrease the serum concentration of Darunavir. Management: Monitor for decreased
concentrations and effects of darunavir and/or increased concentrations and effects
of efavirenz Risk D: Consider therapy modification
• Eplerenone or ivabradine or lovastatin: ritonavir may increase the serum
concentration of Eplerenone. Risk X: Avoid combination
• Estrogen Derivatives (Contraceptive): Protease Inhibitors may decrease the serum
concentration of Estrogen Derivatives (Contraceptive). Management: Use of an
alternative, non-hormonal contraceptive is recommended with other protease
inhibitors. Risk D: Consider therapy modification

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• Fluticasone (Nasal): ritonavir may increase the serum concentration of Fluticasone
(Nasal). Risk X: Avoid combination
• Rifampin or rifapentine: May decrease the serum concentration of Darunavir. Risk X:
Avoid combination
• Sildenafil: ritonavir may increase the serum concentration of Sildenafil.
Management: Erectile dysfunction: sildenafil max = 25 mg/48 hrs with ritonavir,
contraindicated if sildenafil being used for pulmonary arterial hypertension. Risk D:
Consider therapy modification
• Simvastatin, lovastatin: Protease Inhibitors may increase the serum concentration of
Simvastatin. Risk X: Avoid combination
• Tacrolimus (Systemic): ritonavir may increase the serum concentration of Tacrolimus
(Systemic). Tacrolimus dose reductions or prolongation of dosing interval will likely
be required. Risk D: Consider therapy modification
Pregnancy and • No increased risk of overall birth defects has been observed following first trimester
Lactation exposure according to data collected by the antiretroviral pregnancy registry.
The Health and Human Services (HHS) perinatal HIV guidelines consider darunavir
(when combined with low-dose ritonavir boosting) a preferred protease inhibitor for
pregnant females living with HIV.
Breastfeeding is not recommended during use of this drug; if replacement feeding is
not an option, a different drug may be preferred.
Administration Administer with food.
Shake suspension prior to each dose; use provided oral dosing syringe to measure
dose.
Missed doses
In patients taking darunavir once daily, if a dose is missed by >12 hours, the next dose
should be taken at the regularly scheduled time.
If a dose is missed by <12 hours, the dose should be taken immediately and then the
next dose should be taken at the regularly scheduled time.
In patients taking darunavir twice daily, if a dose is missed by >6 hours, the next dose
should be taken at the regularly scheduled time.
If a dose is missed by <6 hours, the dose should be taken immediately and then the
next dose should be taken at the regularly scheduled time.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ • Fat redistribution, Hepatotoxicity, Hypersensitivity reactions, Sulfonamide allergy
Precautions Immune reconstitution syndrome, Diabetes, Hemophilia A or B
• Pediatric: Do not administer darunavir with ritonavir in pediatric patients younger than
3 years (toxicity and mortality observed in animal studies).
Storage Store between 15°C and 30°C. Do not refrigerate or freeze oral suspension.
Refer to manufacturer PIL if there are specific considerations.

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d) Integrase Inhibitors

10. Dolutegravir (DTG)

Generic Name Dolutegravir

Dosage Film Coated Tablets: 50 mg

form/strengths
Route of Oral
administration
Pharmacologic Antiretroviral, Integrase Inhibitor (Anti-HIV)
category ATC: J05AX12
Indications Treatment of HIV-1 infection in combination with other antiretroviral agents for treatment
naïve or experienced adult or pediatric patients
Dosage Adults:
Regimen • INSTI naive: 50 mg daily.
• INSTI-naive when coadministered with carbamazepine, efavirenz, or rifampin: 50 mg
twice daily
• INSTI experienced with suspected resistance: 50 mg twice daily.
• Virologically suppressed patients switching to dolutegravir plus rilpivirine: 50 mg daily.
Pediatrics:
• Treatment-naive or treatment-experienced and integrase strand transfer inhibitor (INSTI)-
naive:
o Infants and Children weighing 3 to <14 kg: Oral:
Soluble tablets for oral suspension:
3 to <6 kg: 5 mg once daily.
6 to <10 kg: 15 mg once daily.
10 to <14 kg: 20 mg once daily.
o Infants, Children, and Adolescents weighing ≥14 kg: Oral:
Soluble tablets for oral suspension: Preferred in patients <20 kg:
14 to <20 kg: 25 mg once daily.
≥20 kg: 30 mg once daily.
Tablets:
14 to <20 kg: 40 mg once daily.
≥20 kg: 50 mg once daily.
• INSTI-experienced with any INSTI-associated resistance mutation or clinically suspected
INSTI resistance:
Children and Adolescents weighing ≥40 kg: Oral: Tablets: 50 mg twice daily.

Dosage Dosing: Renal Impairment

adjustment Treatment-naive or treatment-experienced INSTI-naive: Mild, moderate, or severe
impairment: No dosage adjustment necessary.
INSTI experienced with suspected resistance and creatinie clearance less than 30 ml/min:
it should be used with caution taking into consideration that decreasing dolutegravir doses
may lead to loss of therapeutic effect and the development of resistance.
End-stage renal disease:
No dosage adjustments available
Dosing: Hepatic Impairment
Severe impairment (Child-Pugh C): not recommended
Hepatoxicity during therapy (in pediatrics) : If asymptomatic hepatitis, consider

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discontinuation of therapy for ALT or AST >5 times ULN; if symptomatic hepatitis, discontinue
therapy
Contra- Hypersensitivity to dolutegravir or any other component in the formulation.
indications
Major Adverse Gastrointestinal: Increased serum lipase , Hyperglycemia, Elevated ALT,AST
Drug Reactions
Monitoring ALT – Blood Glucose – Viral load - CD4 count – Monitor signs of hypersensitivity
Parameters
Drug Risk X: Avoid combination
Interactions Dofetilide Fosphenytoin-Phenytoin Nevirapine Oxcarbazepine Phenobarbital Primidone St
John's Wort
Risk D: Consider therapy modification
Aluminum Hydroxide Calcium Salts Carbamazepine Dalfampridine Efavirenz Etravirine
Fosamprenavir Iron Preparations Magnesium Salts Metformin Multivitamins/Minerals (With
ADEK, Folate, Iron) Rifampin Selenium Sucralfate Tipranavir Zinc Salts
Pregnancy and A small but significant increase in neural tube defects (NTDs) was observed following
Lactation maternal use of dolutegravir in a study conducted in Botswana. The risk of NTDs was
increased in women who became pregnant while taking dolutegravir, but not in women who
started dolutegravir during pregnancy.
Dolutegravir has been used safely in HIV-positive mothers during breastfeeding.
Administration Administer without regard to meals. Administer 2 hours before or 6 hours after cation-
containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Hepatotoxicity, Hypersensitivity reactions, Immune reconstitution syndrome
Precautions
Storage Store at 15°C to 30°C, protect from moisture.
Refer to manufacturer PIL if there are specific considerations.

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11. Raltegravir
Generic Name Raltegravir

Dosage Tablet, Oral:100 mg ,400mg, 600 mg

form/strengths Sachets, chewable tablets : 25 mg
Route of Oral
administration
Pharmacologic Antiretroviral, Integrase Inhibitor (Anti-HIV)
category ATC: J05AX08

Indications Treatment of HIV-1 infection in combination with other antiretroviral agents HIV-1
nonoccupational& occupational postexposure prophylaxis
Dosage HIV-1 infection, treatment: Adults, Oral:
Regimen o Treatment-naive patients: 400 mg twice daily or 1,200 mg once daily
o Treatment-experienced patients: 400 mg twice daily.
HIV-1 nonoccupational & occupational postexposure prophylaxis: Adult, Oral:
400 mg twice daily for 28 days in combination with other antiretroviral agents. Initiate therapy
within 72 hours of exposure
Dosage Modifications, Treatment-naïve or treatment-experienced when co-administered with
rifampin 800 mg (two 400-mg tabs) PO BID.
HIV-1 infection, treatment: Pediatrics:
o Oral Chewable tablets: Children weighing ≥11 kg:
Weight-directed dosing: 6 mg/kg/dose twice daily; maximum dose: 300 mg/dose.
o Oral solution: Infants and Children <20 kg
Weight-directed dosing: 6 mg/kg/dose twice daily; maximum dose: 100 mg/dose.
o Oral Film Coated Tablets: Children and Adolescents ≥25 kg to 40 kg:
400 mg twice daily.
o Oral Film Coated Tablet: Children and Adolescents ≥40 kg:
1,200 mg once daily.
Dosage renal impairment
adjustment Mild, moderate, and severe impairment: No dosage adjustment necessary.
End-stage renal disease (ESRD) on intermittent hemodialysis (IHD): Dose after dialysis on
dialysis days.
hepatic impairment
Mild-to-moderate impairment: No dosage adjustment necessary.
Severe impairment: There are no dosage adjustments (has not been studied).
Film-coated tablet (600 mg formulation): Use is not recommended in mild, moderate and
severe (has not been studied).
Contra- Hypersensitivity to raltegravir or any other component of the formulation.
indications
Adverse Drug Hepatic: Increased serum ALT, hyperbilirubinemia, increased serum alkaline phosphatase
Reactions (≤2%), hepatitis (<2%)
Central nervous system: Headache (≤4%), insomnia (≤4%), abnormal dreams (≥2%), suicidal
ideation (<2%),
Endocrine & metabolic: Increased serum glucose (126 to 250 mg/dL: 7% to 10%; 251 to 500
mg/dL: 2% to 3%)
Gastrointestinal: Increased serum lipase (≤5%), increased serum amylase
Hematologic & oncologic: Decrease in absolute neutrophil count (1% to 4%),
thrombocytopenia (≤3%), decreased hemoglobin (≤1%)

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Monitoring Viral load, CD4 count, signs of skin rash, signs/symptoms of depression and suicidal ideation.
Parameters
Drug Risk X: Avoid combination
Interactions Aluminum Hydroxide Fosamprenavir Magnesium Salts
Risk D: Consider therapy modification
Calcium Carbonate Polyvalent Cation Containing Products Rifampin
Pregnancy and No increased risk of overall birth defects has been observed following first trimester exposure
Lactation according to data collected by the antiretroviral pregnancy registry.
The Health and Human Services (HHS) Perinatal HIV Guidelines consider raltegravir a preferred
integrase strand transfer inhibitor (INSTI) for pregnant females living with HIV
Once daily dosing is not recommended for use during pregnancy,
Breastfeeding is not recommended while taking Raltegravir
Administration • May be administered without regard to meals.
• Oral suspension: pour packet contents into water at a concentration of 10 mg/mLand swirl
in a circular motion for 45 seconds; do not shake. Do not turn the mixing cup upside down.
Administer within 30 minutes of mixing with water. Discard any remaining suspension in
the trash.
• Film-coated tablets and chewable tablets or oral suspension are not bioequivalent and are
not substitutable on a mg/mg basis
• Refer to manufacturer PIL if there are specific considerations.
Warnings/ -Immune reconstitution syndrome, Myopathy, Skin and hypersensitivity reactions.
Precautions At birth, the enzyme responsible for the metabolism of raltegravir (UGT1A1) is low and
Raltegravir elimination in neonates may be prolonged. The activity of UGT1A1 increasee
Rapidly over the first 4 to 6 weeks of life.
-Do not use in combination with darunavir and ritonavir in patients with HIV RNA >100,000
copies/mL and/or CD4 count <200 cells/mm3, or in combination with abacavir and
lamivudine in patients with HIV RNA >100,000 copies/mL).
Storage Store at 15°C to 30°C.
Refer to manufacturer PIL if there are specific considerations.

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Antitubercular Agent
1. Ethambutol
Generic Name Ethambutol

Dosage Tablets 500mg

form/strengths
Route of Oral
administration
Pharmacologic Antitubercular Agent
al action ATC: J04AK02
Indications Tuberculosis: Treatment of pulmonary tuberculosis in conjunction with other antituberculosis
agents.
Dosage Must be used in conjunction with other antimycobacterial agents for treatment of active (clinical)
Regimen TB,
Can be used in daily or intermittent (e.g., 2 or 3 times weekly) multiple-drug TB regimens
Treatment of Active (Clinical) Tuberculosis:
Oral: Note: Always administer in combination with other antitubercular drugs.
15 mg/kg once daily in previously untreated adults.
In previously treated adults: 25 mg/kg once daily for 60 days, followed by 15 mg/kg once daily.
Dosing: Doses should be based on lean body weight for patients within a normal weight range for
their height (optimal dosing for obese patients has not been established):
Once-daily therapy: Note: The preferred frequency of administration is once daily; however, 5-
days-per-week administration by directly observed therapy (DOT) is an acceptable alternative

Adults weighing 40–55 kg: 800 mg once daily, 2 g twice weekly, or 1.2 g 3 times weekly
recommended by ATS, CDC, and IDSA.
Adults weighing 56–75 kg: 1.2 g once daily, 2.8 g twice weekly, or 2 g 3 times weekly
recommended by ATS, CDC, and IDSA.
Adults weighing 76-90 kg: 1.6 g once daily, 4 g twice weekly, or 2.4 g 3 times weekly recommended
by ATS, CDC, and IDSA

Treatment of Active (Clinical) Tuberculosis in Children

Children <15 years of age or weighing ≤40 kg 15–25 mg/kg once daily
If an intermittent regimen is used, 50 mg/kg twice weekly
a maximum dose is 1 g per dose; AAP and others recommend a maximum of 2.5 g per dose.
Treatment of Active (Clinical) Tuberculosis in Adolescents
Adolescents ≥15 years of age weighing 40–55 kg: 800 mg daily, 2 g twice weekly, or 1.2 g 3 times
weekly.
Adolescents ≥15 years of age weighing 56–75 kg: 1.2 g daily, 2.8 g twice weekly, or 2 g 3 times
weekly recommended by ATS, CDC, and IDSA.
Adolescents ≥15 years of age weighing 76-90 kg: 1.6 g daily, 4 g twice weekly, or 2.4 g 3 times
weekly recommended by ATS, CDC, and IDSA.
Adolescents: AAP and others recommend 15–25 mg/kg (up to 2.5 g) once daily or 50 mg/kg twice
weekly (up to 2.5 g per dose)
Dosage Altered kidney function Adult:
adjustment CrCl ≥30 mL/minute: No dosage adjustment necessary.
CrCl <30 mL/minute: If usual recommended dose is administered once daily, then do not adjust the

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dose, but only administer 3 times weekly
Hemodialysis, intermittent (thrice weekly): Dialyzable: Dose as CrCl <30 mL/minute; administer
after hemodialysis on dialysis days. Use with caution and close monitoring, as hemodialysis
patients may develop optic adverse effects, even with properly adjusted doses
Peritoneal dialysis: Likely dialyzable
Dosing: Renal Impairment: Pediatric
There are no dosage recommendations specific for pediatric patients; ethambutol is primarily
renally excreted; monitor serum levels to determine adjustments; experience in adult patients
suggests dosing adjustment necessary.
Dosing: Hepatic Impairment:
There are no dosage adjustments needed; use with caution.
Contra- Hypersensitivity to ethambutol or any component of the formulation; optic neuritis (risk vs benefit
indications decision); use in young children, unconscious patients, or any other patient who may be unable to
discern and report visual changes
Adverse Drug Cardiovascular: Myocarditis, pericarditis
Reactions Central nervous system: Confusion, disorientation, dizziness, hallucination, headache, malaise,
peripheral neuritis
Dermatologic: Dermatitis, erythema multiforme, exfoliative dermatitis, pruritus, skin rash
Endocrine & metabolic: Acute gout attack, hyperuricemia
Gastrointestinal: Abdominal pain, anorexia, gastric distress, nausea, vomiting
Hematologic & oncologic: Eosinophilia, leukopenia, lymphadenopathy, neutropenia,
thrombocytopenia
Hepatic: Abnormal hepatic function tests, hepatitis, hepatotoxicity (possibly related to concurrent
therapy)
Hypersensitivity: Anaphylaxis, anaphylactoid reaction, hypersensitivity reaction (syndrome
includes cutaneous reactions, eosinophilia, and organ-specific inflammation)
Neuromuscular & skeletal: Arthralgia
Ophthalmic: Color blindness, decreased visual acuity, optic neuritis, scotoma, visual disturbance
(usually reversible with discontinuation; irreversible blindness has been described)
Renal: Nephritis
Respiratory: Pneumonitis, pulmonary infiltrates (with or without eosinophilia)
Miscellaneous: Fever
Monitoring Baseline and periodic (monthly) visual testing (Snellen test) and color discrimination tests (each
Parameters eye individually, as well as both eyes tested together) in patients receiving >15 mg/kg/day;
baseline and periodic renal, hepatic, and hematopoietic tests
Drug Risk X: Avoid combination
Interactions BCG (Intravesical) Cholera Vaccine
Risk D: Consider therapy modification
Aluminum Hydroxide Sodium Picosulfate Typhoid Vaccine
Risk C: Monitor therapy
BCG Vaccine Lactobacillus and Estriol
Pregnancy Pregnancy factor C
Ethambutol is present in breast milk.
Breastfeeding only if benefits to the mother outweigh the possible risk to the infant. Limited
information indicates that maternal doses of ethambutol up to 15 mg/kg daily produce low levels
in milk and would not be expected to cause any adverse effects in breastfed infants, especially if
the infant is older than 2 months. Breastfed infants should be monitored for jaundice
Administration Administer orally without regard to meals. If GI upset occurs, administer with food. Tablet may be
pulverized and mixed with apple juice or apple sauce. Do not mix with other juices or syrups since

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they do not mask ethambutol's bitter taste or are not stable. Administer ethambutol at least 4
hours before aluminum hydroxide.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Hepatic toxicity: Has been reported, possibly due to concurrent therapy. Monitor liver function
prior to and during treatment.
• Optic neuritis: May cause optic neuritis (unilateral or bilateral), resulting in decreased visual
acuity or other vision changes. Discontinue promptly in patients with changes in vision, color
blindness, or visual defects (effects normally reversible, but reversal may require up to a year).
Irreversible blindness has been reported. Monitor visual acuity prior to and during therapy.
Disease-related concerns:
• Ocular disease: Evaluation of visual acuity changes may be more difficult in patients with
cataracts, optic neuritis, diabetic retinopathy, and inflammatory conditions of the eye;
consideration should be given to whether or not visual changes are related to disease progression
or effects of therapy
• Renal impairment: Use with caution in patients with renal impairment; dosage modification
recommended. Monitor renal function prior to and during treatment.
Special populations:
• Pediatric: Use only in children whose visual acuity can accurately be determined and monitored
(not recommended for use in children <13 years of age unless the benefit outweighs the risk).
Storage Store at controlled room temperature of 20°C to 25°C
Refer to manufacturer PIL if there are specific considerations.

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2. Ethambutol, Isoniazid, Rifampicin, and Pyrazinamide

Generic Name Ethambutol , Isoniazid, Rifampicin and Pyrazinamide

Dosage Tablets: Ethambutol 275 mg ; Rifampicin 150mg ; Isoniazid 75 mg ; Pyrazinamide 400

form/strengths mg
Route of Oral
administration
Pharmacologic Antibacterial (antimycobacterial)
action ATC: J04AM06
Indications used to treat tuberculosis (TB) in adults and children at least 15 years old.

Dosage Rifampin, Isoniazid, Pyrazinamide, and Ethambutol tablets

Regimen The World Health Organization (WHO) recommends the fixed-dose combination of
rifampin 150 mg, isoniazid 75 mg, pyrazinamide 400 mg, and ethambutol 275 mg for
the daily administration in the initial phase of tuberculosis treatment
Usual Adult Dose
[ Tuberculosis]
Patients weighing between 30 and 39 kg: Oral, 2 tablets once a day
Patients weighing between 40 and 54 kg: Oral, 3 tablets once a day
Patients weighing between 55 and 70 kg: Oral, 4 tablets once a day
Patients weighing 71 kg or more: Oral, 5 tablets once a day
Usual Pediatric Dose
[ Tuberculosis]
Infants and children under 30 kg of body weight: Use is not recommended.
Children weighing 30 kg or more: See Usual adult dose

The duration of treatment with an antituberculosis regimen is at least 6 months, and

treatment may be continued for 2 years
Dosage Renal function impairment
adjustment Moderate renal impairment (creatinine clearance 30 – 60 ml/min): use with caution
Severe renal impairment (creatinine clearance < 30 ml/min): use is contra-indicated
Hepatic function impairment:
use with caution in impaired liver function.
contraindicated in patients with a history of drug induced hepatitis and in patients with
acute liver diseases
Contra- Hypersensitivity to rifampin, isoniazid, pyrazinamide, ethionamide, niacin (nicotinic
indications acid), rifabutin, rifapentine, or other chemically related medications
Adverse Drug Refer to individual drug monographs.
Reactions
Monitoring Hepatic function determinations (ALT [SGPT], AST [SGOT], alkaline phosphatase, and
Parameters serum bilirubin determinations may be indicated prior to and monthly or more
frequently during treatment, Ophthalmologic examinations, Uric acid concentrations,
serum
Drug Refer to individual drugs
Interactions
Pregnancy and Pregnancy Category C
Lactation breastfeeding should not be discouraged in women taking this drug. breastfed infants
should be monitored for the signs/symptoms of toxicity (e.g., arthralgia, fever,

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hepatitis, jaundice, loss of appetite, nausea, rash, thrombocytopenia, vomiting).

Administration tablets are administered orally. The tablets should be given as a single dose (number of
tablets depending on the patient's bodyweight), in a fasting state at least 1 hour before
a meal.
Warnings/ Alcoholism, active or in remission (increased risk of hepatitis with daily consumption
Precautions of alcohol
Gout, history of (pyrazinamide and ethambutol can increase serum uric acid
concentrations and precipitate an acute attack of gout
» Hepatic function impairment, severe (rifampin, isoniazid, and pyrazinamide are
metabolized in the liver and may also be hepatotoxic
» Hypersensitivity to isoniazid, ethambutol, ethionamide, pyrazinamide, niacin
(nicotinic acid), or other chemically related medications
Hypersensitivity to rifampin, rifabutin, and/or rifapentine
» Optic neuritis (ethambutol may cause retrobulbar optic neuritis
» Renal function impairment (ethambutol is excreted primarily through the kidneys,
patients with a renal function impairment may require a reduction in dosage; there may
be an increased risk of isoniazid toxicity in patients who have severe renal failure
[creatinine clearance < 10 mL/min or 0.17 mL/sec]
Seizure disorders (isoniazid may be neurotoxic and cause seizure)
Storage Do not store above 25°C. Store in the original package in order to protect from
moisture.
Refer to manufacturer PIL if there are specific considerations.

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3. Isoniazid
Generic Name Isoniazid

Dosage Tablets: 50mg, 100mg, 200mg, 300mg

form/strengths
Route of Oral
administration
Pharmacologic Antitubercular Agent
al action ATC: J04AC01
Indications Active tuberculosis infections: Treatment of susceptible active tuberculosis
(eg, Mycobacterium tuberculosis) infections.

Latent tuberculosis infection: Treatment of latent tuberculosis infection (LTBI) caused

by Mycobacterium tuberculosis (also referred to as prophylaxis or preventive therapy).
Dosage Used in conjunction with other antimycobacterial agents for treatment of active (clinical) TB.
Regimen Used alone for treatment of Latent TBI
Adults
Treatment of Active (Clinical) Tuberculosis
Oral
Dosing:
Once-daily therapy: 5 mg/kg/dose (usual dose: 300 mg) once daily Note: The preferred
frequency of administration is once daily during the intensive and continuation phases;
however, 5 days per week administration by directly observed therapy (DOT) is an acceptable
alternative.
Three-times-weekly DOT: 15 mg/kg/dose (usual dose: 900 mg) administered 3 times weekly
Twice-weekly DOT: 15 mg/kg/dose (usual dose: 900 mg) administered twice weekly
Once-weekly DOT: 15 mg/kg/dose (usual dose: 900 mg) administered once weekly
Regimens: Treatment regimens for pulmonary tuberculosis and tuberculous meningitis consist
of an initial 2-month phase of a 4-drug regimen, followed by a continuation phase of an additional
4 to 7 months of isoniazid and rifampin for pulmonary tuberculosis and a continuation phase of
an additional 7 to 10 months of isoniazid and rifampin for tuberculous meningitis (optimal
duration is not defined although continuation phase must continue for a minimum of 7 additional
months). Adjunctive corticosteroid therapy (eg, dexamethasone, prednisolone) tapered over 6
to 8 weeks is also recommended for tuberculous meningitis. Isoniazid frequency and dosing
differs depending on treatment regimen selected; consult current Drug-sensitive TB guidelines
Latent Tuberculosis Infection (LTBI)
Oral
Isoniazid monotherapy (alternative regimen)
5 mg/kg (up to 300 mg) once daily or 15 mg/kg (up to 900 mg) twice weekly recommended by
ATS, CDC, IDSA, USPHS, and others.
Adults weighing >30 kg: 300 mg once daily
The usual duration of isoniazid monotherapy for treatment of LTBI is 9 months. A 6-month
regimen may be used in some adults, but a 9-month regimen should be used in
immunocompromised or HIV-infected individuals or those with fibrotic lesions on chest
radiographs
Pediatric Patients
Tuberculosis
Treatment of Active (Clinical) Tuberculosis

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Oral
Children: 10–15 mg/kg (up to 300 mg) once daily or 20–40 mg/kg (up to 900 mg) 2 or 3 times
weekly recommended.
Children <15 years of age or weighing ≤40 kg: 10–15 mg/kg (up to 300 mg) once daily or 20–
30 mg/kg (up to 900 mg) twice weekly recommended by ATS, CDC, IDSA, AAP, and
others.
Adolescents ≥15 years of age: 5 mg/kg (up to 300 mg) once daily or 15 mg/kg (up to 900 mg)
1–3 times weekly recommended by ATS, CDC, and IDSA
Latent Tuberculosis Infection (LTBI)
Oral
Infants, children, and adolescents: 10–20 mg/kg (up to 300 mg) once daily or 20–40 mg/kg (up
to 900 mg) twice weekly.
The usual duration of isoniazid monotherapy for treatment of LTBI in children is 9 months,
especially in HIV-infected individuals. A 6-month regimen is not recommended for children.
ATS and CDC recommend that completion of therapy for LTBI be based on total number of
administered doses rather duration of therapy alone. When the 9-month once-daily isoniazid
regimen is used, at least 270 doses should be administered within 12 months.
Dosage Dosing: Renal Impairment:
adjustment No dosage adjustment necessary, monitor closely in severe renal impairment.
Hemodialysis: No dosage adjustment necessary; administer after hemodialysis on dialysis days
Dosing: Hepatic Impairment:
Use with caution, may accumulate and additional liver damage may occur in patients with
preexisting liver disease
Contra- Hypersensitivity to isoniazid or any component of the formulation, including drug-induced
indications hepatitis; acute liver disease; previous history of hepatic injury during isoniazid therapy;
previous severe adverse reaction (drug fever, chills, arthritis) to isoniazid

Adverse Drug >10%: Hepatic: Increased serum transaminases (mild and transient 10% to 20%)
Reactions
Monitoring Baseline and periodic (more frequently in patients with higher risk for hepatitis) liver function
Parameters tests (ALT and AST); sputum cultures monthly (until 2 consecutive negative cultures reported);
monitoring for prodromal signs of hepatitis

Drug Risk X: Avoid combination

Interactions BCG (Intravesical), Cholera Vaccine, Methoxyflurane, Pimozide
Risk D: Consider therapy modification
Fosphenytoin, Lemborexant, Lomitapide, Phenytoin, Prothionamide Sodium Picosulfate,
Triazolam, Typhoid Vaccine, Ubrogepant,
Risk C: Monitor therapy,
Acetaminophen, Alcohol, BCG Vaccine (Immunization), Carbamazepine, Chlorzoxazone,
Corticosteroids, Cycloserine, CYP2E1 Inhibitors, Dofetilide, Ethionamide, Flibanserin,
Itraconazole, Ketoconazole (Systemic), Lactobacillus and Estriol, Levodopa-Containing Products,
Nimodipine, Propacetamol, Rifamycin Derivatives, Safinamide, Theophylline Derivatives
Pregnancy and Pregnancy Category C
Lactation Isoniazid is considered compatible with breastfeeding
Breastfed infants should be monitored for jaundice; discontinue breastfeeding or consider
changing to a different maternal medication if jaundice develops. Pyridoxine supplementation
is recommended for the mother and infant
Administration Oral Administration

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Administer orally in the fasting state. Do not administer with food.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Hepatitis: [US Boxed Warning]: Severe and sometimes fatal hepatitis may occur; usually
occurs within the first 3 months of treatment, although may develop even after many months
of treatment.
Disease-related concerns:
• Hepatic impairment: Use with caution in patients with hepatic impairment; contraindicated in
patients with acute liver disease or previous isoniazid-associated hepatic injury. Treatment with
isoniazid for latent tuberculosis infection (LTBI) should be deferred in patients with acute
hepatic diseases.
• Renal impairment: Use with caution in patients with severe renal impairment.
Other warnings/precautions:
• Appropriate use: Multidrug regimens should be utilized for the treatment of active
tuberculosis to prevent the emergence of drug resistance.
• Monitoring: Use should be carefully monitored in the following groups: Daily users of alcohol,
active chronic liver disease, severe renal dysfunction, age >35 years, concurrent use of any
chronically administered drug, history of previous isoniazid discontinuation, existence of or
conditions predisposing to peripheral neuropathy, pregnancy, injection drug use, women in
minority groups (particularly postpartum), HIV seropositive patients.

Storage Tablet: Store at 20°C to 25°C. Protect from moisture and light.
Refer to manufacturer PIL if there are specific considerations.

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4. Pyrazinamide
Generic Name Pyrazinamide

Dosage Tablets 500mg

form/strengths
Route of Oral
administration
Pharmacologic Antitubercular Agent
category ATC: J04AK01

Indications Tuberculosis: Treatment of tuberculosis in combination with other antituberculosis agents.

Dosage Dosing: Adult

Regimen Tuberculosis, treatment (drug-susceptible): Oral: Note: Always administer in combination with
other antitubercular drugs.
Dosing: Doses should be based on lean body weight for patients within a normal weight range for
their height (optimal dosing for obese patients has not been established):
• Once-daily therapy:
40 to 55 kg: 1,000 mg once daily Note: The preferred frequency of administration is once daily;
however, 5-days per week administration by directly-observed therapy (DOT) is an acceptable
alternative.
56 to 75 kg: 1,500 mg once daily.
76 to 90 kg: 2,000 mg once daily.
• Three-times-weekly DOT:
40 to 55 kg: 1,500 mg 3 times weekly.
56 to75 kg: 2,500 mg 3 times weekly.
76 to 90 kg: 3,000 mg 3 times weekly.
Tuberculosis, treatment (drug-resistant) (alternative agent):
Note: Expert consultation for optimal regimen and duration of treatment is advised.
Oral: 25 to 40 mg/kg once daily
Dosing: Pediatric
Note: Recommendations often change due to epidemiology (resistance) and emerging
information; consult CDC and WHO for current recommendations, as appropriate.
Active TB infection, treatment:

• Once daily or 5-times-weekly (DOT):

Infants, Children, and Adolescents weighing <40 kg: Oral: 35 mg/kg/dose once daily or 5 times
weekly DOT; suggested range: 30 to 40 mg/kg/dose
Children and Adolescents weighing ≥40 kg:
Note: Doses should be based on lean body weight for patients within a normal weight range for
their height (optimal dosing for obese patients has not been established):
Oral: Weight-band dosing for whole tablets:
40 to 55 kg: 1,000 mg (18.2 to 25 mg/kg/dose) once daily or 5-times-weekly (DOT)
56 to 75 kg: 1,500 mg (20 to 28.6 mg/kg/dose) once daily or 5-times-weekly (DOT)
76 to 90 kg: 2,000 mg (22.2 to 26.3 mg/kg/dose) once daily or 5-times-weekly (DOT)

• Three-times-weekly DOT:
Infants, Children, and Adolescents weighing <40 kg: Oral: 50 mg/kg/dose 3 times weekly
Children and Adolescents weighing ≥40 kg:

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Oral: Weight-band dosing for whole tablets:
40 to 55 kg: 1,500 mg (27.3 to 37.5 mg/kg/dose) three-times-weekly
56 to 75 kg: 2,500 mg (33.3 to 44.6 mg/kg/dose) three-times-weekly
76 to 90 kg: 3,000 mg (33.3 to 39.5 mg/kg/dose) three-times-weekly
Dosage Dosing: Renal Impairment:
adjustment It may be prudent to select doses at the low end of the dosing range. Dosing is based on lean body
weight
Dosing: Hepatic Impairment:
Use is contraindicated in cases of severe hepatic impairment.
Contra- Hypersensitivity to pyrazinamide or any component of the formulation; acute gout; severe hepatic
indications damage

Adverse Drug 1% to 10%:

Reactions Central nervous system: Malaise
Gastrointestinal: Anorexia, nausea, vomiting
Neuromuscular & skeletal: Arthralgia, myalgia
Monitoring Periodic liver function tests, serum uric acid, sputum culture, chest x-ray 2-3 months into
Parameters treatment and at completion
Drug Risk X: Avoid combination
Interactions BCG (Intravesical) Cholera Vaccine
Risk D: Consider therapy modification
Rifampin Sodium Picosulfate Typhoid Vaccine
Pregnancy and Pregnancy Risk Factor C
Lactation breastfeeding should not be discouraged in women taking this drug.
breastfed infants should be monitored for the signs/symptoms of toxicity (e.g., arthralgia, fever,
hepatitis, jaundice, loss of appetite, nausea, rash, thrombocytopenia, vomiting).
Administration Oral: May take without regard to food
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Hepatotoxicity: Dose-related hepatotoxicity ranging from transient ALT/AST elevations to
jaundice, hepatitis and/or liver atrophy (rare) has occurred.
Disease-related concerns:
• Alcoholism: Due to concerns for preexisting hepatic dysfunction, use with caution in
patients with a history of alcoholism.
• Diabetes: Use with caution in patients with diabetes mellitus.
• Gout: May inhibit uric acid excretion; acute gouty attacks have been reported. Use with
caution in patients with chronic gout; contraindicated with acute gout.
• Porphyria: Use with caution in patients with porphyria.
• Renal impairment: Use with caution in patients with renal failure.
Concurrent drug therapy issues:
• Hepatotoxic agents: Use with caution in patients receiving concurrent medications
associated with hepatotoxicity (particularly with rifampin). The Infectious Diseases Society of
America and Centers for Disease Control and Prevention recommend that the 2-month
rifampin-pyrazinamide regimen should not generally be used in patients with LTBI
Storage Store at controlled room temperature of 15°C to 30°C
Refer to manufacturer PIL if there are specific considerations.

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5. Rifampicin
Watch Group

Generic Name Rifampicin

Dosage form/ Capsule 150mg, 300mg,

strengths Oral Suspension 2% (100mg/5ml)
Ampoule Lyophilized Powder 250mg
Route of Oral, IV
administration
Pharmacologic Antitubercular Agent; Rifamycin
category ATC: J04AB02
Indications Meningococcal prophylaxis: Treatment of asymptomatic carriers of Neisseria meningitidis to
eliminate meningococci from the nasopharynx.

Tuberculosis: Treatment of tuberculosis in combination with other agents.

Dosage Adult Dosing:
Regimen Meningococcal disease, chemoprophylaxis after close contact with a patient with invasive
disease:
Oral: 600 mg twice daily for 2 days. Note: Administer prophylaxis as soon as possible following
exposure (ideally <24 hours after identification of index patient). Close contacts include
persons with prolonged exposure (≥8 hours) in close proximity (<3 feet) to index patient or
direct exposure to oral secretions (eg, household contacts, childcare center contacts).
Tuberculosis, active (drug susceptible):
Note: Always administer in combination with other antitubercular drugs
Oral, IV:
o Initial intensive phase: 10 mg/kg (maximum dose: 600 mg) once daily (or 5 days per week by
directly observed therapy [DOT]) as part of a standard 4-drug regimen for 2 months
o Continuation phase: 10 mg/kg (maximum dose: 600 mg) once daily (or 5 days per week by
DOT) in combination with isoniazid for at least 4 months or longer for cavitary disease with
positive cultures (7 months), bone and joint disease (6 to 9 months), and CNS disease (≥12
months) .
o Alternative dosing intervals: Daily or 5-times-weekly dosing is preferred, particularly during
the intensive phase. If neither is feasible, alternatives in order of preference are: daily (or 5-
times-weekly) dosing for the intensive phase followed by 3-times-weekly dosing during the
continuation phase; 3-times-weekly dosing for the duration of treatment; and daily dosing
for 2 weeks followed by twice-weekly dosing. Use DOT for <7 days/week dosing.
Tuberculosis, latent infection:
Oral: 10 mg/kg (maximum dose: 600 mg) once daily as a single agent for 4 months or in
combination with isoniazid for 3 months
Pediatric Patients
General Dosage for Infants and Children
Oral or IV
Children ≥1 month of age: AAP recommends 10–20 mg/kg (up to 600 mg) daily given in 1 or 2
divided doses for mild to moderate infections or 20 mg/kg (up to 600 mg) daily in 2 divided
doses for severe infections
Meningococcal disease, chemoprophylaxis after close contact with a patient with invasive
disease: Infants, Children, and Adolescents: Oral: 20 mg/kg/day in divided doses every 12
hours for 2 days; maximum dose: 600 mg/dose.
Tuberculosis, active (drug-susceptible); treatment:

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Note: Always administer in combination with other antitubercular drugs. Doses of 20 to 30
mg/kg/dose have been recommended for infants and young children or for treating
disseminated tuberculosis or tuberculous meningitis.
Initial intensive phase: Note: Administer part of a standard 4-drug regimen for 2 months.
Infants, Children, and Adolescents <15 years weighing ≤40 kg: Oral, IV: 10 to 20
mg/kg/dose once daily (or 5 days/week by directly observed therapy [DOT]);
maximum dose: 600 mg/dose.
Children and Adolescents <15 years weighing >40 kg or Adolescents ≥15 years: Oral, IV:
10 mg/kg/dose once daily (or 5 days/week by DOT); maximum dose: 600 mg/dose.
Continuation phase: Note: Administer in combination with isoniazid for ≥4 months;
continuation phase duration should be longer for cavitary disease with positive cultures at
completion of intensive phase (7 months), bone and joint disease (≥4 to 7 months), and CNS
disease (7 to 10 months).
Infants, Children, and Adolescents <15 years weighing ≤40 kg: Oral, IV: 10 to 20
mg/kg/dose once daily (or 5 days/week by DOT); maximum dose: 600 mg/dose.
Children and Adolescents <15 years weighing >40 kg or Adolescents ≥15 years: Oral, IV:
10 mg/kg/dose once daily (or 5 days/week by DOT); maximum dose: 600
mg/dose.
Dosage Dosing: Renal Impairment:
adjustment No dosage adjustment necessary.
CrCl <15 mL/minute, Hemodialysis: No dosage adjustment necessary for usual indication-
specific doses ≤600 mg/day. For usual indication-specific doses ≥900 mg/day, consider limiting
dose to 600 mg/day or monitoring more closely for adverse effects
Dosing: Hepatic Impairment:
Hepatic impairment prior to treatment initiation:
Rifampin is substantially eliminated by the liver and the clearance of rifampin would be
expected to be decreased in patients with liver impairment. use with caution.
Hepatotoxicity during treatment:
New or worsening hepatic damage: Discontinue rifampin.

Contra- Hypersensitivity to rifampin, any rifamycins, or any component of the formulation; concurrent
indications use of atazanavir, darunavir, fosamprenavir, praziquantel, ritonavir/saquinavir, saquinavir, or
tipranavir.
Jaundice associated with reduced bilirubin excretion; premature and newborn infants;
breastfeeding women; hepatic function impairment

Adverse Drug Frequency not defined:

Reactions Cardiovascular: Decreased blood pressure, flushing, shock, vasculitis
Central nervous system: Ataxia, behavioral changes, confusion, dizziness, drowsiness, fatigue,
headache, lack of concentration, myasthenia, numbness, peripheral pain, sore mouth
Dermatologic: Erythema multiforme, pemphigoid reaction, pruritus, skin rash, urticaria
Endocrine & metabolic: Adrenocortical insufficiency, menstrual disease
Gastrointestinal: Abdominal cramps, anorexia, diarrhea, epigastric discomfort, flatulence,
glossalgia, heartburn, nausea, staining of tooth, vomiting
Genitourinary: Hemoglobinuria, hematuria
Hematologic & oncologic: Decreased hemoglobin, disorder of hemostatic components of
blood (vitamin K-dependent), disseminated intravascular coagulation, eosinophilia, hemolysis,
hemolytic anemia, hemorrhage, leukopenia, thrombocytopenia (especially with high-dose
therapy)
Hepatic: Abnormal hepatic function tests, hepatic insufficiency, hyperbilirubinemia, jaundice

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Hypersensitivity: Hypersensitivity reaction
Neuromuscular & skeletal: Myopathy
Ophthalmic: Conjunctivitis, visual disturbance
Renal: Acute renal failure, interstitial nephritis, renal insufficiency, renal tubular necrosis
Respiratory: Dyspnea, flu-like symptoms, wheezing
Miscellaneous: Fever
Monitoring Baseline LFTs (AST, ALT, bilirubin), serum creatinine, CBC; periodic (every 2 to 4 weeks during
Parameters therapy) monitoring of liver function in patients with preexisting hepatic impairment and
periodic monitoring of serum creatinine and CBC in patients with baseline abnormalities.
Mental status, sputum culture, chest X-ray 2 to 3 months into treatment. Monitor coagulation
tests during treatment in patients at risk of vitamin K deficiency.
Drug Risk X: Avoid combination
Interactions Apixaban, Aprepitant, Atazanavir, BCG (Intravesical), Bosutinib, Cholera Vaccine, Dabigatran
Risk D: Consider therapy modification
Antifungal Agents (Azole Derivatives, Systemic), Aripiprazole, Atorvastatin, Brivaracetam,
Calcium Channel Blockers, Canagliflozin, Caspofungin, Cephalosporins, Clarithromycin,
Clozapine, Cyclosporine (Systemic), Dexamethasone (Systemic)
Pregnancy and Pregnancy Category C
Lactation Breastfeeding is not a contraindication during therapy for drug-susceptible tuberculosis in
patients deemed noninfectious who are treated with first-line agents (ie, rifampin).
Administration Administration: IV
Administer IV preparation by slow IV infusion over 30 minutes to 3 hours at a final
concentration not to exceed 6 mg/mL. Do not administer IM or SubQ. Avoid extravasation.
Administration: Oral
Administer on an empty stomach with a glass of water (ie, 1 hour prior to, or 2 hours after
meals or antacids) to increase total absorption (food may delay and reduce the amount of
rifampin absorbed). The compounded oral suspension must be shaken well before using. May
mix contents of capsule with applesauce or jelly.
Preparation for Administration:
Reconstitute vial with 10 mL SWFI. Prior to injection, dilute in appropriate volume of a
compatible solution (ie, D5W, NS) at a final concentration not to exceed 6 mg/mL.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Coagulopathy: May cause vitamin K-dependent coagulation disorders and bleeding. Monitor
coagulation tests during treatment in patients at risk of vitamin K deficiency (eg, chronic liver
disease, poor nutritional status, prolonged use of antibacterial agents or anticoagulants).
Consider discontinuation if abnormal coagulation tests and/or bleeding occurs; consider
supplemental vitamin K administration when appropriate.
• Dermatologic reactions: Cases of severe cutaneous adverse reactions (SCAR) such as Stevens-
Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous
pustulosis (AGEP), and drug reaction with eosinophilia and systemic symptoms (DRESS)
syndrome have been reported. Discontinue treatment immediately and institute appropriate
therapy if signs or symptoms of SCAR develop.
• Flu-like syndrome: Regimens of >600 mg once or twice weekly in adults have been
associated with a high incidence of adverse reactions including a flu-like syndrome.
• Hematologic effects: May cause thrombocytopenia, leukopenia, or anemia with regimens
>600 mg once or twice weekly in adults.
• Hepatotoxicity: Hepatotoxicity of hepatocellular, cholestatic, and mixed patterns has been
reported; may include asymptomatic elevations in liver enzymes, isolated

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jaundice/hyperbilirubinemia, symptomatic self-limited hepatitis, or fulminant liver failure and
death. Severe reactions, including fatalities, have occurred in patients with preexisting hepatic
failure and in patients receiving concomitant hepatotoxic agents. Monitor for signs and
symptoms of liver injury, especially if treatment is prolonged or given with other hepatotoxic
drugs. Patients with impaired liver function should only be given rifampin when medically
indicated and with monitoring of LFTs (AST, ALT, bilirubin) prior to therapy and then every 2 to
4 weeks during therapy. Discontinue use if hepatocellular damage occurs or worsens.
• Hypersensitivity: Hypersensitivity reactions have been reported. Signs and symptoms of
hypersensitivity reactions may include fever, rash, urticaria, angioedema, hypotension, acute
bronchospasm, conjunctivitis, thrombocytopenia, neutropenia, elevated liver transaminases,
or flu-like syndrome. Monitor patients for signs/symptoms of hypersensitivity; discontinue
therapy if signs/symptoms suggestive of hypersensitivity (eg, fever, lymphadenopathy,
eosinophilia, liver abnormalities) occur, even if rash is not evident.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C.
difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed
>2 months postantibiotic treatment.
Disease-related concerns:
• Alcoholism: Use with caution in patients with a history of alcoholism (even if ethanol
consumption is discontinued during therapy).
• Diabetes mellitus: Use with caution in patients with diabetes mellitus; management of
diabetes may be more difficult in patients taking rifampin.
• Hepatic impairment: Use with caution and close monitoring in patients with hepatic
impairment.
• Meningococcal disease: Do not use for treatment of meningococcal disease, only for short-
term treatment of asymptomatic carrier states.
• Porphyria: Use with caution in patients with porphyria; exacerbations have been reported
due to enzyme-inducing properties.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or
frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult
drug interactions database for more detailed information.
Other warnings/precautions:
• Appropriate administration: Do not administer IV form via IM or SubQ routes; restart
infusion at another site if extravasation occurs.
• Compliance: Monitor for compliance in patients on intermittent therapy.
• Contact lenses: Remove soft contact lenses during therapy since permanent staining may
occur.
• Discoloration: Teeth (may be permanent), urine, feces, saliva, sweat, and tears may be
discolored (yellow, orange, red, or brown)
Storage Capsule: Store at 25°C, avoid excessive heat.
Injection: Store intact vials at 25°C avoid excessive heat (>40°C). Protect the intact vials from
light. Reconstituted vials are stable for 30 hours at room temperature. Stability of parenteral
admixture at room temperature (25°C) is 8 hours for D5W or 6 hours for NS.
Refer to manufacturer PIL if there are specific considerations.

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6. Rifampicin and Isoniazid
Generic Name Rifampicin+ Isoniazid

Dosage Capsule/Tablets: 300 Rifampicin + 150 Isoniazid

form/strengths
Route of Oral
administration
Pharmacologic Antibiotic, Miscellaneous
category ATC: J04AM02
Indications Management of active tuberculosis, see individual agents for additional information

Dosage Dosing: Adult

Regimen Tuberculosis: Oral:
Note: Concomitant antituberculosis medications should be administered according to current
guideline recommendations
Capsules: Rifampin 300 mg/isoniazid 150 mg per capsule/tablet: 2 capsules/tablets once daily
Tablets:
Dosing: Pediatric
Tuberculosis: Adolescents ≥15 years: Refer to adult dosing
Dosage Dosing: Renal Impairment: Adult
adjustment There are no dosage adjustments needed. Use with caution in severe renal impairment. Also
see individual agents.
Dosing: Hepatic Impairment: Adult
Hepatic impairment prior to treatment initiation: There are no dosage adjustments needed; use
with caution. Use is contraindicated in patients with severe or acute hepatic impairment or in
cases of previous isoniazid-associated hepatic injury.
Hepatotoxicity during treatment: New or worsening hepatic damage: Discontinue treatment.

Contra- Hypersensitivity to rifampin or other rifamycins, isoniazid, or any component of the

indications formulation; severe hepatic damage; acute hepatic disease; acute gout; history of severe
adverse reactions to isoniazid (eg, drug-induced hepatitis, drug fever, chills, arthritis);
concurrent use of atazanavir, darunavir, fosamprenavir, praziquantel, saquinavir,
saquinavir/ritonavir, or tipranavir.
Adverse Drug See individual agents.
Reactions
Monitoring Baseline and periodic LFTs (AST, ALT), serum uric acid, serum bilirubin, serum creatinine, CBC,
Parameters ophthalmic examinations (including ophthalmoscopy); patients at higher risk for hepatitis (eg,
existing hepatic impairment, older patients, ethanol consumption, alcoholism) should undergo
evaluation of LFTs every 2 to 4 weeks; signs/symptoms of hepatotoxicity; monitor sputum
cultures monthly (until 2 consecutive negative cultures reported); monitor chest x-ray 2 to 3
months into treatment and at completion. Monitor coagulation tests during treatment in
patients at risk of vitamin K deficiency.

Drug Risk X: Avoid Combination

Interactions Abemaciclib Alpelisib Antihepaciviral Combination Products Apixaban Apremilast Aprepitant
Artemether Asunaprevir Atazanavir Atovaquone Avanafil Avapritinib Axitinib BCG (Intravesical)
Bedaquiline Betrixaban Bictegravir Bortezomib Bosutinib Brigatinib Cabotegravir Capmatinib
Cariprazine Ceritinib Cholera Vaccine Cobicistat Cobimetinib Copanlisib Crizotinib Dabigatran
Etexilate Daclatasvir Darolutamide Darunavir Dasabuvir Deflazacort Delamanid Delavirdine

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Dexlansoprazole Dienogest Diltiazem Doravirine Doxorubicin Dronedarone Duvelisib Edoxaban
Elagolix, Estradiol, And Norethindrone Elbasvir Elexacaftor, Tezacaftor, And Ivacaftor Eliglustat
Elvitegravir Encorafenib Entrectinib Erdafitinib Esomeprazole Etravirine Fedratinib Fimasartan
Flibanserin Fosamprenavir Fosaprepitant Fosnetupitant Fostamatinib Fostemsavir Gemigliptin
Gilteritinib Glasdegib Glecaprevir And Pibrentasvir Grazoprevir Ibrutinib Idelalisib Indinavir
Irinotecan Products Isavuconazonium Sulfate Istradefylline Itraconazole Ivabradine Ivacaftor
Ivosidenib Ixazomib Lansoprazole Ledipasvir Lemborexant Letermovir Lonafarnib Lorlatinib
Lumacaftor And Ivacaftor Lumateperone Lumefantrine Lurasidone Lurbinectedin Macimorelin
Methoxyflurane Midostaurin Mifepristone Mycophenolate Naldemedine Naloxegol Nelfinavir
Neratinib Netupitant Nifedipine Nilotinib Nimodipine Nintedanib Nisoldipine Olaparib
Omeprazole Ozanimod Palbociclib Panobinostat Pazopanib Pemigatinib Perampanel
Pexidartinib Pimavanserin Pimozide Piperaquine Praziquantel Pretomanid Quinineranolazine
Regorafenib Revefenacin Rilpivirine Rimegepant Ripretinib Ritonavir Rivaroxaban Roflumilast
Romidepsin Sacituzumab Govitecan Saquinavir Selpercatinib Selumetinib Simeprevir Siponimod
Sofosbuvir Sonidegib Sorafenib Tasimelteon Tazemetostat Telithromycin Tenofovir
Alafenamide Tezacaftor And Ivacaftor Ticagrelor Tipranavir Toremifene Trabectedin Tucatinib
Ubrogepant Ulipristal Upadacitinibvalbenazine Vandetanib Velpatasvir Venetoclax
Vincristine Vinflunine Voclosporin Vorapaxar Voriconazolevoxilaprevir Zanubrutinib Zolpidem
Pregnancy and Isoniazid and rifampin cross the placenta. Refer to individual monographs for additional
Lactation information.
It is considered compatible with breastfeeding. Use caution
breastfed infants should be monitored for the signs/symptoms of toxicity (e.g., arthralgia,
fever, hepatitis, jaundice, loss of appetite, nausea, rash, thrombocytopenia, vomiting).
Administration Administer with a full glass of water 1 hour before or 2 hours after a meal.
Refer to manufacturer PIL if there are specific considerations.

Warnings/ Concerns related to adverse effects:

Precautions • Coagulopathy: May cause vitamin K-dependent coagulation disorders and bleeding. Monitor
coagulation tests during treatment in patients at risk of vitamin K deficiency (eg, chronic liver
disease, poor nutritional status, prolonged use of antibacterial agents or anticoagulants).
Consider discontinuation if abnormal coagulation tests and/or bleeding occur; consider
supplemental vitamin K administration when appropriate.
• Flu-like syndrome: Flu-like syndrome (eg, fever, chills, malaise) may occur; higher incidence is
associated with regimens of rifampin >600 mg once or twice weekly.
• Hematologic effects: May cause thrombocytopenia, leukopenia, or anemia; higher incidence
is associated with regimens of rifampin >600 mg once or twice weekly.
• Hepatotoxicity: [US Boxed Warning]: Severe and sometimes fatal hepatitis may occur with
isoniazid; increased transaminase concentrations usually occur within the first few months of
treatment, although may develop at any time. Liver enzymes often return to normal despite
continuance of drug; however, progressive hepatic dysfunction may occur. The risk of
developing hepatitis is age related; daily ethanol consumption may also increase the
risk. Patients must report symptoms of hepatitis, such as fatigue, weakness, malaise, anorexia,
nausea, or vomiting, immediately. Discontinue therapy immediately if hepatocellular damage
occurs or is suspected; if therapy must be restarted, initiate once symptoms and laboratory
abnormalities have resolved and at small and gradually increasing doses. Defer treatment in
patients with acute hepatic disease
• Hypersensitivity: Hypersensitivity reactions, including severe and potentially fatal reactions
have occurred with antituberculosis therapy. Signs and symptoms of hypersensitivity reactions
may include fever, rash, urticaria, angioedema, hypotension, acute bronchospasm,
conjunctivitis, thrombocytopenia, neutropenia, elevated liver transaminases, or flu-like

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syndrome. discontinue therapy if signs/symptoms suggestive of hypersensitivity (eg, fever,
lymphadenopathy, eosinophilia, liver abnormalities) occur, even if rash is not evident.
• Peripheral neuropathies: Pyridoxine is recommended in individuals at risk for development of
peripheral neuropathies (eg, HIV infection, nutritional deficiency, diabetes, pregnancy).
Disease-related concerns:
• Alcoholism: Use with caution in patients with a history of alcoholism (even if ethanol
consumption is discontinued during therapy).
• Diabetes: Use with caution in patients with diabetes mellitus.
• Hepatic impairment: Use with caution; contraindicated in patients with severe hepatic
damage or acute hepatic disease.
• Porphyria: Use with caution in patients with porphyria; exacerbations have been reported.
• Renal impairment: Use with caution in patients with severe renal impairment.
Other warnings/precautions:
• Appropriate use: Multidrug regimens should be utilized for the treatment of active
tuberculosis to prevent the emergence of drug resistance. Monitor for compliance. Not
recommended for intermittent therapy; avoid intentional or accidental interruption of therapy
(renal hypersensitivity reactions may occur upon resumption of therapy [rare]).
• Contact lenses: Remove soft contact lenses during therapy since permanent staining may
occur.
• Ophthalmic examinations: Periodic ophthalmic examinations are recommended even when
visual symptoms do not occur.
• Red/orange discoloration: Teeth (may be permanent), urine, feces, saliva, sputum, sweat,
tears, and CSF may be discolored (yellow, orange, red, or brown).

Stoarge Store at 25°C; excursions permitted to 15°C to 30°C. Protect from excessive humidity.
Refer to manufacturer PIL if there are specific considerations.

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Antiviral
1. Acyclovir
Generic Name Acyclovir

Dosage Tablet 400mg, 800mg

form/strengths Capsule 200mg
Suspension 200mg/5ml, 400mg/5ml,
Cream 5%
Vial 250mg, 500mg
eye ointment 3%
Route of Oral, Topical, IV, ophthalmic
administration
Pharmacologic Antiviral
action ATC (Topical): D06BB03
ATC (systemic): J05AB01
ATC (Ophthalmic): S01AD03
Indications Oral:
Herpes simplex virus (HSV), genital: Treatment of initial episodes and the management of
recurrent episodes of genital herpes.
Herpes zoster (shingles): Acute treatment of herpes zoster (shingles).
Varicella (chickenpox): Treatment of varicella (chickenpox).
Injection:
Herpes simplex encephalitis: Treatment of herpes simplex encephalitis.
Herpes simplex virus (HSV), genital infection (severe): Treatment of severe initial clinical
episodes of genital herpes in immunocompetent patients.
Herpes simplex virus (HSV), mucocutaneous infection in immunocompromised
patients: Treatment of initial and recurrent mucosal and cutaneous herpes simplex (HSV-1 and
HSV-2) in immunocompromised patients.
Herpes simplex virus (HSV), neonatal: Treatment of neonatal herpes infections.
Herpes zoster (shingles) in immunocompromised patients: Treatment of herpes zoster
(shingles) in immunocompromised patients.
Topical: Herpes virus:
Cream: Treatment of recurrent herpes labialis (cold sores) in immunocompetent children ≥12
years of age, adolescents, and adults
Dosage Dosing: Adult: Note: Use ideal body weight or 40% adjusted body weight for weight-based dosing
Regimen in obese patients to avoid overdosing and subsequent toxicity (eg, acute renal failure)
• Encephalitis: IV: 10 mg/kg/dose every 8 hours. for 14 to 21 days
• Meningitis: IV: 10 mg/kg/dose every 8 hours is 10 to 14 days;
• Herpes simplex virus, mucocutaneous infection:
o Oral: 400 mg 3 times daily or 200 mg 5 times daily for 7 to 10 days
o Immunocompromised patients: Oral: 400 mg 5 times daily for 14 to 21 days
• Genital:
o Oral: 400 mg 3 times daily or 200 mg 5 times daily for 7 to 10 days, while extend
treatment duration until complete resolution in Immunocompromised patients.
o IV (for severe disease): 5 to 10 mg/kg/dose every 8 hours for 2 to 7 days followed by
oral acyclovir (or similar antiviral) to complete ≥10 days of therapy total and until
complete resolution

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o recurrent episode: Oral: 400 mg 3 times daily for 5 days or 800 mg twice daily for 5
days or 800 mg 3 times daily for 2 days
o Suppressive therapy (eg, for severe and/or frequent recurrences):
▪ Immunocompetent patients: Oral: 400 mg twice daily. Note: Reassess
periodically (eg, annually)
▪ Immunocompromised patients: Oral: 400 to 800 mg 2 to 3 times
daily. Note: Reassess periodically (eg, annually)
• Orolabial:
o Oral: 400 mg 3 times daily for 5 to 10 days, while in immunocompromised patients
extend until complete lesion resolution
o IV (for severe disease in immunocompromised patients): 5 mg/kg/dose every 8
hours; switch to oral acyclovir (or similar antiviral) once lesions begin to regress and
continue until complete resolution
o Suppressive therapy (eg, for severe and/or frequent recurrences): Oral: 400 mg twice
daily. Note: Reassess periodically
o Topical cream: Apply 5 times daily for 4 days
• Herpes zoster (shingles), treatment:
o Oral: 800 mg 5 times daily for 7 days
o Extensive cutaneous lesions or visceral involvement: IV: 10 mg/kg/dose every 8 hours
• Varicella (chickenpox), treatment:
o Uncomplicated infection: Oral: 800 mg 5 times daily for ≥5 to 7 days and until all
lesions have crusted
o Severe or complicated infection: IV: 10 mg/kg/dose every 8 hours for 7 to 10 days
• Herpetic keratitis: Ophthalmic: Apply a ½-inch ribbon of ointment in the lower conjunctival
fold of the affected eye(s) 5 times daily (approximately every 3 hours while awake) until the
corneal ulcer heals, then apply a ½-inch ribbon 3 times daily for 7 days.
• Herpes labialis (cold sores), recurrent: Topical cream: Apply 5 times daily for 4 days
Dosing: Pediatric:
• Mucocutaneous, Ocular, and Systemic Herpes Simplex Virus (HSV) Infections
Treatment of Mucocutaneous HSV Infections
Oral
Immunocompromised children: 1 g daily given in 3–5 divided doses for 7–14 days.
IV
Immunocompromised children <12 years of age: 10 mg/kg every 8 hours for 7–14 days.
HIV-infected or immunocompromised adolescents and children ≥12 years of age: 5 mg/kg every
8 hours for 7–14 days. Alternatively, after lesions begin to regress, consider switching to oral
acyclovir in a dosage of 400 mg 3 times daily and continue until lesions are completely healed
• HSV Gingivostomatitis
Oral
HIV-infected children with mild, symptomatic gingivostomatitis: CDC and others recommend 20
mg/kg (up to 400 mg) 3 times daily for 7–14 days.
Immunocompetent children: 15 mg/kg (up to 200 mg) 5 times daily for 7 days has been used in a
few children 1–6 years of age.
IV
HIV-infected children with moderate to severe gingivostomatitis: CDC and others recommend 5–
10 mg/kg 3 times daily for 7–14 days. Consider chronic oral suppressive or maintenance therapy
(secondary prophylaxis) in those with frequent or severe recurrences of gingivostomatitis
• Chronic Suppressive or Maintenance Therapy (Secondary Prophylaxis) of HSV Infections
Oral
HIV-infected infants and children: 80 mg/kg daily (up to 1 g daily) in 3 or 4 divided doses.

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HIV-infected adolescents: 200 mg 3 times daily or 400 mg twice daily.
• Prophylaxis Against Recurrent Ocular HSV Disease
Oral
Children ≥12 years of age: 400 mg twice daily. AAP recommends 80 mg/kg daily (up to 1 g daily)
given in 3 divided doses.
Optimum duration of prophylaxis unclear; has been continued for 12–18 months in clinical studies.
• Treatment of HSV Encephalitis or Disseminated Disease
IV
Immunocompromised children: 20 mg/kg every 8 hours in those 3 months to 12 years of age and
10–15 mg/kg every 8 hours in those ≥12 years of age. AAP and others recommend 14–21 days for
disseminated or CNS infections.
HIV-infected children: CDC and others recommend 10 mg/kg or 500 mg/m2 3 times daily for 21
days.
HIV-infected adolescents: CDC and others recommend 10 mg/kg 3 times daily for 14–21 days.
• Treatment of Neonatal HSV Infections
IV
Neonates and children ≤3 months of age: 10 mg/kg every 8 hours for 10 days
Neonates and children ≤3 months of age: 20 mg/kg every 8 hours given for 14 days for infections
of skin, eyes, or mouth or 21 days for disseminated or CNS infections.
HIV-infected or -exposed neonates: 20 mg/kg 3 times daily given for 14 days for infections of skin,
eyes, or mouth or 21 days for disseminated or CNS infections.
• Prevention of HSV Recurrence in Hematopoietic Stem Cell Transplant (HSCT) Recipients
Oral
HSV-seropositive children: 0.6–1 g daily given in 3–5 divided doses.
HSV-seropositive adolescents: 200 mg 3 times daily.
Initiate prophylaxis at beginning of conditioning therapy and continue until engraftment or until
mucositis resolves (approximately 30 days after allogeneic HSCT). Routine prophylaxis for >30 days
after HSCT not recommended.
IV
HSV-seropositive children: 250 mg/m2 every 8 hours or 125 mg/m2 every 6 hours.
HSV-seropositive adolescents: 250 mg/m2 every 12 hours.
Initiate prophylaxis at beginning of conditioning therapy and continue until engraftment or until
mucositis resolves (approximately 30 days after allogeneic HSCT). Routine prophylaxis for >30 days
after HSCT not recommended.
• Genital Herpes
Treatment of First Episodes
Oral
Children: AAP recommends 40–80 mg/kg daily (maximum 1 g daily) given in 3 or 4 divided doses
for 5–10 days.
Adolescents: CDC recommends 400 mg 3 times daily or 200 mg 5 times daily for 7–10 days;
duration may be extended if healing is incomplete after 10 days.
HIV-infected adolescents: CDC and others recommend 20 mg/kg (up to 400 mg) or 400 mg 3 times
daily for 7–14 days.
IV
Adolescents and children ≥12 years of age with severe initial episodes: 5–10 mg/kg every 8
hours. 5–7 days of IV acyclovir or until clinical improvement occurs, followed by an oral antiviral to
complete at least 10 days of treatment.
• Episodic Treatment of Recurrent Episodes
Oral
Adolescents: CDC recommends 400 mg 3 times daily for 5 days, 800 mg twice daily for 5 days, or

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800 mg 3 times daily for 2 days.
HIV-infected adolescents: CDC recommends 400 mg 3 times daily for 5–10 days. Alternatively,
acyclovir can be given for 7–14 days.
Initiate episodic therapy at the earliest prodromal sign or symptom of recurrence or within 1 day
of the onset of lesions.
• Chronic Suppression of Recurrent Episodes
Oral
Adolescents: CDC recommends 400 mg twice daily.
HIV-infected adolescents: CDC recommends 400–800 mg 2 or 3 times daily.
Discontinue periodically (e.g., after 12 months or once yearly) to reassess need for continued
therapy.
• Varicella-Zoster Infections
Treatment of Varicella (Chickenpox)
Oral
Immunocompetent children ≥2 years of age: 20 mg/kg 4 times daily (maximum 80 mg/kg daily)
for 5 days in those weighing ≤40 kg and 800 mg 4 times daily for 5 days in those weighing >40
kg. Alternatively, some clinicians recommend 20 mg/kg (up to 800 mg) 4 times daily for 5 days.
HIV-infected children with mild immunosuppression and mild varicella: CDC and others
recommend 20 mg/kg (up to 800 mg) 4 times daily for 7 days or until no new lesions have
appeared for 48 hours.
Initiate therapy at the earliest sign or symptom of infection (within 24 hours of onset of rash).
IV
Immunocompromised children: AAP recommends 10 mg/kg 3 times daily for 7–10 days for those
<1 year of age and 500 mg/m2 3 times daily for 7–10 days in those ≥1 year of age.
Immunocompromised adolescents and children: Some clinicians recommend 20 mg/kg every 8
hours for 7–10 days in those ≤12 years of age and 10 mg/kg every 8 hours for 7 days in those >12
years of age.
HIV-infected children with moderate or severe immunosuppression and varicella associated with
high fever or necrotic lesions: CDC and others recommend 10 mg/kg 3 times daily for 7 days or
until no new lesions have appeared for 48 hours. Alternatively, a dosage of 500 mg/m2 every 8
hours has been suggested for those ≥1 year of age.
HIV-infected adolescents: CDC and others recommend 10 mg/kg every 8 hours for 7–10
days. After defervescence and if there is no evidence of visceral involvement, switch to oral
acyclovir in a dosage of 800 mg 4 times daily.
• Treatment of Herpes Zoster (Shingles, Zoster)
Oral
Immunocompetent children ≥12 years of age: 800 mg every 4 hours 5 times daily (4 g daily) for 5–
10 days.
HIV-infected children with mild immunosuppression and mild varicella: CDC and others
recommend 20 mg/kg (up to 800 mg) 4 times daily for 7–10 days.
Initiate therapy preferably within 48 hours of onset of rash.
IV
Immunocompetent children: AAP recommends 10 mg/kg 3 times daily for 7–10 days for those <1
year of age and 500 mg/m2 3 times daily for 7–10 days in those ≥1 year of age.
Immunocompromised children: 20 mg/kg every 8 hours for 7–10 days in those <12 years of
age and 10 mg/kg every 8 hours for 7 days in those ≥12 years of age.
HIV-infected children with severe immunosuppression and extensive multidermatomal zoster or
zoster with trigeminal nerve involvement: CDC and others recommend 10 mg/kg 3 times daily for
7–10 days.
HIV-infected adolescents: CDC and others recommend 10 mg/kg every 8 hours until cutaneous

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and visceral disease resolves

Topical: Herpes labialis (cold sores), recurrent:

Topical cream: Apply 5 times daily for 4 days

Prescribing Limits
Pediatric Patients
Oral: Maximum 20 mg/kg 4 times daily (1 g daily) in children ≥2 years of age weighing ≤40 kg.
IV: Maximum 20 mg/kg every 8 hours.
Adults:
Oral: 800 mg per dose.
IV: Maximum 20 mg/kg every 8 hours
Dosage Renal Impairment:
adjustment Oral:
CrCl >25 mL/minute/1.73 m2: No dosage adjustment necessary.
CrCl 10 to 25 mL/minute/1.73 m2: If the usual recommended dose is 800 mg 5 times daily:
Administer 800 mg every 8 hours
CrCl <10 mL/minute/1.73 m2:
If the dose is 200 mg 5 times daily or 400 mg every 12 hours: Administer 200 mg every 12 hours
If the dose is 800 mg 5 times daily: Administer 200 mg every 12 hours
Intermittent hemodialysis (IHD): Dialyzable (60% reduction following a 6-hour session): same doses
as CrCl <10 mL/minute/1.73 m2
Continuous ambulatory peritoneal dialysis (CAPD): 600 to 800 mg daily
IV:
If the usual recommended dose is 5-10 mg/kg/dose every 8 hours:
CrCl >50 mL/minute/1.73 m2: No dosage adjustment necessary.
CrCl 25 to 50 mL/minute/1.73 m2: 5-10 mg/kg/dose every 12 hours
CrCl 10 to <25 mL/minute/1.73 m2: 5-10 mg/kg/dose every 24 hours
CrCl <10 mL/minute/1.73 m2: 2.5-5 mg/kg/dose every 24 hours
Intermittent hemodialysis (IHD): Dialyzable (60% reduction following a 6-hour session): 2.5 to 5
mg/kg/dose every 24 hours
Peritoneal dialysis (PD): 2.5 to 5 mg/kg/dose every 24 hours;
Dosing: Hepatic Impairment:
There are no dosage adjustments needed.

Contra- Hypersensitivity to acyclovir, valacyclovir, or any component of the formulation

indications
Adverse Drug Adverse Reactions (Significant): Considerations
Reactions Acute kidney injury
Neurotoxicity
Thrombotic microangiopathy

>10%:
Hematologic & oncologic: Decreased hemoglobin (neonates: 13%), decrease in absolute neutrophil
count (neonates: 3% to 16%)
Nervous system: Malaise (oral: 12%)

1% to 10%:
Central nervous system: Headache
Dermatologic: Pruritus, skin rash, urticaria

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Gastrointestinal: Nausea, vomiting, diarrhea
Hematologic & oncologic: Thrombocytopenia
Hepatic: Increased serum bilirubin, increased serum transaminases
Local: Inflammation at injection site, injection site phlebitis
Renal: Increased blood urea nitrogen, increased serum creatinine

Monitoring Urinalysis, BUN, serum creatinine, urine output; liver enzymes, CBC; monitor for neurotoxicity and
Parameters nephrotoxicity in pediatric patients when using high dose therapy; neutrophil count at least twice
weekly in neonates receiving acyclovir 60 mg/kg/day IV. Monitor infusion site.
Drug Systemic treatment:
Interactions Risk X: Avoid combination
Cladribine, Foscarnet, Varicella Virus Vaccine, Zoster Vaccine (Live/Attenuated)
Risk D: Consider therapy modification
Tizanidine
Risk C: Monitor therapy
Clozapine, Mycophenolate, Tenofovir Products, Theophylline Derivatives, Zidovudine
Pregnancy and Pregnancy Category B
Lactation Acyclovir is considered compatible with breastfeeding
Administration Administration: Oral
Administer with or without food.

Administration: IV
For IV infusion only. Avoid rapid infusion. Infuse over 1 hour to prevent renal damage. Maintain
adequate hydration of patient. Check for phlebitis and rotate infusion sites.
Do not administer IM or SubQ.
Acyclovir IV is an irritant (depending on concentration); avoid extravasation. If extravasation
occurs, stop infusion immediately and disconnect (leave cannula/needle in place); gently aspirate
extravasated solution (do NOT flush the line); remove needle/cannula; elevate extremity. Apply
dry warm compresses. Intradermal hyaluronidase may be considered for refractory cases.

Preparation for Administration:

Powder for injection: Reconstitute acyclovir 500 mg powder with SWFI 10 mL (final concentration
50 mg/mL); do not use bacteriostatic water containing benzyl alcohol or parabens.
For intravenous infusion, dilute reconstituted powder for injection or solution for injection in D5W
or NS to a final concentration ≤7 mg/mL. Concentrations >10 mg/mL increase the risk of phlebitis.

Refer to manufacturer PIL if there are specific considerations.

Warnings/ Systemic treatment:
Precautions • CNS effects: Neurotoxicity (eg, tremor/myoclonus, confusion, agitation, lethargy,
hallucination, impaired consciousness) has been reported; risk may be increased with higher
doses and in patients with renal failure. Monitor patients for signs/symptoms of
neurotoxicity;
• Extravasation: Acyclovir IV is an irritant.
• Renal effects: Renal failure (sometimes fatal) has been reported. Dehydration, preexisting
renal disease, and nephrotoxic drugs increase risk
• Thrombotic microangiopathy: Has been reported in immunocompromised patients
receiving acyclovir.

Disease-related concerns:

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• Varicella: Appropriate use: For maximum benefit, treatment should begin within 24 hours
of appearance of rash; oral route not recommended for routine use in otherwise healthy
children with varicella but may be effective in patients at increased risk of moderate-to-
severe infection (>12 years of age, chronic cutaneous or pulmonary disorders, long-term
salicylate therapy, corticosteroid therapy).

Storage Solid form: store at 15°C to 25°C

Solution: Store solution at 20°C to 25°C
Reconstituted solutions or solutions diluted for infusion with NS or D5W, Do not refrigerate,
use within 24 hours.
Cream: Store at or below 25°C
Refer to manufacturer PIL if there are specific considerations.

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2. Adefovir Dipivoxil
Generic Name Adefovir Dipivoxil

Dosage Tablet 10 mg
form/strengths
Route of Oral
administration
Pharmacologic Antihepadnaviral, Reverse Transcriptase Inhibitor, Nucleotide (Anti-HBV)
category ATC: J05AF08
Indications Treatment of chronic hepatitis B with evidence of active viral replication (based on persistent
elevation of ALT/AST or histologic evidence)
Dosage Dosing: Adult, Geriatric
Regimen Hepatitis B (chronic): Oral: 10 mg once daily. Treatment duration for is variable and influenced
by HBeAg status, duration of HBV suppression, and presence of cirrhosis/decompensation

Dosing: Pediatric
Children 2 to <7 years: Limited data available, Oral: 0.3 mg/kg/dose once daily; maximum dose:
10 mg
Children ≥7 to <12 years: Limited data available; Oral: 0.25 mg/kg/dose once daily; maximum
dose: 10 mg
Children ≥12 years and Adolescents: Oral: 10 mg once daily; in HIV-exposed/-positive patients
not requiring combination antiretroviral therapy or receiving a lamivudine- or emtricitabine-
containing HIV-suppressive regimen, adefovir may be considered as HBV alternate therapy.

Hepatitis B infection, chronic: Note: Optimal duration of treatment not established, continuation
of therapy for at least 12 months after seroconversion has been suggested.
Prolonged therapy (up to 4 years) has been reported to be safe and well-tolerated in pediatric
patients (2 to 18 years).

Dosage Renal Impairment: Adult

adjustment CrCl ≥50 mL/minute: No dosage adjustment necessary
CrCl 30-49 mL/minute: 10 mg every 48 hours
CrCl 10-29 mL/minute: 10 mg every 72 hours
Hemodialysis: Dialyzable: 10 mg every 7 days (following dialysis)
Not been evaluated in patients with creatinine clearance < 10 mL/minute
Dosing: Altered Kidney Function: Pediatric
Children ≥12 years and Adolescents: no data available; consider dosage reduction.

Dosing: Hepatic Impairment: Adult

No adjustment required.

Contra- Hypersensitivity to adefovir or any component of the formulation

indications
Adverse Drug >10%:
Reactions Central nervous system: Headache (24% to 25%)
Gastrointestinal: Abdominal pain (15%), diarrhea (≤13%)
Genitourinary: Hematuria (grade ≥3: 11%)
Hepatic: Hepatitis (exacerbation; ≤25% within 12 weeks of adefovir discontinuation)
Neuromuscular & skeletal: Weakness (≤25%)

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1% to 10%:
Dermatologic: Pruritus, skin rash
Endocrine & metabolic: Hypophosphatemia (<2 mg/dL: 1% and 3% in pre-/post-liver transplant
patients, respectively)
Gastrointestinal: Flatulence (≤8%), dyspepsia (5% to 9%), nausea, vomiting
Neuromuscular & skeletal: Back pain (≤10%)
Renal: Increased serum creatinine (≥0.5 mg/dL: 2% to 3% in compensated liver disease;
incidence may be higher in patients with decompensated cirrhosis or in liver transplant
recipients), renal failure
Respiratory: Cough (6% to 8%), rhinitis (≤5%)

Monitoring HIV status (prior to initiation of therapy);

Parameters Renal function (prior to initiation, during therapy and following discontinuation)
Hepatic function with both clinical and laboratory follow-up at repeated intervals for several
months following discontinuation
Drug Risk X: Avoid combination
Interactions Cladribine, Tenofovir Products
Risk D: Consider therapy modification
Fexinidazole
Risk C: Monitor therapy
Ataluren Cabozantinib Nitisinone Orlistat Pretomanid Teriflunomide
Pregnancy and Category C
Lactation There are no adequate and well-controlled studies in pregnant women
Breastfeeding is not recommended during use of this drug.

Administration Oral without regard to food.

Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • [US Boxed Warning]: Fatal cases of lactic acidosis and severe hepatomegaly with steatosis
have been reported with the use of nucleoside analogues alone or in combination with other
antiretroviral; use with caution in patients with risk factors for liver disease (risk may be
increased with female gender, obesity, pregnancy or prolonged exposure) and suspend
treatment in any patient who develops clinical or laboratory findings suggestive of lactic acidosis
or hepatotoxicity (transaminase elevation may/may not accompany hepatomegaly and
steatosis).
Disease-related concerns:
• [US Boxed Warning]: Severe, acute exacerbation of hepatitis B may occur upon
discontinuation. Exacerbations may occur in up to 25% of patients and usually within 12 weeks
and may be self-limited or resolve upon resuming treatment; risk may be increased with
advanced liver disease or cirrhosis. Monitor liver function several months after stopping
treatment; reinitiating of ant hepatitis B therapy may be required. Ethanol should be avoided in
hepatitis B infection due to potential hepatic toxicity.
• [US Boxed Warning]: May cause the development of HIV resistance in chronic hepatitis B
patients with unrecognized or untreated HIV infection. Determine HIV status prior to initiating
treatment with adefovir.
• [US Boxed Warning]: Use with caution in patients with renal dysfunction or in patients at risk
of renal toxicity (including concurrent nephrotoxic agents or NSAIDs). Chronic administration

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may result in nephrotoxicity. Dosage adjustment is required in adult patients with renal
dysfunction or in patients who develop renal dysfunction during therapy; no data available for
use in children ≥12 years or adolescents with renal impairment. Calculation of creatinine
clearance in all patients is recommended prior to initiating therapy.
Other warnings/precautions:
Current clinical hepatitis B practice guidelines do not recommend adefovir for initial use in the
management of chronic HBV due to high rate of resistance with long-term use; other antiviral
agents with a high barrier to drug resistance are preferred (eg, tenofovir or entecavir).

In the setting of lamivudine-resistant HBV, adefovir is also not a preferred strategy to manage
antiviral resistance If used, combination therapy with lamivudine should be used to decrease the
risk of resistance in patients with lamivudine-resistant HBV.

Additional Pediatric Considerations

Efficacy in pediatric patients <12 years has not been reported; in clinical trials of children 2 to 12
years, positive responses to adefovir therapy were observed (13% to 17% of subjects evaluated);
however, findings did not reach statistical significance.

Storage Store controlled room temperature of 25°C

Refer to manufacturer PIL if there are specific considerations.

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3. Daclatasvir
Generic Name Daclatasvir

Dosage Tablets 30mg, 60mg

form/strengths
Route of Oral
administration
Pharmacologic Antihepaciviral, NS5A Inhibitor
action ATC: J05AP07
Indications Chronic hepatitis C: Treatment of chronic hepatitis C virus (HCV) genotype 1 or
genotype 3 infection in combination with sofosbuvir, with or without ribavirin.
Dosage Dosing: Adult
Regimen Note: Not indicated as monotherapy.
Chronic hepatitis C (genotype 1): Oral:
− Patients without cirrhosis or with compensated cirrhosis (Child-Pugh class A): 60
mg once daily with concomitant sofosbuvir for 12 weeks.
− Patients with decompensated (Child-Pugh class B or C) cirrhosis or post–liver
transplant: 60 mg once daily with concomitant sofosbuvir and ribavirin for 12
weeks.
Chronic hepatitis C (genotype 3):
− Patients without cirrhosis: 60 mg once daily with concomitant sofosbuvir for 12
weeks.
− Patients with compensated (Child-Pugh class A) or decompensated cirrhosis
(Child-Pugh class B or C) or post–liver transplant: 60 mg once daily with
concomitant sofosbuvir and ribavirin for 12 weeks.
Dosage Dosing: Renal Impairment: Adult
adjustment No dosage adjustment necessary.
Dosing: Hepatic Impairment: Adult
Child-Pugh class A, B, or C: No dosage adjustment necessary.

Contra- Hypersensitivity to daclatasvir or any component of the formulation; concurrent use

indications with strong inducers of CYP3A4 and P-glycoprotein (P-gp)
Concurrent use of strong CYP3A inducers (eg, carbamazepine, phenytoin, rifampin, St
John's wort). When used in combination with other agents (eg, ribavirin), the
contraindications to those agents also apply (refer to respective labeling information).
Adverse Drug >10%:
Reactions Central nervous system: Fatigue (14% to 15%), headache (12% to 14%)
Gastrointestinal: Nausea (8% to 15%)
Hematologic & Oncologic: Anemia (20%)
1% to 10%:
Central nervous system: Drowsiness, insomnia
Dermatologic: Skin rash
Gastrointestinal: Diarrhea, increased serum lipase (>3x ULN, transient)

Monitoring − Baseline hepatitis C virus (HCV) genotype and subtype, quantitative HCV viral load.
Parameters Baseline (within 6 months prior to treatment initiation) CBC, INR, hepatic function
(albumin, total and direct bilirubin, ALT, AST, alkaline phosphatase), calculated
GFR. Before initiating DAA therapy, serum pregnancy test (women of childbearing

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age) and assessment for HIV coinfection.
− During treatment, monitor CBC, serum creatinine, calculated GFR, hepatic
function panel as clinically indicated. Quantitative HCV viral load testing at ≥12
weeks after completion of therapy. Hepatitis B virus (HBV) surface antigen, HBV
core antibody, and HBV surface antibody prior to initiation (AASLD/IDSA 2020).
− Prior to treatment initiation in genotype 1a patients with cirrhosis, consider
screening for the presence of NS5A polymorphisms at amino acid positions M28,
Q30, L31, and Y93 in patients with cirrhosis.
− In patients with serologic evidence of HBV infection, monitor for clinical and
laboratory signs of hepatitis flare or HBV reactivation during treatment and during
post-treatment follow-up.
− If used in combination with amiodarone or in patients who discontinued
amiodarone just prior to initiating sofosbuvir in combination with daclatasvir,
inpatient cardiac monitoring for the first 48 hours of coadministration, then
outpatient self-monitoring of heart rate daily through at least the first 2 weeks of
treatment.
− In patients with diabetes, monitor blood glucose and for signs/symptoms of
hypoglycemia; in patients taking warfarin, monitor INR during and post-therapy

Drug Risk X: Avoid combination

Interactions Abametapir Amiodarone Asunaprevir Bilastine Conivaptan CYP3A4 Inducers
Doxorubicin Elagolix Elagolix, Estradiol, And Norethindrone Grazoprevir Idelalisib
Ozanimod Pazopanib Revefenacin Rimegepant St John's Wort Topotecan Vincristine
(Liposomal) Voxilaprevir
Risk D: Consider Therapy Modification
Afatinib Alpelisib Berotralstat Betrixaban Cladribine Colchicine CYP3A4 Inducers
CYP3A4 Inhibitors Dabrafenib Dexamethasone (Systemic) Digoxin Eluxadoline
Lefamulin Mifepristone Nevirapine Relugolix Rifapentine Sirolimus Stiripentol
Ubrogepant Venetoclax
Pregnancy and FDA pregnancy category: Not assigned.
Lactation Risk summary: No data available on use of this drug in pregnant women to inform a
drug-related risk.
Breastfeeding is not recommended during use of this drug.
Administration Administer with or without food.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Bradycardia: When used in combination with sofosbuvir and amiodarone,
symptomatic bradycardia has been reported; pacemaker intervention may be
required. Risk factors include concomitant beta blocker use, underlying cardiac
morbidities, and/or advanced hepatic disease. Bradycardia usually resolves after
HCV treatment discontinuation.
Disease-related concerns:
• Cardiovascular disease: Patients with underlying cardiac morbidities and also
taking concomitant amiodarone are at increased risk for symptomatic
bradycardia; use with caution and monitor for bradycardia.
• Diabetes: Rapid reduction in hepatitis C viral load during direct-acting antiviral
(DAA) therapy for hepatitis C may lead to improvement in glucose metabolism in
patients with diabetes, potentially resulting in symptomatic hypoglycemia if

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antidiabetic agents are continued at the same dose. Monitor for changes in
glucose tolerance and inform patients of the risk of hypoglycemia during DAA
therapy, particularly within the first 3 months. Modification of antidiabetic
therapy may be necessary.
• Hepatic disease: Patients with advanced hepatic disease and also taking
concomitant amiodarone are at increased risk for symptomatic bradycardia; use
with caution. Sustained virologic response rates are reduced in HCV genotype 3-
infected patients with cirrhosis. Optimal duration of treatment for HCV genotype
3-infected patients with cirrhosis or HCV genotype 1 patients with Child-Pugh
class C cirrhosis has not been established.
• Hepatitis B virus reactivation: [US Boxed Warning]: Hepatitis B virus (HBV)
reactivation has been reported in hepatitis C virus (HCV)/HBV coinfected patients
who were receiving or had completed treatment with HCV direct-acting antivirals
and were not receiving HBV antiviral therapy; some cases have resulted in
fulminant hepatitis, hepatic failure, and death. Test all patients for evidence of
current or prior HBV infection prior to initiation of daclatasvir; monitor HCV/HBV
co-infected patients for hepatitis flare or HBV reactivation during treatment and
post-treatment follow-up. Initiate treatment for HBV infection as clinically
indicated.
Other warnings/precautions:
• Appropriate use: Do not use as monotherapy; use only in combination with
other antihepatitis C virus drugs

Storage Store at 25°C; excursions permitted between 15°C and 30°C.

Refer to manufacturer PIL if there are specific considerations.

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4. Entecavir
Generic Name Entecavir

Dosage Tablets/capsules 0.5mg, 1mg

form/strengths Oral solution 0.25mg/5ml (0.5mg/10ml)
Route of Oral
administration
Pharmacologic Antihepadnaviral, Reverse Transcriptase Inhibitor, Nucleoside (Anti-HBV)
action ATC: J05AF10
Indications Chronic hepatitis B: Treatment of chronic hepatitis B virus (HBV) infection in adults and
pediatric patients ≥2 years of age with evidence of active viral replication and either
evidence of persistent transaminase elevations or histologically-active disease.

Note: In adults, indication is based on data in patients with compensated and

decompensated liver disease; in children, indication is based on data in patients with
compensated, HBeAg-positive liver disease.
Dosage Adults
Regimen Hepatitis B virus infection, treatment: Oral:
Nucleoside-treatment naive, compensated liver disease: 0.5 mg once daily.
Decompensated liver disease: 1 mg once daily.
Treatment duration (AASLD practice guidelines): Treatment duration is variable and
influenced by HBeAg status, duration of hepatitis B virus (HBV) suppression, and presence
of cirrhosis/decompensation

Dosing: Pediatric
Note: Oral tablets and solution may be used interchangeably on a mg: mg basis.
Hepatitis B infection (HBV), chronic: Oral:
Note: Optimal duration of treatment not established for nucleoside analogs, a minimum of
12 months and typically longer required; consolidation therapy of at least 6 months after
seroconversion and complete viral suppression has been suggested.
Children and Adolescents 2 to <16 years with compensated liver diseases:
Treatment naive:
10 to 11 kg: 0.15 mg oral solution once daily
>11 to 14 kg: 0.2 mg oral solution once daily
>14 to 17 kg: 0.25 mg oral solution once daily
>17 to 20 kg: 0.3 mg oral solution once daily
>20 to 23 kg: 0.35 mg oral solution once daily
>23 to 26 kg: 0.4 mg oral solution once daily
>26 to 30 kg: 0.45 mg oral solution once daily
>30 kg: 0.5 mg oral solution or tablet once daily
Lamivudine-experienced:
10 to 11 kg: 0.3 mg oral solution once daily
>11 to 14 kg: 0.4 mg oral solution once daily
>14 to 17 kg: 0.5 mg oral solution once daily
>17 to 20 kg: 0.6 mg oral solution once daily
>20 to 23 kg: 0.7 mg oral solution once daily
>23 to 26 kg: 0.8 mg oral solution once daily
>26 to 30 kg: 0.9 mg oral solution once daily
>30 kg: 1 mg oral solution or tablet once daily
Adolescents ≥16 years:
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Nucleoside treatment naïve with compensated liver disease: 0.5 mg once daily
Lamivudine-refractory or known lamivudine or telbivudine-resistant mutations: 1 mg once
daily
Dosage Dosing: Renal Impairment: Adult
adjustment Daily-dosage regimen preferred:
CrCl ≥50 mL/minute: No dosage adjustment necessary.
CrCl 30 to 49 mL/minute: Administer 50% of usual dose daily or administer the normal dose
every 48 hours
CrCl 10 to 29 mL/minute: Administer 30% of usual dose daily or administer the normal dose
every 72 hours
CrCl <10 mL/minute (including hemodialysis and CAPD): Administer 10% of usual dose daily
or administer the normal dose every 7 days; administer after hemodialysis
Dosing: Hepatic Impairment: Adult
No dosage adjustment necessary.
Dosing: Renal Impairment: Pediatric
Children and Adolescents: Insufficient data to recommend a specific dose adjustment in
pediatric patients with renal impairment; a reduction in the dose or an increase in the
dosing interval similar to adjustments for adults should be considered.
Dosing: Hepatic Impairment: Pediatric
Children ≥ 2 years and Adolescents: No adjustment necessary.

Contra- Hypersensitivity to entecavir or any component of the formulation

indications
Adverse Drug >10%:
Reactions Hepatic: Increased serum alanine aminotransferase (>5 x ULN: 11% to 12%; >10 x ULN and
>2 x baseline: 2%)
1% to 10%:
Dermatologic: Skin rash
Endocrine & metabolic: Glycosuria, hyperglycemia
Gastrointestinal: Abdominal pain, diarrhea, dyspepsia, increased serum lipase, nausea,
vomiting
Genitourinary: Hematuria
Hepatic: Increased serum bilirubin
Nervous system: Fatigue, headache
Renal: Increased serum creatinine

Monitoring HIV status (prior to initiation of therapy); periodic monitoring of hepatic function is
Parameters recommended during treatment and for at least several months after treatment in patients
who discontinue anti-hepatitis B therapy. Monitor patients for signs and symptoms of lactic
acidosis and hepatotoxicity.
Renal function at baseline and at least annually; monitor renal function more frequently in
patients at high risk of renal dysfunction.

Drug Cladribine: Agents that Undergo Intracellular Phosphorylation may diminish the
Interactions therapeutic effect of Cladribine. Risk X: Avoid combination
Pregnancy and pregnancy category C
Lactation Entecavir has not been studied in nursing mothers. An alternate drug may be preferred,
especially while nursing a newborn or preterm infant.
Administration Administration:

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Oral: Administer on an empty stomach (2 hours before or after a meal).
Oral solution: Do not dilute or mix oral solution with water or other beverages; use
calibrated oral dosing syringe.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Lactic acidosis/hepatomegaly: [US Boxed Warning]: Lactic acidosis and severe
hepatomegaly with steatosis (including fatal cases) have been reported with nucleoside
analogue inhibitors
Disease-related concerns:
• Chronic hepatitis B: [US Boxed Warning]: Severe, acute exacerbation of hepatitis B may
occur upon discontinuation of antihepatitis B therapy, including entecavir. Monitor liver
function for at least several months after stopping treatment; reinitiation of antihepatitis
B therapy may be required.
• HIV: [US Boxed Warning]: May cause the development of HIV resistance in chronic
hepatitis B patients with unrecognized or untreated HIV infection. Determine HIV status
prior to initiating treatment with entecavir. Not recommended for HIV/HBV coinfected
patients unless also receiving antiretroviral therapy.
• Hepatic impairment: Dose adjustment not required. Limited data supporting treatment
of chronic hepatitis B in patients with decompensated liver disease; observe for increased
adverse reactions, including hepatorenal dysfunction.
• Renal impairment: Use with caution in patients with renal impairment or patients
receiving concomitant therapy which may reduce renal function; dose adjustment
recommended for CrCl <50 mL/minute.
Special populations:
• Children: There are limited data available on the use of entecavir in lamivudine-
experienced pediatric patients; use in these patients only if the potential benefit justifies
the potential risk to the child.
Dosage form specific issues:
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as
Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported
following exposure to pharmaceutical products containing polysorbate 80 in certain
individuals. Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic
failure have been reported in premature neonates after receiving parenteral products
containing polysorbate 80.
Other warnings/precautions:
• Resistance: Cross-resistance may develop in patients failing previous therapy with
lamivudine
Storage Store at 25°C; excursions permitted to 15°C to 30°C. Protect from light.
After opening, oral solution can be used up to expiration date on the bottle.
Refer to manufacturer PIL if there are specific considerations.

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5. Famciclovir
Generic Name Famciclovir

Dosage Tablets 125,250,500 mg

form/strengths
Route of Oral
administration
Pharmacologic Antiviral
category ATC: J05AB09
Indications Treatment of acute herpes zoster (shingles) in immunocompetent patients
Treatment and suppression of recurrent episodes of genital herpes in immunocompetent
patients
Treatment of herpes labialis (cold sores) in immunocompetent patients
Treatment of recurrent orolabial/genital (mucocutaneous) herpes simplex in adult patients
with HIV
Dosage Dosing: Adult
Regimen Genital herpes simplex virus infection:
Immunocompetent patients:
Recurrence:
125 mg twice daily for 5 days or 500 mg as a single dose, followed by 250 mg twice daily for 2
days.
Suppressive therapy: 250 mg twice daily. Note: Duration not established, but efficacy/safety
have been demonstrated for 1 year.
Immunocompromised patients (including patients with HIV):
Initial or recurrent episodes: 500 mg twice daily for 5 to 10 days; extend treatment duration if
lesions have not healed completely after 10 days.
Herpes labialis/orolabial (cold sores): Oral: Note: Initiate therapy as soon as possible after
diagnosis and within 72 hours of rash onset.
Immunocompetent patients:
Recurrent episodes: 1,500 mg as a single dose; initiate therapy at first sign or symptom such
as tingling, burning, or itching (initiated within 1 hour).
Immunocompromised patients (including patients with HIV):
Treatment: 500 mg twice daily for 5 to 10 days; extend treatment duration if lesions have not
healed completely after 10 days.
Herpes zoster (shingles): Oral: Note: Initiate therapy as soon as possible after diagnosis and
within 1 week of rash onset or any time before full crusting of lesions.
Immunocompetent patients: 500 mg every 8 hours for 7 days.

Dosing: Pediatric
Herpes simplex virus (HSV) genital infection:
Immunocompetent patients:
Initial episode: Children weighing ≥45 kg and Adolescents: Oral: 250 mg 3 times daily for 7 to 10
days. Note: Treatment can be extended if healing is incomplete after 10 days of therapy.

Recurrence: Adolescents: Note: Initiate treatment within 1 day of lesion onset or during the
prodrome that precedes some outbreaks.
One-day regimen: Oral: 1,000 mg twice daily for 1 day
Two-day regimen: Oral: 500 mg once as a single dose, followed 12 hours later by 250 mg twice
daily for a total of 2 days
Five-day regimen: Oral: 125 mg twice daily for 5 days

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Suppressive therapy: Adolescents: Oral: 250 mg twice daily. Note: Duration not established;
efficacy/safety have been demonstrated for 1 year.

HIV-exposed/-positive patients:
Initial or recurrent episodes: Adolescents: Oral: 500 mg twice daily for 5 to 10
days. Note: Treatment can be extended if healing is incomplete after 10 days of therapy.

Chronic suppressive therapy: Adolescents: Oral: 500 mg twice daily; suppressive therapy can be
continued indefinitely regardless of CD4 count in patients with severe recurrences of genital
herpes or in patients who want to minimize frequency of recurrences, or to reduce the risk of
genital ulcer disease in patients with CD4 cell counts <250 cells/mm3 who are starting
antiretroviral therapy. However, continuation of therapy should be reviewed annually,
particularly if immune reconstitution has occurred.
Herpes labialis/orolabial (cold sores) in HIV-exposed/-positive patients, treatment: Limited data
available: Adolescents: Oral: 500 mg twice daily for 5 to 10 days
Herpes zoster (shingles) in HIV- exposed/-positive patients, treatment: Adolescents: Oral:
Acute localized dermatomal lesion: 500 mg 3 times daily for 7 to 10 days; consider longer
duration if lesions heal slowly
Extensive cutaneous lesion or visceral involvement: Initial therapy with acyclovir IV may be
switched to famciclovir 500 mg 3 times daily to complete a 10- to 14-day course, when formation
of new lesions has ceased and signs and symptoms of visceral VZV infection are improving
Varicella infection (chickenpox) in HIV-exposed/-positive patients (uncomplicated cases),
treatment: Limited data available: Adolescents: Oral: 500 mg 3 times daily for 5 to 7 days.
Dosage Dosing: Renal Impairment: Adult
adjustment Herpes zoster:
CrCl ≥60 mL/minute: No dosage adjustment necessary.
CrCl 40 to 59 mL/minute: Administer 500 mg every 12 hours
CrCl 20 to 39 mL/minute: Administer 500 mg every 24 hours
CrCl <20 mL/minute: Administer 250 mg every 24 hours
Hemodialysis: Administer 250 mg after each dialysis session.
Recurrent genital herpes: Treatment:
Single-day regimen:
CrCl ≥60 mL/minute: No dosage adjustment necessary.
CrCl 40 to 59 mL/minute: Administer 500 mg every 12 hours for 1 day
CrCl 20 to 39 mL/minute: Administer 500 mg as a single dose
CrCl <20 mL/minute: Administer 250 mg as a single dose
Hemodialysis: Administer 250 mg as a single dose after a dialysis session.
Recurrent genital herpes: Suppression:
CrCl ≥40 mL/minute: No dosage adjustment necessary.
CrCl 20 to 39 mL/minute: Administer 125 mg every 12 hours
CrCl <20 mL/minute: Administer 125 mg every 24 hours
Hemodialysis: Administer 125 mg after each dialysis session.
Recurrent herpes labialis: Treatment (single-dose regimen):
CrCl ≥60 mL/minute: No dosage adjustment necessary.
CrCl 40 to 59 mL/minute: Administer 750 mg as a single dose
CrCl 20 to 39 mL/minute: Administer 500 mg as a single dose
CrCl <20 mL/minute: Administer 250 mg as a single dose
Hemodialysis: Administer 250 mg as a single dose after a dialysis session.
Recurrent orolabial/genital (mucocutaneous) herpes in patients with HIV:

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CrCl ≥40 mL/minute: No dosage adjustment necessary.
CrCl 20 to 39 mL/minute: Administer 500 mg every 24 hours
CrCl <20 mL/minute: Administer 250 mg every 24 hours
Hemodialysis: Administer 250 mg after each dialysis session.
Dosing: Hepatic Impairment: Adult
No dosage adjustment is necessary
Dosing: Renal Impairment: Pediatric
There are no pediatric specific recommendations available; based on experience in adult patients;
dosage adjustment suggested.
Dosing: Hepatic Impairment: Pediatric
There are no pediatric specific recommendations available; experience in adults suggests no
dosage adjustment is necessary.
Contra- Hypersensitivity to famciclovir, penciclovir, or any component of the formulation
indications
Adverse Drug 10%:
Reactions Central nervous system: Headache (9% to 23%)
Gastrointestinal: Nausea (11% to 13%)
1% to 10%:
Central nervous system: Fatigue (≤5%), migraine (≤3%), paresthesia (≤3%)
Dermatologic: Pruritus (2% to 4%), skin rash (3%)
Gastrointestinal: Diarrhea (2% to 8%), flatulence (≤5%), vomiting (≤5%)
Genitourinary: Dysmenorrhea (≤8%)
Hematologic & oncologic: Neutropenia (3%), leukopenia (1%)
Hepatic: Increased serum ALT (3%), increased serum AST (2%), increased serum bilirubin (2%)
Monitoring Periodic CBC during long-term therapy; renal function
Parameters
Drug Risk X: Avoid combination
Interactions Cladribine, Varicella Virus Vaccine, Zoster Vaccine (Live/Attenuated)
Pregnancy and Pregnancy category B
Lactation Because there is no published experience with famciclovir during breastfeeding, other agents may
be preferred, especially while nursing a newborn or preterm infant.
Administration Oral: May be administered without regard to meals
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Disease-related concerns:
Precautions • Renal impairment: Use with caution in patients with renal impairment; dosage adjustment
required. Acute renal failure has been reported with use of inappropriate high doses in patients
with underlying renal disease.
Dosage form specific issues:
• Lactose: Tablets contain lactose; do not use with galactose intolerance, severe lactase
deficiency, or glucose-galactose malabsorption syndromes.
Other warnings/precautions:
• Appropriate use: Has not been established for use in initial episodes of genital herpes,
recurrent episodes of genital herpes in Black and African-American patients, patients with
ophthalmic or disseminated zoster, immunocompromised patients (except patients with HIV with
orolabial or genital herpes).
Storage Store at 20°C to 25°C; excursions permitted to 15°C to 30°C
Refer to manufacturer PIL if there are specific considerations.

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6. Favipiravir

Generic Name Favipiravir

Dosage Tablets 200 mg

form/strengths
Route of Oral
administration
Pharmacologic Antiviral
category ATC: J05AX27
Indications Coronavirus disease 2019 (COVID-19)

Dosage Dosing: Adult

Regimen 1.6 g twice daily on day 1, followed by 600 mg twice daily for a total duration of 7 to 14 days
For mild to moderate COVID-19, some international markets have studied and approved a dose of
1.8 g twice daily on day 1, followed by 800 mg twice daily for a total duration of up to 14 days.
Dosage Dosing: Renal Impairment: Adult
adjustment Mild to moderate impairment: There are no specific dosage adjustments recommended.
Severe impairment: Use is contraindicated.
Dosing: Hepatic Impairment: Adult
Mild to moderate impairment: There are no specific dosage adjustments recommended.
Severe impairment: Use is contraindicated.
Contra- Hypersensitivity to favipiravir or any component of the formulation; severe renal or hepatic
indications impairment; pregnancy; breastfeeding.
Adverse Drug Frequency not defined:
Reactions Cardiovascular: Chest pain
Endocrine & metabolic: Hyperuricemia
Gastrointestinal: Decreased appetite, diarrhea, nausea, vomiting
Hematologic & oncologic: Decreased neutrophils
Hepatic: Hepatic injury, increased serum transaminases
Monitoring No data available
parameters
Drug Risk D: Consider therapy modification
Interactions Influenza Virus Vaccine (Live/Attenuated)
Pregnancy and Based on animal data, use is contraindicated in pregnant patients & breastfeeding
Lactation
Administration Favipiravir should be taken orally, either with or without food. Favipiravir tablets should be
swallowed whole with water.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Hyperuricemia: Caution in patients with a history of uric acid metabolism abnormalities.
Disease-related concerns:
• Gout: Use with caution; may increase uric acid.
Storage Store in a temperature not exceeding 30 0C, in a dry place
Refer to manufacturer PIL if there are specific considerations.

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7. Ganciclovir
Generic Name Ganciclovir

Dosage Powder for injection: 500mg

form/strengths Ophthalmic gel 1.5 mg/gm
Ophthalmic drops 0.150 gm/100g
Route of IV, IM, ophthalmic
administration
Pharmacologic Antiviral Agent
action ATC (Systemic): J05AB06
ATC (Ophthamic): S01AD09
Indications Cytomegalovirus disease, prophylaxis (transplant patients): Prevention of cytomegalovirus (CMV)
disease in adult transplant recipients at risk for CMV disease.
Cytomegalovirus retinitis (immunocompromised patients): Treatment of CMV retinitis in
immunocompromised adult patients, including patients with AIDS.
Dosage Dosing: Adult
Regimen Cytomegalovirus retinitis (immunocompromised patients):
Immediate sight-threatening lesions (adjacent to the optic nerve or fovea):
IV (alternative agent): 5 mg/kg/dose every 12 hours for 14 to 21 days followed by chronic
maintenance therapy (secondary prophylaxis)
Chronic maintenance therapy (alternative agent): IV: 5 mg/kg/dose once daily (7 days/week) or 6
mg/kg/dose once daily (5 days/week) for 3 to 6 months until sustained CD4 count >100
cells/mm3 in response to antiretroviral therapy; discontinue only after consultation with an
ophthalmologist
Cytomegalovirus disease prophylaxis in transplant patients: IV:
Hematopoietic cell transplant recipients (allogeneic): 5 mg/kg/dose every 12 hours for 5 to 7 days,
then 5 mg/kg/dose every 24 hours until day 100 post-transplant.
Solid organ transplant recipients: 5 mg/kg/dose every 24 hours; duration of prophylaxis is
dependent on type of transplant, as well as donor and recipient cytomegalovirus (CMV) serostatus
Dosing: Pediatric
CNS infection, treatment (HIV-exposed/-positive):
Infants and Children:
Induction: 5 mg/kg/dose every 12 hours; continue until symptoms improve, followed by chronic
maintenance therapy (secondary prophylaxis)
Chronic maintenance therapy (secondary prophylaxis): IV: 5 mg/kg/dose once daily; continue
maintenance therapy (with ganciclovir, valganciclovir, or foscarnet as appropriate) until patient
has been receiving antiretroviral therapy for ≥6 months and achieves CD4 cell count targets for
at least 6 months (age <6 years: CD4 percentage ≥15%; age ≥6 years: >100 cells/mm3).
Adolescents: 5 mg/kg/dose every 12 hours in combination with foscarnet until symptoms improve;
optimal duration not defined
Cytomegalovirus retinitis (immunocompromised patients [including patients with HIV]):
Induction therapy: 5 mg/kg/dose every 12 hours for 14-21 days; may be increased to 7.5
mg/kg/dose every 12 hours
Maintenance therapy: Infants ≥ 3 months and Children: 5 mg/kg/dose as a single daily dose for 5-7
days/week
Secondary prevention in HIV-exposed/-infected patients: Infants and Children: 5 mg/kg/dose
once daily
Prevention in transplant recipients: Children: Initial: 5 mg/kg/dose every 12 hours for 1-2 weeks,

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followed by 5 mg/kg/dose once daily 7 days/week or 6 mg/kg/dose once daily 5 days/week for 100
days
Cytomegalovirus disease, prophylaxis (transplant patients): Note: For patients considered at risk
for CMV disease based on donor and recipient CMV serostatus:
Hematopoietic cell transplant recipients (allogeneic) Infants, Children, and Adolescents: Limited
data available: IV: 5 mg/kg/dose every 12 hours for 5 to 7 days starting at neutrophil engraftment,
then 5 mg/kg/dose every 24 hours until day 100 posttransplant.
Solid organ transplant recipients: Infants, Children, and Adolescents: Limited data available: IV: 5
mg/kg/dose every 24 hours; initiate therapy within 10 days after transplant. Oral valganciclovir
typically preferred when appropriate. Total duration of prophylaxis varies depending on organ(s)
transplanted, donor and recipient CMV serostatus, and immunosuppressive regimen; typically
continued for 3 to 6 months; may be continued for up to 12 months in certain case
Other CMV infections: Children: Initial: 5 mg/kg/dose every 12 hours for 14-21 days; maintenance
therapy: 5 mg/kg/dose once daily for 7 days/week or 6 mg/kg/dose once daily for 5 days/week
Dosage Dosing: Renal Impairment: Adult
adjustment Clcr (mL/minute) Initial Treatment Maintenance Dosage
(Induction) Dosage

50–69 2.5 mg/kg every 12 hours 2.5 mg/kg every 24 hours

25–49 2.5 mg/kg every 24 hours 1.25 mg/kg every 24

hours

10–24 1.25 mg/kg every 24 hours 0.625 mg/kg every 24

hours

<10 1.25 mg/kg 3 times weekly 0.625 mg/kg 3 times

weekly

Intermittent hemodialysis (IHD) (administer after hemodialysis on dialysis days):

Dialyzable (50%): CMV Infection: IV: Induction: 1.25 mg/kg every 3days;
Maintenance: 0.625 mg/kg every 3days. Note: Dosing dependent on the
assumption of 3 times/week, complete IHD sessions

Dosing: Renal Impairment: Pediatric

Infants, Children and Adolescents: There are no specific pediatric recommendations; based on
experience in adult patients, dosage adjustment necessary.
Dosing: Hepatic Impairment:
There are no dosage adjustments data.
Contra- Hypersensitivity to ganciclovir, valganciclovir, acyclovir, or any component of the formulation
indications
Adverse Drug Dermatologic: Hyperhidrosis (12%)
Reactions Gastrointestinal: Diarrhea (44%), anorexia (14%), vomiting (13%)
Hematologic & oncologic: Thrombocytopenia
Infection: Sepsis (15%), infection (13%)
Ophthalmic: Retinal detachment (11%; relationship to ganciclovir not established)
Renal: Increased serum creatinine
Miscellaneous: Fever (48%)
Monitoring CBC with differential and platelet count at baseline and twice weekly, serum creatinine at baseline
Parameters and once weekly; pregnancy test prior to initiation in females of reproductive potential; frequent

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ophthalmological exams in patients with CMV retinitis.

Drug Risk X: Avoid combination

Interactions Cladribine
Risk D: Consider therapy modification
Imipenem
Risk C: Monitor therapy
Zidovudine, Tenofovir Products, Probenecid, Mycophenolate, Didanosine,
cyclosporine, Amphotericin B
Pregnancy and Ganciclovir caused maternal and fetal toxicity, embryofetal mortality, and teratogenic effects in
Lactation animal studies.
It is unknown if ganciclovir is excreted in human breast milk, but the possibility of ganciclovir being
excreted in breast milk and causing serious adverse reactions in the breastfed infant cannot be
excluded. Therefore, breastfeeding must be discontinued during treatment with ganciclovir
Administration Administration: IV
For IV infusion; should not be administered by IM, SubQ, or rapid or bolus IV injection. Administer
by slow IV infusion over at least 1 hour. Too rapid infusion can cause increased toxicity due to
excessive plasma levels. Flush line well with NS before and after administration.
Preparation for Administration:
Reconstitute 500 mg vial with 10 mL unpreserved sterile water (do not use bacteriostatic water;
parabens may cause precipitation). Shake vial to dissolve. Typically, dilute in 100 mL D5W or NS to a
concentration ≤10 mg/mL for infusion.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Carcinogenic/teratogenic: [US Boxed Warning]: Based on animal data and limited human data,
ganciclovir may cause temporary or permanent inhibition of spermatogenesis in males and
suppression of fertility in females. Based on animal data, ganciclovir has the potential to cause birth
defects and cancers in humans.
• Hematologic toxicity: [US Boxed Warning]: Granulocytopenia (neutropenia), anemia,
thrombocytopenia, and pancytopenia may occur
• Renal toxicity: Increased serum creatinine levels have been reported in elderly patients and
transplant patients receiving concomitant nephrotoxic medications (eg, cyclosporine, amphotericin
B). Monitor renal function during therapy, especially in elderly patients and those receiving
concomitant nephrotoxic agents.
Special populations:
• Elderly: Increased serum creatinine levels have been reported; use with caution and closely
monitor serum creatinine.
Other warnings/precautions:
• Administration: Ensure patients are adequately hydrated. Avoid rapid infusion. Phlebitis and/or
pain may occur at injection site despite adequate dilution; infuse solution into veins with adequate
blood flow.
Storage • Store intact vials and premixed solution bags at 25°C.
• Reconstituted solution in the vial is stable at room temperature for 12 hours; do not
refrigerate or freeze.
• Diluted solutions for infusion should be refrigerated and used within 24 hours of preparation;
do not freeze.
Refer to manufacturer PIL if there are specific considerations.

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8. Lamivudine and Zidovudine
Generic Name Lamivudine and Zidovudine

Dosage Tablets Lamivudine 150 mg ; Zidovudine 300 mg ;

form/strengths
Route of Oral
administration
Pharmacologic Antiretroviral, Reverse Transcriptase Inhibitor, Nucleoside (Anti-HIV)
category ATC: J05AR01
Indications HIV-1 infection, treatment: Treatment of HIV-1 infection in combination with other
antiretrovirals.
Dosage Dosing: adult
Regimen HIV-1 infection, treatment: Oral: One tablet (lamivudine 150 mg/zidovudine 300 mg) twice
daily.
Dosing: Pediatric
Note: Use in combination with at least one other antiretroviral agent.
HIV-1 Treatment:
Children and Adolescents weighing <30 kg: Not intended for use; product is a fixed-dose
combination; safety and efficacy have not been established in these patients
Children and Adolescents weighing ≥30 kg: Oral: One tablet twice daily

Dosage Dosing: Renal Impairment:

adjustment CrCl ≥50 mL/minute: No dosage adjustment necessary.
CrCl <50 mL/minute: Use is not recommended (use dose-adjusted individual components).
Dosing: Hepatic Impairment:
Use is not recommended (use dose-adjusted individual components).

Contra- Hypersensitivity to lamivudine or zidovudine, or any component of the formulation.

indications Neutrophil count <750/mm3 or hemoglobin <7.5 g/dL (4.65 mmol/L)

Adverse Drug Refer to single drug adverse effects

Reactions
Monitoring Amylase, bilirubin, signs and symptoms of pancreatitis. Monitor CBC with differential and
Parameters platelet count at least every 2 weeks, liver function tests (including signs/symptoms of
hepatomegaly), MCV, serum creatinine kinase, viral load, and CD4 count; observe for
appearance of opportunistic infections; signs of muscle weakness or pain; blood lactate levels
and signs of acidosis
Drug Risk X: Avoid combination
Interactions Amodiaquine BCG (Intravesical) Cladribine Dipyrone Emtricitabine Stavudine
Risk D: Consider therapy modification
Clarithromycin Deferiprone Doxorubicin Ribavirin Sorbitol Tolvaptan
Risk C: Monitor therapy
Teriflunomide Trimethoprim Acemetacin Acyclovir Valacyclovir Cabozantinib Clozapine
Dexketoprofen Fluconazole Ganciclovir Valganciclovir Interferons Levomethadone Mesalamine
Methadone Nitisinone Orlistat Pretomanid Probenecid Promazine Protease Inhibitors
Raltegravir Rifamycin Derivatives Except: Rifabutin Tenoxicam Valproate Products
Pregnancy and Pregnancy factor C
Lactation Lamivudine is allowed during breastfeeding, use caution due to lackof long time safety data.
Zidovudine has been well studied during breastfeeding. Milk levels are low and most breastfed

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infants do not have detectable blood levels. Some breastfed infants have developed anemia
during maternal therapy.
Administration Administer without regard to food
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Hematologic toxicity: [US Boxed Warning]: Zidovudine is associated with hematologic
toxicity, including neutropenia and severe anemia. Use with caution in patients with bone
marrow compromise (granulocytes <1,000 cells/mm3 or hemoglobin <9.5 g/dL).
• Immune reconstitution syndrome: Patients may develop immune reconstitution syndrome
resulting in the occurrence of an inflammatory response to an indolent or residual
opportunistic infection during initial HIV treatment or activation of autoimmune disorders (eg,
Graves disease, polymyositis, Guillain-Barré syndrome) later in therapy; further evaluation
and treatment may be required.
• Lactic acidosis/hepatomegaly: [US Boxed Warning]: Lactic acidosis and severe hepatomegaly
with steatosis, including fatal cases, have been reported with the use of nucleoside analogues
and other antiretrovirals. Female gender and obesity may increase the risk for development.
Suspend treatment in any patient who develops clinical or laboratory findings suggestive of
lactic acidosis or hepatotoxicity (transaminase elevation may/may not accompany
hepatomegaly and steatosis).
• Lipoatrophy: Zidovudine may cause loss of subcutaneous fat, especially in the face, limbs,
and buttocks. Lipoatrophy incidence and severity are related to cumulative exposure and may
be only partially reversible; improvement may take months to years after switching to a
regimen that does not contain zidovudine. Monitor patients for signs of lipoatrophy and
consider switching to a non-zidovudine-containing regimen if lipoatrophy occurs.
• Myopathy: [US Boxed Warning]: Prolonged use of zidovudine has been associated with
symptomatic myopathy.
Disease-related concerns:
• Chronic hepatitis B: [US Boxed Warning]: Severe acute exacerbations of hepatitis B have
been reported in patients coinfected with HBV and HIV-1 when therapy is
discontinued; monitor patients with clinical and laboratory follow-up for at least several
months after treatment discontinuation. Emergence of hepatitis B virus lamivudine-resistant
variants has been reported in patients with concurrent HBV infection who received a
lamivudine-containing regimen for HIV-1 treatment.

Storage Store between 2°C and 30°C

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9. Ledipasvir and Sofosbuvir
Generic Name Ledipasvir and Sofosbuvir

Dosage Tablets: Sofosbuvir 400 mg; Ledipasvir 90 mg, Sofosbuvir 400 mg; Ledipasvir 180 mg
form/strengths
Route of Oral
administration
Pharmacologic Antihepaciviral, Polymerase Inhibitor (Anti-HCV); NS5A Inhibitor
action ATC: J05AP51
Indications Chronic hepatitis C: Treatment of chronic hepatitis C virus genotype 1, 4, 5, or 6 infection in
adult and pediatric patients ≥3 years of age, without cirrhosis or with compensated cirrhosis;
genotype 1 in adult patients with decompensated cirrhosis, in combination with ribavirin; and
genotype 1 or 4 in adult liver transplant patients without cirrhosis or with compensated
cirrhosis, in combination with ribavirin.
Dosage Dosing: Adult
Regimen Note: Compensated cirrhosis is defined as Child-Pugh class A and decompensated cirrhosis is
defined as Child-Pugh class B or C.
Chronic hepatitis C infection: Oral: According to.
Genotype 1:
− Treatment-naive patients without cirrhosis or with compensated cirrhosis or
peginterferon/ribavirin treatment–experienced patients without cirrhosis: Ledipasvir 90
mg/sofosbuvir 400 mg once daily for 12 weeks (8 weeks in treatment-naive patients
without cirrhosis who are HIV uninfected and have hepatitis C virus RNA <6 million
units/mL)
− Peginterferon/ribavirin treatment–experienced patients with compensated cirrhosis
(alternative regimen): Ledipasvir 90 mg/sofosbuvir 400 mg once daily with concomitant
ribavirin for 12 weeks.
− NS3 protease inhibitor + peginterferon/ribavirin treatment–experienced patients:
Without cirrhosis: Ledipasvir 90 mg/sofosbuvir 400 mg once daily for 12 weeks.
With compensated cirrhosis (alternative regimen): Ledipasvir 90 mg/sofosbuvir 400 mg
once daily with concomitant ribavirin for 12 weeks.
− Non-NS5A inhibitor, sofosbuvir-containing regimen–experienced patients without cirrhosis
(except in cases of simeprevir failure) (alternative regimen): Ledipasvir 90 mg/sofosbuvir
400 mg once daily with concomitant ribavirin for 12 weeks.
Decompensated cirrhosis: Ledipasvir 90 mg/sofosbuvir 400 mg once daily with
concomitant ribavirin for 12 weeks; if ribavirin ineligible, ledipasvir 90 mg/sofosbuvir 400
mg once daily for 24 weeks.
Decompensated cirrhosis in patients with prior sofosbuvir- or NS5A inhibitor–based
treatment failure: Ledipasvir 90 mg/sofosbuvir 400 mg once daily with concomitant
ribavirin for 24 weeks.
− Liver transplant recipients (treatment-naive and treatment-experienced) without cirrhosis
or with compensated cirrhosis: Ledipasvir 90 mg/sofosbuvir 400 mg once daily for 12
weeks.
Genotype 4:
− Treatment-naive patients without cirrhosis or with compensated cirrhosis and
peginterferon/ribavirin treatment–experienced patients without cirrhosis: Ledipasvir 90

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mg/sofosbuvir 400 mg once daily for 12 weeks.
Note: An 8-week duration may be considered in treatment-naive patients with favorable
baseline characteristics (eg, no cirrhosis, HCV RNA <6 million units/mL, absence of
genotype 4r).
− Peginterferon/ribavirin treatment–experienced patients with compensated cirrhosis
(alternative regimen): Ledipasvir 90 mg/sofosbuvir 400 mg once daily with concomitant
ribavirin for 12 weeks.
− Liver transplant recipients (treatment naive and treatment experienced) without cirrhosis
or with compensated cirrhosis: Ledipasvir 90 mg/sofosbuvir 400 mg once daily with
concomitant ribavirin for 12 weeks.
Genotype 5 or 6:
− Treatment-naive and peginterferon/ribavirin treatment–experienced patients without
cirrhosis or with compensated cirrhosis: Ledipasvir 90 mg/sofosbuvir 400 mg once daily
for 12 weeks.
Note: Not recommended for treatment-naive patients with genotype 6e if subtype is
known.
− Decompensated cirrhosis in patients with sofosbuvir- or NS5A inhibitor–based treatment
failure: Ledipasvir 90 mg/sofosbuvir 400 mg once daily with concomitant ribavirin for 24
weeks.
− Liver transplant recipients (treatment-naive and treatment-experienced) without cirrhosis
or with compensated cirrhosis: Ledipasvir 90 mg/sofosbuvir 400 mg once daily for 12
weeks.
Dosing: Pediatric
Note: Prior to initiating therapy, test patient for evidence of hepatitis B infection (current or
prior).
Chronic hepatitis C infection (monoinfection or co-infected with HIV-1):
Children ≥3 years and Adolescents:
− 17 to <35 kg: tablets: Oral: 45 mg ledipasvir/200 mg sofosbuvir once daily.
− ≥35 kg: tablets: Oral: 90 mg ledipasvir/400 mg sofosbuvir once daily.
− Duration of therapy dependent upon multiple factors (eg, genotype, hepatic function
[cirrhosis/compensation], previous treatment and response).
Note: Treatment-experienced patients are defined as those who have failed an interferon-
based regimen.
Genotype 1:
− Treatment-naive patients without cirrhosis or with compensated cirrhosis (Child-Pugh
class A) or treatment-experienced patients without cirrhosis: 12 weeks.
− Treatment-experienced patients with compensated cirrhosis (Child-Pugh class A): 24
weeks.
− Treatment-naive or treatment-experienced with decompensated cirrhosis (Child-Pugh
class B or C): 12 weeks in combination with ribavirin.
Genotype 1 or 4: Treatment-naive or treatment-experienced liver transplant recipients
without cirrhosis or with compensated cirrhosis (Child-Pugh class A): 12 weeks in combination
with ribavirin.
Genotype 4, 5, or 6: Treatment-naive and treatment-experienced patients without cirrhosis or
with compensated cirrhosis (Child-Pugh class A): 12 weeks.

Dosage Dosing: Renal Impairment:

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adjustment Mild, moderate, or severe impairment: No dosage adjustment necessary.
End-stage renal disease requiring hemodialysis: No dosage adjustment necessary.
Dosing: Hepatic Impairment:
Mild, moderate, or severe impairment: No dosage adjustment necessary.
Contra- If ledipasvir/sofosbuvir is administered with ribavirin, the contraindications to ribavirin also
indications apply.
Hypersensitivity to any component of the formulation.
Adverse Drug >10%:
Reactions Nervous system: Headache (11% to 29%), fatigue (10% to 18%)
Neuromuscular & skeletal: Asthenia (18% to 31%)
1% to 10%:
Gastrointestinal: Nausea, increased serum lipase, diarrhea
Hepatic: Hyperbilirubinemia
Nervous system: Irritability, insomnia, dizziness, depression
Neuromuscular & skeletal: Myalgia, increased serum creatine kinase
Respiratory: Cough, dyspnea
Monitoring − Baseline (obtain any time prior to treatment initiation) quantitative hepatitis C virus (HCV)
Parameters RNA; HCV genotype and subtype (if a non–pan-genotypic direct-acting antiviral [DAA] will
be prescribed); staging of fibrosis. Baseline (within 6 months prior to treatment initiation)
CBC, INR, hepatic function (albumin, total and direct bilirubin, ALT, AST, alkaline
phosphatase), calculated GFR; baseline (obtain any time prior to treatment initiation).
Before initiating DAA therapy, serum pregnancy test (women of childbearing age) and
assessment for HIV coinfection.
− Hepatitis B virus (HBV) surface antigen, HBV core antibody and HBV surface antibody prior
to initiation. If used in combination with amiodarone (or in patients who discontinued
amiodarone just prior to initiating ledipasvir/sofosbuvir), inpatient cardiac monitoring for
the first 48 hours of coadministration, then outpatient or self-monitoring of heart rate
daily through at least the first 2 weeks of treatment.
− In patients with serologic evidence of HBV infection, monitor for clinical and laboratory
signs of hepatitis flare or HBV reactivation during treatment and during posttreatment
follow-up.
− During treatment, monitor CBC, serum creatinine, calculated GFR, hepatic function panel
as clinically indicated. Quantitative HCV viral load testing at ≥12 weeks after completion of
therapy.
− In patients with diabetes, monitor blood glucose and for signs/symptoms of hypoglycemia;
in patients taking warfarin, monitor INR during and post-therapy.
Drug Risk X: Avoid combination
Interactions Amiodarone Asunaprevir Bilastine Doxorubicin Elagolix Elagolix, Estradiol, And Norethindrone
Grazoprevir Modafinil Oxcarbazepine Ozanimod Pazopanib P-Glycoprotein/ABCB1 Inducers
Phenobarbital Primidone Revefenacin Rifabutin Rifapentine Rimegepant Rosuvastatin
Simeprevir Tipranavir Topotecan Vincristine Voxilaprevir
Risk D: Consider therapy modification
Afatinib Alpelisib Antacids Berotralstat Betrixaban Cladribine Colchicine Digoxin Eluxadoline
Histamine H2 Receptor Antagonists Lefamulin Proton Pump Inhibitors Relugolix Sirolimus
Tenofovir Disoproxil Fumarate Ubrogepant Venetoclax
Pregnancy and Pregnancy category: Not assigned.
Lactation Risk summary: No data available on use of this drug in pregnant women to inform a drug-

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related risk. As a precaution, it is preferable to avoid use of this drug during pregnancy.
It is not known if ledipasvir or sofosbuvir are present in breast milk. Because it is 99.8% bound
to maternal plasma proteins, amounts in breastmilk are likely to be very low. If ledipasvir
alone or in combination with sofosbuvir is required by the mother, it is not a reason to
discontinue breastfeeding
Administration Tablets: Administer with or without food.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Disease-related concerns:
Precautions • Diabetes: Rapid reduction in hepatitis C viral load during direct-acting antiviral (DAA)
therapy for hepatitis C may lead to improvement in glucose metabolism in patients with
diabetes, potentially resulting in symptomatic hypoglycemia if antidiabetic agents are
continued at the same dose. Monitor for changes in glucose tolerance and inform patients of
the risk of hypoglycemia during DAA therapy, particularly within the first 3 months.
Modification of antidiabetic therapy may be necessary.
• Hepatitis B virus reactivation: [US Boxed Warning]: Hepatitis B virus (HBV) reactivation has
been reported in hepatitis C virus (HCV)/HBV coinfected patients who were receiving or had
completed treatment with HCV direct-acting antivirals and were not receiving HBV antiviral
therapy; some cases have resulted in fulminant hepatitis, hepatic failure, and death. Test all
patients for evidence of current or prior HBV infection prior to initiation of
ledipasvir/sofosbuvir; monitor HCV/HBV co-infected patients for hepatitis flare or HBV
reactivation during treatment and post-treatment follow-up. Initiate treatment for HBV
infection as clinically indicated.
Concurrent drug therapy issues:
• Amiodarone: Symptomatic bradycardia (some requiring pacemaker intervention) and fatal
cardiac arrest has occurred in patients receiving amiodarone and ledipasvir/sofosbuvir. The
risk of bradycardia may be increased in patients taking beta blockers or patients with
underlying cardiac comorbidities and/or advanced liver disease. Bradycardia generally
resolves following discontinuation of ledipasvir/sofosbuvir.
Storage Tablets: Store below 30°C. Dispense in original packaging.
Refer to manufacturer PIL if there are specific considerations.

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10. Ombitasvir, Papritaprevir and Ritonavir
Generic Name Ombitsavir + Papritaprevir + Ritonavir

Dosage Ritonavir 50 mg ; Ombitasvir 12.5 mg ; Papritaprevir 75 mg tablets

form/strengths
Route of Oral
administration
Pharmacologic Antiviral
category ATC: J05AP53
Indications -Treatment of chronic hepatitis C (CHC) in adults.
-For Hepatitis C virus (HCV) genotype specific activity including the following genotypes:
- Genotype 1b, without cirrhosis or with compensated cirrhosis
- Genotype 1a, without cirrhosis
- Genotype 1a, with compensated cirrhosis
- Genotype 4, without cirrhosis or with compensated cirrhosis
Dosage -Adults:
Regimen -Two 12.5mg / 75mg / 50mg tablets once daily.
-It should be used in combination with other medicinal products for the treatment of HCV
Dosage -Renal Impairment:
adjustment No dose adjustment required for patients with mild, moderate, or severe renal impairment, or
end-stage-renal disease on dialysis
-Hepatic impairment:
No dose adjustment required in patients with mild hepatic impairment (Child-Pugh A).
-Contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B or C)
Contra- - Hypersensitivity to the active substances or to any of the drug components
indications - Moderate to severe hepatic impairment (Child-Pugh B or C)
- Use of ethinyloestradiol-containing medicinal products such as those contained in most
combined oral contraceptives or contraceptive vaginal rings
- Medicinal products that are highly dependent on CYP3A for clearance and for which elevated
plasma levels are associated with serious events including the following:
-CYP3A4 substrates:
➢ alfuzosin hydrochloride, amiodarone, disopyramide, dronedarone, quinidine, ranolazine,
astemizole, terfenadine, cisapride
➢ colchicine in patients with renal or hepatic impairment
➢ ergotamine, dihydroergotamine, ergonovine, methylergometrine
➢ fusidic acid, lomitapide, lovastatin, simvastatin, atorvastatin, lurasidone, oral midazolam,
triazolam, pimozid, quetiapine, salmeterol, sildenafil (when used for the treatment of
pulmonary arterial hypertension), ticagrelor
- Medicinal products that are strong or moderate enzyme inducers is expected to decrease
ombitasvir, paritaprevir, and ritonavir plasma
concentrations and reduce their therapeutic effect including the following:
-carbamazepine, phenytoin, phenobarbital, efavirenz, nevirapine, etravirine, apalutamide,
enzalutamide, mitotane, rifampicin, St. John’s Wort (Hypericum perforatum)
- Medicinal products that are strong inhibitors of CYP3A4 is expected to increase paritaprevir
plasma concentrations including the following:
-Cobicistat , indinavir, lopinavir/ritonavir, saquinavir, tipranavir, itraconazole, ketoconazole,
posaconazole, voriconazole , clarithromycin, telithromycin , conivaptan
Adverse Drug -Fatigue, nausea, pruritus, other skin reactions, insomnia and asthenia
Reactions

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Monitoring - Clinical signs and symptoms of hepatic decompensation (such as ascites, hepatic
Parameters encephalopathy, variceal haemorrhage).
- Direct bilirubin levels should be performed at baseline, during the first 4 weeks of starting
treatment and as clinically indicated thereafter.
Drug Risk X: Avoid combination:
Interactions Alfuzosin , Amiodarone ,Disopyramide, Dronedarone , Quinidine ,Ranolazine , Clarithromycin,
Telithromycin , Fusidic Acid , Apalutamide , Enzalutamide, Mitotane , Carbamazepine ,
Phenobarbital , Phenytoin , Conivaptan , Ketoconazole , Itraconazole , Posaconazole ,
Voriconazole , Astemizole , Terfenadine , Lomitapide , Rifampicin , Lurasidone , Pimozide ,
Quetiapine , Ticagrelor , Ethinyloestra diol/ norgestimate , Ergotamine Dihydroergot amine ,
Ergonovine Methylergom etrine , Cisapride , St. John's Wort (hypericum perforatum) , Lopinavir
/ ritonavir , Indinavir Saquinavir Tipranavir , Efavirenz/ emtricitabine/ tenofovir disoproxil
fumarate , Nevirapine etravirine , Cobicistatcontaining regimens , Lovastatin , Simvastatin ,
atorvastatin , Salmeterol , Sildenafil (when used for treatment of pulmonary hypertension) , Oral
midazolam Triazolam, Colchicine (in patients with renal or hepatic impairment )
Risk D: Consider therapy modification
Abemaciclib Ado-Trastuzumab Emtansine Afatinib Alfentanil Alitretinoin (Systemic) Almotriptan
Alpelisib Amiodarone Apixaban Aripiprazole Aripiprazole Lauroxil Atogepant Avacopan Axitinib
Bedaquiline Berotralstat Brexpiprazole Brigatinib Brincidofovir Bromocriptine
Budesonide Buspirone Cabazitaxel Cabozantinib Candesartan Cariprazine Ceritinib Cilostazol
Cladribine Clarithromycin Copanlisib Crizotinib Cyclosporine (Systemic) Daclatasvir Darifenacin
Darunavir Dasatinib Deflazacort Delamanid Digoxin Docetaxel Duvelisib Elexacaftor, Tezacaftor,
And Ivacaftor Eliglustat Eluxadoline Encorafenib Entrectinib Erdafitinib Erlotinib Eszopiclone
Fedratinib Felodipine Fentanyl Fesoterodine Fexinidazole Fluticasone (Oral Inhalation)
Gilteritinib Glasdegib Guanfacine Halofantrine Hydrocodone Ibrexafungerp Idelalisib Iloperidone
Irinotecan Products Istradefylline Ivacaftor Ivosidenib Ixabepilone Ketoconazole (Systemic)
Lapatinib Larotrectinib Levomilnacipran Losartan Manidipine Maraviroc Midostaurin
Mifepristone Mirodenafil Nifedipine Nilotinib Olaparib Osilodrostat Palbociclib Panobinostat
Pemigatinib Pimavanserin Ponatinib Pralsetinib Pravastatin Quetiapine Relugolix Relugolix,
Estradiol, And Norethindrone Riociguat Ruxolitinib (Systemic) Saxagliptin Selpercatinib
Selumetinib Sildenafil Solifenacin Sufentanil Sunitinib Tadalafil Temsirolimus Tezacaftor And
Ivacaftor Thioridazine Thiotepa Tofacitinib Tolterodine Toremifene Trazodone Triamcinolone
(Systemic) Upadacitinib Valbenazine Valsartan Vardenafil Vemurafenib Venetoclax Vilazodone
Vincristine Voriconazole Zanubrutinib Zopiclone
Pregnancy and -Potential risk for humans is unknown. Viekirax should not be used during pregnancy or in
Lactation women of childbearing potential not using effective contraception.
Ritonavir is present in breast milk; it is not known if ombitasvir or paritaprevir are present in
breast milk.
A decision should be made to discontinue breastfeeding or discontinue the drug, taking into
account the importance of the drug to the mother.
Administration -Take with food without regard to fat and calorie content.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ - Watch for early warning signs of liver inflammation, such as fatigue, weakness, lack of appetite,
Precautions nausea and vomiting, as well as later signs such as jaundice and discoloured faeces
- Efficacy of Viekirax has not been established in patients with HCV genotypes 2, 3, 5 and 6;
therefore, it should not be used to treat patients infected with these genotypes.
- HIV co-infected patients without suppressive antiretroviral therapy should not be treated with
the drug.
- Diabetics may experience improved glucose control, potentially resulting in symptomatic
hypoglycaemia, after initiating HCV direct acting antiviraltreatment. Glucose levels of diabetic

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patients initiating direct acting antiviraltherapy should be closely monitored, particularly within
the first 3 months, and their diabetic medicinal productsmodified when necessary.
Storage Store at or below 30°C
Refer to manufacturer PIL if there are specific considerations.

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11. Oseltamivir
Generic Name Oseltamivir

Dosage Capsule 75mg

form/strengths Powder (or Granules) for Oral Suspension 12mg/ml
Route of Oral
administration
Pharmacologic Antiviral Agent; Neuraminidase Inhibitor
category ATC: J05AH02
Indications Influenza, seasonal, prophylaxis: Prophylaxis of influenza (A or B) infection in patients ≥1
year of age.

Influenza, seasonal, treatment: Treatment of uncomplicated acute illness due to influenza

(A or B) infection in patients ≥2 weeks of age who have been symptomatic for no more than
48 hours.

Note: The Advisory Committee on Immunization Practices (ACIP) recommends that

treatment and prophylaxis be given to children <1 year of age when indicated.
Dosage Dosing: Adult
Regimen Influenza, seasonal, prophylaxis: Oral: 75 mg once daily
Continue for 1 week after last exposure (if previously vaccinated) or 2 weeks (if
unvaccinated).
Preexposure prophylaxis: Only during widespread outbreaks for persons at very high risk for
influenza complications (eg, severely immunocompromised patients) not protected by
vaccination. Continue for the duration of influenza activity or for 2 weeks following
vaccination.
Influenza, seasonal, treatment: Oral: 75 mg twice daily.
Note: Higher doses (150 mg twice daily) are not currently recommended even in severely ill
or immunocompromised patients.
Duration of therapy: Usual duration: 5 days; a longer duration can be considered in severely
ill or immunocompromised patients.
Dosing: Pediatric
Influenza, treatment: Note: Treatment should ideally begin within 48 hours of illness onset;
however, initiation after 48 hours is recommended for patients with severe, complicated, or
progressive illness; hospitalized patients; or those at increased risk for complications
(see Use for additional information). Initiate as early as possible in any hospitalized patient
with suspected/confirmed influenza.
The usual duration of therapy is 5 days; a longer duration may be necessary in severely ill or
immunocompromised patients.
Infants ≤8 months: Oral: 3 mg/kg/dose twice daily
Infants ≥9 months: Oral: 3.5 mg/kg/dose twice daily
Children and Adolescents:
≤15 kg: Oral: 30 mg twice daily.
>15 to 23 kg: Oral: 45 mg twice daily.
>23 to 40 kg: Oral: 60 mg twice daily.
>40 kg: Oral: 75 mg twice daily.
Influenza, prophylaxis:
Infants ≥9 months: Limited data available: Oral: 3.5 mg/kg/dose once daily; some experts still
recommend 3 mg/kg/dose once daily.
Children and Adolescents:

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≤15 kg: Oral: 30 mg once daily.
>15 kg to 23 kg: Oral: 45 mg once daily.
>23 kg to 40 kg: Oral: 60 mg once daily.
>40 kg: Oral: 75 mg once daily.
Dosage Dosing: Renal Impairment: Adult
adjustment Influenza, seasonal, treatment:
CrCl >60 mL/minute: No dosage adjustment necessary
CrCl >30 to 60 mL/minute: 30 mg twice daily
CrCl >10 to 30 mL/minute: 30 mg once daily
ESRD not undergoing dialysis: Use is not recommended (has not been studied)
Influenza, seasonal, prophylaxis:
CrCl >60 mL/minute: No dosage adjustment necessary
CrCl >30 to 60 mL/minute: 30 mg once daily
CrCl >10 to 30 mL/minute: 30 mg every other day
ESRD not undergoing dialysis: Use is not recommended (has not been studied)
Dosing: Renal Impairment: Pediatric
Children and Adolescents:
Treatment: Limited data available
Intermittent hemodialysis (IHD): Fixed dosing:
≤15 kg: 7.5 mg after each hemodialysis session.
>15 kg to ≤23 kg: 10 mg after each hemodialysis session.
>23 kg to ≤40 kg: 15 mg after each hemodialysis session.
>40 kg: 30 mg after each hemodialysis session.

Prophylaxis: There are no pediatric specific recommendations; based on experience in adult

patients, dosage adjustment suggested.

Dosing: Hepatic Impairment: Adult

Mild-to-moderate impairment: No dosage adjustment necessary.
Severe impairment: No dosage adjustment data.

Contra- Hypersensitivity to oseltamivir or any component of the formulation

indications
Adverse Drug >10%:
Reactions Gastrointestinal: Vomiting (2% to 16%)
Nervous system: Headache (adolescents and adults: 2% to 17%)
1% to 10%:
Gastrointestinal: Nausea
Nervous system: Pain
Monitoring signs or symptoms of unusual behavior, including attempts at self-injury, confusion, and/or
Parameters delirium
Critically ill patients: Repeat rRT-PCR or viral culture may help to determine on-going viral
replication

Drug Risk X: Avoid combination

Interactions Dichlorphenamide
Risk D: Consider therapy modification
Influenza Virus Vaccine (Live/Attenuated)
Pregnancy and Pregnancy Category C

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Lactation Limited data indicate that oseltamivir and its active metabolite are poorly excreted into
breastmilk. Maternal dosages of 150 mg daily produce low levels in milk and would not be
expected to cause any adverse effects in breastfed infants, especially if the infant is older
than 2 months. Infants over 1 year of age can receive oseltamivir directly in doses much
larger than those in breastmilk.
Administration Administration: Pediatric
Oral: May administer with or without food; may decrease stomach upset if administered
with food.
• Capsules: May be opened and mixed with sweetened liquid (eg, chocolate syrup, light
brown sugar [dissolved in water]).
• Oral suspension: Shake suspension well before use; measure dose in an appropriately
sized calibrated oral syringe that provides accurate measurement of prescribed dose.

Preparation of 6 mg/mL Oral Suspension

If the commercially prepared oral suspension is not available, compounding
information to prepare a 6 mg/mL suspension in emergency situations is:
1. Place the specified amount of water into a polyethyleneterephthalate (PET) or glass
bottle.
2. Carefully separate the capsule body and cap and pour the contents of the required
number of 75 mg capsules into the PET or glass bottle.
3. Gently swirl the suspension to ensure adequate wetting of the powder for at least 2
minutes.
4. Slowly add the specified amount of vehicle to the bottle.
5. Close the bottle using a child-resistant cap and shake well for 30 seconds to
completely dissolve the active drug.
6. Label “Shake Well Before Use.”
Stable for 35 days at 2°C to 8°C or 5 days at 25° C.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Disease-related concerns:
Precautions • Cardiovascular disease: Use with caution in patients with chronic cardiac disease.
• Hepatic impairment: Use with caution in patients with severe hepatic impairment; safety
and efficacy have not been established.
• Renal impairment: Use with caution; dosage adjustment is required for patients with renal
impairment. Not recommended for patients with end stage renal disease (ESRD) not
undergoing dialysis.
• Respiratory disease: Use with caution in patients with respiratory disease.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic
acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl
alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping
syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory
distress, gasping respirations, CNS dysfunction, hypotension, and cardiovascular collapse;
avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates.
• Sorbitol: Oral suspension contains sorbitol (delivers ~2 g sorbitol per 75 mg dose) which is
greater than the maximum daily limit for patients with hereditary fructose intolerance; may
cause diarrhea and dyspepsia; use with caution.
Other warnings/precautions:
• Appropriate use: Oseltamivir is not a substitute for the influenza virus vaccine. It has not
been shown to prevent primary or concomitant bacterial infections that may occur with

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influenza virus. Antiviral treatment should begin within 48 hours of symptom onset.
However, the CDC recommends that treatment may still be beneficial and should be started
in hospitalized patients with severe, complicated or progressive illness if >48 hours.
Treatment should not be delayed while awaiting results of laboratory tests for influenza.
Nonhospitalized persons who are not at high risk for developing severe or complicated
illness and who have a mild disease are not likely to benefit if treatment is started >48 hours
after symptom onset. Nonhospitalized persons who are already beginning to recover do not
need treatment.

Storage Capsules: Store at 25°C; excursions permitted to 15°C to 30°C.

Oral suspension: Store powder for suspension at 25°C; excursions permitted to 15°C to 30°C.
Once reconstituted, store oral suspension under refrigeration at 2°C to 8°C or at room
temperature; do not freeze. Use within 10 days of preparation if stored at room temperature
or within 17 days of preparation if stored under refrigeration.
Refer to manufacturer PIL if there are specific considerations.

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12. Ribavirin
Generic Name Ribavirin

Dosage Capsule 200mg, 400mg

form/strengths Tablets 200mg, 400mg, 500mg, 600mg
Oral Syrup 100mg/5ml
Route of Oral
administration
Pharmacologic Antihepaciviral, Nucleoside (Anti-HCV)
category ATC: J05AP01
Indications Hepatitis C virus infection, chronic: Ribavirin, in combination with direct-acting antivirals, is
recommended in the AASLD/IDSA guidelines as part of an antiviral regimen for certain clinical
scenarios. Hepatitis C treatment guidelines are frequently changing with the advent of new
treatment therapies and information; consult current clinical practice guidelines for the most
recent treatment recommendations.
Dosage Dosing: Adult
Regimen Hepatitis C virus infection, chronic: according to (AASLD/IDSA 2020)
Weight-based ribavirin:
<75 kg: 1 g/day in 2 divided doses.
≥75 kg: 1.2 g/day in 2 divided doses.
Low initial dose ribavirin: 600 mg; increase as tolerated (maximum dose: 1 g/day [<75 kg] or
1.2 g/day [≥75 kg]).
Dosing regimen, concomitant therapy, and duration is dependent on HCV genotype and
treatment status (treatment-naive or treatment-experienced), as well as other factors (eg,
presence and type of cirrhosis). Combination therapy with peginterferon is not recommended
in HCV treatment guidelines.
Dosing: Pediatric
Hepatitis C monoinfection, chronic:
Note: Combination therapy with interferon or peginterferon is not recommended; refer to
current AASLD/IDSA clinical practice guidelines for most recent treatment recommendations.
Children ≥3 years and Adolescents: Oral:
Children ≥3 years and Adolescents: Oral:
<47 kg: 15 mg/kg/day in 2 divided doses.
47 to 59 kg: 400 mg twice daily.
60 to 73 kg: 400 mg in the morning; 600 mg in the evening.
>73 kg: 600 mg twice daily.

• Discontinue treatment If:

Hemoglobin <8.5 g/dL, WBC <1,000 mm3, neutrophils <500 mm3 , Platelets <25 x 109/L for
adults or 50 x 109/L in children

Dosage Dosing: Renal Impairment:

adjustment Hepatitis C monoinfection, chronic:
Capsules/solution: Oral:
Baseline:
CrCl ≥50 mL/minute: No dosage adjustments are recommended.
CrCl <50 mL/minute: Use is contraindicated.
During therapy: Serum creatinine >2 mg/dL: Permanently discontinue treatment.

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tablets:
CrCl >50 mL/minute: No dosage adjustments necessary.
CrCl 30 to 50 mL/minute: Alternate 200 mg and 400 mg every other day.
CrCl <30 mL/minute: 200 mg once daily.
ESRD requiring hemodialysis: 200 mg once daily.

Dosing: Hepatic Impairment:

Hepatitis C, chronic: Hepatic decompensation (Child-Pugh class B and C): Oral tablets: Use
contraindicated.

Dosing adjustment for toxicity:

Patient without cardiac history:
• Dose modifications in adults with Hemoglobin 8.5 to <10 g/dL:
First reduction: ≤105 kg: Decrease by 200 mg daily; >105 kg: Decrease by 400 mg daily
Second reduction: Decrease by an additional 200 mg daily (not weight-based)
Oral tablets: Decrease dose to 600 mg daily (200 mg in the morning, 400 mg in the evening)

Patient with stable cardiac history:

Hemoglobin has decreased ≥2 g/dL during any 4-week period of treatment:
Oral capsules, solution: Decrease dose by 200 mg daily; decrease peginterferon alfa-2b dose
by 50%. If hemoglobin <8.5 g/dL any time after dose reduction or <12 g/dL after 4 weeks of
dose reduction, permanently discontinue treatment.
Oral tablets: Decrease dose to 600 mg daily (200 mg in the morning, 400 mg in the evening). If
hemoglobin <8.5 g/dL any time after dose reduction or <12 g/dL after 4 weeks of dose
reduction, permanently discontinue treatment.
Hemoglobin <8.5 g/dL: Oral capsules, solution, tablets: Permanently discontinue treatment.
WBC <1,000 mm3, neutrophils <500 mm3: Oral capsules, solution: Permanently discontinue
treatment.
Platelets <25 x 109/L: Oral capsules, solution: Permanently discontinue treatment.
Contra- Hypersensitivity to ribavirin or any component of the formulation; women who are pregnant
indications or may become pregnant; males whose female partners are pregnant; patients with
hemoglobinopathies (eg, thalassemia major, sickle cell anemia); concomitant use with
didanosine
Patients with a CrCl <50 mL/minute

Adverse Drug >10%:

Reactions Dermatologic: Alopecia (17% to 36%; children and adolescents: 17% to 23%), dermatitis (13%
to 16%), dermatologic disorder (children and adolescents: 47%), diaphoresis (4% to 11%),
pruritus (13% to 29%; children and adolescents: 11% to 12%), skin rash (5% to 34%; children
and adolescents: 15% to 17%), xeroderma (10% to 24%)
Endocrine & metabolic: Growth retardation (children and adolescents: <3rd percentile height
decrease: 70%, >15 percentile height or weight decrease: 11% to 43%, >30 percentile height
decrease: ≤13%), hyperuricemia (33% to 38%), weight loss (10% to 29%; children and
adolescents: 19%)
Gastrointestinal: Abdominal pain (8% to 21%), anorexia (21% to 32%; children and
adolescents: 29% to 51%), decreased appetite (children and adolescents: 11% to 22%),
diarrhea (10% to 22%), dyspepsia (5% to 16%; children and adolescents: <1%), gastrointestinal
disease (children and adolescents: 49% to 56%), nausea (≤47%; children and adolescents: 18%
to 33%), upper abdominal pain (children and adolescents: 12%), vomiting (≤29%; children and
adolescents: 27% to 42%), xerostomia (4% to 12%)

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Hematologic & oncologic: Anemia (11% to 35%), hemolytic anemia (10% to 13%),
lymphocytopenia (12% to 14%), neutropenia (8% to 40%; severe neutropenia (children and
adolescents: 1%)
Hepatic: Hyperbilirubinemia (10% to 14%)
Infection: Viral infection (12%)
Local: Erythema at injection site (children and adolescents: 29%), inflammation at injection
site (13% to 25%; children and adolescents: 14%), injection site reaction (5% to 58%; children
and adolescents: 19% to 45%)
Nervous system: Anxiety (≤47%), chills (23% to 39%; children and adolescents: 21%),
depression (≤40%, severe depression: <1%; children and adolescents: 1% to 13%), dizziness
(13% to 26%), emotional lability (≤47%; children and adolescents: 16%), fatigue (≤68%;
children and adolescents: 25% to 58%), headache (41% to 69%; severe headache: children and
adolescents: 1%), insomnia (26% to 41%; children and adolescents: 9% to 14%), irritability
(≤47%; children and adolescents: 10% to 24%), lack of concentration (10% to 21%; children
and adolescents: 5%), nervousness (≤38%; children and adolescents: 3% to 7%), pain (9% to
13%), right upper quadrant pain (6% to 12%), rigors (25% to 48%; children and adolescents:
25%)
Neuromuscular & skeletal: Arthralgia (21% to 34%; children and adolescents: 15% to 17%),
asthenia (≤68%; children and adolescents: 5% to 15%), musculoskeletal pain (19% to 21%;
children and adolescents: 21% to 35%), myalgia (22% to 64%; children and adolescents: 17% to
32%)
Respiratory: Cough (7% to 23%), dyspnea (13% to 26%; children and adolescents: 5%), flu-like
symptoms (15% to 16%; children and adolescents: 31% to 91%), pharyngitis (12% to 13%),
sinusitis (5% to 12%; children and adolescents: <1%), upper respiratory tract infection
(children and adolescents: 60%)
Miscellaneous: Fever (21% to 55%; children and adolescents: 61% to 80%; high fever: children
and adolescents: 4%)

1% to 10%:
Cardiovascular: Chest pain, flushing
Dermatologic: Eczema
Endocrine & metabolic: Hypothyroidism, menstrual disease
Gastrointestinal: Constipation, decompensated liver disease, dysgeusia
Hematologic & oncologic: Leukopenia, thrombocytopenia
Hepatic: Hepatomegaly, increased serum alanine aminotransferase
Infection: Bacterial infection, fungal infection
Local: Pain at injection site
Nervous system: Aggressive behavior, agitation, hostility, malaise, memory impairment, mood
changes, suicidal ideation
Neuromuscular & skeletal: Back pain, limb pain
Ophthalmic: Blurred vision, conjunctivitis
Respiratory: Dyspnea on exertion, rhinitis
Monitoring − Pretreatment hematological and biochemical tests are recommended for all patients;
Parameters dental exam, ECG (if preexisting cardiac abnormalities or disease) and ophthalmic exam
(also periodically during treatment for those with preexisting ophthalmologic disorders)
are also recommended. In adults, hematologic tests should be performed at treatment
weeks 2 and 4, biochemical tests at week 4, and TSH every 12 weeks.
− Pregnancy testing: Evaluate pregnancy status prior to use in females of reproductive
potential. A negative pregnancy test is required immediately before initiation, periodically

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during therapy, and during the 6 months after treatment is discontinued.
− Growth velocity and weight should also be monitored during and periodically after
treatment discontinuation.
− Serum HCV RNA (pretreatment, week 12 and week 24, and 24 weeks after completion of
therapy).
− Baseline values used in adult clinical trials in combination with alfa interferons:
✓ Platelet count ≥90,000/mm3 (75,000/mm3 for cirrhosis or 70,000/mm3 for coinfection
with HIV)
✓ ANC ≥1,500/mm3
✓ Hemoglobin ≥12 g/dL for women and ≥13 g/dL for men (11 g/dL for HIV coinfected
women and 12 g/dL for HIV coinfected men)
✓ TSH and T4 within normal limits or adequately controlled
✓ CD4+ cell count ≥200 cells/microL or CD4+ cell count 100 to 200 cells/microL and HIV-1
RNA <5,000 copies/mL for coinfection with HIV

Drug •Risk X: Avoid combination

Interactions Cladribine Didanosine
• Risk D: Consider therapy modification
Azathioprine Influenza Virus Vaccine (Live/Attenuated) Zidovudine
Pregnancy and Pregnancy category X
Lactation There are no data on the excretion of ribavirin into human milk. Due to the potential for
serious adverse reactions in nursing infants, a decision should be made to discontinue nursing
or discontinue the drug, taking into account the importance of the drug to the mother.
Administration Administration: Oral
Capsule: Administer with food. Capsule should not be opened, crushed, or broken.
Solution: Administer with food.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Hemolytic anemia: [US Boxed Warning]: Hemolytic anemia has been reported with
ribavirin therapy; anemia associated with ribavirin may worsen underlying cardiac disease
and lead to fatal and nonfatal myocardial infarctions. Avoid use in patients with
significant/unstable cardiac disease.
Disease-related concerns:
• Hepatic impairment: Risk of hepatic decompensation in chronic hepatitis C patients
treated with combination therapy; monitor hepatic function closely and discontinue
therapy immediately if evidence of hepatic decompensation is observed.
• Hepatitis C: Appropriate use: [US Boxed Warning]: Ribavirin monotherapy is not effective
for chronic hepatitis C infection and should not be used alone for hepatitis C.
• Renal impairment: Use with caution in patients with renal impairment; dosage
adjustment or discontinuation may be required.
Concurrent drug therapy issues:
Combination therapy with alfa interferons:
• Autoimmune/infectious disorders: Have occurred with combination therapy; use with
caution in patients with autoimmune disease or severe infection.
• Bone marrow suppression: Pancytopenia has occurred with combination therapy and
concomitant use of azathioprine; onset occurs within 3 to 7 weeks; discontinue
combination therapy and azathioprine if pancytopenia occurs; may be reversible (usually
within 4 to 6 weeks).

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• Dental and periodontal disorders: Have been reported with combination therapy; patients
should be instructed to brush teeth twice daily and have regular dental exams. Xerostomia
may contribute to and/or exacerbate dental disorders.
• Dermatologic reactions: Severe cutaneous reactions, including Stevens-Johnson syndrome
and exfoliative dermatitis have been reported (rarely) with combination therapy;
discontinue immediately with signs or symptoms of severe skin reactions.
• Diabetes: Has occurred with combination therapy; monitor blood sugars closely.
• Hypersensitivity reactions: Acute hypersensitivity reactions (eg, anaphylaxis, angioedema,
bronchoconstriction, and urticaria) have been observed with combination therapy;
discontinue immediately with signs or symptoms of severe hypersensitivity reactions.
• Ophthalmologic disorders: Serious disorders (eg, retinopathy, macular edema, retinal
artery/vein thrombosis, optic neuritis, retinal detachment) have occurred with combination
therapy. All patients require an eye exam at baseline; those with preexisting
ophthalmologic disorders (eg, diabetic or hypertensive retinopathy) require periodic follow
up. Discontinue therapy in patients with new or worsening ophthalmologic disorders.
• Pancreatitis: Has occurred with combination therapy; interrupt therapy if pancreatitis is
suspected and discontinue if confirmed.
• Psychiatric disorders: Severe psychiatric events have occurred including depression and
suicidal/homicidal ideation during combination therapy. Suicidal ideation or attempts
occurred more often in pediatric patients versus reports in adults during treatment and off-
therapy follow-up (2.4% vs 1%). Avoid use in patients with a psychiatric history; discontinue
if severe psychiatric symptoms occur.
• Pulmonary events: Pulmonary symptoms (eg, dyspnea, pulmonary infiltrates,
pneumonitis, pulmonary hypertension, and pneumonia [rarely fatal]) have been associated
with combination therapy; use with caution in patients with pulmonary disease, including
sarcoidosis (exacerbation reported).
Special populations:
• Elderly: Use with caution in the elderly; may be more susceptible to adverse effects such
as anemia. Monitor renal function closely.
• Pediatric: In combination therapy with alfa interferons, ribavirin may cause a reduction in
growth velocity in pediatric and adolescent patients 5 to 17 years of age for the length of
treatment. Following treatment, rebound growth and weight gain occurred in most
patients; however, a small percentage did not. Long-term data indicate that combination
therapy may inhibit growth resulting in reduced adult height in some patients. Growth
should be closely monitored in pediatric patients during therapy and post-treatment for
growth catch-up.
• Pregnancy: [US Boxed Warning]: Use is contraindicated in pregnant females or male
partners of pregnant females. Significant teratogenic and/or embryocidal effects have been
observed in all animal studies. Avoid pregnancy in female patients and female partners of
male patients during therapy; use effective contraceptive measures during treatment and
for at least 6 months after completion of therapy.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic
acid which is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99
mg/kg/day) have been associated with a potentially fatal toxicity ("gasping syndrome") in
neonates;
Other warnings/precautions:
• Appropriate use: Safety and efficacy have not been established in patients who have
failed previous interferon therapy, received organ transplants, or been coinfected with
hepatitis B or HIV. The combination of peginterferon and ribavirin, even with additional

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preferred HCV antiviral agent(s), is not recommended for hepatitis C virus (HCV) (regardless
of genotype) in HCV adult treatment guidelines (treatment-naive or treatment-
experienced); consult current clinical practice guidelines for details on appropriate use.

Storage Store at 25°C; excursions permitted between 15°C and 30°C. Solution may also be
refrigerated at 2°C to 8°C.
Refer to manufacturer PIL if there are specific considerations.

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13. Simeprevir
Generic Name Simeprevir

Dosage Capsule 150 mg

form/strengths
Route of Oral
administration
Pharmacologic Antihepaciviral, NS3/4A Protease Inhibitor (Anti-HCV)
category ATC: J05AP05
Indications Chronic hepatitis C: Treatment of genotype 1 chronic hepatitis C in combination with
sofosbuvir in adults without cirrhosis

Limitations of use: Not recommended for use in patients who have previously failed a
simeprevir-containing regimen or another regimen containing HCV protease inhibitors.
Dosage Dosing: Adult
Regimen Chronic hepatitis C, genotype 1 (without cirrhosis or with compensated cirrhosis [Child-
Pugh class A]): Oral: 150 mg once daily in combination with sofosbuvir for 12 weeks
(without cirrhosis) or 24 weeks (with compensated cirrhosis). Note: The American
Association for the Study of Liver Diseases/Infectious Diseases Society of America
guidelines for testing, managing, and treating hepatitis C no longer include simeprevir as
a component of recommended treatment regimens for HCV infection
Dosage Dosing: Renal Impairment: Adult
adjustment CrCl >30 mL/minute: No dosage adjustment necessary.
CrCl ≤30 mL/minute: There are no dosage adjustments data.
Dialysis is unlikely to result in significant removal of simeprevir.
Dosing: Hepatic Impairment: Adult
Mild impairment (Child-Pugh class A): No dosage adjustment necessary.
Moderate or severe impairment (Child-Pugh class B or C): Use is not recommended.

Contra- Hypersensitivity to simeprevir or any component of the formulation

indications When administered with ribavirin and peginterferon alfa, the contraindications to
ribavirin and peginterferon alfa also apply. See Ribavirin and Peginterferon Alfa
monographs.
Adverse Drug >10%:
Reactions Central nervous system: Headache (with sofosbuvir 7% to 49%), fatigue (with sofosbuvir
10% to 47%), insomnia (with sofosbuvir 14%), dizziness (with sofosbuvir 5% to 10%)
Dermatologic: Skin photosensitivity (with sofosbuvir ≤5% to ≤34%; grade 3: ≤1%; with
Peg-IFN-alfa and RBV ≤28%; grade 3: <1%), skin rash (with sofosbuvir ≤5% to ≤34%; grade
3: ≤1%; with Peg-IFN-alfa and RBV ≤28%; including erythema, eczema, maculopapular
rash, urticaria, toxic skin eruption, dermatitis exfoliative, cutaneous vasculitis; grade 3:
≤1%), pruritus (with Peg-IFN-alfa and RBV 22%; with sofosbuvir 11%)
Endocrine & metabolic: Increased amylase (with sofosbuvir)
Gastrointestinal: Nausea (with sofosbuvir 4% to 40%; with Peg-IFN-alfa and RBV 22%),
diarrhea (with sofosbuvir 5% to 18%)
Hepatic: Increased serum bilirubin (<66%), hyperbilirubinemia (with sofosbuvir)
Neuromuscular & skeletal: Myalgia (16%)
Respiratory: Dyspnea (12%)
1% to 10%:
Gastrointestinal: Increased serum lipase

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Hepatic: Increased serum alkaline phosphatase

Monitoring • Baseline CBC, INR, hepatic function (albumin, total and direct bilirubin, ALT, AST,
Parameters alkaline phosphatase), calculated GFR; baseline hepatitis C virus (HCV) genotype and
subtype, quantitative HCV viral load.
• During treatment, monitor CBC, serum creatinine, calculated GFR, hepatic function
panel (after 4 weeks of therapy and as clinically indicated); quantitative HCV viral load
testing (after 4 weeks of therapy and at 12 weeks after completion of therapy). If
quantitative HCV viral load is detectable at treatment week 4, repeat testing is
recommended after 2 additional weeks of treatment (treatment week 6).
• Screen patients infected with HCV genotype 1a for the presence of virus with the NS3
Q80K polymorphism prior to the initiation of treatment.
• Hepatitis B surface antigen and hepatitis B core antibody prior to initiation; in patients
with serologic evidence of hepatitis B virus (HBV) infection, monitor for clinical and
laboratory signs of hepatitis flare or HBV reactivation during treatment and during
posttreatment follow-up.
Drug Risk X: Avoid combination
Interactions Abametapir Aminolevulinic Acid (Systemic) Asunaprevir Bilastine Cisapride Conivaptan
Cyclosporine CYP3A4 Inducers CYP3A4 Inhibitors Delavirdine Dexamethasone (Systemic)
Doxorubicin Elagolix Elagolix, Estradiol, And Norethindrone Erythromycin (Systemic)
Grazoprevir Idelalisib Milk Thistle Nevirapine Ozanimod Pazopanib Protease Inhibitors
Revefenacin Rimegepant St John's Wort Topotecan Vincristine (Liposomal) Voxilaprevir
Risk D: Consider Therapy Modification
Afatinib Alpelisib Betrixaban Cladribine Colchicine Digoxin Eluxadoline Relugolix
Rosuvastatin Stiripentol Tizanidine Ubrogepant Venetoclax
Pregnancy and − FDA pregnancy category: Not assigned.
Lactation No data available on use of this drug in pregnant women to inform a drug-related risk;
findings in animal studies suggest potential risk to the fetus
It is not known if simeprevir is present in breast milk. The decision to continue or
discontinue breastfeeding during therapy should take into account the risk of infant
exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the
mother.
Administration Administration: Oral
Administer with food. Swallow capsules whole; do not chew, crush, break, cut, or
dissolve the capsule.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Hepatic decompensation/failure: Hepatic decompensation and failure (including fatal
cases) have been reported in patients treated with simeprevir in combination with
peginterferon alfa and ribavirin or sofosbuvir. Most cases occurred in patients with
advanced and/or decompensated cirrhosis. Monitor hepatic function at baseline and as
clinically indicated; closely monitor patients who experience an increase in total bilirubin
>2.5 times the ULN. Discontinue treatment if elevated bilirubin accompanied by liver
transaminase increases or clinical signs or symptoms of hepatic decompensation occur.
• Photosensitivity: Photosensitivity reactions, including serious reactions resulting in
hospitalization, have been reported when used in combination with peginterferon alfa
and ribavirin. Most frequently occurs within the first 4 weeks of treatment. Avoid
excessive sunlight, tanning devices, and take precautions to limit exposure (eg, loose

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fitting clothing, sunscreen). Discontinue use if photosensitivity occurs and monitor until
the reaction resolves. If therapy is to be continued in a patient who has experienced
photosensitivity, expert consultation is advised.
• Skin reactions: Rash has been typically observed within first 4 weeks of therapy
initiation, but can occur at any time during treatment. Severe rashes and rash requiring
discontinuation have occurred in combination with peginterferon alfa and ribavirin. If a
patient experiences a mild to moderate rash, follow for progression and/or development
of mucosal signs (eg, oral lesions, conjunctivitis) or systemic symptoms. If rash becomes
severe, discontinue simeprevir and monitor for rash resolution.
• Sulfa allergy: Contains a sulfonamide moiety. Discontinue if signs of hypersensitivity are
noted.
Disease-related concerns:
• Diabetes: Rapid reduction in hepatitis C viral load during direct-acting antiviral (DAA)
therapy for hepatitis C may lead to improvement in glucose metabolism in patients with
diabetes, potentially resulting in symptomatic hypoglycemia if antidiabetic agents are
continued at the same dose. Monitor for changes in glucose tolerance and inform
patients of the risk of hypoglycemia during DAA therapy, particularly within the first 3
months. Modification of antidiabetic therapy may be necessary.
• Hepatic impairment: Not recommend in patients with moderate or severe hepatic
impairment (Child-Pugh class B or C).
• Hepatitis B virus reactivation: [US Boxed Warning]: Hepatitis B virus (HBV) reactivation
has been reported in hepatitis C virus (HCV)/HBV co-infected patients who were receiving
or had completed treatment with HCV direct-acting antivirals and were not receiving HBV
antiviral therapy; some cases have resulted in fulminant hepatitis, hepatic failure, and
death. Test all patients for evidence of current or prior HBV infection prior to initiation of
simeprevir; monitor HCV/HBV co-infected patients for hepatitis flare or HBV reactivation
during treatment and post-treatment follow-up. Initiate treatment for HBV infection as
clinically indicated.
Concurrent drug therapy issues:
• Amiodarone: Symptomatic bradycardia (some requiring pacemaker intervention) has
occurred in patients receiving amiodarone and a sofosbuvir-containing regimen. The risk
of bradycardia may be increased in patients taking beta blockers or patients with
underlying cardiac comorbidities and/or advanced liver disease. Bradycardia generally
resolves following discontinuation of HCV treatment.
Other warnings/precautions:
• Appropriate use: Do not use as monotherapy; use only as part of a multiple-drug
regimen for treatment of HCV; consult current HCV treatment guidelines for guidance.
• Resistance: Reduced sustained virologic response (SVR) rates of simeprevir in
combination with sofosbuvir were observed in patients infected with hepatitis C
genotype 1a with an NS3 Q80K polymorphism compared to patients without the
polymorphism; consider alternative therapy in these patients. Patients with compensated
cirrhosis and hepatitis C genotype 1a should be evaluated for the presence of the Q80K
polymorphism; alternative regimens should be used if Q80K variant is present.
Storage Store below 30°C. Store in the original bottle. Protect from light.
Refer to manufacturer PIL if there are specific considerations.

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14. Sofosbuvir

Generic Name Sofosbuvir

Dosage Tablets 400 mg

form/strengths
Route of Oral
administration
Pharmacologic Antihepaciviral, Polymerase Inhibitor (Anti-HCV); NS5B RNA Polymerase Inhibitor
category ATC: J05AP08
Indications Chronic hepatitis C: Treatment of genotype 1, 2, 3, or 4 chronic hepatitis C virus
(HCV) infection in adults and genotype 2 or 3 chronic HCV infection in pediatric
patients ≥3 years of age, without cirrhosis or with compensated cirrhosis, as a
component of a combination antiviral treatment regimen.
Dosage Dosing: Adult
Regimen Genotype 3, peginterferon + ribavirin treatment–experienced patients with
compensated cirrhosis (Child-Pugh class A) (alternative agent): Oral: 400 mg once
daily with concomitant elbasvir/grazoprevir for 12 weeks.
All genotypes, patients with prior glecaprevir/pibrentasvir or
sofosbuvir/velpatasvir/voxilaprevir treatment failure, without cirrhosis or with
compensated cirrhosis (Child-Pugh class A): Oral: 400 mg once daily in combination
with ribavirin and glecaprevir/pibrentasvir for 16 weeks

Dosing: Pediatric
Note: Prior to initiating therapy, test patient for evidence of hepatitis B infection
(current or prior).
Chronic hepatitis C infection (monoinfection or coinfected with HIV-1); treatment-
naive or treatment-experienced without cirrhosis or with compensated cirrhosis
(Child-Pugh class A): Note: Use in combination with ribavirin.
Children ≥3 years and Adolescents:
Patient weight:
17 to <35 kg: tablets: Oral: 200 mg once daily.
≥35 kg: tablets: Oral: 400 mg once daily.
Treatment duration based on genotype:
Genotype 2: 12 weeks.
Genotype 3: 24 weeks.
Dosage Dosing: Renal Impairment: Adult
adjustment Adults, Adolescents and Children ≥3 years:
eGFR ≥30 mL/minute: No dosage adjustment necessary.
eGFR <30 mL/minute: There are no dosage recommendations available. safety and
efficacy not established in such patients. Predominant metabolite accumulates (up to
20-fold) in impaired renal function.
Dosing: Hepatic Impairment: Adult
Mild, moderate, or severe impairment (Child-Pugh class A, B, or C): No dosage
adjustment necessary
Contra- When administered with ribavirin and peginterferon alfa, the contraindications to
indications ribavirin and peginterferon alfa also apply. See Ribavirin and Peginterferon Alfa
monographs.

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Adverse Drug >10%:
Reactions Dermatologic: Pruritus (11% to 27%), skin rash (8% to 18%)
Gastrointestinal: Decreased appetite (18%), diarrhea (9% to 12%), nausea (22% to
34%)
Hematologic & oncologic: Anemia (6% to 21%), neutropenia (<1% [interferon-free
regimen] to 17% [interferon-containing regimen])
Nervous system: Chills (2% to 17%), fatigue (30% to 59%), headache (24% to 36%),
insomnia (15% to 25%), irritability (10% to 13%)
Neuromuscular & skeletal: Asthenia (5% to 21%), myalgia (6% to 14%)
Respiratory: Flu-like symptoms (6% to 16%)
Miscellaneous: Fever (4% to 18%)
1% to 10%:
Gastrointestinal: Increased serum lipase
Hematologic & oncologic: Thrombocytopenia
Hepatic: Increased serum bilirubin
Renal: Increased creatine phosphokinase in blood specimen
Monitoring • Baseline CBC, INR, hepatic function (albumin, total and direct bilirubin, ALT, AST,
Parameters alkaline phosphatase), calculated GFR; baseline (obtain any time prior to
treatment initiation) HCV genotype and subtype, quantitative HCV viral load.
• During treatment, monitor CBC, serum creatinine, calculated GFR, hepatic
function panel (after 4 weeks of therapy and as clinically indicated); quantitative
HCV viral load testing (after 4 weeks of therapy and at 12 weeks after completion
of therapy). If quantitative HCV viral load is detectable at treatment week 4,
repeat testing is recommended after 2 additional weeks of treatment (treatment
week 6). If used in combination with amiodarone and another direct acting
antiviral (DAA) (or in patients who discontinued amiodarone just prior to
initiating sofosbuvir in combination with a DAA), inpatient cardiac monitoring for
the first 48 hours of coadministration, then daily outpatient or self monitoring of
heart rate through at least the first 2 weeks of treatment.
• Hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) prior
to initiation; in patients with serologic evidence of hepatitis B virus (HBV)
infection, monitor for clinical and laboratory signs of hepatitis flare or HBV
reactivation during treatment and during post-treatment follow-up.
• In patients with diabetes, monitor blood glucose and for signs/symptoms of
hypoglycemia

Drug Risk X: Avoid Combination

Interactions Modafinil Oxcarbazepine P-Glycoprotein /ABCB1 Inducers Phenobarbital
Primidone Rifapentine Tipranavir
Risk D: Consider therapy modification
Amiodarone
Pregnancy and Pregnancy Category B
Lactation It is not known if sofosbuvir is present in breast milk.
The decision to breastfeed during therapy should consider the risk of infant exposure,
the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
According to some authorities: Breastfeeding is not recommended during use of this
drug.

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Administration Administration: Oral
Tablets: Administer with or without food.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Disease-related concerns:
Precautions • Diabetes: Rapid reduction in hepatitis C viral load during direct-acting antiviral
(DAA) therapy for hepatitis C may lead to improvement in glucose metabolism in
patients with diabetes, potentially resulting in symptomatic hypoglycemia if
antidiabetic agents are continued at the same dose. Monitor for changes in glucose
tolerance and inform patients of the risk of hypoglycemia during DAA therapy,
particularly within the first 3 months. Modification of antidiabetic therapy may be
necessary.
• Hepatitis B virus reactivation: [US Boxed Warning]: Hepatitis B virus (HBV)
reactivation has been reported in hepatitis C virus (HCV)/HBV co-infected patients
who were receiving or had completed treatment with HCV direct-acting antivirals and
were not receiving HBV antiviral therapy; some cases have resulted in fulminant
hepatitis, hepatic failure, and death. Test all patients for evidence of current or prior
HBV infection prior to initiation of sofosbuvir; monitor HCV/HBV co-infected patients
for hepatitis flare or HBV reactivation during treatment and post-treatment follow-
up. Initiate treatment for HBV infection as clinically indicated.
Concurrent drug therapy issues:
• Amiodarone: Symptomatic bradycardia (some requiring pacemaker intervention)
has occurred in patients receiving amiodarone and a sofosbuvir-containing regimen.
The risk of bradycardia may be increased in patients taking beta blockers or patients
with underlying cardiac comorbidities and/or advanced liver disease. Bradycardia
generally resolves following discontinuation of HCV treatment.
Special populations:
• Hepatic impairment: Safety and efficacy have not been established in patients with
decompensated cirrhosis.
Other warnings/precautions:
• Appropriate use: Do not use as monotherapy; use only as part of a multiple drug
regimen for treatment of HCV; consult current HCV treatment guidelines for
guidance.
Storage Tablets: Store below 30°C. Dispense only in original packaging.
Refer to manufacturer PIL if there are specific considerations.

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15. Sofosbuvir and Velpatasvir

Generic Name Sofosbuvir and Velpatasvir

Dosage Tablets: Sofosbuvir 400 mg ; velpatasvir 100 mg

form/strengths
Route of Oral
administration
Pharmacologic Antihepaciviral, NS5A Inhibitor; Antihepaciviral, Polymerase Inhibitor (Anti-HCV); NS5B RNA
category Polymerase Inhibitor
ATC: J05AP55
Indications Chronic hepatitis C: Treatment of chronic hepatitis C virus genotype 1, 2, 3, 4, 5, or 6 infection in
adults and pediatric patients ≥3 years of age without cirrhosis or with compensated cirrhosis or
in combination with ribavirin in patients with decompensated cirrhosis.
Dosage Dosing: Adult
Regimen Chronic hepatitis C: Oral:
Note: One tablet contains sofosbuvir 400 mg/velpatasvir 100 mg. Compensated cirrhosis is
defined as Child-Pugh class A and decompensated cirrhosis is defined as Child-Pugh class B or C.
Genotype 4, 5, or 6:
• Treatment naive or peginterferon/ribavirin experienced without cirrhosis or with
compensated cirrhosis: One tablet once daily for 12 weeks.
• With decompensated cirrhosis: One tablet once daily with concomitant ribavirin for 12
weeks (if ribavirin ineligible, one tablet once daily for 24 weeks).
o Prior treatment failure with sofosbuvir- or NS5A-based regimens: One tablet once
daily with concomitant ribavirin for 24 weeks.
• Post kidney transplantation, treatment-naive or nondirect-acting antiviral-experienced
patients without cirrhosis or with compensated cirrhosis: One tablet once daily for 12
weeks.
• Post liver transplantation:
o Treatment-naive and -experienced patients without cirrhosis or with compensated
cirrhosis: One tablet once daily for 12 weeks; in patients with compensated
cirrhosis, consider adding ribavirin.
o Treatment-naive and -experienced patients with decompensated cirrhosis: One
tablet once daily with concomitant ribavirin for 12 weeks (treatment naive) or 24
weeks (treatment experienced).
Hepatitis C virus-uninfected recipients of organs from hepatitis C virus-viremic
donors: Oral: One tablet once daily for 12 weeks

Dosing: Pediatric
Chronic hepatitis C virus infection:
Children ≥3 years and Adolescents:
o <17 kg: Oral pellets: Oral: Sofosbuvir 150 mg/velpatasvir 37.5 mg once daily.
o 17 to <30 kg: Oral pellets, tablet: Oral: Sofosbuvir 200 mg/velpatasvir 50 mg once daily.
o ≥30 kg: Oral pellets, tablet: Oral: Sofosbuvir 400 mg/velpatasvir 100 mg once daily.
Duration of therapy dependent upon multiple factors (eg, genotype, hepatic function
[cirrhosis/compensation], previous treatment and response). Note: Treatment-experienced
patients are defined as those who have failed an interferon-based regimen.
• Genotype 1, 2, 3, 4, 5, or 6:
o Treatment-naive or treatment-experienced patients without cirrhosis or with

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compensated cirrhosis (Child-Pugh class A), including patients post-liver
transplantation: 12 weeks.
o Treatment-naive or treatment-experienced patients with decompensated cirrhosis
(Child-Pugh class B or C): 12 weeks in combination with ribavirin.

Dosage Dosing: Renal Impairment:

adjustment No dosage adjustment necessary.
Dosing: Hepatic Impairment:
No dosage adjustment necessary.
Note: Safety data in pediatric patients with renal impairment unavailable.
Contra- Hypersensitivity to sofosbuvir, velpatasvir, or any component of the formulation.
indications
Adverse Drug >10%: Nervous system: Fatigue (15%), headache (22%)
Reactions 1% to 10%:
Cardiovascular: Increased serum creatine kinase (≥10X ULN: 1% to 2%)
Dermatologic: Skin rash (2%)
Gastrointestinal: Increased serum lipase (>3X ULN: 3% to 6%), nausea (9%)
Nervous system: Depressed mood (1%), insomnia (5%), irritability (≥5%)
Neuromuscular & skeletal: Asthenia (5%)
Postmarketing: Infection: Reactivation of HBV (including fulminant hepatitis and hepatic failure)

Monitoring • Baseline (at any time prior to starting therapy) quantitative hepatitis C virus (HCV) viral load
Parameters and HCV genotype and subtype (if non–pan-genotypic direct-acting antiviral [DAA] will be
prescribed); repeat quantitative HCV viral load testing ≥12 weeks after completion of
therapy.
• Baseline (within 6 months prior to starting DAA therapy) CBC, INR, hepatic function panel
(albumin, total and direct bilirubin, ALT, AST, and alkaline phosphatase), and calculated GFR;
repeat hepatic function panel as clinically indicated.
• Presence of HIV coinfection and serum pregnancy test (women of childbearing age) prior to
initiation of therapy. Hepatitis B virus (HBV) surface antigen, HBV core antibody, and HBV
surface antibody prior to initiation. In patients with serologic evidence of HBV infection,
monitor for clinical and laboratory signs of hepatitis flare or HBV reactivation during
treatment and during post treatment follow-up.
• In patients with diabetes, monitor blood glucose and for signs/symptoms of hypoglycemia;
in patients taking warfarin, monitor INR during and post-therapy.

Drug Risk X: Avoid combination

Interactions Asunaprevir, Bilastine, CYP2B6 Inducers, CYP3A4 Inducers, CYP3A4 Inducers, Doxorubicin
(Conventional), Elagolix, Elbasvir and Grazoprevir, Modafinil, Oxcarbazepine, Pazopanib P-
Glycoprotein/ABCB1 Inducers, Phenobarbital, Primidone, Revefenacin, Rifabutin, Rifapentine,
Rimegepant, Tipranavir, Topotecan, Vincristine (Liposomal), Voxilaprevir Phenobarbital
Primidone Revefenacin Rifabutin Rifapentine Rimegepant Tipranavir Topotecan Vincristine
(Liposomal)
Risk D: Consider therapy modification
Afatinib, Alpelisib, Amiodarone, Antacids, Atogepant, Berotralstat, Betrixaban, Brincidofovir,
Cladribine, Colchicine, Digoxin, Eluxadoline, Inhibitors Of The Proton Pump (Ppis And Pcabs)
Lefamulin, Relugolix, Rosuvastatin, Sirolimus, Ubrogepant, Venetoclax
Pregnancy and Pregnancy category B
Lactation It is not known if sofosbuvir or velpatasvir are present in breast milk. The decision to continue or

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discontinue breastfeeding during therapy should take into account the risk of infant exposure,
the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
Administration Administration: Oral
Administer with or without food.
Refer to manufacturer PIL if there are specific considerations.

Warnings/ Disease-related concerns:

Precautions • Diabetes: Rapid reduction in hepatitis C viral load during direct-acting antiviral (DAA) therapy
for hepatitis C may lead to improvement in glucose metabolism in patients with diabetes,
potentially resulting in symptomatic hypoglycemia if antidiabetic agents are continued at the
same dose. Monitor for changes in glucose tolerance and inform patients of the risk of
hypoglycemia during DAA therapy, particularly within the first 3 months. Modification of
antidiabetic therapy may be necessary.
• Hepatitis B virus reactivation: [US Boxed Warning]: Hepatitis B virus (HBV) reactivation has
been reported in hepatitis C virus (HCV)/HBV co-infected patients who were receiving or had
completed treatment with HCV direct-acting antivirals and were not receiving HBV antiviral
therapy; some cases have resulted in fulminant hepatitis, hepatic failure, and death. Test all
patients for evidence of current or prior HBV infection prior to initiation of ledipasvir/sofosbuvir;
monitor HCV/HBV co-infected patients for hepatitis flare or HBV reactivation during treatment
and post-treatment follow-up. Risk of HBV reactivation may be increased in patients receiving
certain immunosuppressants or chemotherapeutic agents.
Concurrent drug therapy issues:
• Amiodarone: Symptomatic bradycardia (some requiring pacemaker intervention) has occurred
in patients receiving amiodarone and a sofosbuvir-containing regimen. A fatal cardiac arrest was
reported in a patient taking amiodarone with sofosbuvir/ledipasvir. Coadministration of
amiodarone and sofosbuvir/velpatasvir is not recommended. However, if patients have no
treatment alternatives, patients should have inpatient cardiac monitoring for the first 48 hours,
followed by daily outpatient or self-monitoring of heart rate for at least the first 2 weeks of
treatment. Patients should seek medical attention immediately if they experience fainting or
near-fainting, dizziness, lightheadedness, malaise, weakness, excessive tiredness, shortness of
breath, chest pains, confusion or memory problems.

Storage Store below 30°C. Dispense in original container.

Refer to manufacturer PIL if there are specific considerations.

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16. Sofosbuvir, Velpatasvir and Voxilaprevir
Generic Name Sofosbuvir, Velpatasvir and Voxilaprevir

Dosage Tablet: Sofosbuvir 400 mg ; velpatasvir 100 mg ; Voxilaprevir 100 mg ;

form/strengths
Route of Oral
administration
Pharmacologic Antihepaciviral, Polymerase Inhibitor (Anti-HCV); NS3/4A Inhibitor; NS5A Inhibitor; NS5B RNA
category Polymerase Inhibitor
ATC: J05AP56
Indications Chronic hepatitis C: Treatment of adults with chronic hepatitis C virus (HCV) infection without
cirrhosis or with compensated cirrhosis (Child-Pugh class A) who have genotype 1, 2, 3, 4, 5, or 6
infection and have previously been treated with an HCV regimen containing an NS5A inhibitor or
who have genotype 1a or 3 infection and have previously been treated with an HCV regimen
containing sofosbuvir without an NS5A inhibiton
Dosage Dosing: Adult
Regimen Chronic hepatitis C:
Note: Compensated cirrhosis is defined as Child-Pugh class A
Genotype 4, 5 or 6:
• Direct-acting antiviral–experienced without cirrhosis or with compensated
cirrhosis: Oral: One tablet once daily for 12 weeks.
• Prior sofosbuvir/velpatasvir/voxilaprevir treatment failure without cirrhosis or with
compensated cirrhosis: Oral: One tablet once daily in combination with ribavirin for 24
weeks.
• Liver or kidney transplant recipients, direct-acting antiviral–experienced without cirrhosis or
with compensated cirrhosis (off-label use): Oral: One tablet once daily for 12 weeks. For
patients with cirrhosis and multiple negative baseline characteristics, consider adding
concomitant ribavirin.

Dosage Dosing: Renal Impairment:

adjustment No dosage adjustment necessary.
Dosing: Hepatic Impairment:
No dosage adjustment necessary.
Hepatotoxicity during treatment: Hepatic decompensation/failure: Discontinue use.

Contra- Concurrent use with rifampin

indications Additional contraindications: Hypersensitivity to sofosbuvir, velpatasvir, voxilaprevir, or any
component of the formulation; concurrent use with dabigatran, phenobarbital, phenytoin,
rosuvastatin, or St John’s wort
Adverse Drug >10%:
Reactions Central nervous system: Headache (21% to 23%), fatigue (17% to 19%)
Gastrointestinal: Diarrhea (13% to 14%), nausea (10% to 13%)
Hepatic: Increased serum bilirubin (4% to 13%)
1% to 10%:
Central nervous system: Insomnia (3% to 6%), depression (≤1%)
Dermatologic: Skin rash (2%)
Gastrointestinal: Increased serum lipase (2%)
Neuromuscular & skeletal: Asthenia (4% to 6%)

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Frequency not defined: Infection: Reactivation of HBV

Monitoring Baseline (obtain any time prior to treatment initiation) quantitative hepatitis C virus RNA; HCV
Parameters genotype and subtype (if a non-pan-genotypic direct-acting antiviral [DAA] will be prescribed);
staging of fibrosis.
Baseline (within 6 months prior to starting antiviral therapy) CBC, INR, hepatic function panel
(albumin, total and direct bilirubin, ALT, AST, and alkaline phosphatase), and calculated GFR.
Before initiating DAA therapy, serum pregnancy test (women of childbearing age) and
assessment for HIV coinfection. Hepatitis B virus (HBV) surface antigen, HBV core antibody, and
HBV surface antibody prior to initiation.
During treatment, monitor CBC, serum creatinine, calculated GFR, hepatic function panel (as
clinically indicated). Quantitative HCV viral load testing (at ≥12 weeks after completion of
therapy). In patients with serologic evidence of HBV infection, monitor for clinical and laboratory
signs of hepatitis flare or HBV reactivation during treatment and during post-treatment follow-
up.
In patients with diabetes, monitor blood glucose and for signs/symptoms of hypoglycemia; in
patients taking warfarin, monitor INR during and post-therapy.
If used in combination with amiodarone (or in patients who discontinued amiodarone just prior
to initiating sofosbuvir/velpatasvir), inpatient cardiac monitoring for the first 48 hours of
coadministration, then outpatient or self-monitoring of heart rate daily through at least the first
2 weeks of treatment.
Drug Risk X: Avoid Combination
Interactions Asunaprevir Atazanavir BCRP/ABCG2 Substrates Bilastine CYP2B6 Inducers CYP3A4 Inducers
Doxorubicin (Conventional) Elagolix Elbasvir and Grazoprevir Lopinavir Modafinil Oxcarbazepine
Pazopanib P-Glycoprotein/ABCB1 Inducers Phenobarbital Pitavastatin Primidone Revefenacin
Rifabutin Rifampin Rifapentine Rimegepant Rosuvastatin Tipranavir Topotecan Vincristine
(Liposomal) Voxilaprevir
Risk D: Consider Therapy Modification
Afatinib Alpelisib Amiodarone Antacids Atogepant Atorvastatin Betrixaban Brincidofovir
Cladribine Colchicine Digoxin HMG-Coa Reductase Inhibitors (Statins) Inhibitors Of The Proton
Pump (PPIs And PCABs) Lefamulin Relugolix Sirolimus Venetoclax
Pregnancy and This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus. No
Lactation adequate data available on use of this drug in pregnant women to inform a drug-related risk.
It is not known if sofosbuvir, velpatasvir, or voxilaprevir are present in human breast milk. The
decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of
breastfeeding to the infant, and benefits of treatment to the mother.
Administration Administration: Oral: Administer with food.
Refer to manufacturer PIL if there are specific considerations.
Warnings Concerns related to adverse effects:
/Precautions • Hepatitis B virus reactivation: [US Boxed Warning]: Hepatitis B virus (HBV) reactivation has
been reported in hepatitis C virus (HCV)/HBV co-infected patients who were receiving or had
completed treatment with HCV direct-acting antivirals and were not receiving HBV antiviral
therapy; some cases have resulted in fulminant hepatitis, hepatic failure, and death. Test all
patients for evidence of current or prior HBV infection prior to initiation of
sofosbuvir/velpatasvir/voxilaprevir; monitor HCV/HBV co-infected patients for hepatitis flare or
HBV reactivation during treatment and post-treatment follow-up. Initiate treatment for HBV
infection as clinically indicated. Risk of HBV reactivation may be increased in patients receiving
certain immunosuppressants or chemotherapeutic agents.
Disease-related concerns:
• Diabetes: Rapid reduction in hepatitis C viral load during direct-acting antiviral (DAA) therapy

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for hepatitis C may lead to improvement in glucose metabolism in patients with diabetes,
potentially resulting in symptomatic hypoglycemia if antidiabetic agents are continued at the
same dose. Monitor for changes in glucose tolerance and inform patients of the risk of
hypoglycemia during DAA therapy, particularly within the first 3 months. Modification of
antidiabetic therapy may be necessary.
• Hepatic effects: Hepatic decompensation and hepatic failure (including fatal cases) have been
reported; cases occurred in patients with baseline cirrhosis with and without moderate or severe
liver impairment (Child-Pugh class B or C). Assess hepatic function as clinically indicated; monitor
patients with compensated cirrhosis or with evidence of advanced liver disease (eg, portal
hypertension) for signs/symptoms of hepatic decompensation (eg, ascites, hepatic
encephalopathy, variceal hemorrhage). Discontinue treatment in patients who develop
signs/symptoms of hepatic decompensation/failure.
• Hepatic impairment: Use is not recommended in patients with moderate or severe hepatic
impairment (Child-Pugh class B or C) or patients with history of prior hepatic decompensation.
Concurrent drug therapy issues:
• Amiodarone: Coadministration of amiodarone and sofosbuvir/velpatasvir/voxilaprevir is not
recommended due to bradycardia risk. However, if patients have no treatment alternatives,
patients should have inpatient cardiac monitoring for the first 48 hours, followed by daily
outpatient or self-monitoring of heart rate for at least the first 2 weeks of treatment. Due to the
long half-life of amiodarone, cardiac monitoring (as described) is also recommended if
amiodarone was discontinued just prior to beginning treatment with
sofosbuvir/velpatasvir/voxilaprevir. Patients should seek medical attention immediately if they
experience fainting or near-fainting, dizziness, light-headedness, malaise, weakness, excessive
tiredness, shortness of breath, chest pains, confusion, or memory problems.
Storage Store below 30°C; dispense in original container.
Refer to manufacturer PIL if there are specific considerations.

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17. Tenofovir Alafenamide
Generic Name Tenofovir Alafenamide

Dosage Tablets: 25 mg
form/strengths
Route of Oral
administration
Pharmacologic Antihepadnaviral, Reverse Transcriptase Inhibitor, Nucleotide (Anti-HBV)
category ATC: J05AF13
Indications Chronic hepatitis B: Treatment of chronic hepatitis B virus (HBV) infection in adults with
compensated liver disease
Dosage Dosing: Adult
Regimen Chronic hepatitis B: Oral: 25 mg once daily.

Dosage Dosing: Renal Impairment: Adult

adjustment CrCl ≥15 mL/minute: No dosage adjustment necessary.
CrCl <15 mL/minute: Use is not recommended.
ESRD requiring hemodialysis: No dosage adjustment necessary; administer postdialysis on
hemodialysis days.
Dosing: Hepatic Impairment: Adult
Mild impairment (Child-Pugh class A): No dosage adjustment necessary.
Decompensated cirrhosis (Child-Pugh class B or C): Use is not recommended.
Contra- Hypersensitivity to tenofovir alafenamide or any component of the formulation
indications
Adverse Drug >10%:
Reactions Nervous system: Headache (12%)
Neuromuscular & skeletal: Decreased bone mineral density (≥5% at lumbar spine: 11%; ≥7% at
femoral neck: 5%)
1% to 10%:
Cardiovascular: Increased serum creatine kinase (grades 3/4: 3%)
Dermatologic: Skin rash (<5%)
Endocrine & metabolic: Glycosuria (grades 3/4: 5%), increased amylase (grades 3/4: 3%),
increased LDL cholesterol (grades 3/4: 6%)
Gastrointestinal: Abdominal pain (9%), diarrhea (5%), dyspepsia (5%), flatulence (<5%), nausea
(6%), vomiting (<5%)
Hepatic: Increased serum alanine aminotransferase (grades 3/4: 8%), increased serum aspartate
aminotransferase (grades 3/4: 3%)
Nervous system: Fatigue (6%)
Neuromuscular & skeletal: Arthralgia (5%), back pain (6%)
Respiratory: Cough (8%)
Monitoring Serum creatinine, estimated CrCl, serum phosphorus (in patients with chronic kidney disease),
Parameters urine glucose, urine protein (prior to initiation and as clinically indicated during therapy); HIV
testing (prior to initiation); hepatic function tests; monitor clinical and laboratory data closely for
several months following therapy discontinuation.
Drug Risk X: Avoid combination
Interactions Adefovir Carbamazepine Cladribine Fosphenytoin-Phenytoin Oxcarbazepine Phenobarbital
Primidone Rifabutin Rifampin Rifapentine St John's Wort Tipranavir
Risk D: Consider therapy modification
Nonsteroidal Anti-Inflammatory Agents

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Pregnancy and Pregnancy Category B drug
Lactation It is not known if tenofovir alafenamide is present in breast milk. In lactation Benefit should
outweigh risk.
According to some authorities: Use is not recommended.
Administration Administration: Oral: Administer with food.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Lactic acidosis/hepatomegaly: Lactic acidosis and severe hepatomegaly with steatosis,
sometimes fatal, have been reported with the use of nucleoside analogs, alone or in
combination with other antiretrovirals. Suspend treatment in any patient who develops clinical
or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity (marked
transaminase elevation may/may not accompany hepatomegaly and steatosis).
• Renal toxicity: Renal toxicity (acute renal failure, Fanconi syndrome, and/or proximal renal
tubulopathy) has been reported with use of tenofovir prodrugs; patients with impaired renal
function and those with concurrent or recent nephrotoxic therapy (including nonsteroidal anti-
inflammatory drug use) are at an increased risk. Discontinue use in patients who develop
clinically significant decreases in renal function or evidence of Fanconi syndrome.
Disease-related concerns:
• Hepatic impairment: Use is not recommended in patients with Child-Pugh class B or C hepatic
impairment.
• Hepatitis B acute exacerbation: [US Boxed Warning]: Discontinuation of anti-hepatitis B
therapy may result in severe acute exacerbations of hepatitis B. Monitor clinical and laboratory
data closely for several months after treatment discontinuation. If clinically indicated, anti-
hepatitis B therapy may be resumed.
• HIV-1 and HBV coinfection: Should not be used as a single agent for the treatment of HIV-1 due
to resistance development risk.
• Renal impairment: Use is not recommended in patients with CrCl <15 mL/minute who are not
receiving hemodialysis.
Other warnings/precautions:
• HIV testing: HIV antibody testing should be offered to all HBV infected patients prior to
treatment initiation. If HIV testing is positive, institute an appropriate antiretroviral (HIV-1)
combination regimen.

Storage Store below 30°C. Dispense in original container.

Refer to manufacturer PIL if there are specific considerations.

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18. Valacyclovir
Generic Name Valacyclovir

Dosage Tablets 500mg, 1gm

form/strengths
Route of Oral
administration
Pharmacologic Antiviral Agent, Oral
category ATC: J05AB11
Indications Treatment of herpes zoster (shingles) in immunocompetent patients; treatment of first-
episode and recurrent genital herpes in immunocompetent patients; suppression of recurrent
genital herpes and reduction of transmission of genital herpes in immunocompetent patients;
suppression of genital herpes in patients with HIV; treatment of herpes labialis (cold sores);
treatment of chickenpox in immunocompetent children
Dosage Adults
Regimen Genital: Herpes simplex virus, mucocutaneous infection:
Treatment of First Episodes
Oral
Immunocompetent adults: 1 g twice daily for 7–10 days. extent duration of treatment if
healing is incomplete after 10 days.
Immunocompromised or HIV-infected adults: 1 g twice daily for 5–14 days.
Initiate therapy within 48 hours of onset of signs and symptoms; efficacy not established if
initiated >72 hours after onset of signs or symptoms.
Episodic Treatment of Recurrent Episodes
Oral
Immunocompetent adults: 500 mg twice daily for 3 days or 1 g once daily for 5 days.
Immunocompromised or HIV-infected adults: 1 g twice daily for 5–10 days; may be continued
for 7–14 days.
Initiate therapy at first sign or symptom of an episode; efficacy not established if initiated >24
hours after onset of signs or symptoms.
Suppressive Therapy of Recurrent Episodes
Oral
Immunocompetent adults: 1 g once daily. Alternatively, 500 mg once daily for those with a
history of ≤9 recurrences per year.
Immunocompromised or HIV-infected adults: 500 mg twice daily.
Note: Reassess need periodically (eg, annually)
Reduction of Transmission
Oral
500 mg once daily in source partner with a history of ≤9 recurrences per year.
Efficacy for reducing transmission not established beyond a duration of 8 months in discordant
couples.
Herpes Labialis
Oral
Immunocompetent adults:
Treatment, recurrent infection (eg, cold sores): 2 g every 12 hours for 1 day only
Initiate treatment at earliest symptom of cold sore (e.g., tingling, itching, burning).
Treatment, initial infection (eg, gingivostomatitis): Oral: 1 g twice daily for 7 to 10 days
Immunocompromised patients (including patients with HIV):
Treatment, initial or recurrent infection: Oral: 1 g twice daily for 5 to 10 days and until
complete lesion resolution

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Mucocutaneous Herpes Simplex Virus (HSV) Infections
Chronic Suppression of Recurrent Episodes
Oral
HIV-infected adults: 500 mg twice daily for chronic suppressive or maintenance therapy
(secondary prophylaxis) of HSV infections in those who have frequent or severe recurrences.
Herpes Zoster
Oral
Immunocompetent adults: 1 g 3 times daily for 7 days.
Immunocompromised patients (including patients with HIV):
Local dermatomal herpes zoster in HIV-infected adults or adolescents: 1 g 3 times daily
for 7–10 days recommended by CDC and others.
Initiate therapy at earliest sign or symptom (preferably within 48 hours of rash
onset); efficacy not established if initiated >72 hours after rash onset
Extensive cutaneous lesions or visceral involvement: Oral: 1 g 3 times daily to complete a
10- to 14-day course.
Pediatric Patients
Herpes labialis (cold sores), treatment:
Immunocompetent: Children ≥12 years and Adolescents: Oral: 2,000 mg every 12 hours for 1
day (2 doses); initiate at earliest symptom onset
HIV-exposed/-positive: Adolescents: Oral: 1,000 mg twice daily for 5 to 10 days.
Herpes simplex virus (HSV), genital infection; immunocompetent patients: Limited data
available:
First episode; treatment: Children and Adolescents: Oral: 20 mg/kg/dose twice daily, maximum
dose: 1,000 mg/dose; for 7 to 10 days.
Recurrent episodes; treatment: Begin with onset of symptoms or lesion appearance: Children
and Adolescents:
Patient weight <50 kg: Oral: 20 mg/kg/dose twice daily; maximum dose: 1,000 mg/dose; for 5
days.
Patient weight ≥50 kg: Oral: 1,000 mg once daily for 5 days.
Suppressive therapy: Children and Adolescents: Oral: 20 mg/kg/dose once daily; maximum
dose: 1,000 mg/dose.
Dosage Dosing: Renal Impairment: Adult
adjustment Herpes zoster (shingles), treatment:
CrCl 30 to 49 mL/minute: Oral: 1 g every 12 hours
CrCl 10 to 29 mL/minute: Oral: 1 g every 24 hours
CrCl <10 mL/minute: Oral: 500 mg every 24 hours
Herpes simplex virus, genital:
Initial episode:
CrCl 10 to 29 mL/minute: Oral: 1 g every 24 hours
CrCl <10 mL/minute: Oral: 500 mg every 24 hours
Recurrent episode: CrCl <29 mL/minute: Oral: 500 mg every 24 hours
Suppressive therapy: CrCl <29 mL/minute: Oral:
For usual dose of 1 g every 24 hours or 500 mg every 12 hours, decrease dose to 500 mg every
24 hours
For usual dose of 500 mg every 24 hours, decrease dose to 500 mg every 48 hours
Herpes simplex virus, orolabial (immunocompetent patients):
CrCl 30 to 49 mL/minute: Oral: 1 g every 12 hours for 2 doses
CrCl 10 to 29 mL/minute: Oral: 500 mg every 12 hours for 2 doses
CrCl <10 mL/minute: Oral: 500 mg as a single dose

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Hemodialysis: Dialyzable (~33% removed during 4-hour session); administer dose postdialysis
Chronic ambulatory peritoneal dialysis/continuous arteriovenous hemofiltration dialysis:
Pharmacokinetic parameters are similar to those in patients with ESRD; supplemental dose not
needed following dialysis
Dosing: Hepatic Impairment: Adult
No dosage adjustment necessary.
Dosing: Renal Impairment: Pediatric
Herpes labialis: Adolescents:
CrCl 30 to 49 mL/minute: 1,000 mg every 12 hours for 2 doses
CrCl 10 to 29 mL/minute: 500 mg every 12 hours for 2 doses
CrCl <10 mL/minute: 500 mg as a single dose
Genital herpes: Adolescents:
Initial episode:
CrCl 10 to 29 mL/minute: 1,000 mg every 24 hours
CrCl <10 mL/minute: 500 mg every 24 hours
Recurrent episode: CrCl ≤29 mL/minute: 500 mg every 24 hours
Suppressive therapy: CrCl ≤29 mL/minute:
For usual dose of 1,000 mg every 24 hours, decrease dose to 500 mg every 24 hours
For usual dose of 500 mg every 24 hours, decrease dose to 500 mg every 48 hours
HIV-infected patients: 500 mg every 24 hours
Hemodialysis: Dialyzable (~33% removed during 4-hour session); administer dose postdialysis
Dosing: Hepatic Impairment: Pediatric
Children ≥2 years and Adolescents: No dosage adjustment necessary.
Contra- Hypersensitivity to valacyclovir, acyclovir, or any component of the formulation
indications
Adverse Drug Adverse Reactions (Significant): Considerations
Reactions Acute kidney injury
Neurotoxicity
Thrombotic microangiopathy

>10%:
Gastrointestinal: Abdominal pain (3% to 11%), nausea (8% to 15%)
Hematologic & oncologic: Neutropenia (HIV-1-infected patients: 18% [placebo: 10%])
Hepatic: Increased serum alanine aminotransferase (2%; HIV-1-infected patients: 14%),
increased serum aspartate aminotransferase (≤4%; HIV-1-infected patients: 16%)
Nervous system: Headache (13% to 38%)
Respiratory: Nasopharyngitis (16%)
1% to 10%:
Central nervous system: Fatigue, depression, dizziness
Dermatologic: Skin rash
Endocrine & metabolic: Dehydration
Gastrointestinal: Vomiting, diarrhea
Genitourinary: Dysmenorrhea
Hematologic & oncologic: Thrombocytopenia, leukopenia
Hepatic: Increased serum alkaline phosphatase
Infection: Herpes simplex infection
Neuromuscular & skeletal: Arthralgia
Respiratory: Rhinorrhea
Miscellaneous: Fever

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Monitoring Urinalysis, BUN, serum creatinine, liver enzymes, and CBC
Parameters
Drug Risk X: Avoid combination
Interactions Cladribine Foscarnet Varicella Virus Vaccine Zoster Vaccine (Live/Attenuated)
Risk D: Consider therapy modification
Tizanidine
Risk C: Monitor therapy
Clozapine Mycophenolate Tenofovir Products Theophylline Derivatives Zidovudine
Pregnancy and Pregnancy Category B- No proven risk in humans.
Lactation Valacyclovir is rapidly metabolized to acyclovir. Following administration of valacyclovir,
acyclovir is present in breast milk; unchanged valacyclovir has not been detected in breast
milk. valacyclovir is considered compatible with breastfeeding.
Administration Administration: Oral
If GI upset occurs, administer with meals.
Administration: Pediatric
Oral: May administer with or without food
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • CNS effects: CNS adverse effects (including agitation, hallucinations, confusion, delirium,
seizures, and encephalopathy) have been reported in both adult and pediatric patients with or
without renal dysfunction. Elderly patients are more likely to experience CNS adverse effects.
• Thrombotic microangiopathy: Has occurred in immunocompromised patients (at doses of 8
g/day).
Disease-related concerns:
• Renal impairment: Use caution in patients with renal impairment, the elderly, and/or those
receiving nephrotoxic agents. Acute renal failure and CNS effects have been observed in
patients with renal dysfunction; dose adjustment may be required. Precipitation in renal
tubules may occur; maintain adequate hydration.
Special populations:
• Elderly: Use with caution in the elderly; CNS effects have been reported.
• Immunocompromised patients: Advanced HIV (CD4 <100 cells/mm3): Safety and efficacy
have not been established for treatment/suppression of recurrent genital herpes or
disseminated herpes in patients with profound immunosuppression.
Other warnings/precautions:
• Appropriate use: For cold sores, treatment should begin at the earliest symptom (tingling,
itching, burning). For genital herpes, treatment should begin as soon as possible after the first
signs and symptoms (within 72 hours of onset of first diagnosis or within 24 hours of onset of
recurrent episodes). For herpes zoster, treatment should begin within 72 hours of onset of
rash. For chickenpox, treatment should begin with earliest sign or symptom.
Storage Store at 15°C to 25°C
Refer to manufacturer PIL if there are specific considerations.

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19. Valganciclovir
Generic Name Valganciclovir

Dosage Tablets 450mg

form/strengths
Route of Oral
administration
Pharmacologic Antiviral Agent
category ATC: J05AB14
Indications Cytomegalovirus, prophylaxis (solid organ transplant recipients):
Prevention of cytomegalovirus (CMV) in high-risk adult patients (donor CMV
seropositive/recipient CMV seronegative) undergoing kidney, heart, or kidney/pancreas
transplantation
Prevention of CMV in high risk pediatric patients undergoing kidney transplant (age 4 months
to 16 years) or heart transplant (age 1 month to 16 years)
CMV retinitis, treatment (AIDS-related):
Treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency
syndrome (AIDS)
Dosage Dosing: Adult
Regimen Cytomegalovirus (CMV) retinitis, treatment (AIDS-related): Oral:
Induction: 900 mg twice daily for 14 to 21 days followed by maintenance therapy.
Maintenance: 900 mg once daily
CMV, prophylaxis (solid organ transplant recipients): Oral:
900 mg once daily; duration of prophylaxis is dependent on type of transplant, as well as donor
and recipient CMV serostatus
Dosing: Pediatric
Note: In pediatric patients, valganciclovir oral solution is the preferred oral dosage form in
pediatric patients for accuracy in dosing; valganciclovir tablets can be considered if the calculated
dose is within 10% of the available tablet strength (450 mg). In pediatric patients, dosing may be
based on either BSA (mg/m2) or weight (mg/kg); use extra precaution to verify dosing parameters
during calculations.
Prevention of CMV disease: Oral:
Following solid organ transplantation:
Heart, kidney or liver transplantation: Oral: Dosing based on BSA and CrCl calculation using
modified Schwartz formula which bases k constant on age*:
Dose (mg) = 7 x BSA x CrCl* administered once daily
Maximum daily dose: 900 mg/day.
*CrCl calculation (based on the modified Schwartz formula):
CrCl (mL/minute/1.73 m2) = [k x height (cm)] ÷ SCr (mg/dL)
Calculated using a modified Schwartz formula where k =
• 0.33 in infants <1 year of age with low birthweight for GA
• 0.45 in infants <1 year of age with birthweight appropriate for GA
• 0.45 in children 1 to <2 years
• 0.55 in boys age 2 to <13 years
• 0.55 in girls age 2 to <16 years
• 0.7 in boys age 13 to 16 years
Limit the CrCl used to calculate dosage to a value of 150 mL/minute/1.73 m2, regardless of value
calculated with the Schwartz equation, to avoid overexposure.
Initiate therapy within 10 days after transplant; duration of prophylaxis varies depending on
organ(s) transplanted, donor and recipient CMV serostatus, and immunosuppressive regimen;

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typically continued for 3 to 6 months; may be continued up to 12 months in certain cases
CMV retinitis; treatment: Adolescents: Oral:
Induction (active retinitis): 900 mg twice daily for 14 to 21 days
Maintenance: Following induction treatment or for patients with inactive CMV retinitis who
require maintenance therapy: 900 mg once daily for at least 3 to 6 months

Dosage Dosing: Renal Impairment: Adult

adjustment
Clcr (mL/minute) Initial Treatment Maintenance Dosage
(Induction) Dosage
40–59 450 mg twice daily 450 mg once daily
25–39 450 mg once daily 450 mg once every 2
days
10–24 450 mg once every 2 450 mg twice weekly
days
<10 (hemodialysis Not recommended Not recommended
patients)

Dosing: Renal Impairment: Pediatric

Infants, Children, and Adolescents 1 month to 16 years: No additional dosage adjustments
required; use of equation adjusts for renal function.
Adolescents >16 years: refer to adult dosing
Dosing: Hepatic Impairment: Adult
There are no dosage adjustments data.
Hazardous Drugs Handling Considerations
Hazardous agent.
Use appropriate precautions for receiving, handling, administration, and disposal. Gloves (single)
should be worn during receiving, unpacking, and placing in storage.

Contra- Hypersensitivity (eg, anaphylaxis) to valganciclovir, ganciclovir, or any component of the

indications formulation
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to acyclovir
or valacyclovir

Adverse Drug Significant considerations:

Reactions Hematologic toxicity
Impairment of fertility
Fetal toxicity
Mutagenesis and carcinogenesis

>10%:
Cardiovascular: Hypertension (12% to 18%)
Central nervous system: Headache (6% to 22%), insomnia (6% to 20%)
Gastrointestinal: Diarrhea (16% to 41%), nausea (8% to 30%), vomiting (3% to 21%), abdominal
pain (15%)
Hematologic & oncologic: Anemia (≤31%), thrombocytopenia (≤22%), neutropenia (3% to 19%)
Immunologic: Graft rejection (24%)
Neuromuscular & skeletal: Tremor (12% to 28%)
Ophthalmic: Retinal detachment (15%)
Renal: Increased serum creatinine (Scr >1.5 to 2.5 mg/dL: 12% to 50%; Scr >2.5: 3% to 17%)

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Miscellaneous: Fever (9% to 31%)
1% to 10%:
Cardiovascular: Hypotension (≥5%), peripheral edema (≥5%), cardiac arrhythmia (<5%)
Central nervous system: Peripheral neuropathy (9%), paresthesia (≤8%), anxiety (≥5%), chills
(≥5%), depression (≥5%), dizziness (≥5%), fatigue (≥5%), malaise (≥5%), pain (≥5%), agitation
(<5%), confusion (<5%), hallucination (<5%), psychosis (<5%), seizure (<5%)
Dermatologic: Dermatitis (≥5%), increased wound secretion (≥5%), night sweats (≥5%), pruritus
(≥5%), cellulitis (<5%)
Endocrine & metabolic: Hyperkalemia (≥5%), hypophosphatemia (≥5%), weight loss (≥5%)
Gastrointestinal: Abdominal distention (≥5%), constipation (≥5%), decreased appetite (≥5%),
dyspepsia (≥5%), oral mucosa ulcer (≥5%), dysgeusia (<5%), pancreatitis (<5%)
Genitourinary: Hematuria (≥5%), urinary tract infection (≥5%)
Hematologic & oncologic: Bone marrow depression (<5%; including aplastic anemia), febrile
neutropenia (<5%), hemorrhage (<5%; associated with thrombocytopenia), pancytopenia (<5%)
Hepatic: Hepatic insufficiency (≥5%), increased serum ALT (<5%), increased serum AST (<5%)
Hypersensitivity: Hypersensitivity reaction (<5%)
Immunologic: Organ transplant rejection (6% to 9%)
Infection: Candidiasis (≥5%; including oral candidiasis), influenza (≥5%), wound infection (≥5%),
sepsis (<5%)
Neuromuscular & skeletal: Arthralgia (≥5%), back pain (≥5%), muscle spasm (≥5%), myalgia (≥5%),
weakness (≥5%), limb pain (<5%)
Ophthalmic: Eye pain (≥5%), macular edema (<5%)
Otic: Deafness (<5%)
Renal: Decreased creatinine clearance (≥5%), renal impairment (≥5%), renal failure (<5%)
Respiratory: Cough (≥5%), dyspnea (≥5%), pharyngitis (≥5%; including nasopharyngitis), upper
respiratory tract infection (≥5%)
Miscellaneous: Postoperative complication (≥5%), postoperative pain (<5%), wound dehiscence
(<5%)
Monitoring CBC, platelet count, serum creatinine at baseline and periodically during therapy; monitor CBC
Parameters and platelet count more frequently during therapy in infants and in patients with renal
impairment, those with previous drug-induced leukopenia, and those with neutrophil counts
<1,000 cells/mm3 at treatment initiation; pregnancy test prior to initiation in females of
reproductive potentia
Drug Risk X: Avoid combination
Interactions Cladribine
Risk D: Consider therapy modification
Imipenem
Risk C: Monitor therapy
Amphotericin B Cyclosporine Didanosine Mycophenolate Probenecid Tenofovir Products
Zidovudine
Pregnancy and Based on animal data, valganciclovir has the potential to cause birth defects in humans. Based on
Lactation animal data and limited human data, valganciclovir may cause temporary or permanent inhibition
of spermatogenesis in males and suppression of fertility in females.
It is not known if ganciclovir or valganciclovir are present in breast milk.
Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not
recommended
Administration Valganciclovir should be administered with meals. Do not break or crush tablets.
Administration: Pediatric
Due to the carcinogenic and mutagenic potential, avoid direct contact with broken or crushed
tablets, powder for oral solution, and oral solution. Consideration should be given to handling and

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disposal according to guidelines issued for antineoplastic drugs; however, there is no consensus
on the need for these precautions.
Oral: Administer with meals. The preferred dosage form for pediatric patients is the oral solution;
however, valganciclovir tablets may be used as long as the calculated dose is within 10% of the
available tablet strength (450 mg)
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Acute renal failure: Acute renal failure may occur; ensure adequate hydration and use with
caution in patients receiving concomitant nephrotoxic agents.
• Blood dyscrasias: [US Boxed Warning]: Severe leukopenia, neutropenia, anemia,
thrombocytopenia, pancytopenia, and bone marrow failure, including aplastic anemia have been
reported. May occur at any time during treatment and worsen with continued use; cell counts
usually begin to recover within 3 to 7 days of treatment discontinuation. Do not use in patients
with an absolute neutrophil count <500 cells/mm3, platelet count <25,000/mm3, or hemoglobin
<8 g/dL; use with caution in patients with preexisting bone marrow suppression, cytopenias, or in
those receiving myelosuppressive drugs/irradiation. Monitor CBC and platelet count at baseline
and frequently during therapy, especially in infants and in patients with renal impairment, those
with previous drug-induced leukopenia, and those with neutrophil counts <1,000 cells/mm3 at
treatment initiation.
• Carcinogenic/teratogenic: [US Boxed Warning]: May cause temporary or permanent inhibition
of spermatogenesis and suppression of fertility; has the potential to cause birth defects and
cancers in humans.
Disease-related concerns:
• Renal impairment: Use with caution in patients with impaired renal function; dosage
adjustment required.
Special populations:
• Elderly: Acute renal failure may occur in elderly patients with or without preexisting renal
impairment; use with caution and adjust dose as needed based on renal function.
• Liver transplant recipients: Not indicated for use in liver transplant patients (higher incidence of
tissue-invasive cytomegalovirus [CMV] relative to oral ganciclovir was observed in trials).
• Pediatric: The preferred dosage form for pediatric patients is the oral solution; however,
valganciclovir tablets may be used so long as the calculated dose is within 10% of the available
tablet strength (450 mg). Use of valganciclovir for the treatment of congenital CMV disease has
not been evaluated.
Storage Tablet: Store at 20°C to 25°C; excursions permitted to 15°C to 30°C
Refer to manufacturer PIL if there are specific considerations.

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Carbapenenems

1. Ertapenem Watch Group

Generic Name Ertapenem

Dosage Powder for injection: 1g

form/strengths
Route of IV, IM
administration
Pharmacologic Antibiotic, Carbapenem
category ATC: J01DH03
Indications Intra-abdominal infection, complicated: For the treatment of complicated intra-abdominal
infections

Pelvic infection: For the treatment of acute pelvic infections, including postpartum
endomyometritis, septic abortion, and postsurgical gynecologic infections

Pneumonia, community acquired: For the treatment of community-acquired pneumonia (CAP)

Skin and skin structure infection, complicated: For the treatment of complicated skin and skin
structure infections, including diabetic foot infections without osteomyelitis. Ertapenem has not
been studied in diabetic foot infections with concomitant osteomyelitis.

Surgical prophylaxis: For the prophylaxis of surgical site infection in adults following elective
colorectal surgery.

Urinary tract infection, complicated: For the treatment of complicated urinary tract infections
(UTIs),
Dosage Adults
Regimen Gynecologic Infections
IV or IM
1 g once daily for 3–10 days.
Intra-abdominal Infections
IV or IM
1 g once daily for 5–14 days.
Respiratory Tract Infections
Community-acquired Pneumonia
IV or IM
1 g once daily. Usual duration is 10–14 days; treatment may be switched to an appropriate oral
anti-infective after ≥3 days.
Skin and Skin Structure Infections
IV or IM
1 g once daily for 7–14 days. In adults with diabetic foot infections, anti-infective therapy
(parenteral or parenteral followed by oral) has been given for up to 28 days.
Urinary Tract Infections (UTIs)
IV or IM
1 g once daily. Usual duration is 10–14 days; treatment may be switched to an appropriate oral
anti-infective after ≥3 days
Pediatric Patients
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Gynecologic Infections
IV or IM
Children 3 months to 12 years of age: 15 mg/kg twice daily (up to 1 g daily) for 3–10 days.
Adolescents ≥13 years of age: 1 g once daily for 3–10 days.
Intra-abdominal Infections
IV or IM
Children 3 months to 12 years of age: 15 mg/kg twice daily (up to 1 g daily) for 5–14 days.
Adolescents ≥13 years of age: 1 g once daily for 5–14 days.
Respiratory Tract Infections
Community-acquired Pneumonia
IV or IM
Children 3 months to 12 years of age: 15 mg/kg twice daily (up to 1 g daily). Usual duration is 10–
14 days; treatment may be switched to an appropriate oral anti-infective after ≥3 days.
Adolescents ≥13 years of age: 1 g once daily. Usual duration is 10–14 days; treatment may be
switched to an appropriate oral anti-infective after ≥3 days.
Skin and Skin Structure Infections
IV or IM
Children 3 months to 12 years of age: 15 mg/kg twice daily (up to 1 g daily) for 7–14 days.
Adolescents ≥13 years of age: 1 g once daily for 7–14 days.
Urinary Tract Infections (UTIs)
IV or IM
Children 3 months to 12 years of age: 15 mg/kg twice daily (up to 1 g daily). Usual duration is 10–
14 days; treatment may be switched to an appropriate oral anti-infective after ≥3 days.
Adolescents ≥13 years of age: 1 g once daily. Usual duration is 10–14 days; treatment may be
switched to an appropriate oral anti-infective after ≥3 days
Dosage Dosing: renal impairment: Adult
adjustment Adults with Clcr ≤30 mL/minute, including those with end-stage renal disease (Clcr ≤10
mL/minute) and those undergoing hemodialysis, should receive 500 mg once daily
Dosing: Renal Impairment: Pediatric
There are no pediatric specific recommendations; based on experience in adult patients, dosage
adjustment suggested
Dosing: Hepatic Impairment:
Adjustments cannot be recommended (lack of experience and research in this patient population
Contra- Known hypersensitivity to any component of this product or to other drugs in the same class or in
indications patients who have demonstrated anaphylactic reactions to beta-lactams; known hypersensitivity
to local anesthetics of the amide type due to the use of lidocaine as a diluent (IM use only).

Adverse Drug Gastrointestinal: Diarrhea (6% to 12%)

Reactions 1% to 10%:
Cardiovascular: Asystole (<2%), atrial fibrillation (<2%), bradycardia (<2%), cardiac arrhythmia
(<2%), cardiac failure (<2%), chest pain (infants, children, adolescents, adults: <2%), edema
(≤3%), facial edema (<2%), flushing (<2%), heart murmur (<2%), hypertension (<2%), hypotension
(1% to 2%), phlebitis (infants, children, adolescents, adults: <2%), septic shock (<2%), subdural
hematoma (<2%), syncope (<2%), tachycardia (<2%), thrombophlebitis (<2%), ventricular
tachycardia (<2%)
Dermatologic: Dermatitis (infants, children, adolescents, adults: <2%), desquamation (<2%),
diaphoresis (<2%), erythema of skin (<2%), erythematous rash (infants, children, and adolescents:
<2%), genital rash (infants, children, and adolescents: <2%), injection site pruritus (infants,
children, and adolescents: <2%), pruritus (infants, children, adolescents, adults: 1% to 2%), skin
lesion (infants, children, and adolescents: <2%), skin rash (infants, children, adolescents, adults:

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2% to 3%), urticaria (<2%)
Endocrine & metabolic: Decreased serum albumin (<2%), decreased serum potassium (<2%),
dehydration (<2%), gout (<2%), increased serum glucose (<2%), increased serum potassium
(<2%), increased serum sodium (<2%), weight loss (<2%)
Gastrointestinal: Abdominal distention (<2%), abdominal pain (infants, children, adolescents,
adults: 4% to 5%), acid regurgitation (<2%), anorexia (<2%), cholelithiasis
(<2%), Clostridioides difficile-associated diarrhea (<2%), constipation (infants, children,
adolescents, adults: 2% to 4%), decreased appetite (infants, children, and adolescents: <2%),
duodenitis (<2%), dysgeusia (<2%), dyspepsia (<2%), dysphagia (<2%), esophagitis (<2%),
flatulence (<2%), gastritis (<2%), gastrointestinal hemorrhage (<2%), hemorrhoids (<2%), hiccups
(<2%), intestinal obstruction (<2%), nausea (infants, children, adolescents: <2%; adults: 6% to
9%), oral candidiasis (infants, children, adolescents, adults: <2%), oral mucosa ulcer (<2%),
pancreatitis (<2%), pyloric stenosis (<2%), sore throat (<2%), stomatitis (<2%), upper abdominal
pain (infants, children, and adolescents: <2%), vomiting (infants, children, adolescents, adults: 4%
to 10%)
Genitourinary: Anuria (<2%), bladder dysfunction (<2%), finding of blood in urine (1% to 3%),
hematuria (<2%), oliguria (<2%), proteinuria (infants, children, and adolescents: <2%), urinary
retention (<2%), vaginitis (1% to 3%), vulvovaginal candidiasis (<2%), vulvovaginal pruritus (<2%),
vulvovaginitis (<2%)
Hematologic & oncologic: Decreased hematocrit (3%), decreased hemoglobin (5%), decreased
neutrophils (infants, children, adolescents: 6%; adults: <2%), decreased platelet count (<2%),
decreased white blood cell count (infants, children, adolescents, adults: <2%), eosinophilia
(infants, children, adolescents, adults: 1% to 2%), hematoma (<2%), leukocyturia (2% to 3%),
prolonged partial thromboplastin time (<2%), prolonged prothrombin time (<2%),
thrombocythemia (infants, children, adolescents: <2%; adults: 4% to 7%)
Hepatic: Increased serum alanine aminotransferase (infants, children, adolescents, adults: 4% to
9%), increased serum alkaline phosphatase (infants, children, adolescents: <2%; adults: 4% to
7%), increased serum aspartate transaminase (infants, children, adolescents, adults: 4% to 8%),
increased serum bilirubin (<2%; including increased direct serum bilirubin or increased indirect
serum bilirubin), jaundice (<2%)
Infection: Abscess (abdominal: infants, children, and adolescents: <2%), candidiasis (infants,
children, adolescents, adults: <2%), herpes simplex infection (infants, children, and adolescents:
<2%), septicemia (<2%)
Local: Erythema at injection site (infants, children, and adolescents: 4%), induration at injection
site (infants, children, adolescents, adults: <2%), infused vein complication (5% to 7%), infusion-
site pain (infants, children, adolescents: 7%), injection site phlebitis (infants, children,
adolescents: <2%), pain at injection site (<2%), swelling at injection site (infants, children, and
adolescents: <2%), warm sensation at injection site (infants, children, and adolescents: <2%)
Nervous system: Aggressive behavior (<2%), altered mental status (infants, children, adolescents,
adults: 3% to 5%; including agitation, confusion, decreased mental acuity, disorientation,
drowsiness, stupor), anxiety (<2%), chills (<2%), depression (<2%), dizziness (infants, children,
adolescents, adults: 2%), fatigue (<2%), flank pain (<2%), headache (infants, children,
adolescents, adults: 4% to 7%), hypoesthesia (<2%), hypothermia (infants, children, and
adolescents: <2%), insomnia (infants, children, adolescents, adults: ≤3%), malaise (<2%),
nervousness (<2%), pain (<2%), paresthesia (<2%), vertigo (<2%), voice disorder (<2%)
Neuromuscular & skeletal: Arthralgia (infants, children, and adolescents: <2%), asthenia (<2%),
lower extremity pain (<2%), muscle spasm (<2%), tremor (<2%)
Renal: Increased blood urea nitrogen (<2%), increased serum creatinine (<2%), renal insufficiency
(<2%)
Respiratory: Asthma (<2%), bronchoconstriction (<2%), cough (≤4%), dyspnea (1% to 3%),

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epistaxis (<2%), hemoptysis (<2%), hypoxemia (<2%), nasopharyngitis (<2%), pharyngitis (<2%;
including viral), pleural effusion (<2%), pleuritic chest pain (<2%), rales (<2%), respiratory distress
(<2%), rhinitis (<2%), rhinorrhea (<2%), rhonchi (<2%), upper respiratory tract infection (2%),
wheezing (<2%)

Miscellaneous: Fever (infants, children, adolescents, adults: 2% to 5%), swelling (infants, children,
adolescents, adults: ≤3%), tissue necrosis (<2%)
Monitoring Periodic renal, hepatic, and hematopoietic assessment during prolonged therapy; neurological
Parameters assessment.

Drug Risk X: Avoid combination

Interactions BCG (Intravesical) Cholera Vaccine
Risk D: Consider therapy modification
Valproate Products, Typhoid Vaccine, Sodium Picosulfate
Risk C: Monitor therapy
BCG Vaccine (Immunization) Lactobacillus and Estriol: Probenecid: Tacrolimus (Systemic)
Pregnancy and pregnancy category: Not assigned. Risk summary: Insufficient data available on use of this drug
Lactation in pregnant women
Animal studies have revealed evidence of slightly decreased fetal weight and effects on vertebral
ossification
Ertapenem is present in breast milk.
The relative infant dose (RID) of ertapenem is <1%
The decision to breastfeed during therapy should consider the risk of infant exposure, the
benefits of breastfeeding to the infant, and benefits of treatment to the mother. In general,
antibiotics that are present in breast milk may cause non-dose-related modification of bowel
flora. Monitor infants for GI disturbances, such as thrush or diarrhea
Administration Administration: IM
Avoid injection into a blood vessel. Make sure patient does not have an allergy to lidocaine or
another anesthetic of the amide type. Administer by deep IM injection into a large muscle mass
(eg, gluteal muscle or lateral part of the thigh).
Administration: IV
Administer as an IV infusion over 30 minutes.
Do not infuse with dextrose-containing solutions.
Reconstitution and Dilution
IV Infusion
Reconstitute 1-g vial with 10 mL of sterile water for injection, 0.9% sodium chloride injection, or
bacteriostatic water for injection. shake well; Further dilute dose with NS; for adolescents and
adults, transfer dose to 50 mL NS; for children, dilute dose to a final concentration ≤20 mg/mL.
IM
Reconstitute 1,000 mg vial with 3.2 mL of 1% lidocaine HCl injection (without epinephrine);
shake well. Administer within 1 hour of reconstitution.
N.B. Hypersensitivity test must be done before using injection form of this medicine.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Anaphylaxis/hypersensitivity reactions: Serious hypersensitivity reactions, including
anaphylaxis, have been reported (some without a history of previous allergic reactions to beta-
lactams).
• CNS effects: Carbapenems have been associated with CNS adverse effects, including
confusional states and seizures (myoclonic); use caution with CNS disorders (eg, brain lesions and

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history of seizures) and adjust dose in renal impairment to avoid drug accumulation, which may
increase seizure risk.
• Superinfection: Use may result in fungal or bacterial superinfection,
including Clostridioides (formerly Clostridium) difficile-associated diarrhea (CDAD) and
pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
Disease-related concerns:
• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment
required in patients with moderate to severe renal dysfunction. Increased seizure risk has been
reported in patients with renal dysfunction.
Concurrent drug therapy issues:
• Valproic acid and derivatives: Carbapenems, including ertapenem, may decrease the serum
concentration of divalproex sodium/valproic acid increasing the risk of breakthrough seizures.
Concurrent use of carbapenem antibiotics with divalproex sodium/valproic acid is generally not
recommended. Alternative antimicrobial agents should be considered, but if a concurrent
carbapenem is necessary, consider additional antiseizure medication.
Special populations:
• Elderly: Lower doses (based upon renal function) are often required in the elderly.
Other warnings/precautions:
• IM administration: Doses for IM administration are mixed with lidocaine; consult Lidocaine
(Systemic) information for associated Warnings/Precautions.

Storage Prior to reconstitution, store vials at ≤25°C.

The reconstituted IM solution should be used within 1 hour after preparation.
The reconstituted IV solution may be stored at room temperature 25°C and used within 6
hours, or stored for 24 hours under refrigeration 5°C and used within 4 hours after removal
from refrigeration. Do not freeze.
Refer to manufacturer PIL if there are specific considerations.

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2. Imipenem and Cilastatin Watch Group
Generic Name Imipenem and Cilastatin
Dosage Powder for injection: 500/500mg
form/strengths
Route of IV
administration
Pharmacologic Antibiotic, Carbapenem
category ATC: J01DH51
Indications For treatment of:
Bacterial septicemia
Bone and joint infections
Endocarditis
Gynecologic infections
Intra-abdominal infections
Lower respiratory tract infections
Skin and skin structure infections
Urinary tract infections (complicated and uncomplicated)
Dosage Dosing: Adult
Regimen Doses based on imipenem content.
Recommended IV adult dosages are for adults weighing ≥70 kg. Modification of dosage is
recommended for patients weighing <70 kg
Usual dosage range: IV:
Susceptible bacterial species: 500 mg every 6 hours or 1,000 mg every 8 hours (maximum
dose: 4,000 mg/day)
Intermediate susceptibility bacterial species: 1,000 mg every 6 hours (maximum dose: 4,000
mg/day)
Dosing: Pediatric
Note: Dosage recommendations are based on imipenem component.
General Dosage for Neonates
IV
Neonates <1 week of age weighing ≥1.5 kg: 25 mg/kg every 12 hours.
Neonates 1–4 weeks of age weighing ≥1.5 kg: 25 mg/kg every 8 hours.
General Dosage for Infants and Children
IV
Children 1–3 months of age weighing ≥1.5 kg: 15–25 mg every 6 hours, maximum daily dose:
4,000 mg/day
Dosage Dosing: Renal Impairment: Adult
adjustment Note: Estimation of renal function for the purpose of dosing adjustment should be done
using the Cockcroft-Gault formula:
• Usual dosing regimen of 500 mg every 6 hours:
CrCl ≥90 mL/minute: No dosage adjustment necessary.
CrCl ≥60 to <90 mL/minute: 400 mg every 6 hours
CrCl ≥30 to <60 mL/minute: 300 mg every 6 hours
CrCl ≥15 to <30 mL/minute: 200 mg every 6 hours
CrCl <15 mL/minute: Do not administer imipenem and cilastatin unless hemodialysis is
instituted within 48 hours.
• Usual dosing regimen of 1,000 mg every 8 hours:
CrCl ≥90 mL/minute: No dosage adjustment necessary.
CrCl ≥60 to <90 mL/minute: 500 mg every 6 hours

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CrCl ≥30 to <60 mL/minute: 500 mg every 8 hours
CrCl ≥15 to <30 mL/minute: 500 mg every 12 hours
CrCl <15 mL/minute: Do not administer imipenem and cilastatin unless hemodialysis is
instituted within 48 hours.
• Usual dosing regimen of 1,000 mg every 6 hours:
CrCl ≥90 mL/minute: No dosage adjustment necessary.
CrCl ≥60 to <90 mL/minute: 750 mg every 8 hours
CrCl ≥30 to <60 mL/minute: 500 mg every 6 hours
CrCl ≥15 to <30 mL/minute: 500 mg every 12 hours
CrCl <15 mL/minute: Do not administer imipenem and cilastatin unless hemodialysis is
instituted within 48 hours.
Dosing: Renal Impairment: Pediatric
Infants, Children, and Adolescents: IV:
Patient weight <30 kg and impaired renal function: Use not recommended
The following adjustments have been recommended: Note: Renally adjusted dose
recommendations are based on doses of 60 to 100 mg/kg/day divided every 6 hours.
GFR 30 to 50 mL/minute/1.73 m2: Administer 7 to 13 mg/kg/dose every 8 hours
GFR 10 to 29 mL/minute/1.73 m2: Administer 7.5 to 12.5 mg/kg/dose every 12 hours
GFR <10 mL/minute/1.73 m2: Administer 7.5 to 12.5 mg/kg/dose every 24 hours
Intermittent hemodialysis (IHD): Dialysis: Moderately dialyzable (20% to 50%): 7.5 to 12.5
mg/kg/dose every 24 hours (administer after hemodialysis on dialysis days)
Peritoneal dialysis (PD): 7.5 to 12.5 mg/kg/dose every 24 hours
Continuous renal replacement therapy (CRRT): 7 to 13 mg/kg/dose every 8 hours
Dosing: Hepatic Impairment:
There are no dosage adjustments needed.

Contra- Hypersensitivity to imipenem/cilastatin or any component of the formulation

indications
Adverse Drug >10%
Reactions Hematologic & oncologic: Decreased hematocrit (infants and children 3 months to 12 years:
18%; neonates and infants <3 months: 2%), decreased hemoglobin (infants and children 3
months to 12 years: 15%), eosinophilia (neonates, infants, and children to 12 years: 9% to
13%), thrombocythemia (infants and children 3 months to 12 years: 13%; neonates and
infants <3 months: 4%)
Hepatic: Increased serum AST (infants and children 3 months to 12 years: 18%; neonates and
infants <3 months: 6%), increased serum ALT (infants and children 3 months to 12 years:
11%; neonates and infants <3 months: 3%)
1% to 10%:
Cardiovascular: Phlebitis (2% to 3%), tachycardia (neonates and infants ≤3 months: 2%;
adults <1%)
Central nervous system: Seizure (neonates and infants ≤3 months: 6%; adults <1%)
Dermatologic: Skin rash (≤2%)
Gastrointestinal: Diarrhea (neonates, infants, and children to 12 years: 3% to 4%; adults 2%),
nausea (2%), oral candidiasis (neonates and infants ≤3 months: 2%), vomiting (≤1% to 2%),
gastroenteritis (≤1%)
Genitourinary: Proteinuria (infants and children 3 months to 12 years: 8%), urine
discoloration (≤1%), oliguria (neonates and infants ≤3 months: 2%; adults <1%)
Hematologic & oncologic: Neutropenia (infants and children 3 months to 12 years: 3%;
adults <1%), decreased platelet count (neonates and infants <3 months: 2%), increased
hematocrit (neonates and infants <3 months: 1%)

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Hepatic: Increased serum alkaline phosphatase (neonates and infants <3 months: 3%),
increased serum bilirubin (neonates and infants <3 months: 3%), decreased serum bilirubin
(neonates and infants <3 months: 1%)
Local: Irritation at injection site (infants, children, and adolescents 3 months to 16 years: 1%)
Renal: Increased serum creatinine (neonates and infants <3 months: 5%)
Monitoring Periodic renal, hepatic, and hematologic function tests; monitor for signs of anaphylaxis
Parameters during first dose
Drug Risk X: Avoid combination
Interactions BCG (Intravesical), Cholera Vaccine
Risk D: Consider therapy modification
Ganciclovir-Valganciclovir Sodium Picosulfate Typhoid Vaccine Valproate Products
Risk C: Monitor therapy
BCG Vaccine Cyclosporine Lactobacillus and Estriol Probenecid
Pregnancy and pregnancy category C
Lactation Imipenem is not one of the preferred antibiotics used for the management of cystic fibrosis
in lactating females; however, when a safer alternative is not available, imipenem is the
preferred carbapenem antibiotic. Due to poor oral bioavailability, exposure to a breastfed
infant is expected to be limited
Administration Administration: IV
For IV infusion only; do not administer IV push.
Infuse doses ≤500 mg over 20 to 30 minutes;
infuse doses >500 mg over 40 to 60 minutes.
If nausea and/or vomiting occur during administration, decrease the rate of IV infusion.
Preparation for Administration: Adult
Reconstitute vials with approximately 10 mL of NS, D5W, D5NS. Shake well and transfer to
100 mL of an appropriate infusion solution; repeat transfer with an additional 10 mL of
infusion solution to ensure complete transfer of vial contents to the infusion solution.
Agitate resulting mixture until clear. Solutions range from colorless to yellow.
concentrations >5 mg/mL may have shortened stability; Imipenem is inactivated at acidic or
alkaline pH.
N.B. Hypersensitivity test must be done before using injection form of this medicine.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • CNS effects: including confusion states and seizures (myoclonic); use caution with CNS
disorders and adjust dose in renal impairment to avoid drug accumulation, which may
increase seizure risk.
• Hypersensitivity reactions: Serious hypersensitivity/anaphylactic reactions have been
reported, including fatalities
• Superinfection: Prolonged use
Disease-related concerns:
• Renal impairment.
Concurrent drug therapy issues:
• Valproic acid and derivatives: Concurrent use of carbapenem antibiotics with divalproex
sodium/valproic acid is generally not recommended as increasing the risk of breakthrough
seizures.
Special populations:
• Pediatric: Not recommended in pediatric CNS infections due to seizure potential. Not
recommended in pediatric patients <30 kg with impaired renal function (no data
available).

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Storage Store intact vials at <25°C.
Reconstituted solution is stable for 4 hours at room temperature or 24 hours when
refrigerated at 5°C. Do not freeze.
Refer to manufacturer PIL if there are specific considerations.

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3. Meropenem
Watch Group

Generic Name Meropenem

Dosage Powder for injection: 500mg, 1gm
form/strengths
Route of IV
administration
Pharmacologic Antibiotic, Carbapenem
category ATC: J01DH02
Indications Intra-abdominal infections: Treatment of complicated appendicitis and peritonitis in adult and
pediatric patients
Meningitis, bacterial: Treatment of bacterial meningitis in pediatric patients 3 months and
older
Skin and skin structure infection, complicated: Treatment of complicated skin and skin
structure infections in adults and pediatric patients 3 months and older
Dosage Dosing: Adult
Regimen Note: Infusion method: Dosing is presented based on the traditional infusion method over 30
minutes, unless otherwise specified.
Usual dosage range:
Traditional intermittent infusion method (over 30 minutes):
IV: 500 mg every 6 hours or 1 g every 8 hours
500 mg every 6 hours achieves comparable pharmacokinetic and pharmacodynamic
parameters to 1 g every 8 hours
Meningitis
IV: 2 g every 8 hours. Treatment duration is 7 to 21 days depending on causative pathogen(s)
and clinical response. Note: Consider use of an extended or continuous infusion for more
resistant pathogens
Dosing: Pediatric
General dosing, susceptible infection (non-CNS): Infants, Children, and Adolescents: IV:
Children≥3 months weighing≤50 kg:10-20 mg/kg/dose every 8 hours
Children ≥3 months weighing >50 kg: 500-1000mg every 8 hours
Meningitis:
Children ≥3 months of age weighing ≤50 kg: 40 mg/kg (up to 2 g) every 8 hours.
Children ≥3 months weighing >50 kg: 2 g every 8 hours.
extended infusions may be needed for infections due to isolates with elevated MICs
Prescribing Limits
Pediatric Patients
IV: 2 g every 8 hours
- Safety and efficacy not established in children <3 months of age
Dosage Dosing: Renal Impairment: Adult
adjustment If the usual If the usual
CrCl (mL/minute) recommended dose recommended dose
is 1 g every 8 hoursc is 2 g every 8 hoursc
No dosage No dosage
>50 to <130 adjustment adjustment
necessary necessary
>25 to ≤50 1 g every 12 hours 2 g every 12 hours
10 to ≤25 500 mg every 12 1 g every 12 hours

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hours
500 mg every 24
<10 1 g every 24 hours
hours

Dosing: Renal Impairment: Pediatric

Data insufficient to make dosage recommendations for pediatric patients with renal
impairment
Dosing: Hepatic Impairment:
No dosage adjustment necessary.
Contra- Hypersensitivity to meropenem, other drugs in the same class, or any component of the
indications formulation; patients who have experienced anaphylactic reactions to beta-lactams
Adverse Drug 1% to 10%:
Reactions CNS: Headache, pain
Dermatologic: Skin rash
Endocrine & metabolic: Hypoglycemia, hypervolemia
Gastrointestinal: Nausea, diarrhea, constipation, vomiting, oral candidiasis
Infection: Sepsis
Local: Inflammation at injection site
Monitoring Perform culture and sensitivity testing prior to initiating therapy. Monitor for signs of
Parameters anaphylaxis during first dose. During prolonged therapy, monitor renal function, liver function,
CBC
Drug Risk X: Avoid combination
Interactions BCG (Intravesical) Cholera Vaccine Probenecid
Risk D: Consider therapy modification
Sodium Picosulfate Typhoid Vaccine Valproate Products
Risk C: Monitor therapy
BCG Vaccine Lactobacillus and Estriol
Pregnancy and Pregnancy Category C
Lactation Meropenem is present in breast milk.
Information related to the use of meropenem in breastfeeding women is limited.
Administration Administration: IV
Administer IV infusion over 15 to 30 minutes; IV bolus injection (5 to 20 mL) over 3 to 5
minutes
IV push: Infants ≥3 months, Children, and Adolescents: Administer reconstituted solution (up
to 1,000 mg) over 3 to 5 minutes; safety data is limited with 40 mg/kg doses up to a maximum
of 2,000 mg
Preparation for Administration:
Parenteral: Reconstitute meropenem 500 mg and 1,000 mg vials with 10 mL and 20 mL SWFI
respectively to yield a concentration of 50 mg/mL. For IV infusion, may further dilute with
D5W or NS to a final concentration ranging from 1 to 20 mg/mL.
N.B. Hypersensitivity test must be done before using injection form of this medicine.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Anaphylaxis/hypersensitivity reactions
• CNS effects: Carbapenems have been associated with CNS adverse effects, including
confusional states and seizures (myoclonic); use caution with CNS disorders (eg, brain lesions
and history of seizures).
• Dermatological effects: Severe cutaneous adverse reactions, including Stevens-Johnson
syndrome. discontinue immediately for severe reactions.

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• Superinfection: Prolonged use
Disease-related concerns:
• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment
required in patients with creatinine clearance ≤50 mL/minute. Increased seizure risk and
thrombocytopenia have been reported in patients with renal impairment.
Special populations:
• Elderly: Lower doses (based upon renal function) are often required in the elderly.
Storage • Vials: stored at controlled room temperature 20°C to 25°C.
• Stability of vial after reconstitution (up to 50 mg/mL) with
SWFI: Stable for up to 3 hours at up to 25°C or for up to 13 hours at up to 5°C.
• Infusion admixture (1 to 20 mg/mL): Solution is stable when diluted in NS for 1 hour at up
to 25°C or 15 hours at up to 5°C. Solutions constituted with dextrose injection 5% should
be used immediately
Refer to manufacturer PIL if there are specific considerations.

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Cephalosporins

Access Group
a) First Generation Cephalosporins
1. Cefadroxil
Generic Name Cefadroxil

Dosage Tablets 1g,

form/strengths Capsule 250mg, 500mg
Oral suspension 125mg/5ml, 250mg/5ml, 500mg/5ml
Oral drops 100mg/ml
Route of Oral
administration
Pharmacologic Antibiotic, Cephalosporin (First Generation)
category ATC: J01DB05
Indications Pharyngitis and/or tonsillitis: Treatment of pharyngitis and/or tonsillitis caused
by Streptococcus pyogenes (group A beta-hemolytic streptococci).
Skin and skin structure infections: Treatment of skin and skin structure infections
caused by staphylococci and/or streptococci.
Urinary tract infection: Treatment of urinary tract infections caused by Escherichia
coli, Proteus mirabilis, and Klebsiella species.
Dosage Dosing: Adult
Regimen Skin and skin structure infections: Oral: 1 g daily in a single or 2 divided doses
Streptococcal pharyngitis (group A) (alternative agent for mild [non-anaphylactic]
penicillin allergy): Oral: 1 g once daily for 10 days
Urinary tract infection (UTI) (alternative agent):
Note: Use with caution and only when recommended agents cannot be used (due to
decreased efficacy of oral beta-lactams compared to other agents)
Cystitis, acute uncomplicated: Oral: 500 mg twice daily for 5 to 7 days
UTI, complicated (including pyelonephritis): Oral: 1 g twice daily for 10 to 14 days.
Dosing: Pediatric
General dosing, susceptible infection: Mild to moderate infection: Infants, Children, and
Adolescents: Oral: 15 mg/kg/dose twice daily; maximum daily dose: 2,000 mg/day
Impetigo: Children and Adolescents: Oral: 30 mg/kg/day in a single dose or divided every
12 hours; maximum daily dose: 1,000 mg/day
Pharyngitis/tonsillitis: Children and Adolescents: Oral: 30 mg/kg/day in a single dose or
divided every 12 hours for 10 days; maximum daily dose: 1,000 mg/day
Skin and skin structure infections: Children and Adolescents: Oral: 15 mg/kg/dose every 12
hours; maximum daily dose: 1,000 mg/day
Urinary tract infections: Children and Adolescents: Oral: 15 mg/kg/dose every 12 hours;
maximum daily dose: 2,000 mg/day

Dosage Dosing: Renal Impairment: Adult

adjustment Initial: 1 g as a single dose.
Maintenance:
CrCl >50 mL/minute: No dosage adjustment necessary.
CrCl 25 to 50 mL/minute: 500 mg every 12 hours.
CrCl 10 to 25 mL/minute: 500 mg every 24 hours.
CrCl <10 mL/minute: 500 mg every 36 hours

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Dosing: Renal Impairment: Pediatric
Infants, Children, and Adolescents: Dosing based on a usual dose of 30 mg/kg/day in
divided doses every 12 hours:
CrCl ≥30 mL/minute/1.73 m2: No dosage adjustment necessary
CrCl 10 to 29 mL/minute/1.73 m2: 15 mg/kg/dose every 24 hours
CrCl <10 mL/minute/1.73 m2: 15 mg/kg/dose every 36 hours
Hemodialysis, intermittent: 15 mg/kg/dose every 24 hours
Peritoneal dialysis: 15 mg/kg/dose every 36 hours
Dosing: Hepatic Impairment:
There are no dosage adjustments needed.
Contra- Hypersensitivity to cefadroxil, any component of the formulation, or other cephalosporins
indications
Adverse Drug 1% to 10%: Gastrointestinal: Diarrhea
Reactions
Monitoring Monitor renal function. Observe for signs and symptoms of anaphylaxis during first dose.
Parameters
Drug Risk X: Avoid combination
Interactions BCG (Intravesical), Cholera Vaccine,
Risk D: Consider therapy modification
Tolvaptan, Typhoid Vaccine, Sodium Picosulfate:
Risk C: Monitor therapy
Acemetacin, Aminoglycosides, BCG Vaccine (Immunization), Dichlorphenamide,
Lactobacillus and Estriol, Methotrexate, Mycophenolate, Probenecid, Teriflunomide,
Tetracyclines, Vitamin K Antagonists
Pregnancy and Pregnancy Risk Factor B
Lactation Cefadroxil is present in breast milk. Caution should be exercised when administering
cefadroxil to breastfeeding women. Monitor infants for GI disturbances.
Administration Administration: Oral
Administer around-the-clock to promote less variation in peak and trough serum levels.
Administer without regards to meals; administration with food diminishes GI complaints.
Administration: Pediatric
Oral: May be administered without regard to food; administration with food may
decrease nausea or vomiting; shake suspension well before use.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Hypersensitivity reactions: Hypersensitivity reactions, including anaphylaxis, may occur.
If an allergic reaction occurs, discontinue treatment and institute supportive measures.
• Penicillin allergy: Use with caution in patients with a history of penicillin allergy.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection,
including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD
has been observed >2 months postantibiotic treatment.
Storage Store capsules, tablets and unreconstituted oral suspension at 15°C to 30°C. After
reconstitution, oral suspension may be stored for 14 days under refrigeration (4°C).
Refer to manufacturer PIL if there are specific considerations.

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Access Group
2. Cefazolin
Generic Name Cefazolin

Dosage Vial 500mg, 1g

form/strengths
Route of IV, IM
administration
Pharmacologic First-generation cephalosporin antibacterial
category ATC: J01DB04
Indications Treatment of
Biliary tract infection
Bloodstream infection
Bone and joint infection
Endocarditis, treatment
Genital infection: (ie, prostatitis, epididymitis)
Respiratory tract infection
Skin and soft tissue infection.
Urinary tract infection

Surgical prophylaxis: To reduce the incidence of certain postoperative infections in

adults and pediatric patients 10 to 17 years of age undergoing surgical procedures.
Dosage Regimen Adult:
Bloodstream infection:
Pathogen-directed therapy for methicillin-susceptible staphylococci:
IV: 2 g every 8 hours treat uncomplicated Staphylococcus aureus bacteremia for ≥14
days starting from day of first negative blood culture, with longer courses warranted
for endocarditis or metastatic sites of infection

Pathogen-directed therapy for susceptible Enterobacteriaceae:

IV: 2 g every 8 hours. Usual duration is 7 to 14 days; individualize depending on
source and extent of infection as well as clinical response. A 7-day duration is
recommended for patients with uncomplicated Enterobacteriaceae infection who
respond appropriately to antibiotic therapy

Endocarditis, treatment:
Pathogen-directed therapy for methicillin-susceptible staphylococci (alternative agent
for patients with nonsevere, non-IgE-mediated penicillin allergy):

Native valve: IV: 2 g every 8 hours for 6 weeks

Prosthetic valve: IV: 2 g every 8 hours for ≥6 weeks (combine with rifampin for entire
duration of therapy and gentamicin for the first 2 weeks)

Intra-abdominal infection, community-acquired (mild to moderate infection in low-

risk patients):

Note: Reserve for patients with low risk for resistant pathogens (eg, local
Enterobacteriaceae resistance rate to cefazolin <10% and no recent antibiotic
exposure)

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Cholecystitis, acute: IV: 1 to 2 g every 8 hours; continue for 1 day after gallbladder
removal or until clinical resolution in patients managed nonoperatively. Note: The
addition of anaerobic therapy is recommended if biliary-enteric anastomosis is
present.

Osteomyelitis and/or discitis:

Treatment, pathogen-directed therapy for methicillin-susceptible S. aureus:
IV: 2 g every 8 hours for ≥6 weeks depending on extent of infection, debridement,
and clinical response.
Prevention, following open fractures:
IV: 2 g for patients <120 kg or 3 g for patients ≥120 kg every 8 hours; ideally
administer within 6 hours of injury.
Pneumonia: Pathogen-directed therapy for methicillin-susceptible S. aureus: IV: 2 g
every 8 hours. Minimum duration is 5 to 7 days
Urinary tract infection, complicated (including pyelonephritis): Pathogen-directed
therapy for susceptible organisms: IV: 1 g every 8 hours
Pediatric:
General dosing, susceptible infection: Infants, Children, and Adolescents: IM, IV:
Mild to moderate infections: 25 to 100 mg/kg/day divided every 8 hours; maximum
daily dose: 6 g/day
Severe infections (eg, bone/joint infections): 100 to 150 mg/kg/day divided every 6 to
8 hours; maximum daily dose: 12 g/day
Dosage Dosing in renal impairment: Adult
adjustment CrCl ≥50 mL/minute: 1 to 2 g every 8 hours.
CrCl 30 to <50 mL/minute: 1 to 2 g every 8 to 12 hours.
CrCl >10 to <30 mL/minute: 500 mg to 1 g every 12 hours (some experts give 2 g every
12 hours for severe infections in patients with CrCl 10 to <30 mL/minute).
CrCl ≤10 mL/minute or haemodialysis: 500 mg to 1 g every 24 hours.
Dosing: Renal Impairment: Pediatric
Infants >1 month, Children, and Adolescents: After initial loading dose is
administered, modify dose based on the degree of renal impairment:
CrCl >70 mL/minute: No dosage adjustment required
CrCl 40 to 70 mL/minute: Administer 60% of the usual daily dose divided every 12
hours
CrCl 20 to 40 mL/minute: Administer 25% of the usual daily dose divided every 12
hours
CrCl 5 to 20 mL/minute: Administer 10% of the usual daily dose given every 24 hours
Hemodialysis: 25 mg/kg/dose every 24 hours
Peritoneal dialysis: 25 mg/kg/dose every 24 hours
Continuous renal replacement therapy: 25 mg/kg/dose every 8 hours
Dosing in hepatic impairment adults & pediatrics:
There are no dosage adjustments data.

Contra- hypersensitivity reactions to the drug

indications
Adverse Drug Frequency not defined:
Reactions Cardiovascular: Localized phlebitis
Central nervous system: Seizure
Dermatologic: Pruritus, skin rash, Stevens-Johnson syndrome
Gastrointestinal: Abdominal cramps, anorexia, diarrhea, nausea, oral candidiasis,

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pseudomembranous colitis, vomiting
Genitourinary: Vaginitis
Hepatic: Hepatitis, increased serum transaminases
Hematologic: Eosinophilia, leukopenia, neutropenia, thrombocythemia,
thrombocytopenia
Hypersensitivity: Anaphylaxis
Local: Pain at injection site
Renal: Increased blood urea nitrogen, increased serum creatinine, renal failure
Miscellaneous: Fever
Monitoring Renal function periodically, hepatic function tests, CBC; monitor for signs of
Parameters anaphylaxis during first dose
Drug Interactions Risk X: Avoid combination:
BCG (Intravesical), Cholera Vaccine,
Risk D: Consider therapy modification:
Rifampin, Typhoid Vaccine
Risk C: Monitor therapy
Aminoglycosides BCG Vaccine (Immunization) Fosphenytoin Immune Checkpoint
Inhibitors Lactobacillus and Estriol Phenytoin Probenecid Vitamin K Antagonists (eg,
warfarin)
Pregnancy Adverse events have not been reported in the fetus following administration of
cefazolin prior to cesarean delivery.
Cefazolin is present in breast milk.
Caution should be exercised when administering cefazolin to breastfeeding women.
Administration Administration: IM
Inject deep IM into large muscle mass.
Administration: IV
Inject direct IV over 3 to 5 minutes or may infuse as an intermittent infusion over 30
to 60 minutes.
Preparation for Administration: Dilute 500 mg vial with 2 mL SWFI and 1 g vial with
2.5 mL SWFI; reconstituted solution may be directly injected after further dilution
with 5 mL SWFI or further diluted for IV administration in 50 to 100 mL compatible
solution (eg, D5W, NS); 10 g vial may be diluted with 45 mL to yield 1 g/5 mL or 96 mL
to yield 1 g/10 mL.
N.B. Hypersensitivity test must be done before using injection form of this medicine.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ • Elevated INR: May be associated with increased INR, especially in nutritionally-
Precautions deficient patients, prolonged treatment, hepatic or renal disease.

• Hypersensitivity reactions
• Penicillin allergy
• Superinfection: Prolonged use may result in fungal or bacterial superinfection,
including Clostridioides (formerly Clostridium) difficile-associated diarrhea (CDAD)
and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic
treatment.
Storage • Store intact vials at room temperature and protect from temperatures exceeding
40°C.
• Reconstituted solutions of cefazolin are light yellow to yellow. Protection from light

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is recommended for the powder and for the reconstituted solutions. Reconstituted
solutions are stable for 24 hours at room temperature and for 10 days under
refrigeration.
• Stability of parenteral admixture in D5W, D5LR, D51/4NS, D51/2NS, D5NS, D10W,
LR, or NS at room temperature (25°C) is 48 hours.
• Stability of parenteral admixture at refrigeration temperature (4°C) is 14 days.
Refer to manufacturer PIL if there are specific considerations.

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Access Group
3. Cephalexin
Generic Name Cephalexin

Dosage form/ Oral suspension: 125mg/5ml, 250mg/5ml

strengths Tablets 250mg, 500mg, 1000mg
Capsule 250mg, 500mg,
Vial 500mg, 1g
Route of Oral , parentral
administration
Pharmacologic Antibiotic, Cephalosporin (First Generation)
action ATC: J01DB01
Indications Bone infections: Treatment of bone infections caused by Staphylococcus
aureus and/or Proteus mirabilis.

Genitourinary tract infections: Treatment of genitourinary tract infections, including acute

prostatitis, caused by Escherichia coli, P. mirabilis, and Klebsiella pneumoniae.

Otitis media: Treatment of otitis media caused by Streptococcus pneumoniae, Haemophilus

influenzae, S. aureus, Streptococcus pyogenes, and Moraxella catarrhalis.

Respiratory tract infections: Treatment of respiratory tract infections (including

pharyngitis) caused by S. pneumoniae and S. pyogenes.

Skin and skin structure infections: Treatment of skin and skin structure infections caused
by S. aureus and/or S. pyogenes.
Dosage Usual adult dosage range: Oral: 250 to 1,000 mg every 6 hours or 500 mg every 12 hours
Regimen (maximum: 4 g/day).
Dosing: Pediatric
General dosing, susceptible infection: Infants, Children, and Adolescents:
Mild to moderate infection: Oral: 25 to 50 mg/kg/day divided every 6 or 12 hours; maximum
daily dose: 2,000 mg/day.
Severe infection (eg, bone and joint infections): Oral: 75 to 100 mg/kg/day divided every 6 to
8 hours; maximum daily dose: 4,000 mg/day.
• Suspension/tablet bioequivalence: Tablets and oral suspension are not bioequivalent; do
not substitute on a mg-per-mg basis.
Dosage Dosing: Renal Impairment: Adult
adjustment CrCl 30 to 59 mL/minute: Maximum recommended daily dose: 1,000 mg/day.
CrCl 15 to 29 mL/minute: 250 mg every 8 to 12 hours
CrCl 5 to 14 mL/minute: 250 every 24 hours
CrCl 1 to 4 mL/minute: 250 mg every 48 to 60 hours
End-stage renal disease (on intermittent hemodialysis): The following guidelines have been
used by some clinicians: Oral: 250 to 500 mg every 12 to 24 hours; moderately dialyzable
(20% to 50%); give dose after dialysis session.
Peritoneal dialysis: The following guidelines have been used by some clinicians: Oral: 250 to
500 mg every 12 to 24 hours.
Dosing: Hepatic Impairment:
There are no dosage adjustments needed.

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Contra- Hypersensitivity to cephalexin, other cephalosporins, or any component of the formulation
indications
Adverse Drug Frequency not defined:
Reactions Central nervous system: Agitation, confusion, dizziness, fatigue, hallucination, headache
Dermatologic: Erythema multiforme (rare), genital pruritus, skin rash, Stevens-Johnson
syndrome (rare), toxic epidermal necrolysis (rare), urticaria
Gastrointestinal: Abdominal pain, diarrhea, dyspepsia, gastritis, nausea (rare),
pseudomembranous colitis, vomiting (rare)
Genitourinary: Genital candidiasis, vaginal discharge, vaginitis
Hematologic & oncologic: Eosinophilia, hemolytic anemia, neutropenia, thrombocytopenia
Hepatic: Cholestatic jaundice (rare), hepatitis (transient, rare), increased serum ALT,
increased serum AST
Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction
Neuromuscular & skeletal: Arthralgia, arthritis, arthropathy
Renal: Interstitial nephritis (rare)
Monitoring With prolonged therapy monitor renal, hepatic, and hematologic function periodically;
Parameters monitor for signs of anaphylaxis during first dose
Drug Risk X: Avoid combination
Interactions BCG (Intravesical), Cholera Vaccine,
Risk D: Consider therapy modification
Multivitamins/Minerals (with ADEK, Folate, Iron), Sodium Picosulfate, Sucroferric
Oxyhydroxide, Typhoid Vaccine, Zinc Salts
Risk C: Monitor therapy
Aminoglycosides, BCG Vaccine (Immunization), Lactobacillus and Estriol, Metformin,
Probenecid, Vitamin K Antagonists
Pregnancy and Pregnancy Category B
Lactation Cephalexin is present in breast milk.
When an antibiotic is needed, cephalexin may be used to treat mastitis in breastfeeding
patients allergic to preferred agents. The decision to breastfeed during therapy should
consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits
of treatment to the mother.Monitor infants for GI disturbances
Administration Administration: Oral adult, Pediatric
Administer without regard to food. If GI distress, take with food. Give around-the-clock to
promote less variation in peak and trough serum levels.
Oral suspension: Shake suspension well before use. Administer with an accurate measuring
device; do not use a household teaspoon (overdosage may occur).
N.B. Hypersensitivity test must be done before using injection form of this medicine.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ • Hypersensitivity: Allergic reactions (eg, rash, urticaria, angioedema, anaphylaxis,
Precautions erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis [TEN]) have
been reported. If an allergic reaction occurs, discontinue immediately and institute
appropriate treatment.
• Elevated INR: May be associated with increased INR, especially in nutritionally-deficient
patients, prolonged treatment, hepatic or renal disease.
• Penicillin allergy: Use with caution in patients with a history of penicillin allergy, especially
IgE-mediated reactions (eg, anaphylaxis, angioedema, urticaria).
• Seizure disorder: Use with caution in patients with a history of seizure disorder; high
levels, particularly in the presence of renal impairment, may increase risk of seizures.

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• Superinfection: Prolonged use may result in fungal or bacterial superinfection,
including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has
been observed >2 months post antibiotic treatment
• A false-positive reaction may occur when testing for the presence of glucose in the
urine using Benedict's solution or Fehling's solution
Storage - Capsule: Store at 25°C; excursions permitted to 15ºC to 30ºC.
- Powder for oral suspension: Store at 20°C to 25°C.
- Refrigerate after reconstitution; discard after 14 days.
- Tablet: Store at 20°C to 25°C.
Refer to manufacturer PIL if there are specific considerations.

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Access Group
4. Cephradine
Generic Name Cephradine

Dosage Capsule 250mg, 500mg, 1g

form/strengths Tablets 1g
Oral suspension 125mg/5ml, 250mg/5ml,
Vial 250 mg, 500mg, 1g
Route of Oral, IV, IM
administration
Pharmacologic a first-generation cephalosporin antibacterial
action ATC: J01DB09
Indications Treatment of infections caused by susceptible Gram-positive and Gram-negative
bacteria (including infections of the respiratory and urinary tracts, bones and joints, and
of the skin and skin structure)
Dosage Regimen Adult:
Oral: 1 to 2 g daily in 2 to 4 divided doses; up to 4 g daily
IV, IM: 2 to 4 g daily in 4 divided doses; up to 8 g daily may be given parenterally.
For surgical infection prophylaxis, 1 to 2 g may be given pre-operatively by
intramuscular or intravenous injection; subsequent parenteral or oral doses are given as
appropriate
Pediatric:
The usual oral dose is 25 to 50 mg/kg daily in 2 or 4 divided doses; for otitis media 75 to
100 mg/kg daily in divided doses every 6 to 12 hours (to a maximum of 4 g daily) may be
given.
Cefradine is given parenterally in a dose of 50 to 100 mg/kg daily in 4 divided doses,
increasing to 200 to 300 mg/kg daily in severe infections.
Dosage Dosing in renal impairment:
adjustment Clcr more than 20 mL/minute: 500 mg every 6 hours
Clcr 5 to 20 mL/minute: 250 mg every 6 hours
Clcr less than 5 mL/minute: 250 mg every 12 hours
Patients undergoing chronic, intermittent haemodialysis may be given a 250-mg dose at
the start of the session, repeated after 6 to 12 hours, then again 36 to 48 hours after
the initial dose, and again at the start of the next haemodialysis if more than 30 hours
have elapsed since the previous dose.
Further dosage modification may be required in children with renal impairment.
Contra- hypersensitivity reactions to the drug
indications
Adverse Drug Gastrointestinal disturbances and hypersensitivity reactions. Pseudomembranous colitis
Reactions has been reported.
Monitoring Renal functions
Parameters
Drug Interactions • The renal excretion of cefalexin, and many other cephalosporins, is delayed by
probenecid.
• There have been isolated reports of cefalexin decreasing the efficacy of oestrogen-
containing oral contraceptives.1However, evidence does not generally support an
interaction between broad-spectrum antibacterials and hormonal contraceptives
• Warfarin: The concomitant use of cephradine with warfarin may result in

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increased INR and thereby increase the risk for bleeding. If concomitant use is
deemed necessary, more frequent monitoring of INR is recommended especially
during initiation and discontinuation of the antibiotic.
Pregnancy and Pregnancy factor B
Lactation Cephradine is excreted into human milk in small amounts. Adverse effects in the nursing
infant are unlikely
Administration IM,IV: deep intramuscular injection or intravenously by slow injection over 3 to 5
minutes or by intermittent or continuous infusion
N.B. Hypersensitivity test must be done before using injection form of this medicine.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Use of Cephradine in patients with renal dysfunction should be monitored intensively. A
Precautions modified dosage schedule in patients with decreased renal function is necessary
Storage Store at room temperature. Refer to manufacturer PIL if there are specific
considerations.

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Watch Group
b) Second Generation Cephalosporins
1. Cefaclor
Generic Name Cefaclor

Dosage Oral suspension 125mg/5ml, 250mg/5ml, 375mg/5ml

form/strengths Modified Release Tablet: 375mg, 500mg, 750mg
Capsule 250mg, 500mg
Route of Oral
administration
Pharmacologic Antibiotic, Cephalosporin (Second Generation)
action ATC: J01DC04
Indications Treatment of
Acute bacterial exacerbations of chronic bronchitis (extended-release tablets only)
Lower respiratory tract infections (capsules and oral suspension only) including
pneumonia
Otitis media (capsules and oral suspension only)
Pharyngitis and tonsillitis
Secondary bacterial infections of acute bronchitis (extended-release tablets only)
Skin and skin structure infections, uncomplicated
Urinary tract infections (capsules and oral suspension only)
Dosage Dosing Adult:
Regimen Note: An ER tablet dose of 500 mg twice daily is clinically equivalent to an IR capsule
dose of 250 mg 3 times daily; an ER tablet dose of 500 mg twice daily is NOT clinically
equivalent to 500 mg 3 times daily of other cefaclor formulations.
Treatment of susceptible infections: Oral:
Immediate-release: 250 to 500 mg every 8 hours
Extended-release: 500 mg every 12 hours
Indication-specific dosing:
Acute bacterial exacerbations of chronic bronchitis:
Oral: Extended-release: 500 mg every 12 hours for 7 days
Secondary bacterial infection of acute bronchitis:
Oral: Extended-release: 500 mg every 12 hours for 7 days
Pneumonia, community-acquired, outpatient empiric therapy (patients with
comorbidities): Oral: Immediate release: 500 mg every 8 hours as part of an
appropriate combination regimen
Streptococcal pharyngitis, group A (alternative agent for mild, nonanaphylactic
penicillin allergy):
Oral: Immediate release: 250 mg every 8 hours for 10 days
Urinary tract infection (alternative agent):
Note: Use only when first-line agents cannot be used; limited evidence suggests
inferior efficacy of oral beta-lactams.
Cystitis, acute uncomplicated or acute simple cystitis (infection limited to the bladder
without signs/symptoms of upper tract, prostate, or systemic infection), treatment:
Oral: Immediate release: 250 mg every 8 hours for 5 to 7 days
Urinary tract infection, complicated (including pyelonephritis):
Oral: Immediate release: 500 mg 3 times daily for 10 to 14 days

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Dosing: Pediatric
General dosing, susceptible infection:
Mild to moderate infection: Infants, Children, and Adolescents:
Oral, immediate release: 20 to 40 mg/kg/day divided every 8 to 12 hours. Maximum
daily dose: 1,500 mg/day
Dosage Dosing: Renal Impairment: Adult
adjustment Alternative recommendations:
Oral, immediate-release:
Mild to severe impairment: No dosage adjustment necessary. use with caution.
End-stage renal disease (ESRD) on intermittent hemodialysis (IHD) (administer after
hemodialysis on dialysis days): Supplement with 250 to 500 mg after dialysis.
Peritoneal dialysis: Administer 250 to 500 mg every 8 hours.

Dosing: Renal Impairment: Pediatric

Dosing based on usual dose of 20 to 40 mg/kg/day in divided doses every 8 to 12 hours
Infants, Children, and Adolescents: Oral, immediate release:
GFR ≥10 mL/minute/1.73 m2: No dosage adjustment necessary.
GFR <10 mL/minute/1.73 m2: Administer 50% of the recommended dose.
End-stage renal disease (ERD) on intermittent hemodialysis (IHD) (supplemental dose
posthemodialysis needed): Administer 50% of the recommended dose.
Peritoneal dialysis: Administer 50% of the recommended dose.
Hemodialysis: Hemodialysis shortens half-life by 25% to 35%
Moderately dialyzable (20% to 50%)
Dosing: Hepatic Impairment:
There are no dosage adjustments needed

Contra- Hypersensitivity to cefaclor, any component of the formulation, or other

indications cephalosporins
Adverse Drug 1% to 10%:
Reactions Dermatologic: Rash (1% to 2%; includes erythematous rash, maculopapular rash, or
morbilliform rash)
Gastrointestinal: Diarrhea (3%)
Genitourinary: Vaginitis (2%), vulvovaginal candidiasis (2%)
Hematologic & oncologic: Eosinophilia (2%)
Hepatic: Increased serum transaminases (3%)

Monitoring Monitor renal function. Observe for signs of anaphylaxis during first dose.
Parameters
Drug Risk X: Avoid combination:
Interactions BCG (Intravesical), Cholera Vaccine,
Risk D: Consider therapy modification:
Tolvaptan, Typhoid Vaccine, Sodium Picosulfate:
Risk C: Monitor therapy:
Acemetacin, Aminoglycosides, BCG Vaccine (Immunization), Dichlorphenamide,
Lactobacillus and Estriol, Methotrexate, Mycophenolate, Probenecid, Teriflunomide,
Tetracyclines, Vitamin K Antagonists
Pregnancy and Pregnancy Risk Factor B
Lactation Small amounts of cefaclor are excreted in breast milk. Caution should be exercised
when administering cefaclor to nursing women. Nondose-related effects could include

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modification of bowel flora.

Administration Administration: Oral

Administer around-the-clock to promote less variation in peak and trough serum
levels.
Capsules and oral suspension: Administer without regard to meals; shake oral
suspension well before using.
ER tablets: Do not chew, crush, or split; administer with or within 1 hour of food.
Bariatric surgery: Some institutions may have specific protocols that conflict with
these recommendations; refer to institutional protocols as appropriate. Switch to IR
formulation. Capsule may be opened and contents sprinkled onto soft food of choice.
Patient should be instructed to swallow the mixture without biting down or chewing.
Administration: Pediatric
Oral: Administer around-the-clock to promote less variation in peak and trough
serum levels.
Capsules and oral suspension: Administer without regard to meals; shake oral
suspension well before using.
Extended release tablets: Do not chew, crush, or split; administer with or within 1
hour of food.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Hypersensitivity: Anaphylactic reactions have occurred. If a serious hypersensitivity
reaction occurs, discontinue and institute emergency supportive measures, including
airway management and treatment (eg, epinephrine, antihistamines, and/or
corticosteroids).
• Penicillin allergy: Use with caution in patients with a history of penicillin allergy.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection,
including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis;
CDAD has been observed >2 months postantibiotic treatment.
Geriatric Considerations
Has not been studied in the elderly. Adjust dose for renal function in elderly.
Considered to be one of the drugs of choice in the outpatient treatment of
community-acquired pneumonia in elderly.
Warnings: Additional Pediatric Considerations
May cause serum sickness-like reaction (estimated incidence ranges from 0.024% to
0.2% per drug course); majority of reactions have occurred in children <5 years of
age with symptoms of fever, rash, erythema multiforme, and arthralgia, often
occurring during the second or third exposure.

Storage Store at 20°C to 25°C.

Refrigerate suspension after reconstitution and discard after 14 days.
Refer to manufacturer PIL if there are specific considerations.

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2. Cefoxitin Watch Group

Generic Name Cefoxitin

Dosage Powder for Solution for Injection: 1gm, 2gm

form/strengths
Route of IV, IM
administration
Pharmacologic Antibiotic, Cephalosporin (Second Generation)
category ATC: J01DC01
Indications Bacteremia/sepsis
Bone and joint infections
Gynecological infections
Lower respiratory tract infections: pneumonia and lung abscess.
Septicemia
Skin and skin structure infections
Urinary tract infections.
Dosage Dosing: Adult, Geriatric
Regimen Usual dosage range: IV: 1 to 2 g every 6 to 8 hours.
Pelvic inflammatory disease:
Inpatients: IV: 2 g every 6 hours plus doxycycline for at least 24 to 48 hours after clinical
improvement, followed by oral doxycycline to complete 14 days.
Outpatients: IM: 2 g as a single dose plus oral probenecid, followed by oral doxycycline (with or
without concomitant metronidazole) for 14 days.
Surgical (perioperative) prophylaxis: IV: 2 g within 60 minutes prior to surgical incision. Doses
may be repeated in 2 hours if procedure is lengthy or if there is excessive blood loss.

Dosing: Pediatric
General dosing: Infants, Children, and Adolescents: IM, IV:
Mild to moderate infection: 80 mg/kg/day divided every 6 to 8 hours; maximum daily dose: 4,000
mg/day
Severe infection: 160 mg/kg/day divided every 6 hours; maximum daily dose: 12 g/day
Intra-abdominal infections, complicated: Infants, Children, and Adolescents: IV: 160 mg/kg/day
divided every 4 to 6 hours; maximum daily dose: 8 g/day.
Peritonitis, prophylaxis for patients receiving peritoneal dialysis undergoing gastrointestinal or
genitourinary procedures: Limited data available: Infants, Children, and Adolescents: IV: 30 to 40
mg/kg administered 30 to 60 minutes before procedure; maximum dose: 2,000 mg/dose.
Surgical prophylaxis: IV:
Infants ≥3 months, Children, and Adolescents: 30 to 40 mg/kg 30 to 60 minutes prior to initial
incision, followed by 30 to 40 mg/kg every 6 hours for up to 24 hours; maximum single dose:
2,000 mg

Dosage Dosing: Renal Impairment: Adult

adjustment Loading dose: 1 to 2 g, followed by maintenance dosing according to CrCl.
Maintenance dosage:
CrCl 30 to 50 mL/minute: 1 to 2 g every 8 to 12 hours
CrCl 10 to 29 mL/minute: 1 to 2 g every 12 to 24 hours

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CrCl 5 to 9 mL/minute: 0.5 to 1 g every 12 to 24 hours
CrCl <5 mL/minute: 0.5 to 1 g every 24 to 48 hours

Hemodialysis: Loading dose: 1 to 2 g after each hemodialysis; maintenance dose as noted above
based on creatinine clearance

Dosing: Renal Impairment: Pediatric

adjusted dose recommendations are based on doses of 20 to 40 mg/kg/dose every 6 hours.
GFR >50 mL/minute/1.73 m2: No adjustment required.
GFR 30 to 50 mL/minute/1.73 m2: 20 to 40 mg/kg/dose every 8 hours
GFR 10 to 29 mL/minute/1.73 m2: 20 to 40 mg/kg/dose every 12 hours
GFR <10 mL/minute/1.73 m2: 20 to 40 mg/kg/dose every 24 hours

Intermittent hemodialysis: Moderately dialyzable (20% to 50%): 20 to 40 mg/kg/dose every 24

hours
Peritoneal dialysis (PD): 20 to 40 mg/kg/dose every 24 hours
Continuous renal replacement therapy (CRRT): 20 to 40 mg/kg/dose every 8 hours

Dosing: Hepatic Impairment: Adult, Pediatric

There are no dosage adjustments needed.
Contra- Hypersensitivity to cefoxitin, any component of the formulation, or other cephalosporins
indications
Adverse Drug 1% to 10%: Gastrointestinal: Diarrhea
Reactions
Monitoring Monitor renal function periodically when used in combination with other nephrotoxic drugs;
Parameters prothrombin time.
Observe for signs and symptoms of anaphylaxis during first dose.
CBC with prolonged use.
Drug Risk X: Avoid combination
Interactions BCG (Intravesical), Cholera Vaccine.
Risk D: Consider therapy modification
Sodium Picosulfate, Typhoid Vaccine
Risk C: Monitor therapy
Aminoglycosides BCG Vaccine (Immunization) Immune Checkpoint Inhibitors Lactobacillus and
Estriol Probenecid Vitamin K Antagonists (eg, warfarin)
Pregnancy and Pregnancy Category B.
Lactation There are no adequate and well-controlled trials in pregnant women
Cefoxitin is present in breast milk. Cephalosporins are generally considered acceptable for use in
breastfeeding women. In general, antibiotics that are present in breast milk may cause nondose-
related modification of bowel flora. Monitor infants for GI disturbances, such as thrush or
diarrhea.
Administration Adult, Pediatric
IM: Inject deep IM into large muscle mass.
IV: Can be administered IV push over 3 to 5 minutes or by IV intermittent infusion over 10 to 60
minutes
Preparation for Administration: Adult
IV Push: reconstitute 1 g vial with at least 10 mL, and 2 g vial with 10 or 20 mL of SWFI,
bacteriostatic water for injection, NS, or D5W.
For IV infusion, solutions may be further diluted in in 50 to 1000 mL of NS, D5NS, D5W, LR,

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mannitol 5% or 10%, or sodium bicarbonate 5%.
Preparation for Administration: Pediatric
IV Push: Reconstitute vials with SWFI, bacteriostatic water for injection, NS, or D5W to a final
concentration of 95 to180 mg/mL.
Intermittent IV infusion: Further dilute to a final concentration not to exceed 40 mg/mL in NS,
D5NS, D5W, LR, mannitol 5% or 10%, or sodium bicarbonate 5%.
In fluid restricted patients, a concentration of 125 mg/mL using SWFI results in a maximum
recommended osmolality for peripheral infusion.
IM: Reconstitute vial with 1 to 2 mL of 0.5% or 1% lidocaine.
N.B. Hypersensitivity test must be done before using injection form of this medicine.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Hypersensitivity: Use with caution in patients with a history of penicillin allergy, especially IgE-
mediated hypersensitivity reactions (eg, anaphylaxis, angioedema, urticaria).
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C.
difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2
months postantibiotic treatment.
Disease-related concerns:
• GI disease: Use with caution in patients with a history of gastrointestinal disease, particularly
colitis.
• Renal impairment: Use with caution in patients with renal impairment; modify dosage in severe
impairment.
• Seizure disorders: Use with caution in patients with a history of seizure disorder; high levels,
particularly in the presence of renal impairment, may increase risk of seizures.
Special populations:
• Children: In pediatric patients ≥3 months of age, higher doses have been associated with an
increased incidence of eosinophilia and elevated AST.
• Elderly: This drug is known to be substantially excreted by the kidney, and the risk of toxic
reactions to this drug may be greater in patients with impaired renal function. Elderly patients are
more likely to have decreased renal function; use care in dose selection and monitor renal
function.
Other:
• Discontinuation of therapy: For group A beta-hemolytic streptococcal infection, antimicrobial
therapy should be given for at least 10 days to guard against the risk of rheumatic fever or
glomerulonephritis.
• Drug/Laboratory Test Interactions:
High concentrations of cefoxitin (>100 micrograms/mL) may interfere with measurement of
serum and urine creatinine levels. Serum samples from patients treated with cefoxitin should not
be analyzed for creatinine if withdrawn within 2 hours of drug administration.
A false-positive reaction for glucose in the urine may occur.
Storage Storage/Stability
Vials at 2°C and 25°C Avoid exposure to high temperatures.
Cefoxitin tends to darken depending on storage conditions.
Reconstituted solutions of 1 g per 10 mL in SWFI, bacteriostatic water for injection, N.S 0.9%
injection, or D5W injection are stable for 6 hours at room temperature or for 7 days under
refrigeration (<5°C). Do not freeze.
Refer to manufacturer PIL if there are specific considerations.

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3. Cefprozil
Watch Group

Generic Name Cefprozil

Dosage Tablets 250mg, 500mg

form/strengths Powder for Oral Suspension 125 mg/5ml 250 mg/5ml
Route of Oral
administration
Pharmacologic Second Generation Cephalosporin Antibiotic
action ATC: J01DC10
Indications Acute bacterial exacerbation of chronic bronchitis: Treatment of mild to moderate acute
bacterial exacerbations of chronic bronchitis.
Otitis media: Treatment of mild to moderate otitis media.
Pharyngitis/tonsillitis: Treatment of mild to moderate pharyngitis/tonsillitis.
Skin and skin-structure infections, uncomplicated: Treatment of mild to moderate
uncomplicated skin and skin-structure infections.
Dosage Dosing: Adult
Regimen Acute bacterial exacerbation of chronic bronchitis: Oral: 500 mg every 12 hours for 10 days.
Pharyngitis/tonsillitis: Oral: 500 mg every 24 hours for 10 days (administer for ≥10 days if due
to S. pyogenes).
Skin and skin-structure infections, uncomplicated: Oral: 250 or 500 mg every 12 hours, or
500 mg every 24 hours for 10 days.
Dosing: Pediatric
General dosing, susceptible infection Infants, Children, and Adolescents: Oral: Mild to
moderate infection: 7.5 to 15 mg/kg/dose twice daily; maximum single dose: 500 mg/dose.
Bronchitis, acute bacterial exacerbation of chronic bronchitis: Adolescents: Oral: 500 mg
every 12 hours for 10 days.
Otitis media, acute: Infants ≥6 months and Children: Oral: 15 mg/kg/dose every 12 hours for
10 days; maximum single dose: 500 mg/dose. Note: Cefprozil is not routinely recommended
as a treatment option in the acute otitis media guidelines.
Pharyngitis/tonsillitis:
Children ≥2 years: Oral: 7.5 mg/kg/dose every 12 hours for 10 days; maximum single dose:
500 mg/dose.
Adolescents: Oral: 500 mg every 24 hours for 10 days.
Rhinosinusitis: Note: Not recommended for the empiric monotherapy of acute sinusitis due
to risk of resistance
Infants ≥6 months and Children: Oral: 7.5 to 15 mg/kg/dose every 12 hours for 10 days;
maximum single dose: 500 mg/dose.
Adolescents: Oral: 250 to 500 mg every 12 hours for 10 days.
Skin and skin structure infection, uncomplicated: Oral:
Children ≥2 years: 20 mg/kg/dose once daily for 10 days; maximum single dose: 500 mg/dose.
Adolescents: 250 mg every 12 hours or 500 mg every 12 to 24 hours for 10 days.
Urinary tract infection: Oral: Infants ≥2 months and Children ≤2 years: 15 mg/kg/dose twice
daily for 7 to 14 days.
Dosage Dosing: Renal Impairment:
adjustment CrCl ≥30 mL/minute: No dosage adjustment necessary.
CrCl <30 mL/minute: Reduce usual recommended dose by 50%.
End-stage renal disease on hemodialysis: Give dose after dialysis on dialysis days.
Dosing: Hepatic Impairment:

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No dosage adjustment necessary.

Contra- Hypersensitivity to cefprozil, any component of the formulation, or other cephalosporins.

indications
Adverse Drug 1% to 10%:
Reactions Central nervous system: Dizziness (1%)
Dermatologic: Diaper rash (2%), genital pruritus (2%)
Gastrointestinal: Nausea (4%), diarrhea (3%), abdominal pain (1%), vomiting (1%)
Genitourinary: Vaginitis
Hepatic: Increased serum transaminases (2%)
Infection: Superinfection
Monitoring Monitor renal functions specially in elderly patients.
Parameters
Drug • Aminoglycoside antibiotics: Nephrotoxicity has been reported following concomitant
Interactions administration of aminoglycoside antibiotics and cephalosporin antibiotics.
• Probenecid: Concomitant administration of probenecid doubled the AUC for cefprozil.
Pregnancy and Pregnancy category B. Small amounts of cefprozil are excreted in breast milk.
Lactation Caution should be exercised when administering cefprozil to nursing women. Nondose-
related effects could include modification of bowel flora.
Administration Oral: Take with or without food. Take with food if it causes an upset stomach.
Shake suspension well before use. Measure liquid doses carefully.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Hypersensitivity: If a serious hypersensitivity reaction occurs, discontinue and institute
emergency supportive measures, including airway management and treatment (eg,
epinephrine, antihistamines and/or corticosteroids).
• Penicillin allergy: Use with caution in patients with a history of penicillin allergy.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C.
difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed
>2 months postantibiotic treatment.
Disease-related concerns:
• Gastrointestinal disease: Use with caution in patients with a history of gastrointestinal
disease, particularly colitis.
• Renal impairment: Use with caution in patients with renal impairment; modify dosage in
severe impairment.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic
acid; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a
potentially fatal toxicity ("gasping syndrome") in neonates; avoid or use dosage forms
containing benzyl alcohol derivative with caution in neonates.
• Phenylalanine: Some products may contain phenylalanine.
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens).
Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure
to pharmaceutical products containing polysorbate 80 in certain individuals.
Storage Store tablets at room temperature in a dry place.
Store suspension in a refrigerator. Throw away any part not used after 2 weeks.
Refer to manufacturer PIL if there are specific considerations.

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4. Cefuroxime
Watch Group

Generic Name Cefuroxime

Dosage Oral suspension 125mg/5ml, 250mg/5ml

form/strengths Tablets 125mg, 250mg, 500mg, 1g,
Powder for injection 250mg, 750mg, 1500mg,
Route of Oral, IV, IM
administration
Pharmacologic Antibiotic, Cephalosporin (Second Generation)
action ATC: J01DC02
Indications Bone and joint infections (injection only)
Chronic obstructive pulmonary disease, acute exacerbation (tablets only): Treatment of mild
to moderate acute bacterial exacerbations of chronic bronchitis in adults and adolescents ≥13
years of age
Lower respiratory tract infections (injection only)
Lyme disease (early) (tablets only): Treatment of adults and adolescents ≥13 years of age
Otitis media, acute (tablets and oral suspension only): Treatment of pediatric patients ≥3
months of age with acute bacterial otitis media
Pharyngitis/tonsillitis (tablets and oral suspension only): Treatment of mild to moderate
pharyngitis/tonsillitis
Septicemia (injection only)
Sinusitis, acute bacterial (tablets and oral suspension only): Treatment of mild to moderate
acute bacterial maxillary sinusitis
Skin and skin-structure infections (impetigo) (oral suspension only): Treatment of pediatric
patients 3 months to 12 years of age.
Skin and skin-structure infections (injection; tablets [uncomplicated infections
only]): Treatment of adults and pediatric patients >3 months of age with skin and skin-
structure infections
Surgical prophylaxis (injection only): Prophylaxis of infection in patients undergoing surgical
procedures that are classified as clean-contaminated or potentially contaminated procedures.
Urinary tract infections (tablets and injection only): Treatment of adults and pediatric patients
>3 months of age with urinary tract
Dosage Adults
Regimen General Adult Dosage
Oral
Tablets: 250 or 500 mg twice daily for 10 days
IV or IM: 750–1.5 g every 8 hours for 5–10 days.
Life-threatening Infections or Those Caused by Less Susceptible Organisms
IV or IM: 1.5 g every 6 hours
Pediatric Patients
General dosing, susceptible infection Infants, Children, and Adolescents:
Mild to moderate infection:
Oral: 20 to 30 mg/kg/day divided twice daily; maximum dose: 500 mg/dose
IM, IV: 75 to 100 mg/kg/day divided in 3 doses; maximum dose: 1,500 mg/dose
Severe infection: IM, IV: 100 to 200 mg/kg/day divided in 3 to 4 doses; maximum dose: 1,500
mg/dose
Dosage Dosing: Renal Impairment: Adult
adjustment Adults with impaired renal function: 750 mg IM or IV every 12 hours in those with Clcr 10–20

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mL/minute or 750 mg IM or IV every 24 hours in those with Clcr <10 mL/minute.
Children with impaired renal function: Adjust dosing frequency for IM or IV cefuroxime similar
to those recommended for adults with renal impairment.
Dosing: Hepatic Impairment: Adult
There are no dosage adjustments needed.
Contra- Hypersensitivity to cefuroxime, any component of the formulation, or other beta-lactam
indications antibacterial drugs (eg, penicillins and cephalosporins)

Adverse Drug >10%: Gastrointestinal: Diarrhea (4% to 11%, duration dependent)

Reactions Hematologic & oncologic: Decreased hematocrit (≤10%), decreased hemoglobin (≤10%
Monitoring Monitor renal, hepatic, and hematologic function periodically with prolonged therapy. Monitor
Parameters prothrombin time in patients at risk of prolongation during cephalosporin therapy
(nutritionally-deficient, prolonged treatment, renal or hepatic disease). Observe for signs and
symptoms of anaphylaxis during first dose
Drug • Risk X: Avoid combination
Interactions BCG (Intravesical), Cholera Vaccine, Histamine H2 Receptor Antagonists, Proton Pump
Inhibitors
• Risk D: Consider therapy modification
Antacids, Sodium Picosulfate, Typhoid Vaccine
• Risk C: Monitor therapy
Aminoglycosides, BCG Vaccine (Immunization), Lactobacillus and Estriol, Probenecid,
Vitamin K Antagonists
Pregnancy and Pregnancy Category B
Lactation Beta-lactam antibiotics are generally considered compatible with breastfeeding when used in
usual recommended doses; cefuroxime was not specifically included within this report. the
decision to breastfeed during therapy should consider the risk of infant exposure, the benefits
of breastfeeding to the infant, and benefits of treatment to the mother.
Administration Administration: IM
• Prepare IM injections by reconstituting vial containing 750 mg of cefuroxime with 3 mL of
sterile water for injection to provide a suspension containing approximately 220 mg/mL.
• Inject deep IM into large muscle mass.
Administration: IV
• Reconstitute vials containing 750 mg or 1.5 g of cefuroxime with 8 or 16 mL of sterile water
for injection, respectively, to provide solutions containing approximately 90 mg/mL.
• Inject direct IV over 3 to 5 minutes. Infuse intermittent infusion over 15 to 30 minutes.
Administration: Oral
Suspension: Administer with food. Shake well before use.
Tablet: May administer with or without food. administer with food to decrease GI upset;
avoid crushing the tablet due to its bitter taste
N.B. Hypersensitivity test must be done before using injection form of this medicine.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ • Elevated INR: May be associated with increased INR, especially in nutritionally-deficient
Precautions patients, prolonged treatment, hepatic or renal disease. Hypersensitivity reactions: Serious and
occasionally severe or fatal hypersensitivity (anaphylactic) reactions have been reported in
patients receiving beta-lactam drugs.
Before initiating therapy, carefully investigate previous penicillin, cephalosporin, or other
allergen hypersensitivity. Use caution if given to a patient with a penicillin or other beta-lactam
allergy because cross sensitivity among beta-lactam antibacterial drugs has been established. If
an allergic reaction occurs, discontinue and institute appropriate therapy.

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• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C.
difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed
>2 months postantibiotic treatment
Storage • Injection: Store intact vials at 15°C to 30°C; protect from light. Reconstituted solution is
stable for 24 hours at room temperature and 48 hours when refrigerated. IV infusion in NS
or D5W solution is stable for 24 hours at room temperature, 7 days when refrigerated, or
26 weeks when frozen. After freezing, thawed solution is stable for 24 hours at room
temperature or 21 days when refrigerated.
• Oral suspension: Prior to reconstitution, store at 2°C to 30°C. Reconstituted suspension is
stable for 10 days at 2°C to 8°C.
• Tablet: Store at 15°C to 30°C
• Refer to manufacturer PIL if there are specific considerations.

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c) Third Generation Cephalosporins Watch Group
1. Cefdinir
Generic Name Cefdinir

Dosage Oral suspension: 125mg/5ml, 250mg/5ml

form/strengths Capsule 300mg,

Route of Oral
administration
Pharmacologic Antibiotic, Cephalosporin (Third Generation)
action ATC: J01DD15
Indications Chronic obstructive pulmonary disease, acute exacerbation: Treatment of acute
exacerbations of chronic bronchitis in adults and adolescents
Otitis media, acute: Treatment of acute bacterial otitis media in pediatrics
Pneumonia, community-acquired: Treatment of community-acquired pneumonia in adults
and adolescents
Sinusitis, acute: Treatment of acute maxillary sinusitis in adults and adolescents
Skin and skin structure infections, uncomplicated: Treatment of uncomplicated skin and skin
structure infections in adults, adolescents, and pediatric patients
Streptococcal pharyngitis (group A): Treatment of pharyngitis/tonsillitis in adults,
adolescents, and pediatric patients
Dosage Dosing: Adult:
Regimen The total daily dose for all infections is 600 mg.
Once-daily dosing for 10 days is as effective as twice dosing.
Once-daily dosing has not been studied in pneumonia or skin infections; therefore, should be
administered twice daily in these infections.
Dosing: Pediatric
General dosing, susceptible infection: Mild to moderate infections: Infants, Children, and
Adolescents: Oral: 14 mg/kg/day in divided doses 1 to 2 times daily; maximum daily dose:
600 mg/day
Dosage Dosing: Renal Impairment: Adult
adjustment CrCl ≥30 mL/minute: No dosage adjustment necessary.
CrCl <30 mL/minute: Oral: 300 mg once daily
ESRD requiring intermittent hemodialysis (IHD): Dialyzable: (63%): Oral: Initial dose: 300 mg
(or 7 mg/kg/dose) every other day. Postdialysis, 300 mg (or 7 mg/kg/dose) should be given.
Subsequent doses (300 mg or 7 mg/kg/dose) should be administered every other day.
Dosing: Renal Impairment: Pediatric
Infants ≥6 months and Children:
CrCl ≥30 mL/minute/1.73 m2: No adjustment required
CrCl <30 mL/minute/1.73 m2: 7 mg/kg/dose once daily; maximum daily dose: 300 mg/day
Adolescents:
CrCl ≥30 mL/minute: No adjustment required
CrCl <30 mL/minute: 300 mg once daily
Hemodialysis: Dialyzable (63%): Infants ≥6 months, Children, and Adolescents: Initial dose: 7
mg/kg/dose (maximum dose: 300 mg) every other day. At the conclusion of each
hemodialysis session, an additional dose (7 mg/kg/dose up to 300 mg) should be given.

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Subsequent doses should be administered every other day.
Dosing: Hepatic Impairment:
No dosage adjustment necessary.
Contra- Hypersensitivity to cefdinir, any component of the formulation, or other cephalosporins.
indications
Adverse Drug Gastrointestinal: Diarrhea (8% to 15%)
Reactions Central nervous system: Headache (2%)
Dermatologic: Skin rash (≤3%)
Genitourinary: Vulvovaginal candidiasis (≤4%)

Monitoring Monitor renal function. Observe for signs and symptoms of anaphylaxis during first dose.
Parameters
Drug Risk X: Avoid combination
Interactions BCG (Intravesical), Cholera Vaccine,
Risk D: Consider therapy modification
Iron Preparations, Multivitamins/Minerals (with ADEK, Folate, Iron), Sodium Picosulfate,
Typhoid Vaccine
Risk C: Monitor therapy
Aminoglycosides, BCG Vaccine (Immunization), Lactobacillus and Estriol, Metformin,
Probenecid, Vitamin K Antagonists
Pregnancy and Pregnancy Risk Factor: B
Lactation Cefdinir was not detectable in breast milk following a single cefdinir 600 mg dose.
Administration Administration: Oral
May be administered with or without food. Administer at least 2 hours before or after
antacids or iron supplements. Shake suspension well before use.
Administration: Pediatric
Oral: May administer with or without food; administer with food if stomach upset occurs;
administer cefdinir at least 2 hours before or after antacids or iron supplements; shake
suspension well before use.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ • Penicillin allergy: Use with caution in patients with a history of penicillin allergy,
Precautions especially IgE-mediated reactions (eg, anaphylaxis, angioedema, urticaria).
• Superinfection: Prolonged use may result in fungal or bacterial superinfection,
including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has
been observed >2 months postantibiotic treatment.
Geriatric Considerations
Cefdinir has not been studied exclusively in the elderly. Patients ≥65 years of age have
been included in clinical trials. No information is available on the elderly's response or
tolerance.
• coadministered Iron-containing products do not affect the pharmacokinetics of
cefdinir but may result in the development of red-appearing, nonbloody stools
Storage Store at 20°C to 25°C.
Store reconstituted suspension at room temperature 20°C to 25°C for 10 days.
Refer to manufacturer PIL if there are specific considerations.

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Watch Group
2. Cefixime
Generic Name Cefixime

Dosage Oral suspension 100mg/5ml, 200mg/5ml

form/strengths Tablets 200mg
Capsules 200mg, 400mg
Route of Oral
administration
Pharmacologic Antibiotic, Cephalosporin (Third Generation)
category ATC: J01DD08
Indications Acute Otitis Media (AOM)
Pharyngitis and tonsillitis
Acute exacerbations of chronic bronchitis
Uncomplicated cervical/urethral gonorrhea
Uncomplicated urinary tract infections
Dosage Dosing: Adult: Usual dosage range:
Regimen Oral: 400 mg daily divided every 12 to 24 hours.
Pediatric dosing; susceptible infection (mild to moderate): Infants, Children, and
Adolescents: Oral: 8 mg/kg/day divided every 12 to 24 hours; maximum daily dose: 400
mg/day
• Do not use capsules or conventional tablets for treatment of Acute otitis media.
Dosage Dosing: Renal Impairment: Adult oral suspension is recommended
adjustment CrCl ≥60 mL/minute: No dosage adjustment necessary.
CrCl 21 to 59 mL/minute: 260 mg once daily
CrCl ≤20 mL/minute: 170-180 mg once daily
Intermittent hemodialysis (not significantly removed by hemodialysis):
Suspension: 260 mg once daily
Adults undergoing peritoneal dialysis:
tablet: 200 mg once daily
oral suspension: 170-180 mg once daily
Dosing: Renal Impairment: Pediatric
Infants ≥6 months, Children, and Adolescents: Very limited data available
Dosing: Hepatic Impairment:
No dosage adjustment needed.

Contra- Hypersensitivity to cefixime, any component of the formulation, or other cephalosporins or

indications penicillins

Adverse Drug >10%: Gastrointestinal: Diarrhea (16%)

Reactions 2% to 10%: Gastrointestinal: Abdominal pain, nausea, dyspepsia, flatulence, loose stools
<2%: Acute renal failure, hepatitis
Monitoring Renal function; with prolonged therapy, monitor renal and hepatic function periodically.
Parameters Observe for signs and symptoms of anaphylaxis during first dose. When used as part of
alternative treatment for gonococcal infection, test-of-cure 7 days after dose
Drug Risk X: Avoid combination
Interactions BCG (Intravesical), Cholera Vaccine,
Risk D: Consider therapy modification
Sodium Picosulfate, Typhoid Vaccine

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Risk C: Monitor therapy
Aminoglycosides, BCG Vaccine (Immunization), Lactobacillus and Estriol, Probenecid,
Vitamin K Antagonists
Pregnancy and Pregnancy Category B
Lactation It is not known whether cefixime is present in breast milk.
Administration Administer without regard to meals.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ • Dermatologic reactions: Severe cutaneous reactions (eg, toxic epidermal necrolysis,
Precautions Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms [DRESS])
have been reported. If a reaction occurs, discontinue and institute supportive therapy.
• Hemolytic anemia: Immune-mediated hemolytic anemia (including fatalities) have been
reported. Monitor patient (including hematologic parameters and drug-induced antibody
testing when clinically appropriate) during and for 2 to 3 weeks after therapy. If hemolytic
anemia occurs during therapy, discontinue use.
• Hypersensitivity: Hypersensitivity and anaphylaxis have been reported in patients
receiving beta-lactam drugs. Use caution in patients with a history of hypersensitivity to
cephalosporins, penicillins, or other beta-lactams. If administered to penicillin-sensitive
patients, use with caution and discontinue use if allergic reaction occurs.
• Renal failure: May cause acute renal failure including tubulointerstitial nephritis. If renal
failure occurs, discontinue and initiate appropriate supportive therapy.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection,
including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has
been observed >2 months postantibiotic treatment.
• Gastrointestinal disease: Use with caution in patients with a history of gastrointestinal
disease.
• Hemolytic anemia: Should not be administered to patients with a history of
cephalosporin-associated hemolytic anemia; recurrence of hemolysis is more severe
Storage • Capsule, chewable tablet: Store at 20°C to 25°C.
• Powder for suspension: Prior to reconstitution, store at 20°C to 25°C. After
reconstitution, suspension may be stored for 14 days at room temperature or under
refrigeration.
• Refer to manufacturer PIL if there are specific considerations.

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Watch Group
3. Cefpodoxime
Generic Name Cefpodoxime

Dosage Oral Suspension: 50,100 mg/5 mL

form/strengths Oral tablets 100, 200 mg

Route of Oral
administration
Pharmacologic Antibiotic, Cephalosporin (Third Generation)
category ATC: J01DD13
Indications − Chronic obstructive pulmonary disease, acute exacerbation
− Cystitis, acute uncomplicated
− Otitis media, acute
− Pneumonia, community-acquired
− Rhinosinusitis, acute bacterial
− Skin and soft tissue infection
− Streptococcal pharyngitis, group A
Dosage Dosing: Adult, Geriatric
Regimen Chronic obstructive pulmonary disease, acute exacerbation: Note: Avoid use in patients with risk
factors for Pseudomonas infection or poor outcomes (eg, ≥65 years of age with major
comorbidities, FEV1 <50% predicted, frequent exacerbations). Oral: 200 mg twice daily for 3 to 7
days
Otitis media, acute (alternative agent for patients with penicillin allergy that does not preclude
cephalosporin use): Oral: 200 mg twice daily. Duration is 5 to 7 days for mild to moderate
infection and 10 days for severe infection.
Pneumonia, community-acquired, outpatient empiric therapy (alternative agent): Oral: 200 mg
twice daily as part of an appropriate combination regimen. Duration of therapy is for a minimum
of 5 days; patients should be clinically stable with normal vital signs before therapy is
discontinued.
Rhino sinusitis, acute bacterial (alternative agent for patients with penicillin allergy who are
able to tolerate cephalosporins):
Oral: 200 mg twice daily with clindamycin for 5 to 7 days; some experts use as monotherapy
when the risk of drug-resistant S. pneumoniae is low (eg, <65 years of age, low endemic
resistance, few comorbidities, no recent hospitalization or antibiotic use).
Skin and soft tissue infection (alternative agent): Oral: 400 mg every 12 hours for 7 to 14 days.
Streptococcal pharyngitis, group A (alternative agent for mild, non-anaphylactic penicillin
allergy): Oral: 100 mg twice daily for 5 to 10 days.
Urinary tract infection (alternative agent): Note: Use only when first-line agents cannot be used;
Cystitis, acute uncomplicated or acute simple cystitis (infection limited to the bladder without
signs/symptoms of upper tract, prostate, or systemic infection): Oral: 100 mg twice daily for 5 to 7
days.

Dosing: Pediatric
General dosing, susceptible infection: Mild to moderate infections: Infants, Children, and
Adolescents: Oral: 5 mg/kg/dose every 12 hours; usual maximum dose: 200 mg/dose; however,
in patients ≥12 years, higher doses (ie, 400 mg/dose) may be required for some types of infection.
Bronchitis, bacterial exacerbation of chronic: Children ≥12 years and Adolescents: Oral: 200 mg

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every 12 hours for 10 days
Otitis media, acute: Infants and Children 2 months to 12 years: Oral: 5 mg/kg/dose every 12
hours; maximum dose: 200 mg/dose. AAP guidelines recommend duration based on patient age:
If <2 years of age or severe symptoms (any age): 10-day course; if 2 to 5 years of age with mild to
moderate symptoms: 7-day course; if ≥6 years of age with mild to moderate symptoms: 5- to 7-
day course.
Pharyngitis/tonsillitis:
Infants ≥2 months and Children <12 years: Oral: 5 mg/kg/dose every 12 hours for 5 to 10 days;
maximum dose: 100 mg/dose
Children ≥12 years and Adolescents: Oral: 100 mg every 12 hours for 5 to 10 days
Pneumonia, acute community-acquired:
Infants >3 months and Children <12 years: Limited data available: Oral: 5 mg/kg/dose every 12
hours; maximum dose: 200 mg/dose
Children ≥12 years and Adolescents: Oral: 200 mg every 12 hours for 14 days
Rhino sinusitis, acute maxillary:
Infants ≥2 months and Children <12 years: Oral: 5 mg/kg/dose every 12 hours for 10 days;
maximum dose: 200 mg/dose; Note: IDSA recommends use in combination with clindamycin for
10 to 14 days in patients with non-type 1 penicillin allergy, after failure of initial therapy or in
patients at risk for antibiotic resistance (eg, daycare attendance, age <2 years, recent
hospitalization, antibiotic use within the past month).
Children ≥12 years and Adolescents: Oral: 200 mg every 12 hours for 10 days.
Skin and skin structure: Children ≥12 years and Adolescents: Oral: 400 mg every 12 hours for 7
to 14 days
Urinary tract infection, uncomplicated: Children ≥12 years and Adolescents: Oral: 100 mg every
12 hours for 7 days
Dosage Dosing: Renal Impairment: Adult
adjustment CrCl ≥30 mL/minute: No dosage adjustment necessary.
CrCl <30 mL/minute: Administer usual recommended dose every 24 hours.
Hemodialysis, intermittent (thrice weekly): Dialyzable (~50%): 100 to 200 mg every 24 hours;
when scheduled dose falls on a dialysis day, administer after hemodialysis.
Peritoneal dialysis: Negligible clearance: 100 to 200 mg every 24 hours.
CRRT: Recommendations are based on high-flux dialyzers and effluent flow rates of 20 to 25
mL/kg/hour (or ~1,500 to 3,000 mL/hour), unless otherwise noted. Close monitoring of response
and adverse reactions due to drug accumulation is important.
Dose as for CrCl ≥30 mL/minute.
PIRRT (eg, sustained, low-efficiency diafiltration): Appropriate dosing requires consideration of
adequate drug concentrations (eg, site of infection) and consideration of initial loading doses.
Close monitoring of response and adverse reactions due to drug accumulation is important.
Dose as for CrCl ≥30 mL/minute.

Dosing: Renal Impairment: Pediatric

Infants ≥2 months, Children, and Adolescents:
CrCl ≥30 mL/minute: No dosage adjustment necessary.
CrCl <30 mL/minute: Administer every 24 hours.
Hemodialysis: Approximately 23% removed during a 3-hour dialysis session. Administer dose 3
times weekly after hemodialysis.
Dosing: Hepatic Impairment: Adult
Cirrhosis (with or without ascites): no dosage adjustments.
Dosing: Hepatic Impairment: Pediatric
Infants ≥ 2 months, Children, and Adolescents: No dosage adjustment necessary in patients with

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cirrhosis.

Contra- Hypersensitivity to cefpodoxime, any component of the formulation, or other cephalosporins.

indications
Adverse Drug >10%:
Reactions Dermatologic: Diaper rash (12%)
Gastrointestinal: Diarrhea (infants and toddlers 15%)
1% to 10%:
Central nervous system: Headache (1%)
Dermatologic: Skin rash (1%)
Gastrointestinal: Diarrhea (7%), nausea (4%), abdominal pain (2%), vomiting (1% to 2%)
Genitourinary: Vaginal infection (3%)
Monitoring Monitor renal function. Observe for signs and symptoms of anaphylaxis during first dose.
Parameters
Drug Risk X: Avoid combination
Interactions BCG (Intravesical), Cholera Vaccine.
Risk D: Consider therapy modification
Sodium Picosulfate, LIVE Typhoid Vaccine
Pregnancy and Pregnancy Category B.
Lactation There are no adequate and well-controlled trials in pregnant women
Cefpodoxime is present in breast milk.
Due to the potential for serious adverse reactions in the breastfed infant, a decision be made to
discontinue breastfeeding or to discontinue the drug, taking into account the importance of
treatment to the mother.
Administration Preparation: Oral suspension:
Reconstitute powder for oral suspension with appropriate amount of water as specified on the
bottle. Shake vigorously until suspended.
Administration: Oral
Administer around-the-clock to promote less variation in peak and trough serum levels.
Administer tablets with food; suspension may be administered without regard to food.
Shake suspension well before using.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Beta-lactam allergy: Use with caution in patients with a history of beta-lactam allergy, especially
IgE-mediated reactions (e.g., anaphylaxis, angioedema, urticaria).
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C.
difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2
months post antibiotic treatment.
Disease-related concerns:
• Renal impairment: Use with caution in patients with renal impairment; modify dosage in severe
impairment.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid;
benzoic acid (benzoate),large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated
with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome”
consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction
(including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse; avoid
or use dosage forms containing benzyl alcohol derivative with caution in neonates.

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Storage Storage/Stability
Suspension: Store at 20°C to 25°C; after reconstitution, suspension may be stored in refrigerator
for 14 days.
Tablet: Store at 20°C to 25°C; protect from light.
Refer to manufacturer PIL if there are specific considerations.

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4. Cefoperazone
Watch Group

Generic Name Cefoperazone

Dosage 500 mg vial, 1 gm vial, 2gm

form/strengths
Route of Parenteral IV, IM
administration
Pharmacologic Third-generation cephalosporin antibacterial
category ATC: J01DD12
Indications Respiratory Tract Infections
Peritonitis and Other Intra-Abdominal Infections
Bacterial Septicemia
Infections of the Skin and Skin Structures
Pelvic Inflammatory Disease, Endometritis, and Other Infections of the Female Genital
Tract
Urinary Tract Infections
Some Enterococcal Infections
Dosage Adult Dosing
Regimen • The usual adult daily dose: 2 - 4 grams daily divided every 12 hours.
• In severe infections: up to 6–12 grams daily divided into 2, 3 or 4 times from 1.5 to
4 grams per dose.
• In case of Streptococcus pyogenes, therapy should be continued for at least 10
days.
Dosage There are no dosage adjustments for hepatic or renal impairment.
adjustment Dose of cefoperazone should not exceed 4 g daily in patients with liver disease or biliary
obstruction or 1 to 2 g daily in those with both hepatic and renal impairment; if higher
doses are used plasma concentrations of cefoperazone should be monitored
Contra- contraindicated in patients with known hypersensitivity to the cephalosporin-class of
indications antibacterial drugs.

Adverse Drug Hypersensitivity: skin reactions, drug fever, or a change in Coombs' test has been
Reactions reported. These reactions are more likely to occur in patients with a history of allergies,
particularly to penicillin.
Hematology: reversible neutropenia may occur with prolonged administration.
Decreased hemoglobins or hematocrits have been reported. Transient eosinophilia has
occurred.
Hepatic: mild transient elevations of liver function enzymes have been observed in 5–10%
of the patients.
Gastrointestinal
Diarrhea or loose stools has been reported in 1 in 30 patients. Most of these experiences
have been mild or moderate in severity and self-limiting in nature. Nausea and vomiting
have been reported rarely.
Symptoms of pseudomembranous colitis can appear during or for several weeks
subsequent to antibiotic therapy
Renal Function Tests: Transient elevations of the BUN and serum creatinine have been
noted.
Local Reactions
well tolerated following intramuscular administration. Occasionally, transient pain (1 in

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140) may follow intramuscular administration. In case of intravenous infusion some
patients may develop phlebitis at the infusion site.
Monitoring CBC, hepatic functions. Prothrombin time should be monitored in patients at risk of
Parameters hypoprothrombinaemia and vitamin K used if necessary.
Drug • Admixture of cefoperazone sodium with aminoglycosides is not recommended
Interactions because of the potential for inactivation of either drug.
• Incompatibility with other drugs including diltiazem, doxorubicin, pentamidine,
perphenazine, pethidine, promethazine, and remifentanil.
• A false-positive reaction for glucose in the urine may occur with Benedict’s or
Fehling’s solution.
Pregnancy and Pregnancy Category B
Lactation Cefoperazone is excreted into human milk in small amounts. Adverse effects in the
nursing infant are unlikely. Other cephalosporins have been classified as compatible with
breast-feeding by the American Academy of Pediatrics.
Administration Preparation for IV
General
Cefoperazone concentrations between 2 mg/mL and 50 mg/mL are recommended for
intravenous administration.
Compatible solutions: 0.9% Sodium Chloride, Dextrose 5% ,10% or Dextrose and Sodium
Chloride Injection
Preparation of Vials
initially reconstitute with a minimum of 2.8 mL per gram of cefoperazone of any
compatible reconstituting solution. For ease of reconstitution the use of 5 mL of
compatible solution per gram vial is recommended.
Intermittent Infusion
should be administered over a 15–30 minutes time period.
Continuous Infusion
can be used for continuous infusion after dilution to a final concentration of between 2
and 25 mg cefoperazone per mL.
Preparation for Intramuscular Injection
Any suitable solution listed above may be used to prepare cefoperazone for intramuscular
injection. When concentrations of 250 mg/mL or more are to be administered, a lidocaine
solution should be used. These solutions should be prepared using a combination of
Sterile Water for Injection and 2% Lidocaine Hydrochloride Injection (USP) that
approximates a 0.5% Lidocaine Hydrochloride Solution. A two-step dilution process as
follows is recommended: First, add the required amount of Sterile Water for Injection and
agitate until powder is completely dissolved. Second, add the required amount of 2%
lidocaine and mix.
N.B. Hypersensitivity test must be done before using injection form of this medicine.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ • Cefoperazone has the potential for promoting colonisation and superinfection with
Precautions resistant organisms. Changes in bowel flora may be more marked than with
cefotaxime because of the greater biliary excretion of cefoperazone; diarrhoea may
occur more often.
• Hypoprothrombinaemia has been reported in patients treated with cefoperazone and
has rarely been associated with bleeding episodes. Prothrombin time should be
monitored in patients at risk of hypoprothrombinaemia and vitamin K used if
necessary.
When administered by intravenous infusion some patients may develop phlebitis (1

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in 120) at the infusion site

Storage Stored at or below 25°C and protected from light prior to reconstitution. After
reconstitution, protection from light is not necessary.
Refer to manufacturer PIL if there are specific considerations.

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5. Cefoperazone and Sulbactam
Generic Name Cefoperazone and Sulbactam

Dosage Injection, powder for reconstitution: Cefoperazone 1000 mg ; Sulbactam 500 mg

form/strengths
Route of IV, IM
administration
Pharmacologic Antibiotic, Cephalosporin
category ATC: J01DD62
Indications Upper and lower respiratory tract infections
Urinary tract infections
Skin, soft tissue, bone and joint infections
Bacterial septicemia, meningitis
Intra-abdominal and soft tissue infections: peritonitis, cholecystitis, cholangitis.
Gynecology infections: pelvic inflammatory disease, endometritis, gonorrhea.
Dosage Dosage:
Regimen Adult
Usual dose: IM, IV: Adults: 1-2 g (cefoperazone) every 12 hours; maximum daily dose: 4 g
(sulbactam). Additional administration of cefoperazone (without sulbactam) may be required in
Severe Cases
Pediatric
Recommended doses: 60-120 mg/kg/day, given in equally divided doses every 6-12 hours. For
serious infections: Up to 160 mg/kg/day, Max dose of sulbactam: 80 mg/kg/day
Dosage CrCl (mL/min) 15-30 mL/min should receive a maximum of 1 g of sulbactam every 12 hours
adjustment (maximum daily dosage of 2 g sulbactam),

CrCl (mL/min): <15 should receive a maximum of 500 mg of sulbactam every 12 hours (maximum
daily dosage of 1 g sulbactam).
In severe infections it may be necessary to administer additional cefoperazone
Hemodialysis: dosing must be scheduled to follow a dialysis period.

Contra- Hypersensitivity to cefoperazone, sulbactam, or other β-lactam antibacterial (e.g. cephalosporin,

indications penicillin).

Adverse Drug Significant:

Reactions Vitamin K deficiency resulting to coagulopathy, overgrowth of non-susceptible organisms
(prolonged use).
Blood and lymphatic system disorders: Neutropenia, leucopenia, eosinophilia,
thrombocytopenia, hypo prothrombinaemia.
Gastrointestinal disorders: Nausea, vomiting, diarrhea.
General disorders and administration site conditions: Pyrexia, chills, infusion site phlebitis,
injection site pain.
Hepatobiliary disorders: Jaundice
Investigations: Decreased Hb conc, hematocrit; increased AST, ALT, blood alkaline phosphatase,
blood bilirubin.
Nervous system disorders: Headache.
Renal and urinary disorders: Hematuria, Transient elevations in BUN and serum creatinine
concentrations

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Skin and subcutaneous tissue disorders: Pruritus, urticaria, Rash, skin reactions, fever
Vascular disorders: Hypotension, vasculitis.

Potentially Fatal: Clostridium-difficile-associated diarrhea, hypersensitivity reactions including

anaphylactic and severe cutaneous adverse reactions (e.g. toxic epidermal necrolysis, Stevens-
Johnson syndrome); serious hemorrhage.
Monitoring Symptoms of overdose include blood in the urine, diarrhea, nausea, upper abdominal pain, and
Parameters vomiting.
Hematologic status (e.g. prothrombin time), renal, and hepatic function. Perform culture and
susceptibility tests; consult local institutional recommendations before treatment initiation due
to antibiotic resistance risks.
Drug Category: X, Avoid combination
Interactions live cholera vaccine & typhoid vaccine, rifampin, BCG
Category: D, consider therapy modification
alcohol, aminoglycosides, heparin, warfarin
Pregnancy and category B
Lactation There are no adequate and well-controlled studies in pregnant women
Only small quantities of cefoperazone and sulbactam are excreted in human milk. Although both
drugs pass poorly into breast milk of nursing mothers, caution should be exercised when
cefoperazone/sulbactam is administered to a nursing mother
Administration IV:
For IV infusion, each vial should be reconstituted with 5-10 ml SWFI, 0.9%NACL, 5% dextrose in
water, and then diluted to 20 ml using the same diluent followed by admin over 15-60 minutes.
For IV injection, each vial should be reconstituted as above and given over at least 3 minutes.
IM:
Vial should be reconstituted with 5 ml SWFI then Lidocaine HCl 2%
N.B. Hypersensitivity test must be done before using injection form of this medicine.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Patient with severe biliary obstruction, poor diet, malabsorption states (e.g. cystic fibrosis).
Precautions Patient on prolonged IV alimentation regimens or receiving anticoagulant therapy.
In patients with hepatic dysfunction and concomitant renal impairment, cefoperazone serum
concentrations should be monitored and dosage adjusted as necessary and not exceed 2 g/day of
cefoperazone.
Sulbactam/cefoperazone has been effectively used in infants. It has not been extensively studied
in premature infants or neonates.
Storage Before reconstitution: Store below 25°C. Protect from light
Reconstituted solutions are stable for 7 days at 2-8°C and for 24 hours at 8-25°C. All unused
portions after the above stated time periods should be discarded.
Refer to manufacturer PIL if there are specific considerations.

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Watch Group
6. Cefotaxime
Generic Name Cefotaxime

Dosage Vial 250 mg, 500 mg, 1 gm, 2gm

form/strengths
Route of IV, IM
administration
Pharmacologic Antibiotic, Cephalosporin (Third Generation)
al category ATC: J01DD01
Indications Treatment of:
Bacteremia/Septicemia.
Bone or joint infections.
CNS infections: (eg, meningitis, ventriculitis)
Genitourinary infections: including urinary tract infections
Gynecologic infections: including pelvic inflammatory disease, endometritis, and pelvic
cellulitis
Intraabdominal infection mild to moderates community-acquired infection in patients
without risk factors for resistance: including peritonitis
Lower respiratory tract infections: including pneumonia
Skin and skin structure infections
Surgical prophylaxis: Reduce the incidence of certain infections in patients undergoing
surgical procedures (eg, abdominal or vaginal hysterectomy, GI and GU tract surgery) that
may be classified as contaminated or potentially contaminated; reduce the incidence of
certain postoperative infections in patients undergoing cesarean section.
Dosage Adults
Regimen General Adult Dosage
Uncomplicated Infections
IV or IM: 1 g every 12 hours.
Moderate to Severe Infections
IV or IM: 1–2 g every 8 hours.
Infections needing higher-doses:2 g IV every 6 to 8 hours
Life-threatening infections:2 g IV every 4 hours

Cesarean section: IM, IV: 1 g IV as soon as the umbilical cord is clamped, then 1 g IV or IM
at 6 and 12 hours after the first dose.

Pediatric Patients
General Dosage
IV or IM
0-1 week: 50 mg/kg IV every 12 hours
1-4 weeks: 50 mg/kg IV every 8 hours
1 month-12 years: 50-180 mg/kg/day IV divided every 4-6 hours
>12 years: refere to adult dose

Prescribing Limits
Adults
Maximum 12 g daily

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Pediatric Patients
Maximum 12 g daily for children weighing >50 kg.
Weighing less than 50 kg: 180 mg/kg/day IV/IM is FDA-approved maximum; however,
doses up to 300 mg/kg/day (Max: 12 g/day) have been used off-label for meningitis.
Neonates
8 days and older: 150 mg/kg/day IV/IM is maximum; however, doses up to 200 mg/kg/day
have been used off-label for meningitis.
0 to 7 days: 100 mg/kg/day IV/IM is maximum; however, doses up to 150 mg/kg/day have
been used off-label for meningitis.

Dosage • Renal impairment:

adjustment Adults:
CrCl <20 mL/minute/1.73 m2: Dose should be decreased by 50%.
Intermittent Hemodialysis Dialysis: approximately 50% of the serum concentration of
cefotaxime is removed during a standard hemodialysis session.
Some clinicians recommend that 0.5 to 2 g be given as single daily doses and that a
supplemental dose of cefotaxime be given after each hemodialysis session.
Peritoneal dialysis: give 1 g IV/IM every 24 hours

Pediatrics:
CrCl 30 to 50 mL/min/1.73 m2: 35 to 70 mg/kg/dose IV/IM every 8 to 12 hours.
CrCl 10 to 29 mL/min/1.73 m2: 35 to 70 mg/kg/dose IV/IM every 12 hours.
CrCl less than 10 mL/min/1.73 m2: 35 to 70 mg/kg/dose IV/IM every 24 hours.
Intermittent Hemodialysis Dialysis/ Peritoneal dialysis: the recommended dose is 35 to
70 mg/kg/dose IV/IM every 24 hours, given after hemodialysis on dialysis days.
• hepatic impairment.
There are no dosage adjustments needed.
Contra- Hypersensitivity to cefotaxime, any component of the formulation, or other cephalosporins
indications
Adverse Drug 1% to 10%:
Reactions Dermatologic: Pruritus, skin rash
Gastrointestinal: Colitis, diarrhea, nausea, vomiting
Hematologic & oncologic: Eosinophilia
Local (IM): Induration at injection site, inflammation at injection site, pain at injection site,
tenderness at injection site
Miscellaneous: Fever
Monitoring Observe for signs and symptoms of anaphylaxis during first dose; CBC with differential
Parameters (especially with long courses [>10 days]); renal function
Drug Risk X: Avoid combination
Interactions BCG, Cholera Vaccine
Risk D: Consider therapy modification
Probenecid, Sodium Picosulfate, Typhoid Vaccine

Pregnancy and Pregnancy risk factor B.

Lactation Cefotaxime is present in breast milk. cephalosporins are generally considered acceptable
for use in breastfeeding women. Monitor infants for GI disturbances, such as thrush or
diarrhea
Administration Administration: IM
Inject deep IM into large muscle mass. Individual doses of 2 g may be given if the dose

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is divided and administered in different IM sites.
Administration: IV
Inject directly IV as a bolus over at least 3 to 5 minutes. Infuse intermittent infusion
over 15 to 30 minutes.
Rapid administration (i.e., less than 60 seconds) of cefotaxime through a central venous
catheter can result in infusion-related reactions that include potentially life-threatening
arrhythmias. Avoid rapid bolus intravenous administration of cefotaxime.
Preparation for Administration:
Parenteral:
IM: Reconstitute powder for injection with SWFI to a final concentration between 230
to 330 mg/mL (2ml for 500mg vial, 3ml for 1 gm vial and 5ml for 2 gm vial). Shake to
dissolve.
IV: IV Push: Reconstitute vials with at least 10 mL SWFI to a maximum concentration of
200 mg/mL.
Intermittent infusion: Reconstitute powder for injection with SWFI, resultant
concentration dependent upon product. Dilute dose to a final concentration of 10 to 40
mg/mL with NS, D5W, D5NS, or LR; some centers have used concentrations up to 60
mg/mL.
N.B. Hypersensitivity test must be done before using injection form of this medicine.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Arrhythmia: in rapid (<1 minute) bolus injection via central venous catheter.
• Granulocytopenia: Granulocytopenia and more rarely agranulocytosis may develop
during prolonged treatment (>10 days).
• Penicillin allergy: Use with caution in patients with a history of penicillin allergy,
especially IgE-mediated reactions (eg, anaphylaxis, angioedema, urticaria).
• Superinfection: Prolonged use
• Tissue inflammation: Minimize tissue inflammation by changing infusion sites when
needed.
Disease-related concerns:
• Colitis: Use with caution in patients with a history of colitis.
• Renal impairment: Use with caution in patients with renal impairment; dosage
adjustment may be required.
Storage Store intact vials below 30°C. Protect from light.
Reconstituted solution is stable for 12 to 24 hours at room temperature, 7 to 10 days when
refrigerated, for 13 weeks when frozen.
For IV infusion in NS or D5W, solution is stable for 1 day at room temperature, 5 days
when refrigerated.
Refer to manufacturer PIL if there are specific considerations.

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Watch Group
7. Ceftazidime
Generic Name Ceftazidime

Dosage Vial 250 mg , 500 mg, 1 gm, 2gm

form/strengths
Route of IV, IM
administration
Pharmacologic Antibiotic, Cephalosporin (Third Generation)
category ATC: J01DD02
Indications Treatment of:
Bloodstream infection (gram-negative bacteremia
Bone and joint infections
CNS infections
Empiric therapy in immunocompromised patients
Gynecologic infections
Intra-abdominal infections
Lower respiratory tract infections
Skin and soft tissue infections
Urinary tract infections
Dosage Adults
Regimen General Adult Dosage
Traditional intermittent infusion method: IV: 1 to 2 g every 8 hours infused over 30 minutes.
For treatment of very severe life-threatening infections, especially in immunocompromised hosts: 2
g every 8 hours.

Extended infusion method (off-label method): IV: 2 g every 8 hours infused over 3 to 4 hours; may
give first dose over 30 minutes, especially when rapid attainment of therapeutic drug
concentrations is desired (eg, sepsis).

Continuous infusion method (off-label method): IV: 6 g infused over 24 hours; may give first dose of
2 g over 30 minutes, especially when rapid attainment of therapeutic drug concentrations is desired
(eg, sepsis).

Pediatric Patients
General dosing, susceptible infection IM, IV: Infants, Children, and Adolescents:

Non-Pseudomonas spp. infections: 90 to 150 mg/kg/day divided every 8 hours; maximum daily
dose: 6 g/day.

Pseudomonas spp. infections:

Mild to moderate infections: 90 to 150 mg/kg/day divided every 8 hours; maximum daily dose: 6
g/day.

Severe infections: 200 to 300 mg/kg/day divided every 8 hours; maximum daily dose: 12 g/day.
Dosage • Renal impairment: adults dosing
adjustment If the usual recommended dose is 1 g every 8 hours
CrCl 31- 50 mL/minute : 1 gm /12 hr.

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Crcl 16-30 ml/min: 1gm/24hr.
Crcl >= 15 ml/min: 500mg/24 hr.
If the usual recommended dose is 2 g every 8 hours
CrCl 31- 50 mL/minute : 2 gm /12 hr.
Crcl 16-30 ml/min: 2gm/24hr.
Crcl >= 15 ml/min: 1gm/24 hr.

Hemodialysis, intermittent (thrice weekly): Dialyzable

IV: 500 mg to 1 g every 24 hours; administer after hemodialysis on dialysis days.
Peritoneal dialysis: IV: 1 g every 24 hours
Renal Impairment: Pediatric dosing
Infants, Children, and Adolescents: Renally adjusted dose recommendations are based on a usual
dose of 25 to 50 mg/kg/dose every 8 hours:
GFR 30 to 50 mL/minute/1.73 m2: 50 mg/kg/dose every 12 hours.
GFR 10 to 29 mL/minute/1.73 m2: 50 mg/kg/dose every 24 hours.
GFR <10 mL/minute/1.73 m2: 50 mg/kg/dose every 48 hours.
Hemodialysis: Dialyzable (50% to 100%): 50 mg/kg/dose every 48 hours, give after dialysis on
dialysis days.
Peritoneal dialysis: 50 mg/kg/dose every 48 hours.
• Hepatic impairment adults & pediatrics.
There are no dosage adjustments needed.
Contra- Hypersensitivity to ceftazidime, other cephalosporins, penicillins, other beta-lactam antibiotics, or
indications any component of the formulation
Adverse Drug 1% to 10%:
Reactions Dermatologic: Pruritus (<2%), skin rash (<2%)
Endocrine & metabolic: Increased lactate dehydrogenase (6%), increased gamma-glutamyl
transferase (5%)
Gastrointestinal: Diarrhea (1%)
Hematologic & oncologic: Eosinophilia (8%), positive direct Coombs test (4%; without hemolysis),
thrombocythemia (2%)
Hepatic: Increased serum ALT (7%), increased serum AST (6%), increased serum alkaline
phosphatase (4%)
Hypersensitivity: Hypersensitivity reactions (2%)
Local: Inflammation at injection site (1%), injection site phlebitis (1%)
Miscellaneous: Fever (<2%)
Monitoring Monitor renal function. Observe for signs and symptoms of anaphylaxis during first dose.
Parameters
Drug Risk X Avoid combination:
Interactions BCG, Cholera Vaccine
Risk D: Consider therapy modification
Chloramphenicol (systemic), typhoid vaccine
Pregnancy and Pregnancy risk factor B.
Lactation Ceftazidime is considered compatible with breastfeeding when used in usual recommended doses.
Monitor infants for GI disturbances, such as thrush or diarrhea
Administration Administration: IM
Inject deep IM into large mass muscle.
Administration: IV
Ceftazidime can be administered IV push over 3 to 5 minutes or IV intermittent infusion over 15 to
30 minutes.

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Preparation for Administration: for adults
Parenteral:
IM: Using SWFI, bacteriostatic water for injection, lidocaine 0.5%, or lidocaine 1%, reconstitute the
500 mg vials with 1.5 mL or the 1 g vials with 3 mL; final concentration of ~280 mg/mL.
IV:
500 mg vial: Reconstitute with 5.3 mL SWFI (final concentration ~100 mg/mL).
1 g or 2 g vial: Reconstitute with 10 mL SWFI.
Note: After reconstitution, may dilute further with a compatible solution [eg, D5W, NS] to
administer via IV infusion

Preparation for Administration: Pediatric

IM: as adults
IV:
IV push: Reconstitute vial using SWFI to a concentration of 100 to 170 mg/mL.
Intermittent IV infusion: Further dilute with a compatible solution (eg, D5W, NS) to a final
concentration ≤40 mg/mL. In fluid-restricted patients, a concentration of 125 mg/mL using SWFI
results in a maximum recommended osmolality for peripheral infusion.
N.B. Hypersensitivity test must be done before using injection form of this medicine.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Elevated INR: May be associated with increased INR, especially in nutritionally deficient
patients, prolonged treatment, hepatic or renal disease. Monitor INR during treatment if patient
is at risk; administer vitamin K as clinically indicated.
• Hemolytic anemia: Immune-mediated hemolytic anemia, sometimes fatal, has been observed in
patients receiving cephalosporins, including ceftazidime. If a patient develops anemia while on
ceftazidime, discontinue treatment until the etiology is determined.
• Hypersensitivity: Hypersensitivity and anaphylaxis have been reported in patients receiving
beta-lactam drugs. Use caution in patients with a history of hypersensitivity to penicillins or other
beta-lactams; use is contraindicated in patients with cephalosporin allergy. If severe
hypersensitivity occurs, discontinue immediately and institute supportive emergency measures.
• Neurotoxicity: High ceftazidime levels in patients with renal insufficiency can lead to seizures,
nonconvulsive status epilepticus, encephalopathy, coma, asterixis, myoclonia, and neuromuscular
excitability. Adjust dosage based on renal function.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection,
including Clostridioides (formerly Clostridium) difficile-associated diarrhea (CDAD) and
pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
Disease-related concerns:
• GI disease: Use with caution in patients with a history of GI disease, especially colitis.
• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment
recommended.
• Seizure disorders: Use with caution in patients with a history of seizure disorder; high levels,
particularly in the presence of renal impairment, may increase risk of seizures.

Storage Vials: Store intact vials at 20°C to 25°C. Protect from light.
Refer to manufacturer PIL if there are specific considerations.

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8. Ceftazidime and Avibactam
Reserve Group

Generic Name Ceftazidime and Avibactam

Dosage Powder for injection: 2 g/0.5 g

form/strengths
Route of IV
administration
Pharmacologic Cephalosporin Combination, Third Generation Cephalosporins
action ATC: J01DD52
Indications Intra-abdominal infections, complicated: Treatment of complicated intra-abdominal infections
(cIAI) in adult and pediatric patients ≥3 months of age, in combination with metronidazole

Pneumonia, hospital-acquired and ventilator-associated: in adult patients

Urinary tract infections, complicated (including pyelonephritis): Treatment of complicated

urinary tract infections (cUTI) (including pyelonephritis) in adult and pediatric patients ≥3
months of age
Dosage Dosing: Adult
Regimen Note: Dosage recommendations are expressed as total grams of the ceftazidime/avibactam
combination.
Intra-abdominal infections, complicated: IV: 2.5 g every 8 hours in combination with
metronidazole for 5 to 14 days
Pneumonia, hospital-acquired and ventilator-associated (HAP/VAP): IV: 2.5 g every 8 hours for
7 to 14 days
Urinary tract infections, complicated (including pyelonephritis): IV: 2.5 g every 8 hours for 7 to
14 days

Dosing pediatric:
Note: Dosage recommendations are based on the ceftazidime component. Dosing presented is
based on traditional infusion method (IV infusion over 2 hours).
Intra-abdominal infections, complicated (cIAI): Note: Use in combination with metronidazole;
treat for 5 to 14 days depending upon severity and clinical response:
Infants ≥3 months to <6 months: IV: 40 mg ceftazidime/kg/dose every 8 hours.
Infants ≥6 months, Children, and Adolescents <18 years: IV: 50 mg ceftazidime/kg/dose every 8
hours; maximum dose: 2,000 mg ceftazidime/dose.
Adolescents ≥18 years: 2,000 mg ceftazidime every 8 hours.
Urinary tract infections, complicated (cUTI) (including pyelonephritis): Note: Treat for 7 to 14
days depending upon severity and clinical response:
Infant ≥3 months to <6 months: IV: 40 mg ceftazidime/kg/dose every 8 hours.
Infants ≥6 months, Children, and Adolescents <18 years: IV: 50 mg ceftazidime/kg/dose every 8
hours; maximum dose: 2,000 mg ceftazidime/dose.
Adolescents ≥18 years: 2,000 mg ceftazidime every 8 hours.
Pneumonia, hospital-acquired and ventilator-associated (HAP/VAP): Adolescents ≥18 years: IV:
2,000 mg ceftazidime every 8 hours for 7 to 14 days.

Dosage Dosing: Renal Impairment: Adult

adjustment Dosage recommendations are expressed as total grams of the ceftazidime/avibactam
combination:

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CrCl >50 mL/minute: No dosage adjustment necessary.
CrCl 31 to 50 mL/minute: 1.25 g (1 g/0.25 g) every 8 hours
CrCl 16 to 30 mL/minute: 0.94 g (0.75 g/0.1875 g) every 12 hours
CrCl 6 to 15 mL/minute: 0.94 g (0.75 g/0.1875 g) every 24 hours
CrCl ≤5 mL/minute: 0.94 g (0.75 g/0.1875 g) every 48 hours

Hemodialysis, intermittent (thrice weekly): Dialyzable (~55% ): 0.94 g every 24 to 48 hours

depending on patient's residual kidney function; when scheduled dose falls on a dialysis day,
administer after hemodialysis.
Dosing: Hepatic Impairment: Adult:
No dosage adjustment necessary.

Dosing: Renal Impairment: Pediatric

Infants ≥3 months and Children <2 years: insufficient data to provide any recommendations for
use in patients with eGFR <50 mL/minute/1.73 m2; use with caution.
Children ≥2 years and Adolescents <18 years: IV:
o eGFR >50 mL/minute/1.73 m2: No dosage adjustment necessary.
o eGFR 31 to 50 mL/minute/1.73 m2: 25 mg ceftazidime/kg/dose every 8 hours; maximum
dose: 1,000 mg ceftazidime/dose.
o eGFR 16 to 30 mL/minute/1.73 m2: 19 mg ceftazidime/kg/dose every 12 hours; maximum
dose: 750 mg ceftazidime/dose.
o eGFR 6 to 15 mL/minute/1.73 m2: 19 mg ceftazidime/kg/dose every 24 hours; maximum
dose: 750 mg ceftazidime/dose.
o eGFR ≤5 mL/minute/1.73 m2: 19 mg ceftazidime/kg/dose every 48 hours; maximum dose:
750 mg ceftazidime/dose.
End-stage renal disease (ESRD) on intermittent hemodialysis (IHD): Administer after
hemodialysis on dialysis days; base dose upon patient's estimated renal function

Adolescents ≥18 years: IV:

CrCl >50 mL/minute: No dosage adjustment necessary.
CrCl 31 to 50 mL/minute: 1,000 mg ceftazidime every 8 hours.
CrCl 16 to 30 mL/minute: 750 mg ceftazidime every 12 hours.
CrCl 6 to 15 mL/minute: 750 mg ceftazidime every 24 hours.
CrCl ≤5 mL/minute: 750 mg ceftazidime every 48 hours.
End-stage renal disease (ESRD) on intermittent hemodialysis (IHD): Administer after
hemodialysis on dialysis days; base dose upon patient's estimated renal function
Dosing: Hepatic Impairment: Pediatric
Infants ≥3 months, Children, and Adolescents: No dosage adjustment necessary.
Contra- Known serious hypersensitivity to ceftazidime, avibactam, other cephalosporins, or any
indications component of the formulation

Adverse Drug >10%:

Reactions Hematologic & oncologic: Positive direct coombs test (3% to 21%)
1% to 10%:
Dermatologic: Injection site phlebitis (children and adolescents: >3%; adults: <1%), skin rash
(children and adolescents: >3%; adults: <1%), pruritus (2%)
Gastrointestinal: Vomiting (>3%), diarrhea (≥3%), nausea (3%), constipation (2%), upper
abdominal pain (1%)
Monitoring Monitor for signs of anaphylaxis during first dose.
Parameters Monitor renal function at baseline in all patients, and at least daily in patients with changing

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renal function.
Observe for seizures or other neurologic activity, especially in patients with renal impairment.

Drug Risk X: Avoid combination

Interactions BCG (Intravesical) Cholera Vaccine Probenecid
Risk D: Consider therapy modification
Chloramphenicol (Systemic) Sodium Picosulfate Tolvaptan Typhoid Vaccine
Pregnancy and Pregnancy Category B.
Lactation Ceftazidime is excreted in breast milk. It is not known if avibactam is excreted in breast milk. The
decision to continue or discontinue breast-feeding during therapy should take into account the
risk of infant exposure, the benefits of breast-feeding to the infant, and benefits of treatment to
the mother.

Administration Administration: IV
Administer by intermittent IV infusion over 2 hours.
Preparation for Administration:
Reconstitute 2.5 g vial with 10 mL of NS, D5W, SWFI, LR, or other compatible solution; mix
gently; resultant concentration: Ceftazidime ~167 mg/mL and avibactam ~42 mg/mL. Withdraw
volume for desired dose and further dilute in a compatible IV solution to achieve a final
ceftazidime concentration of 8 to 40 mg/mL and an avibactam concentration of 2 to 10 mg/mL;
mix gently. Solution ranges in color from clear to light yellow.
N.B. Hypersensitivity test must be done before using injection form of this medicine.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Hypersensitivity reactions
• Neurotoxicity: Severe neurological reactions have been reported with ceftazidime, including
asterixis, coma, encephalopathy, myoclonus, neuromuscular excitability, seizures, and
nonconvulsive status epilepticus. Risk may be increased in the presence of renal impairment;
ensure dose adjusted for renal function. Discontinue therapy if patient develops neurotoxicity.
• Superinfection: Prolonged use
Disease-related concerns:
• Renal impairment: Monitor renal function at baseline and at least daily in adult and pediatric
patients with changing renal function. Adjust the dose accordingly.

Storage • Vials: Store intact vials at 25°C (15-30°C).

Protect from light.
• After reconstitution, contents of the vial should be transferred within 30 minutes to an
infusion bag for further dilution.
• Admixed solutions in NS, D5W, LR, are stable up to 12 hours at room temperature and 24
hours at 2°C to 8°C. Use solutions previously stored at 2°C to 8°C within 12 hours of
subsequent storage at room temperature.
• Refer to manufacturer PIL if there are specific considerations.

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9. Ceftriaxone
Watch Group

Generic Name Ceftriaxone

Dosage Vial 250mg, 500 mg, 1 gm, 2gm

form/strengths
Route of IM, IV
administration
Pharmacologic Antibiotic, Cephalosporin (Third Generation)
category ATC: J01DD04
Indications Blood stream infection
Bone and joint infections (osteomyelitis and/or discitis, prosthetic joint infection, septic
arthritis)
Gonococcal infection, uncomplicated (cervical/urethral, rectal, and pharyngeal)
Intra-abdominal infection, community-acquired (mild to moderate infection in low-risk
patients)
Lower respiratory tract infections (pneumonia, community-acquired)
Meningitis, bacterial
Otitis media, acute
Pelvic inflammatory disease (mild to moderate): Caused by N. gonorrhoeae. Ceftriaxone, like
other cephalosporins, has no activity against Chlamydia trachomatis
Skin and soft tissue infections
Urinary tract infection, complicated (including pyelonephritis)

Surgical prophylaxis, colorectal: To reduce the incidence of postoperative infections in

patients undergoing surgical procedures classified as contaminated or potentially
contaminated.
Dosage Adults Dosing
Regimen General Adult Dosage
IV or IM
1–2 g once or devided twice daily.
Meningitis and Other CNS Infections
IV
2 g every 12 hours.
Pediatric Dosing:
Infants, Children, and Adolescents: IM, IV:
Mild to moderate infection: 50 to 75 mg/kg/dose once daily; maximum daily dose: 1,000
mg/day. Higher doses are recommended in certain infections (eg, endocarditis, meningitis)
Severe infection (eg, meningitis, penicillin-resistant pneumococcal pneumonia): 100
mg/kg/day divided every 12 to 24 hours; maximum daily dose: 4,000 mg/day

Premature and Term Neonates:

50 mg/kg/dose IV or IM every 24 hours

Prescribing Limits
Adults
Maximum 4 g daily
Pediatric Patients
Endocarditis or meningitis: Maximum 4 g daily.

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Most other infections: Maximum 2 g daily.

Dosage No dosage adjustments for renal or hepatic impairment. however, in patients with
adjustment concurrent renal and hepatic impairment, maximum daily dose should not exceed 2 g.
Contra- Hypersensitivity to ceftriaxone, any component of the formulation, or other cephalosporins;
indications concomitant use with intravenous calcium-containing solutions/products in neonates (≤28
days);
IV use of ceftriaxone solutions containing lidocaine
do not use in hyperbilirubinemic neonates, particularly those who are premature since
ceftriaxone is reported to displace bilirubin from albumin binding sites
Adverse Drug Adverse Reactions (Significant): Considerations
Reactions • Hypersensitivity: Serious and sometimes fatal hypersensitivity has been reported.
Hypersensitivity reactions (immediate and delayed) range from maculopapular skin
rash to rare cases of anaphylaxis and anaphylactic shock. Severe cutaneous adverse
reactions (SCARs), including acute generalized exanthematous pustulosis (AGEP), drug
reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson
syndrome (SJS), and toxic epidermal necrolysis (TEN) have been reported.
Urticaria and serum sickness-like reaction have also occurred.
Mechanism: Non dose-related; immunologic. Immediate hypersensitivity reactions (eg,
anaphylaxis, urticaria) are IgE-mediated. Delayed hypersensitivity reactions, including
maculopapular rash and SCARs, are T-cell-mediated.
Onset: Immediate hypersensitivity reactions: rapid; occur within 1 hour of
administration but may occur up to 6 hours after exposure. Delayed hypersensitivity
reactions: Maculopapular reactions: intermediate; occur 7 to 10 days after initiation.
Other reactions (including SCARs): varied; occur after 7 to 14 days up to 3 months.
Risk factors:
Cross-reactivity between penicillins and cephalosporins and among cephalosporins is
mostly related to side chain similarity. A meta-analysis showed negligible cross-
reactivity between penicillins and third-generation cephalosporins, such as ceftriaxone
Assessment of allergy: Unlike penicillin skin testing, cephalosporin skin testing has
several limitations. Specific skin testing of cephalosporins has not been standardized,
but some centers use this type of testing in the evaluation of cephalosporin allergy. If
skin tests are negative, intradermal testing may be performed
• Ceftriaxone-calcium precipitation
Ceftriaxone may exhibit incompatibility with calcium, causing precipitation. Fatal lung
and kidney damage associated with calcium-ceftriaxone precipitates has been
observed in premature and term neonates. However, ceftriaxone and calcium-
containing solutions may be administered sequentially of one another for use in
patients other than neonates if infusion lines are thoroughly flushed (with a
compatible fluid) between infusions
• Clostridioides difficile infection
• Immune hemolytic anemia
• Kernicterus
>10%:
Dermatologic: Skin tightness
Local: Induration at injection site, warm sensation at injection site
1% to 10%:
Dermatologic: Skin rash
Gastrointestinal: Diarrhea

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Genitourinary: Casts in urine, vaginitis
Hematologic & oncologic: Eosinophilia, leukopenia, thrombocythemia
Hepatic: Increased serum transaminases
Local: Pain at injection site, tenderness at injection site
Renal: Increased blood urea nitrogen
Monitoring Prothrombin time/INR. Observe for signs and symptoms of anaphylaxis
Parameters
Drug Risk X: Avoid combination
Interactions BCG (Intravesical) Cholera Vaccine
Risk D: Consider therapy modification
Calcium Salts (Intravenous) Ringer's Injection (Lactated) Sodium Picosulfate, Typhoid Vaccine

Pregnancy and Ceftriaxone is considered compatible with pregnancy and breastfeeding when used in usual
Lactation recommended doses. Monitor infants for GI disturbances
Administration Administration: IM
Inject deep IM into large muscle mass; a concentration of 250 mg/mL or 350 mg/mL is
recommended; can be diluted with D5W, NS, SWFI or 1% lidocaine for IM administration
only.
Administration: IV
Do not coadminister with calcium-containing solutions.
Infuse as an intermittent infusion over 30 minutes.
IV push administration over 1 to 4 minutes has been reported (concentration: 100
mg/mL), primarily in patients outside the hospital setting, although a 2 g dose
administered IV push over 5 minutes resulted in tachycardia, restlessness, diaphoresis,
and palpitations in one patient
Administration: Pediatric
Parenteral: Do not coadminister with calcium-containing solutions.
IM: Administer IM injections deep into a large muscle mass
Intermittent IV infusion:
Neonates: Administer over 60 minutes to decrease risk of bilirubin encephalopathy
Infants, Children, and Adolescents: Administer over 30 minutes; shorter infusion times
(15 minutes) have been reported
IV Push: Administration over 2 to 4 minutes has been reported in pediatric patients >11
years and adults primarily in the outpatient setting and over 5 minutes in pediatric
patients ages newborn to 15 years with meningitis. Rapid IVP injection over 5 minutes of
a 2,000 mg dose resulted in tachycardia, restlessness, diaphoresis, and palpitations in an
adult patient. IV push administration in young infants may also have been a contributing
factor in risk of cardiopulmonary events occurring from interactions between ceftriaxone
and calcium.
Preparation of IV infusion:
Reconstitute powder with appropriate IV diluent (including SWFI, D5W, D10W, NS) to
create an initial solution of ~100 mg/mL. Recommended volume to add:
250 mg vial: 2.4 mL
500 mg vial: 4.8 mL
1 g vial: 9.6 mL
2 g vial: 19.2 mL
Note: After reconstitution of powder, further dilution into a volume of compatible

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solution (eg, 50-100 mL of D5W or NS) is recommended or to a final concentration of 10 to
40 mg/mL for pediatrics
N.B. Hypersensitivity test must be done before using injection form of this medicine.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Elevated INR: rarely occured especially in nutritionally-deficient patients, prolonged
treatment, hepatic or renal disease.
• Hemolytic anemia: Severe cases (including some fatalities) have been reported.
• Pancreatitis
• Superinfection: Prolonged use.
Disease-related concerns:
• Gallbladder pseudolithiasis: Abnormal gallbladder sonograms have been reported,
possibly due to ceftriaxone-calcium precipitates; probability is greatest in pediatric
patients. disontinue
• Renal/hepatic impairment (concurrent): Use with caution; dosage should not exceed 2
g/day without close clinical monitoring
Special populations:
• Neonates: Use extreme caution in neonates due to risk of hyperbilirubinemia,
particularly in premature infants (contraindicated in hyperbilirubinemic neonates and
neonates <41 weeks postmenstrual age).
Storage Powder for injection: store at ≤25°C. Protect from light.
Stability of reconstituted solutions:
o 10 to 100 mg/mL: Reconstituted in D5W, NS, or SWFI: Stable for 2 days at room
temperature of 25°C or for 10 days when refrigerated at 4°C. Do not refreeze.
o Reconstituted in lidocaine 1% solution or bacteriostatic water: Stable for 1 day at room
temperature of 25°C or for 10 days when refrigerated at 4°C.
o 250 to 350 mg/mL: Reconstituted in D5W, NS, lidocaine 1% solution, bacteriostatic
water, or SWFI: Stable for 1 day at room temperature of 25°C or for 3 days when
refrigerated at 4°C
o Refer to manufacturer PIL if there are specific considerations.

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d) Fourth Generation Cephalosporins Watch Group

1. Cefepime
Generic Name Cefepime

Dosage Vial 500mg, 1g, 2g

form/strengths
Route of Parentral (IM, IV)
administration
Pharmacologic Antibiotic, Cephalosporin (Fourth Generation)
action ATC: J01DE01
Indications Intra-abdominal infection: Treatment, in combination with metronidazole, of complicated intra-
abdominal infections

Neutropenic fever: Empiric treatment of febrile neutropenic patients.

Pneumonia (moderate to severe): Treatment of moderate to severe pneumonia

Skin and soft tissue infection: Treatment of moderate to severe skin and soft tissue infections

Urinary tract infection, including pyelonephritis: Treatment of urinary tract infections, including
pyelonephritis including cases associated with concurrent bacteremia with these
microorganisms.
Dosage Dosing: Adult
Regimen Usual dosage range:
Traditional intermittent infusion method (over 30 minutes): IV: 1 to 2 g every 8 to 12 hours.
For coverage of serious Pseudomonas aeruginosa infections: 2 g every 8 hours for 7 to 10 days or
until resolution of neutropenia.

Dosing: Pediatric (2 months up to 16 years)

General dosing, susceptible infection:
Traditional intermittent-infusion method:
• Non-Pseudomonas spp. infections: IM, IV: 50 mg/kg/dose every 12 hours; maximum
dose: 2,000 mg/dose (for uncomplicated and complicated urinary tract infections,
uncomplicated skin and skin structure infections, and pneumonia)
• Pseudomonas spp. infections (suspected or proven): IM, IV: 50 mg/kg/dose every 8 hours;
maximum dose: 2,000 mg/dose (For moderate to severe pneumonia due to P.
aeruginosa and for febrile neutropenic patients).
Dosage Dosing: Renal Impairment: Adult
adjustment

Creatinine Recommended Maintenance Schedule

Clearance (mL/min)

Greater than 60 1 g /12 hours 2 g /12 hours 2 g /8 hours

30 to 60 1 g /24 hours 2 g /24 hours 2 g /12 hours

11 to 29 500 mg /24 hours 1 g /24 hours 2 g /24 hours

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Less than 11 250 mg /24 hours 500 mg /24 hours 1 g /24 hours

Continuous 1 g /48 hours 2 g /48 hours 2 g /48 hours

Ambulatory
Peritoneal Dialysis
(CAPD)

Hemodialysis* 1 g on day 1, then 500 mg / 24 hours 1 g /24 hours

thereafter

Cefepime for injection should be administered at the same time each day and following the
completion of hemodialysis on hemodialysis days
Dosing: Renal Impairment: pediatric
Changes in the dosing regimen proportional to those in adults are recommended for pediatric
patients.

Dosing: Hepatic Impairment:

No dosage adjustment necessary.

Contra- Hypersensitivity to cefepime, other cephalosporins, penicillins, other beta-lactam antibiotics, or

indications any component of the formulation

Adverse Drug Hematologic & oncologic: Positive direct Coombs test (without hemolysis; 16%)
Reactions Endocrine & metabolic: Hypophosphatemia (3%)
Monitoring Monitor renal function. Observe for signs and symptoms of anaphylaxis during first dose.
Parameters
Drug Risk X: Avoid combination
Interactions BCG (Intravesical), Cholera Vaccine,
Risk D: Consider therapy modification
Sodium Picosulfate, Typhoid Vaccine
Risk C: Monitor therapy
Aminoglycosides, BCG Vaccine (Immunization), Lactobacillus and Estriol, Probenecid, Vitamin
K Antagonists
Pregnancy and Pregnancy Category B
Lactation Cefepime is present in breast milk
Breastfeeding may continue when otherwise appropriate, however discontinuing the antibiotic
or changing to an alternate maternal therapy may be needed
Administration Administration: IM
Inject deep IM into large muscle mass.
Administration: IV
Administer as an intermittent infusion over 30 minutes
Preparation for Administration: Adult
IV: Reconstitute 500 mg vial with 5 mL and 1 or 2 g vial with 10 mL of a compatible diluent
(resulting concentration of 100 mg/mL for 500 mg and 1 g vial and 160 mg/mL for 2 g vial) and
further dilute in a compatible IV infusion fluid.
IM: Reconstitute 500 mg or 1 g vial with 1.3 mL or 2.4 mL, respectively, of SWFI, NS, D5W,
lidocaine 0.5% or 1%, or bacteriostatic water for injection; resulting concentration is 280
mg/mL.
Preparation for Administration: Pediatric
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Parenteral:
IV: Reconstitute 500 mg vial with 5 mL and 1 or 2 g vial with 10 mL of a compatible diluent
(resulting concentration of 100 mg/mL for 500 mg and 1 g vial and 160 mg/mL for 2 g vial);
further dilute in D5W, NS, D10W, D5NS, or D5LR; final concentration should not exceed 40
mg/mL.
IM: Reconstitute 500 mg or 1 g vial with 1.3 mL or 2.4 mL, respectively, of SWFI, NS, D5W,
lidocaine 0.5% or 1%, or bacteriostatic water for injection to a final concentration of 280
mg/mL
N.B. Hypersensitivity test must be done before using injection form of this medicine.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ • Elevated INR: May be associated with increased INR, especially in nutritionally-deficient
Precautions patients, prolonged treatment, hepatic or renal disease.
• Hypersensitivity: May occur; use caution in patients with a history of penicillin sensitivity;
cross-hypersensitivity may occur. If a hypersensitivity reaction occurs, discontinue therapy and
institute supportive measures.
• Neurotoxicity: Severe neurological reactions (some fatal) have been reported, including
encephalopathy, aphasia, myoclonus, seizures, and nonconvulsive status epilepticus. Risk may
be increased in the presence of renal impairment; ensure dose adjusted for renal function and
discontinue therapy if patient develops neurotoxicity; effects are often reversible upon
discontinuation of cefepime.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C.
difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2
months postantibiotic treatment.
• Elderly: Serious adverse reactions have occurred in elderly patients with renal insufficiency
given unadjusted doses of cefepime, including life-threatening or fatal occurrences of
encephalopathy, myoclonus, and seizures.
• The administration of Cefepime may result in a false-positive reaction for glucose in the urine
with certain methods. It is recommended that glucose tests based on enzymatic glucose oxidase
reactions be used.
Storage • Vials: Store intact vials at 20°C to 25°C. Protect from light.
• After reconstitution, stable in NS and D5W for 24 hours at 20°C to 25°C and 7 days at 2°C
to 8°C.
• Refer to manufacturer PIL if there are specific considerations.

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e) Fifth Generation Cephalosporins
Reserve Group
1. Ceftaroline fosamil

Generic Name Ceftaroline fosamil

Dosage Powder for Reconstitution for I.V. infusion: 400mg, 600mg

form/strengths
Route of IV
administration
Pharmacologic Antibiotic, Cephalosporin (Fifth Generation)
category ATC: JO1DI02
Indications effective in treating complicated skin and soft tissue infections and community-acquired
pneumonia and its side effects in both adults and children. It had shown activity against certain
bacteria, such as MRSA, against which other beta-lactam antibiotics do not work
Dosage Dosing: Adult
Regimen Note: Reserve for patients with or at risk for methicillin-resistant S. aureus infection who cannot
receive preferred agents
Pneumonia:
Community-acquired pneumonia (alternative agent): Inpatients without risk factors
for Pseudomonas aeruginosa:
IV: 600 mg every 12 hours as part of an appropriate combination regimen. Total duration
(including oral step-down therapy) is a minimum of 7 days for methicillin-resistant S.
aureus (MRSA) infection; patients should be clinically stable with normal vital signs before
therapy is discontinued. Note: Switch to a narrower beta-lactam if MRSA is not isolated
Skin and soft tissue infection (alternative agent):
IV: 600 mg every 12 hours. Total duration of therapy is ≥5 days (including oral step-down
therapy); may extend up to 14 days depending on severity and clinical response
Dosing: pediatric:
Pneumonia, community acquired: Treatment duration is dependent on severity of infection and
clinical response.
Infants ≥2 months and Children <2 years: IV: 8 mg/kg/dose every 8 hours for 5 to 7 days.
Children ≥2 years and Adolescents <18 years:
≤33 kg: IV: 12 mg/kg/dose every 8 hours for 5 to 7 days.
>33 kg: IV: 400 mg every 8 hours or 600 mg every 12 hours for 5 to 7 days.
Adolescents ≥18 years: 600 mg every 12 hours for 5 to 7 days.
Skin and skin structure infection: Treatment duration is variable (5 to 14 days); dependent on
severity of infection and clinical response.
Infants ≥2 months and Children <2 years: IV: 8 mg/kg/dose every 8 hours.
Children ≥2 years and Adolescents <18 years:
≤33 kg: IV: 12 mg/kg/dose every 8 hours.
>33 kg: IV: 400 mg every 8 hours or 600 mg every 12 hours.
Adolescents ≥18 years: IV: 600 mg every 12 hours.

Dosage Dosing: Altered Kidney Function: Adult

adjustment CrCl Modification If the usual recommended
dose is 600 mg IV every 12 hours
>50 mL/minute No dosage adjustment necessary
>30 to ≤50 mL/minute 400 mg every 12 hours

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≥15 to ≤30 mL/minute 300 mg every 12 hours
<15 mL/minute
200 mg every 12 hours
Hemodialysis,
intermittent (thrice 200 mg every 12 hours
weekly) or Peritoneal
dialysis

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments needed

Dosing: Altered Kidney Function: Pediatric

Infants, Children, and Adolescents <18 years: Note: Renal function estimated using the Schwartz
equation.
CrCl >50 mL/minute/1.73 m2: No adjustment necessary
CrCl ≤50 mL/minute/1.73 m2: data is insufficient; use with caution, dosage adjustment may
be necessary
Dosing: Hepatic Impairment: Pediatric
There are no dosage adjustments needed.

Contra- Known serious hypersensitivity to ceftaroline, other members of the cephalosporin class, or any
indications component of the formulation

Adverse Drug >10%: Hematologic & oncologic: Positive direct Coombs test (10% to 18%; no evidence of
Reactions hemolysis)
1% to 10%:
Cardiovascular: Bradycardia (adults: <2%), palpitations (adults: <2%), phlebitis (adults: 2%)
Dermatologic: Pruritus (infants, children, and adolescents: <3%), skin rash (3% to 7%), urticaria
(adults: <2%)
Endocrine & metabolic: Hyperglycemia (adults: <2%), hyperkalemia (adults: <2%), hypokalemia
(adults: 2%)
Gastrointestinal: Abdominal pain (adults: <2%), Clostridioides difficile colitis (adults: <2%),
constipation (adults: 2%), diarrhea (5% to 8%), nausea (3% to 4%), vomiting (2% to 5%)
Hematologic & oncologic: Anemia (adults: <2%), eosinophilia (adults: <2%), neutropenia (adults:
<2%; risk may be increased with high doses and prolonged use [>14 days]) (Sullivan 2019; Varada
2015), thrombocytopenia (adults: <2%)
Hepatic: Hepatitis (adults: <2%), increased serum alanine aminotransferase (infants, children,
and adolescents: <3%), increased serum aspartate aminotransferase (infants, children, and
adolescents: <3%), increased serum transaminases (adults: 2%)
Hypersensitivity: Anaphylaxis (adults: <2%), hypersensitivity reaction (adults: <2%)
Nervous system: Dizziness (adults: <2%), headache (infants, children, and adolescents: <3%),
seizure (adults: <2%)
Renal: Renal failure syndrome (adults: <2%)
Miscellaneous: Fever (≤3%)

Monitoring CBC (baseline and at least weekly); specimen for culture and susceptibility prior to the first dose;
Parameters renal function; signs or symptoms of anaphylaxis during first dose and for neurotoxicity
throughout therapy.

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Drug Risk X: Avoid combination
Interactions BCG (Intravesical) Cholera Vaccine
Risk D: Consider therapy modification
Sodium PicosulfateTyphoid Vaccine
Pregnancy and pregnancy category B
Lactation Adverse events have been observed in some animal reproduction studies. should be used during
pregnancy only if the potential benefit justifies the potential risk to the fetus
It is not known if ceftaroline fosamil is excreted in breast milk. Caution be exercised when
administering ceftaroline fosamil to nursing women.

Administration Administration: IV
Administer by slow IV infusion over 5 to 60 minutes
Preparation for Administration:
IV: Reconstitute 400 mg or 600 mg vial with 20 mL SWFI, NS, D5W, or LR; mix gently and ensure
contents dissolve completely; resultant concentration is 20 mg/mL (400 mg vial) or 30 mg/mL
(600 mg vial). Reconstituted solution should be further diluted for IV administration in a
compatible solution to a final concentration not to exceed 12 mg/mL. Use of the same solution
as used for reconstitution is suggested with the exception of SWFI; if SWFI was used for
reconstitution, then appropriate infusion solutions include NS, 1/2NS, D5W, D2.5W, or LR. Color of
infusion solutions ranges from clear and light to dark yellow depending on concentration and
storage conditions; potency is not affected.
N.B. Hypersensitivity test must be done before using injection form of this medicine.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Hemolytic anemia: Seroconversion from a negative to a positive direct Coombs’ test has been
reported. Hemolytic anemia was not reported in clinical studies; however, if anemia develops
during or after treatment, consider drug-induced hemolytic anemia. Diagnostic tests should
include a direct Coombs’ test. If hemolytic anemia is suspected, discontinue the drug and
institute supportive care as clinically indicated.
• Hypersensitivity: Serious hypersensitivity (anaphylactic) and skin reactions have occurred with
ceftaroline. Use with caution in patients with a history of penicillin, cephalosporin, or
carbapenem allergy. Maintain clinical supervision if given to penicillin or beta-lactam allergic
patients; cross sensitivity among beta-lactam antibacterial agents has been reported. If a serious
reaction occurs, discontinue the drug and institute supportive measures as clinically indicated.
• Neurotoxicity: Neurological reactions have been reported, including encephalopathy and
seizures. Risk may be increased in the presence of renal impairment; ensure dose adjusted for
renal function, and discontinue therapy if patient develops neurotoxicity; effects are often
reversible upon discontinuation of therapy.
• Neutropenia: Neutropenia and agranulocytosis have been reported; risk may be increased with
high doses and prolonged therapy (>14 days), patients with kidney dysfunction, and patients on
concurrent antibiotics associated with neutropenia. Monitor CBC at baseline and at least weekly;
limit duration of therapy when possible.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C.
difficile-associated diarrhea (CDAD) and pseudomembranous colitis (including fatalities); CDAD
has been observed >2 months postantibiotic treatment.
Disease-related concerns:
• Renal impairment: Use with caution in patients with renal impairment (CrCl ≤50 mL/minute);
dosage adjustments recommended.
• Seizure disorders: Use with caution in patients with a history of seizure disorder; high levels,
particularly in the presence of renal impairment, may increase risk of seizures.

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Storage Store unused vials at 25°C; excursions permitted between 15°C and 30°C. Diluted solutions in
D2.5W, 1/2NS, D5W, LR, or NS should be used within 6 hours when stored at room temperature
or within 24 hours if refrigerated at 2°C to 8°C.
Refer to manufacturer PIL if there are specific considerations.

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2. Ceftolozane and Tazobactam
Reserve Group

Generic Name Ceftolozane and Tazobactam

Dosage powder for solution Tazobactam 0.5 gm; Ceftolozane 1 gm

form/strengths
Route of IV
administration
Pharmacologic Cephalosporin’s Combination
category ATC: J01DI54
Indications ** Not recommended for routine empiric use. Reserve use for patients with or at risk for certain
multidrug-resistant gram-negative organisms (e.g., extensively drug-resistant P. aeruginosa) with
limited treatment options
1-Intra-abdominal infection: complicated intra-abdominal infection in patients ≥18 years of age,
in combination with metronidazole
2-Pneumonia, hospital-acquired or ventilator-associated: in patients ≥18 years of age.
3-Urinary tract infection, complicated (pyelonephritis or urinary tract infection with systemic
signs/symptoms): in patients ≥18 years of age
Dosage Dosing: Adult, Geriatric
Regimen 1-Intra-abdominal infection: IV:1.5 to 3 g every 8 hours in combination with metronidazole for
4 to 14 days.
2-Pneumonia, hospital-acquired or ventilator-associated: IV: 3 g every 8 hours; treatment is
typically given for 7 days.
3-Urinary tract infection, complicated (pyelonephritis or urinary tract infection with systemic
signs/symptoms): IV: 1.5 g every 8 hours. Switch to an appropriate oral regimen once symptoms
improve, for 5 to 14 days and depends on clinical response.
Dosing: Pediatric <18 years: Safety and efficacy not established
Dosage Dosing: Renal Impairment: Adult
adjustment
CrCl (mL/minute) If the usual recommended If the usual recommended
dose is 1.5 g every 8 hours dose is 3 g every 8 hours
>50 to 130 (usual 1.5 g every 8 hours 3 g every 8 hours
recommended dosing schedule)
30 to 50 750 mg every 8 hoursc 1.5 g every 8 hoursc

15 to 29 375 mg every 8 hoursc 750 mg every 8 hoursc

<15 mL/minute not on dialysis No suffecient data .

c
Note: May consider delaying dosage adjustment (eg, administer full doses for 48 hours after
initiation) before decreasing the dose for acute kidney injury (AKI).
Hemodialysis, intermittent (thrice weekly): IV: Dialyzable (ceftolozane 66%; tazobactam 56%).
If the usual recommended dose is 1.5 g every 8 hours: Initial: 750 mg as a single dose, followed
by 150 mg every 8 hours. Administer dose immediately after dialysis on dialysis days.
If the usual recommended dose is 3 g every 8 hours: Initial: 2.25 g as a single dose, followed by
450 mg every 8 hours. Administer dose immediately after dialysis on dialysis.
Dosing: Hepatic Impairment: Adult
No dosage adjustment necessary.

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Contra- Serious hypersensitivity to ceftolozane/tazobactam, piperacillin/tazobactam, other members of
indications the beta-lactam class, or any component of the formulation.
Adverse Drug >10%:
Reactions Hematologic & oncologic: Positive direct Coombs test [HAP] and [VAP]: 31%; complicated intra-
abdominal infections and UTIs: <1%)
Hepatic: Increased serum transaminases (HAP and VAP: 12%)
1% to 10%:
Cardiovascular: Hypotension (≤2%), atrial fibrillation (≤1%)
Central nervous system: Headache (3% to 6%), intracranial hemorrhage (HAP and VAP: 4%),
insomnia (1% to 4%), anxiety (≤2%), dizziness (≤1%)
Dermatologic: Skin rash (≤2%)
Endocrine & metabolic: Hypokalemia (≤3%), increased gamma-glutamyl transferase (<2%)
Gastrointestinal: Nausea (3% to 8%), diarrhea (2% to 6%), constipation (2% to
4%), Clostridioides difficile associated diarrhea (3%), vomiting (1% to 3%), abdominal pain (≤1%)
Hematologic & oncologic: Anemia (≤2%), thrombocythemia (≤2%)
Hepatic: Increased serum alanine aminotransferase (2%), increased serum alkaline phosphatase
(<2%), increased serum aspartate aminotransferase (1% to 2%)
Renal: Renal failure syndrome or renal insufficiency (HAP and VAP: ≤9%; complicated intra-
abdominal infections and UTIs: <1%)
Miscellaneous: Fever (2% to 6%)
Monitoring Serum creatinine and CrCl at baseline and daily in patients with changing renal function.
Parameters
Drug Risk X: Avoid combination
Interactions BCG (Intravesical), Cholera Vaccine.
Risk D: Consider therapy modification
Probenecid: Sodium Picosulfate, Typhoid Vaccine
Pregnancy and Pregnancy Category B. There are no adequate and well-controlled trials in pregnant women.
Lactation It is not known if ceftolozane or tazobactam are present in breast milk.
Administration Administer over 1 hour; for the treatment of multidrug-resistant gram-negative organisms and
administration of 3 g doses, administer 3 g by IV infusion over 3 hours.
Preparation for Administration: Adult
Reconstitute the vial with 10 mL SWFI or NS and gently shake to dissolve. The final volume is
approximately 11.4 mL.
To prepare the required dose, withdraw the appropriate volume from the reconstituted vial(s).
Add the withdrawn volume to an infusion bag containing 100 mL of NS or D5W.
Infusions range from clear, colorless solutions to solutions that are clear and slightly yellow.
Variations in color within this range do not affect the potency of the product.
N.B. Hypersensitivity test must be done before using injection form of this medicine.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Hypersensitivity: Hypersensitivity and anaphylaxis (serious and sometimes fatal).
• Superinfection: Use may result in fungal or bacterial superinfection, including C. difficile-
associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months
postantibiotic treatment.
Disease-related concerns:
• Renal impairment: Exposure to ceftolozane is increased with increasing degrees of renal
impairment; monitor creatinine clearance (CrCl) at least daily in patients with changing renal
function and adjust the dose. In clinical trials, cure rates were lower in patients with a baseline
CrCl of 30 to 50 mL/minute.

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Special population:
• Higher incidence of adverse reactions was observed in patients age 65 years and older
Storage • Intact vials: at 2°C to 8°C; protect from light. Diluted solution in D5W or NS: may be stored for
24 hours at room temperature or for 7 days at 2°C to 8°C. Do not freeze.
• Refer to manufacturer PIL if there are specific considerations.

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Macrolide Watch Group
1. Azithromycin
Generic Name Azithromycin
Dosage 500 mg vial
form/strengths Tablets 500mg, 600mg, 1000mg
Capsules 250mg, 500mg
Suspension 100mg/5ml, 200mg/5ml, 2000mg/60ml, 2gm ER
Eye drops 1%
Route of Parenteral, Oral, ophthalmic
administration
Pharmacologic Antibiotic, Macrolide
action Systemic ATC: J01FA10
Opthalmic ATC: S01AA26
Indications Oral, IV:
Chancroid: Treatment of genital ulcer disease (in men)
Chronic obstructive pulmonary disease, acute exacerbation: Treatment of acute
bacterial exacerbations of COPD
Mycobacterium avium complex: Prevention of Mycobacterium avium complex (MAC)
in patients with advanced HIV infection; treatment of disseminated MAC (in
combination with ethambutol) in patients with advanced HIV infection
Otitis media, acute: Treatment of acute otitis media
Pneumonia, community-acquired: Treatment of community-acquired pneumonia
(CAP)
Skin and skin structure infection, uncomplicated: Treatment of uncomplicated skin
and skin structure infections
Streptococcal pharyngitis (group A): Treatment of pharyngitis/tonsillitis due to S.
pyogenes as an alternative to first-line therapy
Urethritis/cervicitis: Treatment of urethritis and cervicitis

Ophthalmic: Bacterial conjunctivitis

Dosage Adult dosing:
Regimen Chronic obstructive pulmonary disease, acute exacerbation:
Acute exacerbation, treatment:
Oral: 500 mg in a single loading dose on day 1, followed by 250 mg once daily on days
2 to 5 or 500 mg once daily for 3 days
Mycobacterial (nontuberculous) infection:
Mycobacterium avium complex (MAC) infection:
Disseminated disease in patients with HIV:
Treatment: Oral: 500 to 600 mg daily as part of a combination therapy regimen
Primary prophylaxis: Oral: 1.2 g once weekly (preferred) or 600 mg twice weekly
Secondary prophylaxis: Oral: 500 to 600 mg daily as part of an appropriate
combination regimen;
Pneumonia, community acquired:
Outpatient: Oral: 500 mg on day 1, followed by 250 mg once daily for 4 days or 500
mg once daily for 3 days.
Inpatient: Oral, IV: 500 mg once daily for a minimum of 3 days, as part of an
appropriate combination regimen
Sexually transmitted infections:

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Oral: 1 g as a single dose. Given alone or in combination.
Streptococcal pharyngitis (group A) (alternative agent for severely penicillin-allergic
patients): Oral: 500 mg on day 1, followed by 250 mg once daily on days 2 through 5
or 500 mg once daily for 3 days
Ophthalmic: Bacterial conjunctivitis: Ophthalmic: Instill 1 drop into affected eye(s)
twice daily (8 to 12 hours apart) for 2 days, then 1 drop into affected eye(s) once daily
for the next 5 days

Pediatric Dosing:
General dosing, susceptible infection:
Infants, Children, and Adolescents:
Oral: 10 to 12 mg/kg/dose once on day 1 (usual maximum dose: 500 mg/dose)
followed by 5 to 6 mg/kg once daily (usual maximum dose: 250 mg/dose) for
remainder of treatment duration.
IV: 10 mg/kg once daily; maximum dose: 500 mg/dose

Ophthalmic: Bacterial conjunctivitis: Children and Adolescents: Ophthalmic: Instill 1

drop in the affected eye(s) twice daily (8 to 12 hours apart) for 2 days, then 1 drop
once daily for 5 days
Dosage Dosing: Renal Impairment:
adjustment Dosage adjustment not necessary.
Use caution in severe renal impairment (GFR <10 mL/minute) because of limited
data.
Dosing: Hepatic Impairment:
Azithromycin is predominantly hepatically eliminated. Use with caution due to
potential for hepatotoxicity (rare); discontinue immediately for signs or symptoms of
hepatitis
Contra- • Hypersensitivity to azithromycin, erythromycin, other macrolide (eg, azalide or
indications ketolide) antibiotics, or any component of the formulation.
Adverse Drug >10%:
Reactions Gastrointestinal: Diarrhea, nausea, vomiting
Monitoring Liver function tests, CBC with differential
Parameters QTc monitoring recommendations combined with hydroxychloroquine
Drug Risk X: Avoid combination
Interactions Atorvastatin Bilastine Doxorubicin Fexinidazole Mizolastine Pazopanib Pimozideqt-
Prolonging Strong CYP3A4 Inhibitors Rimegepant Topotecan Vincristine
Risk D: Consider therapy modification
Afatinib Betrixaban Colchicine Domperidone Edoxaban Lefamulin QT-prolonging
Agents Sincalide Sirolimus Sodium Picosulfate Typhoid Vaccine Ubrogepant
Pregnancy and Pregnancy risk factor B.
Lactation Azithromycin is present in breast milk.
should be used only if clearly needed. Breastfed infants should be monitored for
gastrointestinal side effects (e.g., diarrhea, fungal infections, sensitization).
Administration Administration: IV
Infuse over 1 hour (2 mg/mL infusion) or over 3 hours (1 mg/mL infusion). Not for IM
or IV bolus administration.
Preparation for Administration:
Parenteral: Reconstitute the 500 mg vial by adding 4.8 mL of SWFI; shake vial until
drug is completely dissolved; resultant concentration: 100 mg/mL. The reconstituted

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solution should be further diluted to a concentration of 1 mg/mL (500 mL) to 2
mg/mL (250 mL) in NS, D5W, or LR.
Administration: Oral
Immediate release suspension and tablet may be taken without regard to food;
extended release suspension should be taken on an empty stomach (at least 1 hour
before or 2 hours following a meal), within 12 hours of reconstitution.
do not administer with antacids that contain aluminum or magnesium.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Hypersensitivity reactions: Allergic reactions have been reported (rare), including
fatalities.
• Altered cardiac conduction: Macrolides (especially erythromycin) have been
associated with rare QTc prolongation and ventricular arrhythmias.
• Cardiac risk.
Disease-related concerns:
• Bronchiolitis obliterans: When studied to prevent bronchiolitis obliterans
syndrome in patients with hematologic malignancy who underwent allogeneic
hematopoietic cell transplantation, rates of cancer relapse and mortality were
increased among patients receiving long-term azithromycin.
• Gonorrhea/syphilis: May mask or delay symptoms of incubating gonorrhea or
syphilis, so appropriate culture and susceptibility tests should be performed prior to
initiating a treatment regimen.
• Hepatic impairment: Use with caution.
• Myasthenia gravis: Use with caution in patients with myasthenia gravis;
exacerbation and new onset of symptoms have occurred.
• Renal impairment: Use with caution in patients with severe renal impairment
(GFR <10 mL/minute); increased gastrointestinal adverse effects may occur.
Special populations:
• Infants: Use of azithromycin in neonates and infants <6 weeks of age has been
associated with infantile hypertrophic pyloric stenosis (IHPS); the strongest
association occurred with exposure during the first 2 weeks of life; observe for
nonbilious vomiting or irritability with feeding.
Dosage form specific issues:
• Oral suspensions: Immediate release and extended release suspensions are not
interchangeable
Storage • Injection: Store intact vials at room temperature.
• Reconstituted solution is stable for 24 hours when stored below 30°C.
• The diluted solution is stable for 24 hours at or below room temperature (30°C)
and for 7 days if stored under refrigeration (5°C)
• Suspension, immediate release: Store dry powder below 30°C. Store
reconstituted suspension at 5°C to 30°C and use within 10 days.
• Suspension, extended release: Store dry powder ≤30°C. Following
reconstitution, store at 25°C; excursions permitted to 15°C to 30°C; do not
refrigerate or freeze. Should be consumed within 12 hours following
reconstitution.
• Tablet: Store between 15°C to 30°C
• Refer to manufacturer PIL if there are specific considerations.

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2. Clarithromycin Watch Group

Generic Name Clarithromycin

Dosage form/ Tablets 250mg, 500mg, 500mg SR,

strengths Granules or powder for Oral Suspension 125mg/5ml, 250mg/5ml,
Powder for injection 500mg
Route of Oral, IV
administration
Pharmacologic Antibiotic, Macrolide
action ATC: J01FA09
Indications Chronic obstructive pulmonary disease, acute exacerbation: Treatment of acute
bacterial exacerbation of chronic bronchitis in adults

Helicobacter pylori eradication: Eradication of Helicobacter pylori to reduce the risk of

duodenal ulcer recurrence as a component of combination therapy (triple therapy) in
adults with H. pylori infection and duodenal ulcer disease (active or 5-year history of
duodenal ulcer).

Limitations of use: Regimens that contain clarithromycin as the single antibacterial

agent are more likely to be associated with the development of clarithromycin
resistance. Clarithromycin-containing regimens should not be used in patients with
known or suspected clarithromycin-resistant isolates (efficacy is reduced).

Mycobacterial (nontuberculous) infection: Prophylaxis and treatment of disseminated

mycobacterial infections

Otitis media: Treatment of acute otitis media in pediatric patients due to

susceptible H. influenzae, M. catarrhalis, or S. pneumoniae.

Pneumonia, community-acquired: Treatment of community-acquired pneumonia

Skin/skin structure infection: Treatment of uncomplicated skin/skin structure

infection.

Streptococcal pharyngitis: Treatment of pharyngitis/tonsillitis

Dosage Dosing: Adult
Regimen General dosing note: IR and ER formulations are available; 500 mg every 12 hours of
immediate release is equivalent to 1 g of extended release (two 500 mg ER tablets)
once daily.
Chronic obstructive pulmonary disease, acute exacerbation: Note: Avoid use in
patients with risk factors for Pseudomonas infection or poor outcomes (eg, ≥65 years
of age with major comorbidities, FEV1 <50% predicted, frequent exacerbations).
Oral: Immediate release: 500 mg every 12 hours for 3 to 7 days
Helicobacter pylori eradication: Note: Avoid clarithromycin-based therapy in patients
with risk factors for macrolide resistance (eg, prior macrolide exposure, local
clarithromycin resistance rates ≥15% [which is assumed in the United States] or
eradication rates with clarithromycin triple therapy ≤85%).

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Oral: Immediate release: 500 mg twice daily for 7 to 14 days as part of an appropriate
combination regimen
Pneumonia, community-acquired:
Inpatient: Oral: Immediate release: 500 mg twice daily as part of an appropriate
combination regimen.
Outpatient: Oral: 500 mg (immediate release) twice daily or 1 g (two 500 mg ER
tablets) once daily. Note: Use as part of an appropriate combination regimen; if local
pneumococcal macrolide resistance is <25%, monotherapy is an alternative approach
for outpatients without comorbidities or risk factors for antibiotic-resistant pathogens.
Duration of therapy: Minimum of 5 days; patients should be clinically stable with
normal vital signs before therapy is discontinued
Dosing: Pediatric
Note: All pediatric dosing recommendations based on immediate release product
formulations (tablet and oral suspension):
General dosing, susceptible infection, mild to moderate infection: Infants, Children,
and Adolescents: Oral: 15 mg/kg/day divided every 12 hours; maximum single dose:
500 mg

Dosage Dosing: Renal Impairment: adults

adjustment creatinine clearance under 30 ml/min: reduce normal dosage by 50%
Dosing: Renal Impairment: pediatrics
Renally adjusted dose recommendations are based on a dose 15 mg/kg/day divided
twice daily.
GFR ≥30 mL/minute/1.73 m2: No dosage adjustment necessary
GFR 10 to 29 mL/minute/1.73 m2: 4 mg/kg/dose every 12 hours
GFR <10 mL/minute/1.73 m2: 4 mg/kg/dose once daily
Hemodialysis: Administer after HD session is completed: 4 mg/kg/dose once daily
Peritoneal dialysis: 4 mg/kg/dose once daily
Dosing: Hepatic Impairment: adults & pediatrics
No dosage adjustment necessary if renal function is normal; however, in patients with
hepatic impairment and concomitant severe renal impairment, a dosage reduction or
prolonged dosing intervals may be appropriate
Contra- Hypersensitivity to clarithromycin, erythromycin, any of the macrolide antibiotics, or
indications any component of the formulation; history of cholestatic jaundice/hepatic dysfunction
associated with prior use of clarithromycin; concomitant use with cisapride, pimozide,
ergot alkaloids (eg, ergotamine, dihydroergotamine), lomitapide, or HMG-CoA
reductase inhibitors extensively metabolized by CYP3A4 (eg, lovastatin, simvastatin);
concomitant use with colchicine in patients with renal or hepatic impairment
Severe hepatic failure in combination with renal impairment; history of QT
prolongation (congenital or documented acquired QT prolongation or ventricular
cardiac arrhythmia, including torsades de pointes; hypokalemia; concomitant use with
saquinavir, midazolam (oral), colchicine (regardless of hepatic/renal impairment),
ticagrelor; concomitant use with astemizole, domperidone, terfenadine, or ranolazine
(not available in Canada)
Adverse Drug 1% to 10%:
Reactions Central nervous system: Headache (2%), insomnia
Dermatologic: Skin rash (children 3%)
Gastrointestinal: Dysgeusia (adults 3% to 7%), vomiting (children 6%), diarrhea (3% to
6%), nausea (adults 3%), abdominal pain (2% to 3%), dyspepsia (adults 2%)
Hematologic & oncologic: Prolonged prothrombin time (adults 1%)

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Hepatic: Abnormal hepatic function tests
Hypersensitivity: Anaphylactoid reaction
Infection: Candidiasis (including oral)
Renal: Increased blood urea nitrogen (4%)

Monitoring BUN, creatinine; perform culture and sensitivity studies prior to initiating drug therapy
Parameters as appropriate
Drug Long list of interactions must be checked before adminsterations includes:
Interactions Risk X: Avoid combination:
Aprepitant, Budesonide (Topical), Doxorubicin, Everolimus, Fusidic Acid (Systemic),
Ibrutinib, Irinotecan Products, Lopinavir, Lovastatin, Pimozide, Posaconazole,
Simvastatin, Vincristine (Liposomal),
Risk D: Consider therapy modification
Calcium Channel Blockers Except Clevidipine, Colchicine, Fentanyl,
Methylprednisolone, Midazolam, Rivaroxaban, Sildenafil, Sirolimus, Theophylline
Derivatives
Pregnancy and Pregnancy factor C
Lactation Clarithromycin and its active metabolite (14-hydroxy clarithromycin) are present in
breast milk in low levels. Decreased appetite, diarrhea, rash, and somnolence have
been reported in breastfed infants exposed to macrolide antibiotics. should consider
the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of
treatment to the mother.
Administration • Immediate Release tablets and granules for suspension: Administer with or without
meals. Administer every 12 hours rather than twice daily to avoid peak and trough
variation. Shake suspension well before each use.
• Extended Release tablets: Administer with food. Do not break, crush, or chew.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions Altered cardiac conduction: Use has been associated with QT prolongation and
infrequent cases of arrhythmias, including torsades de pointes (may be fatal); avoid
use in patients with known prolongation of the QT interval, ventricular cardiac
arrhythmia (including torsades de pointes), uncorrected hypokalemia or
hypomagnesemia, clinically significant bradycardia, and patients receiving Class IA (eg,
quinidine, procainamide) or Class III (eg, amiodarone, dofetilide, sotalol)
antiarrhythmic agents or other drugs known to prolong the QT interval.
• Hepatic effects: Elevated liver function tests and hepatitis (hepatocellular and/or
cholestatic with or without jaundice) have been reported; usually reversible after
discontinuation of clarithromycin. May lead to hepatic failure or death (rarely),
especially in the presence of preexisting diseases and/or concomitant use of
medications. Discontinue immediately if symptoms of hepatitis (eg, anorexia, jaundice,
abdominal tenderness, pruritus, dark urine) occur.
• Hypersensitivity reactions: Severe acute reactions have been reported, including
anaphylaxis, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug
rash with eosinophilia and systemic symptoms (DRESS), Henoch-Schönlein purpura
(IgA vasculitis), and acute generalized exanthematous pustulosis; discontinue therapy
and initiate treatment immediately for severe acute hypersensitivity reactions.
• Superinfection: Use may result in fungal or bacterial superinfection, including C.
difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been
observed >2 months postantibiotic treatment.

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Disease-related concerns:
• CAD: Use with caution in patients with CAD. A clinical trial in patients with CAD
demonstrated an increase in risk of all-cause mortality ≥1 year after the end of
treatment in patients randomized to receive clarithromycin. Other epidemiologic
studies evaluating this risk have variable results.
• Myasthenia gravis: Use with caution in patients with myasthenia gravis; exacerbation
of symptoms and new onset of symptoms has occurred.
• Renal impairment: Use with caution in severe renal impairment; dosage adjustment
required.
Special populations:
• Elderly: Use with caution; elderly patients may be at increased risk of torsades de
pointes.
• Patients with HIV: Decreased survival has been observed in patients with HIV
with Mycobacterium avium complex (MAC) receiving clarithromycin doses above the
maximum recommended dose; maximum recommended dosing should not be
exceeded in this population. Development of resistance to clarithromycin has been
observed when used as prophylaxis and treatment of MAC infection (Biaxin Canadian
product labeling).
Dosage form specific issues:
• Extended release formulation: The presence of extended release tablets in the stool
has been reported, particularly in patients with anatomic (eg, ileostomy, colostomy) or
functional GI disorders with decreased transit times. Consider alternative dosage forms
(eg, suspension) or an alternative antimicrobial for patients with tablet residue in the
stool and no signs of clinical improvement.
• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts
are potentially toxic and have been associated hyperosmolality, lactic acidosis,
seizures, and respiratory depression; use caution
Other warnings/precautions:
• Appropriate use: Helicobacter pylori eradication: Short-term combination therapy
(≤7 days) has been associated with a higher incidence of treatment failure. Current
guidelines recommend 10 to 14 days of therapy (triple or quadruple) for eradication
of H. pylori in pediatric and adult patients
Storage • Tablets: Store at 20°C to 25°C; excursions are permitted between 15°C and 30°C.
Protect from light.
• Granules for suspension: Store at 25°C prior to and following reconstitution. Do not
refrigerate. Use within 14 days of reconstitution
• Refer to manufacturer PIL if there are specific considerations.

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Watch Group
3. Erythromycin
Generic Name Erythromycin

Dosage Topical gel/ointment/solution/lotion 2%

form/strengths Tablets 250mg, 500mg
powder for orl Suspension 125mg/5ml, 200mg/5ml, 250mg/5ml, 400mg/5ml
Route of Oral, topical
administration
Pharmacologic Antibiotic, Macrolide
action Systemic ATC: J01FA01
Topical ATC: D10AF02
Indications Bacterial infections: Treatment of susceptible bacterial infections, including S. pyogenes,
some S. pneumoniae, some S. aureus, M. pneumoniae, Legionella pneumophila, diphtheria,
pertussis, Chlamydia, erythrasma, N. gonorrhoeae, E. histolytica, syphilis and nongonococcal
urethritis, and Campylobacter gastroenteritis; used in conjunction with neomycin for
decontaminating the bowel

Surgical (preoperative) prophylaxis (colorectal): Colorectal decontamination, in conjunction

with other agents, prior to surgical intervention

Topical: Treatment of acne vulgaris

Dosage Usual dosage range:

Regimen Note: Due to differences in absorption, 400 mg erythromycin ethylsuccinate produces the
same serum levels as 250 mg erythromycin base or stearate.
Oral:
Base: 250 to 500 mg every 6 to 12 hours; maximum: 4 g daily.
Ethylsuccinate: 400 to 800 mg every 6 to 12 hours; maximum: 4 g daily.
Dosing: Pediatric
General dosing, susceptible infection: Infants, Children, and Adolescents:
Oral: Base, ethylsuccinate, stearate: 30 to 50 mg/kg/day divided every 6 to 8 hours usually;
for severe infection may double dose;
maximum daily dose: Mild to moderate infection: 2,000 mg/day;
severe infection: 4,000 mg/day
Topical:
Dosing: Adult and Adolescents
Acne: Topical: Note: The American Academy of Dermatology acne guidelines recommend
erythromycin (topical) be used in conjunction with other therapies (not as monotherapy) due
to the risk of bacterial resistance.
Gel: Apply sparingly as a thin film over the affected area once or twice daily. Therapeutic
response may take up to 6 to 8 weeks; discontinue use if no improvement after 6 to 8 weeks
or if condition worsens.
Ointment, solution: Apply to affected area twice daily (morning and evening); drying and
peeling may be controlled by reducing the frequency of application.
Dosage Dosing: Renal Impairment: Adult
adjustment There are no dosage adjustments needed
Dialysis: Slightly dialyzable (5% to 20%). Supplemental dose is not necessary in hemo- or
peritoneal dialysis or in continuous arteriovenous or venovenous hemofiltration

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Dosing: Renal Impairment: Pediatric
GFR ≥10 mL/minute/1.73 m2: No adjustment required
GFR <10 mL/minute/1.73 m2: Intermittent hemodialysis, peritoneal dialysis: Not removed by
peritoneal dialysis or hemodialysis: 10 to 17 mg/kg/dose every 8 hours
Dosing: Hepatic Impairment:
There are no dosage adjustments needed; use with caution
Contra- Hypersensitivity to erythromycin, any macrolide antibiotics, or any component of the
indications formulation
Concomitant use with pimozide, cisapride, ergotamine or dihydroergotamine, terfenadine,
astemizole, lovastatin, or simvastatin
Adverse Drug Frequency not defined:
Reactions Cardiovascular: QTc prolongation, torsade de pointes, ventricular arrhythmia, ventricular
tachycardia
Central nervous system: Seizure
Dermatologic: Erythema multiforme, pruritus, skin rash, Stevens-Johnson syndrome, toxic
epidermal necrolysis, urticaria
Gastrointestinal: Abdominal pain, anorexia, diarrhea, nausea, oral candidiasis, pancreatitis,
pseudomembranous colitis, pyloric stenosis (infantile hypertrophic), vomiting
Hepatic: Abnormal hepatic function tests, cholestatic jaundice (most common with estolate),
hepatitis
Hypersensitivity: Anaphylaxis, hypersensitivity reaction
Local: Injection site phlebitis
Neuromuscular & skeletal: Weakness
Otic: Hearing loss
Renal: Interstitial nephritis
Postmarketing and/or case reports: Hepatotoxicity
Monitoring Assess results of culture and sensitivity tests and patient's previous allergy history prior to
Parameters therapy. Obtain liver function tests and monitor for liver toxicity. Assess other medicines
patient may be taking; alternate therapy or dosage adjustments may be needed. Assess for
effectiveness of treatment. Test for C. difficile if patient develops diarrhea. May lead to
ototoxicity when used in high doses with other ototoxic medications or in the elderly patient.
Drug Risk X: Avoid combination:
Interactions Amiodarone, Aprepitant, Bosutinib, Cholera Vaccine, Cisapride, Clindamycin (Topical),
Domperidone, Doxorubicin (Conventional), Dronedarone, Ergot Derivatives, Fluconazole,
Fosaprepitant, Ivabradine, Lovastatin, Quinidine, Simeprevir, Simvastatin
Risk D: Consider therapy modification
Budesonide (Systemic), Buspirone, Calcium Channel Blockers, Carbamazepine, Cilostazol,
Colchicine, Edoxaban, Eplerenone, Everolimus, Fentanyl, Guanfacine, Methadone,
Midazolam, Mitotane, Ranolazine, Rivaroxaban, Sildenafil, Sirolimus, Typhoid Vaccine,
Pregnancy and Pregnancy category B
Lactation Although Caution should be used if administered to a breastfeeding patient, erythromycin is
considered compatible when used in usual recommended doses. Erythromycin is a preferred
agent for the treatment of granuloma inguinale and lymphogranuloma venereum in
breastfeeding patients. If systemic erythromycin is needed for the treatment of dermatologic
conditions, only short-term use is recommended if breastfeeding.
Topical erythromycin is considered to be compatible with breastfeeding.
Administration Administration: Oral
Administer base or stearate dosage forms on an empty stomach (2 hours before or after a
meal); administer ethylsuccinate (EES) without regard to meals; may consider administering

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after food to decrease GI discomfort.
Topical:
Prior to treatment, thoroughly wash affected area with mild soap and warm water, rinse,
and pat dry. Wash hands after use. Avoid contact with the eyes, nose, mouth and other
mucous membranes, and broken skin.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Altered cardiac conduction: Macrolides have been associated with rare QTc prolongation
and ventricular arrhythmias, including torsade de pointes; use with caution in patients at risk
of prolonged cardiac repolarization; avoid use in patients with prolonged QT interval,
uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, or
concurrent use of Class IA (eg, quinidine, procainamide) or Class III (eg, amiodarone,
dofetilide, sotalol) antiarrhythmic agents.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C.
difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been
observed >2 months postantibiotic treatment.
Disease-related concerns:
• Hepatic impairment: Use with caution in patients with preexisting liver disease; hepatic
impairment, including hepatocellular and/or cholestatic hepatitis, with or without jaundice,
has been observed. Discontinue if symptoms of malaise, nausea, vomiting, abdominal colic,
and fever.
• Myasthenia gravis: Exacerbation of and new onset of myasthenia gravis symptoms have
been reported.
Special populations:
• Infants: Use of erythromycin has been associated with infantile hypertrophic pyloric
stenosis (IHPS); observe for non-bilious vomiting or irritability with feeding.
• Elderly: May be at increased risk of adverse events, including hearing loss and/or torsade
de pointes, particularly if concurrent renal/hepatic impairment

Storage • Granules: Prior to mixing, store at 20°C to 25°C. After mixing, store under refrigeration
and use within 10 days.
• Powder: Prior to mixing, store at <30°C. After mixing, store at ≤25°C and use within 35
days.
• Tablet and Topicsl formulations: Store at 20°C to 25°C.
Refer to manufacturer PIL if there are specific considerations.

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4. Roxithromycin
Watch Group

Generic Name Roxithromycin

Dosage Tablets: 100mg, 150 mg, 300mg

form/strengths
Route of Oral
administration
Pharmacologic a semi-synthethic macrolide antibiotic
category ATC: J01FA06
Indications used to treat various infections caused by bacteria such as:

• upper respiratory tract infection - acute pharyngitis, tonsillitis and sinusitis

• dental infections
• lower respiratory tract infection - acute bronchitis; acute exacerbations of chronic
bronchitis and community acquired pneumonia
• skin and skin structure infections
• non-gonococcal urethritis.

Dosage Adults dosing:

Regimen Usual dosage: Roxithromycin 300 mg tablet daily or 150 mg twice daily.
The usual duration of treatment is five to ten days depending on the indication and clinical
response.
The usual duration of treatment is five to ten days depending on the indication and clinical
response.
Pediatric dosing:
Roxithromycin is administered twice daily at a dose of 5 to 8 mg/kg/day.
For children≥ 40 kg: One 150 mg tablet morning and evening.

Dosage Dosing: Renal Impairment: Adult

adjustment No dosage adjustment necessary.
Dosing: Hepatic Impairment: Adult
150 mg tablet once daily for patients with documented cirrhotic liver disease.
Contra- known hypersensitivity to macrolide (such as azithromycin, clarithromycin or erythromycin),
indications severely impaired hepatic function, concomitant therapy with vasoconstrictive ergot alkaloids.

Adverse Drug Roxithromycin primarily causes gastrointestinal adverse events, such as diarrhoea, nausea,
Reactions abdominal pain and vomiting.
Less common adverse events include headaches, rashes, abnormal liver function values and
alteration in senses of smell and taste
Monitoring Signs of hypersensitivity to roxithromycin; development of superinfection or antibiotic-associated
Parameters diarrhea
Drug Risk X: Avoid combination
Interactions Ergotamine and derivatives, Terfenadine, Astemizole, cisapride, pimozide, Thioridizine, Dofetilide
Risk D: Consider therapy modification
Theophylline, Disopyramide, Warfarin, Digoxin and other cardiac glycosides, Midazolam,
Pregnancy and Safety in this group of patients has not been determined. It passes to breast milk.
Lactation This medicine is not recommended for use during pregnancy.

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low levels of roxithromycin in breastmilk, it would not be expected to cause adverse effects in
breastfed infants. Monitor the infant for possible effects on the gastrointestinal flora, such as
diarrhea, candidiasis (thrush, diaper rash)
Administration Oral: should be taken at least 15 minutes before food or on an empty stomach (i.e. more than
three hours after a meal). The film coated tablets must be swallowed whole with a drink.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ • Prolonged or repeated use of antibiotics including roxithromycin may result in superinfection
Precautions by resistant organisms. In the event of superinfection, roxithromycin should be discontinued
and appropriate therapy instituted.
• Drugs that delay peristalsis, e.g. opiates and diphenoxylate with atropine, may prolong and/or
worsen the condition and should not be used.
• Drugs that delay peristalsis, e.g. opiates and diphenoxylate with atropine, may prolong and/or
worsen the condition and should not be used. As with other macrolides, roxithromycin may
have the potential to aggravate myasthenia gravis.
• Cases of severe bullous skin reactions such as Stevens Johnson Syndrome or Toxic Epidermal
Necrosis have been reported with roxithromycin (see Undesirable effects). If symptoms or
signs of SJS or TEN (eg. progressive skin rash often with blisters or mucosal lesions) are
present, roxithromycin treatment should be discontinued.
• Severe vasoconstriction (“ergotism”) with possibly necrosis of the extremities has been
reported when macrolide antibiotics have been associated with vasoconstrictive ergot
alkaloids. Absence of treatment by these alkaloids must always be checked before prescribing
roxithromycin.
• Increased INR levels have been reported in patients when Arrow - Roxithromycin and
coumarin anticoagulants are used concomitantly. Patients using Arrow - Roxithromycin and
coumarin anticoagulants should be closely monitored.
• Prolongation of the QT Interval Ventricular arrhythmias associated with prolonged QT interval,
including ventricular tachycardia and torsades de pointes have been reported with macrolide
antibiotics including roxithromycin.
Storage Store in a cool, dry place where it stays below 25°C, and protect from light and moisture.
Refer to manufacturer PIL if there are specific considerations.

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5. Spiramycin
Watch Group

Generic Name Spiramycin

Dosage Tablets 1.5 MIU, 3MIU

form/strengths
Route of Oral
administration
Pharmacologic Antibiotic, Macrolide
category ATC: J01FA02
Indications Treatment of infections of the respiratory tract, buccal cavity, skin and soft tissues due to
susceptible organisms. N. gonorrhoeae: as an alternate choice of treatment for gonorrhea
in patients allergic to the penicillins. Before treatment of gonorrhea, the possibility of
concomitant infection due to T. pallidum should be excluded

Dosage Dosing: Adult

Regimen Mild to moderate infections: Oral: 6 MIU to 9 MIU per day in 2 divided doses
Severe infections: Oral: 12 MIU to 15 MIU per day in 2 divided doses
Gonorrhea: Oral: 12 MIU to 13.5 MIU as a single dose
Acute toxoplasmosis in pregnancy (<18 weeks' gestation) (off-label use): Oral: 1 g (3
MIU) every 8 hours to prevent transmission to fetus. At ≥18 weeks, if there is no evidence
of transmission to the fetus, spiramycin can be continued until term. Note: If intrauterine
fetal Toxoplasma infection is confirmed, treatment should be switched to pyrimethamine
plus sulfadiazine and folinic acid
Dosing: Pediatric
Susceptible infections: Oral: Dosage by body weight; usual dosage 1.5 MIU/kg. Daily dose
should be administered in 2 to 3 divided doses.
Note: In severe infections, dosage may be increased by 50%.

Dosage Dosing: Renal Impairment: Adult

adjustment No dosage adjustment required.
Dosing Hepatic impairment:
Use with caution in patients with pre-existing liver disease
Contra- Hypersensitivity to spiramycin, other macrolides (eg, erythromycin) or any component of
indications the formulation
Adverse Drug Frequency not defined.
Reactions Central nervous system: Paresthesia (transient)
Dermatologic: Pruritus, skin rash, urticaria
Gastrointestinal: Diarrhea, nausea, vomiting
Monitoring Hepatic functions
Parameters
Drug Risk X: Avoid combination
Interactions BCG (Intravesical) Mizolastine
Risk D: Consider therapy modification
Typhoid Vaccine: Sodium Picosulfate
Risk C: Monitor therapy
BCG Vaccine Carbidopa Lactobacillus and Estriol
Pregnancy Spiramycin has not been found to be teratogenic and has been found to be safe in the
pregnant woman, fetus, and newborn.

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Administration Administer without regard to meals. But Food may improve gastrointestinal tolerance.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Altered cardiac conduction: Macrolides have been associated with rare
QTc prolongation and ventricular arrhythmias, including torsade de pointes; use with
caution in patients at risk of prolonged cardiac repolarization.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection,
including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD
has been observed >2 months postantibiotic treatment.
Disease-related concerns:
• Hepatic impairment: Use with caution in patients with pre-existing liver disease; hepatic
impairment, including hepatocellular and/or cholestatic hepatitis, with or without
jaundice, has been observed. Discontinue if symptoms of malaise, nausea, vomiting,
abdominal colic, and fever.
Storage Store at 20°C to 25°C
Refer to manufacturer PIL if there are specific considerations.

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Miscellaneous

1. Aztreonam
Reserve Group

Generic Name Aztreonam

Dosage Powder for injection :1gm

form/strengths
Route of IV, IM
administration
Pharmacologic Antibiotic, Monobactam
category ATC: J01DF01

Indications Treatment of patients with urinary tract infections, lower respiratory tract infections,
septicemia, skin/skin structure infections, intra-abdominal infections, and gynecological
infections caused by susceptible gram-negative bacilli
Dosage Dosing: Adult
Regimen Moderately severe systemic infections:
1 g IV or IM or 2 g IV every 8 to 12 hours; maximum: 8 g/day.
Pneumonia:
- Community-acquired pneumonia: For empiric therapy of inpatients at risk of infection
with a resistant gram-negative pathogen, including P. aeruginosa:
IV: 2 g every 8 hours as part of an appropriate combination regimen. Total duration is
for a minimum of 5 days.
- Hospital-acquired or ventilator-associated (alternative agent): For empiric therapy or
pathogen-specific therapy of resistant gram-negative pathogens, including P.
aeruginosa:
IV: 2 g every 8 hours for 7 days; may consider shorter or longer durations depending on
rate of clinical improvement.
Severe systemic or life-threatening infections (eg, Pseudomonas aeruginosa): IV: 2 g every
6 to 8 hours; maximum: 8 g/day.
Urinary tract infection: IM, IV: 500 mg to 1 g every 8 to 12 hours; maximum: 8 g/day.
Dosing: Pediatric
General dosing, susceptible infection: Infants, Children, and Adolescents:
- Mild to moderate infection: IM, IV: 90 mg/kg/day in divided doses every 8 hours;
maximum daily dose: 3,000 mg/day
- Severe infection: IM, IV: 90 to 120 mg/kg/day in divided doses every 6 to 8 hours;
maximum daily dose: 8 g/day
Cystic fibrosis (Pseudomonas aeruginosa): Infants, Children, and Adolescents: IV: 150 to 200
mg/kg/day in divided doses every 6 to 8 hours Intra-abdominal infections,
complicated: Infants, Children, and Adolescents: IV: 90 to 120 mg/kg/day divided every 6 to
8 hours in combination with metronidazole; maximum dose: 2,000 mg
Peritonitis (peritoneal dialysis), treatment: Infants, Children, and Adolescents:
Intraperitoneal: Continuous: Loading dose: 1,000 mg per liter of dialysate; maintenance
dose: 250 mg per liter
Surgical prophylaxis: Children and Adolescents: IV: 30 mg/kg within 60 minutes before
procedure; may repeat in 4 hours for prolonged procedure or excessive blood loss;

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maximum dose: 2,000 mg

Dosage Dosing: Renal Impairment: Adult

adjustment IM, IV: Adults: Following initial dose, maintenance doses should be given as follows:
CrCl 10 to 30 mL/minute: 50% of usual dose at the usual interval
CrCl <10 mL/minute: 25% of usual dosage at the usual interval
Dosing: Renal Impairment: Pediatric
Infants, Children, and Adolescents: IM, IV: The following adjustments have been
recommended.
Note: Renally adjusted recommendations are based on doses of 90 to 120 mg/kg/day
divided every 8 hours.
GFR ≥30 mL/minute/1.73 m2: No adjustment required
GFR 10-29 mL/minute/1.73 m2: 15 to 20 mg/kg every 8 hours
GFR <10 mL/minute/1.73 m2: 7.5 to 10 mg/kg every 12 hours
Intermittent hemodialysis: 7.5 to 10 mg/kg every 12 hours
Peritoneal dialysis (PD): 7.5 to 10 mg/kg every 12 hours
Continuous renal replacement therapy (CRRT): No adjustment required.

Dosing: Hepatic Impairment: Adult-pediatric

There are no dosage adjustments needed. Use with caution (minor hepatic elimination
occurs).
Contra- Hypersensitivity to aztreonam or any component of the formulation
indications
Adverse Drug >10%:
Reactions Hematologic & oncologic: Neutropenia (children 3% to 11%; adults <1%)
Hepatic: Increased serum transaminases (children, high dose: >3 times ULN: 15% to 20%;
children, standard dose: increased serum AST 4%, increased serum ALT 7%)
Local: Pain at injection site (children 12%, adults 2%)
1% to 10%:
Cardiovascular: Phlebitis, thrombophlebitis
Dermatologic: Skin rash
Gastrointestinal: Diarrhea, nausea, vomiting
Hematologic & oncologic: Eosinophilia, thrombocythemia
Local: Erythema at injection site, discomfort at injection site, swelling at injection site
Renal: Increased serum creatinine
Miscellaneous: Fever

Monitoring Periodic renal and hepatic function tests; monitor for signs of anaphylaxis during first dose
Parameters
Drug Risk X: Avoid combination
Interactions BCG (Intravesical) Cholera Vaccine
Risk D: Consider therapy modification
Sodium Picosulfate Typhoid Vaccine

Pregnancy and Pregnancy Risk Factor B

Lactation Aztreonam is present in breast milk in concentrations <1% of the corresponding maternal
serum concentration. In general, antibiotics that are present in breast milk may cause
nondose-related modification of bowel flora. The poor oral absorption of aztreonam from
the gastrointestinal tract (<1%) may limit adverse effects to the infant.

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Administration Preparation for Administration:
IM: Reconstitute vial with at least 3 mL SWFI, sterile bacteriostatic water for injection,
NS, or bacteriostatic sodium chloride per gram of aztreonam to a final concentration of
≤333 mg/mL; immediately shake vigorously. Do not mix with any local anesthetic agent.
IV: Bolus injection: Reconstitute vial with 6 to 10 mL SWFI; immediately shake
vigorously
Infusion: Reconstitute vial with at least 3 mL SWFI per gram of aztreonam; immediately
shake vigorously. Reconstituted solutions are colorless to light yellow straw and may
turn pink upon standing without affecting potency. Further dilute in an appropriate
solution (eg, D5W, NS) for infusion to a final concentration not to exceed 20 mg/mL.
N.B. Hypersensitivity test must be done before using injection form of this medicine.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Beta-lactam allergy: Rare cross-allergenicity to penicillins, cephalosporins, or
carbapenems may occur; use with caution in patients with a history of hypersensitivity
to beta-lactams.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection,
including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD
has been observed >2 months postantibiotic treatment.
Disease-related concerns:
• Renal impairment: Use with caution in patients with renal impairment; dosing
adjustment required.
Special populations:
• Bone marrow transplantation: Use with caution in bone marrow transplant patients
with multiple risk factors for toxic epidermal necrolysis (TEN) (eg, sepsis, radiation
therapy, drugs known to cause TEN); rare cases of TEN in this population have been
reported.

Storage • Vials: store at room temperature; avoid excessive heat.

• After reconstitution, solutions for infusion: should be used within 48 hours if stored at
room temperature or within 7 days if refrigerated.;
• solutions for infusion (prepared with other than SWFI or NS with a final concentration >20
mg/mL) must be used immediately after preparation.
• Refer to manufacturer PIL if there are specific considerations.

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2. Chloramphenicol
Access Group

Generic Name Chloramphenicol

Dosage Eye ointmint 1%

form/strengths Eye drops 0.5%
Capsule 250mg
Ears drops 5%
Oral Suspension 125 mg/5ml
Suppository 500mg
powder for injection 1g
Route of Oral IV Topical Ophthalmic
administration
Pharmacologic Antibiotic, Miscellaneous
category ATC (Topical, dermatological): D06AX02
ATC (Systemic): J01BA01
ATC (Ophthalmic): S01AA01, S03AA08
Indications Serious infections: Treatment of serious infections, including cystic fibrosis exacerbations,
bacterial meningitis, and bacteremia, caused by Chlamydiaceae, Haemophilus
influenzae, Rickettsia, Salmonella spp. (acute infections), and other organisms when other less
toxic agents are ineffective or contraindicated.
Dosage Dosing: Adult
Regimen Due to narrow therapeutic range it is recommended that plasma concentrations of
chloramphenicol be monitored in all patients receiving the drug and dosage adjusted
accordingly.
Generally, adjust chloramphenicol dosage to maintain plasma concentrations of 5–20 mcg/mL
(usually 10–20 mcg/mL).
In pediatric patients beyond the neonatal period, AAP suggests adjusting dosage to maintain
target plasma concentrations of 15–25 mcg/mL
Chloramphenicol plasma concentrations >25 mcg/mL have been associated with toxicity
Serious infections: IV: 50 to 100 mg/kg/day in divided doses every 6 hours; maximum daily
dose: 4 g/day
Pediatric Patients
General Dosage IV
for Neonates
25 mg/kg daily given in 4 equally divided doses every 6 hours usually provides and maintains
blood and tissue concentrations adequate for most indications
for Pediatric Patients Beyond the Neonatal Period
50 mg/kg daily given in 4 divided doses every 6 hours provides blood concentrations adequate
for most indications in pediatric patients
50–100 mg/kg daily given in 4 divided doses for severe infections
maximum daily dose: 4,000 mg/day
Dosage Dosing: Renal Impairment or Hepatic Impairment:
adjustment Use with caution, reduced dosage and serum concentration monitoring is recommended.
Contra- Hypersensitivity to chloramphenicol or any component of the formulation; treatment of trivial
indications or viral infections; bacterial prophylaxis
Adverse Drug Central nervous system: Confusion, delirium, depression, headache
Reactions Dermatologic: Skin rash, urticaria
Gastrointestinal: Diarrhea, enterocolitis, glossitis, nausea, stomatitis, vomiting

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Hematologic & oncologic: Aplastic anemia, bone marrow depression, granulocytopenia,
hypoplastic anemia, pancytopenia, thrombocytopenia
Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction
Ophthalmic: Optic neuritis
Miscellaneous: Drug toxicity (Gray syndrome), fever
Monitoring CBC with differential (baseline and every 2 days during therapy), periodic hepatic and renal
Parameters function tests, serum drug concentration

Drug •Risk X: Avoid combination

Interactions Dipyrone, Cholera Vaccine, BCG (Intravesical), cladribine
• Risk D: Consider therapy modification
Ceftazidime, Cyclosporine, Deferiprone, Sodium Picosulfate, Tacrolimus (Systemic), Typhoid
Vaccine
• Risk C: Monitor therapy
Alcohol ,Barbiturates, BCG Vaccine (Immunization), Carbocisteine, Chloramphenicol
(Ophthalmic), Clozapine, Fosphenytoin, Actobacillus And Estrio, Phenytoin, Promazine,
Rifampin, Sulfonylureas, Vitamin B12, Vitamin K Antagonists
Pregnancy and Pregnancy Risk Factor C
Lactation Due to the potential for serious adverse reactions in the breastfed infant, it is recommended to
take a decision to discontinue breastfeeding or to discontinue the drug, taking into account the
importance of treatment to the mother. Avoid use while breast-feeding, especially young
infants (<34 weeks postconceptual age or <1 month of age) or when unusually large doses are
needed.
Administration Parenteral:
IV push: Administer over at least 1 minute.
Intermittent IV infusion: Infuse over 30 to 60 minutes. In neonates, some centers have
administered as an intermittent IV infusion over 15 minutes
Should not be administered IM; has been shown to be ineffective.
Preparation for Administration: Adult
IV push: Reconstitute with 10 mL SWFI or D5W for a concentration of 100 mg/mL.
Preparation for Administration: Pediatric
IV push: Reconstitute with 10 mL SWFI or D5W for a concentration of 100 mg/mL.
Intermittent IV infusion (over 15-60 min): Further dilute in D5W to a final concentration not to
exceed 20 mg/mL; in neonates, a higher maximum concentration of 25 mg/mL has been used
Refer to manufacturer PIL if there are specific considerations.
Warnings/ • Blood dyscrasias: [US Boxed Warning]: Serious and fatal blood dyscrasias (aplastic anemia,
Precautions hypoplastic anemia, thrombocytopenia, and granulocytopenia) have occurred after both short-
term and prolonged therapy; do not use for minor infections or when less potentially toxic
agents are effective. Monitor CBC frequently in all patients; discontinue if evidence of
myelosuppression. Irreversible bone marrow suppression may occur weeks or months after
therapy. Avoid prolonged or repeated courses of treatment.
• Gray syndrome: Characterized by cyanosis, abdominal distention, vasomotor collapse (often
with irregular respiration), and death. Reaction appears to be associated with serum levels ≥50
mcg/mL.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C.
difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed
>2 months postantibiotic treatment.
• Patients with Hepatic or Renal impairment: Use with caution; reduced dosage and serum
concentration monitoring is recommended.

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• Glucose 6-phosphate dehydrogenase deficiency: Use with caution.

Storage Store intact vials at 20°C to 25°C

Refer to manufacturer PIL if there are specific considerations.

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Access Group
3. Clindamycin
Generic Name Clindamycin

Dosage Capsules 150mg, 300mg, 600mg,

form/strengths Topical solution 1%, 10mg/30ml
Topical jel or cream 1%
Solution for injection 300mg 600mg
Vaginal ovules 100mg,
Vaginal cream2%
Route of Oral IV IM intravaginal
administration
Pharmacologic Antibiotic, Lincosamide
category ATC (Topical): D10AF01
ATC (Gynecological): G01AA10
ATC (systemic): J01FF01
Indications Bone and joint infections: Treatment of bone and joint infections, including acute hematogenous
osteomyelitis caused by Staphylococcus aureus and as adjunctive therapy in the surgical
treatment of chronic bone and joint infections caused by susceptible organisms.
Gynecological infections: Treatment of gynecologic infections, including endometritis,
nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection
caused by susceptible anaerobes.
Intraabdominal infections: Treatment of intraabdominal infections, including peritonitis and
intraabdominal abscess caused by susceptible anaerobic organisms.
Lower respiratory tract infections: Treatment of lower respiratory tract infections, including
pneumonia, empyema, and lung abscess
Septicemia: Treatment of septicemia
Skin and soft tissue infection: Treatment of skin and soft tissue infection
Dosage Adult Dosing:
Regimen Serious Infections
Oral: 150–300 mg every 6 hours.
IV or IM: 600 mg to 1.2 g daily in 2–4 equally divided doses.
More Severe Infections
Oral: 300–450 mg every 6 hours.
IV or IM: 1.2–2.7 g daily in 2–4 equally divided doses.
For life-threatening infections, IV dosage may be increased up 4.8 g daily
Dosing: Pediatric
Note: Dosage should be based on total body weight for obese children ≥2 years of age and
adolescents.
General dosing, susceptible infection:
IM, IV: Infants, Children, and Adolescents 1 month to 16 years:
o Weight-directed dosing: 20-40 mg/kg/day divided every 6-8 hours.
o BSA-directed dosing: 350 to 450 mg/m2/day divided every 6 to 8 hours.
Alternate dosing (Red Book [AAP] 2012): Infants, Children, and Adolescents:
o Mild to moderate infections: 20 mg/kg/day divided every 8 hours; maximum daily dose: 1,800
mg/day.
o Severe infections: 40 mg/kg/day divided every 6 to 8 hours; maximum daily dose: 2,700
mg/day.
Oral: Infants, Children, and Adolescents:

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o Hydrochloride salt (capsule): 8 to 20 mg/kg/day divided every 6 to 8 hours.
o Palmitate salt (solution): 8 to 25 mg/kg/day divided every 6 to 8 hours; minimum dose: 37.5 mg
3 times daily.
Alternate dosing (Red Book [AAP]; 2012): Infants, Children, and Adolescents:
o Mild to moderate infections: 10 to 25 mg/kg/day divided every 8 hours; maximum daily dose:
1,800 mg/day.
o Severe infections: 30 to 40 mg/kg/day divided every 6 to 8 hours; maximum daily dose: 1,800
mg/day.
Dosage Dosing: Renal Impairment:
adjustment No dosage adjustment necessary.
Dosing: Hepatic Impairment:
There are no dosage adjustments available. Hepatic impairment significantly prolongs the
elimination of clindamycin
Contra- Hypersensitivity to clindamycin, lincomycin, or any component of the formulation.
indications Canadian labeling: Additional contraindications (not in US labeling): Oral clindamycin: Infants <30
days of age.
Adverse Drug Cardiovascular: Hypotension (rare; IV administration), thrombophlebitis (IV)
Reactions Central nervous system: Metallic taste (IV)
Dermatologic: Acute generalized exanthematous pustulosis, erythema multiforme (rare),
exfoliative dermatitis (rare), maculopapular rash, pruritus, skin rash, Stevens-Johnson syndrome
(rare), toxic epidermal necrolysis, urticaria, vesiculobullous dermatitis
Gastrointestinal: Abdominal pain, antibiotic-associated
colitis, Clostridioides (formerly Clostridium) difficile-associated diarrhea, diarrhea, esophageal
ulcer, esophagitis, nausea, pseudomembranous colitis, unpleasant taste (IV), vomiting
Genitourinary: Azotemia, oliguria, proteinuria, vaginitis
Hematologic & oncologic: Agranulocytosis, eosinophilia (transient), neutropenia (transient),
thrombocytopenia
Hepatic: Abnormal hepatic function tests, jaundice
Hypersensitivity: Anaphylactic shock, anaphylactoid reaction (rare), anaphylaxis, angioedema,
hypersensitivity reaction
Immunologic: DRESS syndrome
Local: Abscess at injection site (IM), induration at injection site (IM), irritation at injection site
(IM), pain at injection site (IM)
Monitoring Observe for changes in bowel frequency. Monitor for colitis and resolution of symptoms. In severe
Parameters liver disease monitor liver function tests periodically; during prolonged therapy monitor CBC, liver
and renal function tests periodically.
Drug Risk X: Avoid combination
Interactions BCG (Intravesical), Cholera Vaccine, Mecamylamine
Risk D: Consider therapy modification
Typhoid Vaccine, Sodium Picosulfate
Pregnancy and Pregnancy factor B
Lactation Clindamycin has the potential to cause adverse effects on the breastfed infant's gastrointestinal
flora. If oral or intravenous clindamycin is required by a nursing mother, alternate drug may be
preferred. Monitor the infant for possible effects on the gastrointestinal flora, such as diarrhea,
candidiasis (thrush, diaper rash) or rarely, blood in the stool indicating possible antibiotic-
associated colitis.
Vaginal application is unlikely to cause infant side effects, although about 30% of a vaginal dose is
absorbed. Infant side effects are unlikely with topical administration for acne; however, topical
application to the breast may increase the risk of diarrhea if it is ingested by the infant.

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Administration Administration: IM
Deep IM sites, rotate sites. Do not exceed 600 mg in a single injection.
Administration: IV
Never administer undiluted as bolus; administer by IV intermittent infusion over at least 10 to
60 minutes, at a maximum rate of 30 mg/minute (do not exceed 1,200 mg/hour). Final
concentration for administration should not exceed 18 mg/mL.
Administration: Oral
Capsule should be taken with a full glass of water to avoid esophageal irritation; shake oral
solution well before use; may administer with or without meals.
Preparation for Administration: Adult
Injection: Never administer undiluted as bolus. For IV infusion, dilute vials with 50 to 100 mL of
compatible diluent (eg, D5W, NS); concentration of clindamycin for IV infusion should not
exceed 18 mg/mL.
Oral solution: Reconstitute bottles of 100 mL with 75 mL of water. Add a large portion of the
water and shake vigorously; add the remainder of the water and shake until the solution is
uniform. When reconstituted with water, each 5 mL of solution contains clindamycin palmitate
hydrochloride equivalent to clindamycin 75 mg.
Preparation for Administration: Pediatric
Oral: Reconstitute powder for oral solution with appropriate amount of water as specified on
the bottle. Shake vigorously until suspended.
Parenteral: IV: Dilute with a compatible diluent (eg, D5W, NS) to a final concentration not to
exceed 18 mg/mL
Refer to manufacturer PIL if there are specific considerations.
Warnings/ • Colitis: [US Boxed Warning]: Can cause severe and possibly fatal colitis. Should be reserved for
Precautions serious infections where less toxic antimicrobial agents are inappropriate. It should not be used in
patients with nonbacterial infections such as most upper respiratory tract infections. Hypertoxin-
producing strains of C. difficile cause increased morbidity and mortality, as these infections can be
refractory to antimicrobial therapy and may require colectomy. C. difficile-associated diarrhea
(CDAD) must be considered in all patients who present with diarrhea following antibiotic use.
CDAD has been observed >2 months postantibiotic treatment.
• Hypersensitivity: Severe hypersensitivity reactions, including severe skin reactions (eg, drug
reaction with eosinophilia and systemic symptoms [DRESS], Stevens-Johnson syndrome [SJS], toxic
epidermal necrolysis [TEN]), some fatal, and anaphylactic reactions, including anaphylactic shock,
have been reported. Permanently discontinue treatment and institute appropriate therapy if
these reactions occur.
• Superinfection: Use may result in overgrowth of nonsusceptible organisms, particularly yeast.
Should superinfection occur, appropriate measures should be taken as indicated by the clinical
situation.
Disease-related concerns:
• GI disease: Use with caution in patients with a history of GI disease, particularly colitis.
• Hepatic impairment: Use with caution in patients with moderate to severe liver disease,
however, when administered at every-8-hour intervals, drug accumulation is rare. Monitor
hepatic enzymes periodically as dosage adjustments may be necessary in patients with severe
liver disease.
Special populations:
• Atopic patients: Use with caution in atopic patients.
• Elderly: A subgroup of older patients with associated severe illness may tolerate diarrhea less
well. Monitor carefully for changes in bowel frequency.
Other warnings/precautions:
• Administration (IV): Do not inject IV undiluted as a bolus. Product should be diluted in

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compatible fluid and infused over 10 to 60 minutes.
• Appropriate use: Not appropriate for use in the treatment of meningitis due to inadequate
penetration into the CSF.
Storage • Oral: Store at 20°C to 25°C. Do not refrigerate the reconstituted oral solution (it will thicken); the
solution is stable for 2 weeks at room temperature.
• IV: Store intact vials and premixed bags at 20°C to 25°C. Infusion solution in NS or D5W solution
is stable for 16 days at room temperature, 32 days refrigerated, or 8 weeks frozen. After initial
use, discard any unused portion of vial after 24 hours.
• Refer to manufacturer PIL if there are specific considerations.

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4. Colistimethate
Reserve Group

Generic Name Colistimethate

Dosage Powder for solution for injection or for nebulizer solution 1MIU
form/strengths Powder for oral solution 50000IU/ml, 750000 I.U./15ml
Tablets 1.5 MIU
Route of Parentral, Oral
administration
Pharmacologic Antibiotic, Miscellaneous
category ATC: J01XB01
Indications Treatment of acute or chronic infections due to sensitive strains of certain gram-negative bacilli
(particularly Pseudomonas aeruginosa) which are resistant to other antibacterials or in patients
allergic to other antibacterials
Dosage Dosing: Adult
Regimen Note: Dosage expressed in terms of mg of colistin base activity (CBA). CBA 1 mg is defined to be
equivalent to colistimethate sodium (CMS) 30,000 units which is equivalent to ~2.4 mg CMS

--Pneumonia, hospital-acquired or ventilator-associated due to susceptible multidrug-resistant

gram-negative bacilli (eg, Pseudomonas aeruginosa, Acinetobacter spp) or
Severe infections (due to multidrug-resistant organisms susceptible to colistin):
Intravenous or Intramuscular dosage
IV: Loading dose: 300 mg CBA followed by 300 to 360 mg CBA/day in divided doses twice daily.
Begin maintenance dose 12 hours after the loading dose. Or 2.5 to 5 mg CBA/kg/day divided
every 6 to 12 hours
Note: This dosing should achieve a target average colistin steady-state plasma concentration of
2 mg/L.
Continuous Intravenous Infusion dosage
Adults:
2.5 to 5 mg/kg/day colistin base activity continuous IV infusion. Give one-half of the total daily
dose IV over 3 to 5 minutes and follow 1 to 2 hours later with the remaining one-half of the total
daily dose by continuous IV infusion over 22 to 23 hours.

Dosing: Pediatric
Note: Doses should be based on ideal body weight in obese patients
General dosing, susceptible infection:
Infants, Children, and Adolescents: Colistin base: IM, IV: 2.5 to 5 mg CBA/kg/day divided every 6
to 12 hours
Dosage Dosing: Renal Impairment: Adult
adjustment IV:
Loading dose: 300 mg CBA, followed by a maintenance dose based on CrCl.
Maintenance dose: The following total daily maintenance doses
CrCl 80 mL/minute or more: No dosage adjustment needed.
CrCl 50 to 79 mL/minute: 2.5 to 3.8 mg/kg/day colistin base activity IV or IM divided in 2 doses.
CrCl 30 to 49 mL/minute: 2.5 mg/kg/day colistin base activity IV or IM once daily or divided in 2
doses.
CrCl 10 to 29 mL/minute: 1.5 mg/kg colistin base activity IV or IM every 36 hours.

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Dosing: Renal Impairment: Pediatric
There are no pediatric specific recommendations. Dosage adjustment is suggested in adult
patients.

Dosing: Hepatic Impairment: Adult, pediatric

There are no dosage adjustments needed.

Dosing: Adjustment for Toxicity:

CNS toxicity: Dose reduction may reduce neurologic symptoms.
Nephrotoxicity: Withhold treatment if signs of renal impairment occur during treatment.

Contra- Hypersensitivity to colistimethate, colistin, or any component of the formulation

indications
Adverse Drug >10%:
Reactions Genitourinary: Nephrotoxicity (18% to 26%)
Renal: Acute renal failure (33% to 60%)
1% to 10%:
Central nervous system: Neurotoxicity (7%; higher incidence with high-dose IV use in cystic
fibrosis)
Frequency not defined:
Central nervous system: Dizziness, oral paresthesia, paresthesia, peripheral paresthesia,
seizures, slurred speech, vertigo
Dermatologic: Pruritus, skin rash, urticaria
Gastrointestinal: Clostridioides (formerly Clostridium) difficile-associated diarrhea, gastric
distress
Genitourinary: Decreased urine output
Hypersensitivity: Anaphylaxis
Renal: Decreased creatinine clearance, increased blood urea nitrogen, increased serum
creatinine
Respiratory: Apnea, respiratory distress
Miscellaneous: Fever
Monitoring Serum creatinine, BUN; urine output; signs of neurotoxicity; signs of bronchospasm (inhalation
Parameters [off-label route]); colistin serum concentrations (to ensure adequate drug exposure particularly
early in therapy).
Reference Range
Target serum concentration is 2 mg/L for susceptible organisms
Drug Risk X: Avoid combination
Interactions Bacitracin (Systemic) BCG (Intravesical) Cholera Vaccine Mecamylamine Methoxyflurane
Risk D: Consider therapy modification
Neuromuscular-Blocking Agents, Sodium Picosulfate Typhoid Vaccine, Vancomycin
Pregnancy and Pregnancy Risk Factor C
Lactation Colistimethate is excreted into human milk in small amounts. The possibility of bowel flora
modification and interference with culture results should be considered. caution should be used
when administering colistimethate to breast-feeding women.
Administration Administration: IV
Infuse over 30 minutes to 1 hour
Administration: Pediatric
Parenteral:
IM: Administer deep into a large muscle mass (eg, gluteal muscle or lateral part of the thigh).

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IV push: Administer over 3 to 5 minutes.
Intermittent IV infusion: Administer over 30 minutes.
Continuous IV infusion: Initially, one-half of the total daily dose is administered by direct IV
injection over 3 to 5 minutes followed 1 to 2 hours later by the remaining one-half of the total
daily dose diluted in a compatible IV solution infused over 22 to 23 hours. Infusion should be
completed within 24 hours of preparation.
Preparation for Administration:
IV use: Reconstitute each vial containing 150 mg of colistin base activity with 2 mL of SWFI
resulting in a concentration of 75 mg colistin base activity/mL; swirl gently to avoid frothing. May
further dilute in D5W or NS for IV infusion.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Bronchoconstriction: Use of inhaled colistimethate (off-label route) may result in
bronchoconstriction. Use with caution in patients with hyperactive airways; consider
administration of a bronchodilator (eg, albuterol) within 15 minutes prior to administration.
• CNS toxicity: Transient, reversible neurological disturbances may occur. Patients must be
cautioned about performing tasks which require mental alertness. Dose reduction may reduce
neurologic symptoms; monitor closely.
• Renal toxicity: Dose-dependent nephrotoxicity has been reported, generally reversible upon
discontinuation of treatment. Withhold treatment if signs of renal impairment occur during
treatment.
• Respiratory arrest: Respiratory arrest has been reported with use; impaired renal function
may increase the risk for neuromuscular blockade and apnea.
• Superinfection: In Prolonged use.
Disease-related concerns:
• Renal impairment: Use with caution in patients with preexisting renal impairment; dosage
adjustments are recommended. Impaired renal function may increase the risk for respiratory
arrest.
Other warnings/precautions:
• Appropriate use: Inhalation (off-label route): Once mixed, colistimethate begins conversion
to bioactive colistin, a component of which may result in severe pulmonary toxicity. Solutions
for inhalation must be mixed immediately prior to administration and used within 24 hours to
reduce the incidence of pulmonary toxicity.
• Appropriate use: IV: Use only to prevent or treat infections strongly suspected or proven to
be caused by susceptible bacteria to minimize development of bacterial drug resistance.
• Safety: Potential for dosing errors due to lack of standardization in literature when referring
to product and dose; colistimethate (inactive prodrug) and colistin base strengths are not
interchangeable; verify prescribed dose is expressed in terms of colistin base activity prior to
dispensing.
Storage Store intact vials at 20-25°C; excursions permitted to 15-30°C.
Reconstituted vials may be refrigerated at 2°C to 8°C or stored at 20°C to 25°C for up to 7 days.
Solutions for infusion should be freshly prepared in D5NS, D5W, LR, or NS; do not use beyond 24
hours.
Refer to manufacturer PIL if there are specific considerations.

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5. Dapsone
Generic Name Dapsone

Dosage Tablets 50mg, 100mg

form/strengths Topical Gel 5%
Route of Oral, Topical
administration
Pharmacologic Antibiotic, Miscellaneous
category ATC (Topical): D10AX05
Atc (Systemic): J04BA02
Indications Treatment of leprosy (due to susceptible strains of Mycobacterium leprae) and dermatitis
herpetiformis
Dosage Adult dosing
Regimen • Dermatitis herpetiformis: Oral:
Start at 50 mg daily, increase to 300 mg daily, or higher to achieve full control, reduce to
minimum maintenance dosage as soon as possible
• Leprosy: Oral:
Tuberculoid (paucibacillary):
− National Hansen's Disease Program 2016: 100 mg daily in combination with rifampin for
12 months.
− World Health Organization: 100 mg daily in combination with rifampin for 6 months (WHO
2012).
Lepromatous (multibacillary):
− National Hansen's Disease Program 2016: 100 mg daily in combination with rifampin and
clofazimine for 24 months.
− World Health Organization: 100 mg daily in combination with rifampin and clofazimine for
12 months (WHO 2012).
Dosing: Pediatric
• Dermatitis herpetiformis:
Infants, Children, and Adolescents:
Oral: Initial: 0.5 to 2 mg/kg/day in 1 to 2 divided doses; maximum initial daily dose in adults: 50
mg/day; increase dose as needed to achieve control; usual adult dose: 300 mg/dose; once
lesions controlled, some have reported that dose may be decreased as tolerated for chronic
therapy to a reported range: 0.125 to 0.5 mg/kg/day
• Leprosy (Hansen's disease):
Note: Treatment should be managed in consultation with a leprosy expert; use of multidrug
therapy is important to prevent drug resistance. Recommended duration varies:
Paucibacillary (Tuberculoid) leprosy (1 to 5 patches):
− National Hansen's Disease Program Recommendations 2018:
Infants, Children, and Adolescents: Oral: 1 mg/kg/dose once daily for 12 months; maximum
dose: 100 mg/dose; use in combination with rifampin.
− WHO Recommendations (WHO 2016):
Infants and Children <10 years and weighing <20 kg: Oral: 2 mg/kg/dose once daily for 6
months; use in combination with rifampin
Children ≥10 years and Adolescents ≤14 years:
20 to 40 kg: Oral: 25 mg once daily for 6 months; use in combination with rifampin
>40 kg: Oral: 50 mg once daily for 6 months; use in combination with rifampin

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Adolescents >14 years: Oral: 100 mg once daily for 6 months; use in combination with rifampin
Multibacillary (Lepromatous) leprosy (≥6 patches):
− National Hansen's Disease Program Recommendations 2018:
Infants, Children, and Adolescents: Oral: 1 mg/kg/dose once daily for 24 months; maximum
dose: 100 mg/dose; use in combination with rifampin and clofazimine.
− WHO Recommendations (WHO 2016):
Infants and Children <10 years and weighing <20 kg: Oral: 2 mg/kg/dose once daily for 12
months; use in combination with rifampin and clofazimine
Children ≥10 years and Adolescents ≤14 years:
20 to 40 kg: Oral: 25 mg once daily for 12 months; use in combination with rifampin and
clofazimine
>40 kg: Oral: 50 mg once daily for 12 months; use in combination with rifampin and clofazimine
Adolescents >14 years: Oral: 100 mg once daily for 12 months; use in combination with
rifampin and clofazimine
Dosage Dosing: Renal Impairment: Adult
adjustment No dosage adjustment necessary
Dosing: Hepatic Impairment: Adult
There are no dosage adjustments available; use with caution
Contra- Hypersensitivity to dapsone or any component of the formulation.
indications Canadian labeling: Additional contraindications (not in US labeling): Advanced amyloidosis of
the kidneys.
Adverse Drug >10%:
Reactions Hematologic: Reticulocyte increase (2% to 12%), hemolysis (>10%; dose related; seen in
patients with and without G6PD deficiency), hemoglobin decrease (>10%; 1-2 g/dL; almost all
patients), methemoglobinemia (>10%), red cell life span shortened (>10%), Agranulocytosis,
anemia, leukopenia, pure red cell aplasia (case report)
Cardiovascular: Tachycardia
Central nervous system: Fever, headache, insomnia, psychosis, vertigo
Dermatologic: Bullous and exfoliative dermatitis, erythema nodosum, exfoliative dermatitis,
morbilliform and scarlatiniform reactions, phototoxicity, Stevens-Johnson syndrome, toxic
epidermal necrolysis, urticaria
Endocrine & metabolic: Hypoalbuminemia (without proteinuria), male infertility
Gastrointestinal: Abdominal pain, nausea, pancreatitis, vomiting
Hepatic: Cholestatic jaundice, hepatitis
Neuromuscular & skeletal: Lower motor neuron toxicity (prolonged therapy), lupus-like
syndrome, peripheral neuropathy (rare, nonleprosy patients)
Ophthalmic: Blurred vision
Otic: Tinnitus
Renal: Albuminuria, nephrotic syndrome, renal papillary necrosis
Respiratory: Interstitial pneumonitis, pulmonary eosinophilia
Miscellaneous: Infectious mononucleosis-like syndrome (rash, fever, lymphadenopathy,
hepatic dysfunction)
Monitoring Check G6PD levels (prior to initiation); CBC (weekly for first month, monthly for 6 months and
Parameters semiannually thereafter); reticulocyte counts; liver function tests (baseline and periodic).
Monitor patients for signs of jaundice, hemolysis, and blood dyscrasias. If the patient is
diabetic, consider alternative methods to monitor diabetes control other than HbA1C
Drug Risk X: Avoid combination
Interactions Cholera Vaccine, BCG (Intravesical)
Risk D: Consider therapy modification

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Antimalarial Agents, Dabrafenib, Enzalutamide, Mitotane, Sodium Picosulfate, Typhoid Vaccine
Risk C: Monitor therapy
BCG Vaccine (Immunization) Atazanavir CYP3A4 Inducers, Deferasirox Ivosidenib Lactobacillus
And Estriol Local Anesthetics, Nitric Oxide, Prilocaine, Probenecid, Sarilumab Siltuximab,
Sodium Nitrite, Tocilizumab, Trimethoprim
Pregnancy Pregnancy Risk Factor C
Hemolytic reactions have been reported in neonates. Due to the potential for serious adverse
effects in a nursing infant, a decision should be made to discontinue nursing or discontinue the
drug, taking into consideration the importance of the drug to the mother.
Administration Administration: Oral
Administer with meals if GI upset occurs.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ • Blood dyscrasias: Aplastic anemia, agranulocytosis and other severe blood dyscrasias (some
Precautions fatal) have been reported; monitor for signs/symptoms (eg, fever, sore throat, pallor, purpura,
jaundice). Closely monitor CBC and discontinue therapy if a significant reduction in leukocytes,
platelets, or hemopoiesis is seen.
• Dermatologic reactions: Serious dermatologic reactions, including toxic erythema, erythema
multiforme, toxic epidermal necrolysis, morbilliform and scarlatiniform reactions, urticaria, and
erythema nodosum have been reported rarely. Discontinue therapy if new or severe
dermatologic reactions occur; leprosy reactional states (eg, erythema nodosum leprosum) do
not require discontinuation.
• Hepatic effects: Toxic hepatitis and cholestatic jaundice have been reported;
hyperbilirubinemia may occur more frequently in G6PD deficient patients. Monitor liver
function; discontinue use if abnormalities occur.
• Peripheral neuropathy: Motor loss and muscle weakness have been reported; discontinue
use if symptoms of peripheral neuropathy develop. Recovery after discontinuation is usually
complete; some patients may tolerate retreatment at reduced doses.
• Sulfonamide allergy: Use with caution in patients with hypersensitivity to other sulfonamides;
sulfone reactions may also occur as potentially fatal hypersensitivity reactions, requiring drug
discontinuation.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C.
difficile-associated diarrhea and pseudomembranous colitis; CDAD has been observed >2
months postantibiotic treatment.
Disease-related concerns:
• Anemia: Use with caution in patients with severe anemia; treat prior to therapy.
• Diabetes mellitus: Dapsone may artificially lower HbA1C by reducing erythrocyte survival time
through hemolysis.
Special populations:
• G6PD deficiency: Use with caution in patients with G6PD deficiency; dose-related hemolysis
and methemoglobinemia may occur.
• Hemoglobin M deficiency: Use with caution in patients with hemoglobin M deficiency.
• Methemoglobin reductase deficiency: Use with caution in patients with methemoglobin
reductase deficiency
Storage Store at 20°C to 25°C. Protect from light.
Refer to manufacturer PIL if there are specific considerations.

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6. Diloxanide
Generic Name Diloxanide

Dosage Tablets 500mg

form/strengths
Route of oral
administration
Pharmacologic Antiprotozoal (systemic)
category ATC: P01AC01
Indications Treatment of intestinal amoebiasis. It is given alone in the treatment of asymptomatic cyst
passers or after an amoebicide that acts in the tissues, such as metronidazole, in patients with
symptomatic (invasive) amoebiasis.
Dosage Usual adult and adolescent dose Diloxanide furoate is given orally in a dosage of 500 mg
Regimen three times daily for 10 days. The course of treatment may be repeated if necessary.
Usual pediatric dose
Children up to 12 years of age: Oral, 20 mg per kg of body weight per day given in three
divided doses for ten days. (maximum: 1,500 mg/day).
Dosage Elimination Renal (90%, rapidly excreted as glucuronide metabolite). 10% is excreted in the
adjustment feces as diloxanide.
Contra- Hypersensitivity.
indications
Adverse Drug Flatulence is the most common adverse effect during treatment with diloxanide furoate.
Reactions Vomiting, pruritus, and urticaria may occasionally occur.
Monitoring fecal examination may be required prior to treatment to establish the diagnosis; follow-up
Parameters stool examinations should be done no earlier than 2 weeks after the end of treatment to
determine efficacy of treatment
Drug There are no known significant interactions.
Interactions
Pregnancy and The safety of diloxanide in pregnancy and lactation has not been established. Use of other
Lactation agents is preferred
Administration Taking with meals to minimize gastrointestinal irritation
Compliance with full course of therapy
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • CNS effects: May cause CNS effects such as dizziness or headache, which may impair
physical or mental abilities; patients must be cautioned about performing tasks that require
mental alertness (eg, operating machinery or driving).

Storage preferably between 15 and 30 °C in a well-closed container. Protect from light

Refer to manufacturer PIL if there are specific considerations.

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7. Doxycycline
Access Group

Generic Name Doxycycline

Dosage Capsules 100mg

form/strengths Tablets 50mg, 100mg, 200mg
Route of Oral
administration
Pharmacologic Antibiotic, Tetracycline Derivative
category ATC: J01AA02
Indications Acne: Adjunctive therapy in severe acne.
Actinomycosis: Treatment of actinomycosis caused by Actinomyces israelii when penicillin is
contraindicated.
Acute intestinal amebiasis: Adjunct to amebicides in acute intestinal amebiasis.
Anthrax, including inhalational anthrax (postexposure)
Cholera: Treatment of cholera infections caused by Vibrio cholerae.
Clostridium: Treatment of infections caused by Clostridium spp. when penicillin is contraindicated.
Gram-negative infections: Treatment of infections caused by Escherichia coli, Enterobacter
aerogenes, Shigella spp., Acinetobacter spp., Klebsiella spp. (respiratory and urinary infections),
and Bacteroides spp.; Neisseria meningitidis (when penicillin is contraindicated).
Gram-positive infections: Treatment of infections caused by Streptococcus spp., when
susceptible.
Listeriosis: Treatment of listeriosis due to Listeria monocytogenes when penicillin is
contraindicated.
Malaria, prophylaxis: Prophylaxis of malaria due to Plasmodium falciparum in short-term
travelers (under 4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine-resistant
strains.
Mycoplasma pneumoniae: Treatment of infections caused by Mycoplasma pneumoniae.
Ophthalmic infections: Treatment of inclusion conjunctivitis or trachoma caused by Chlamydia
trachomatis.
Relapsing fever: Treatment of relapsing fever caused by Borrelia recurrentis.
Respiratory tract infections: Treatment of respiratory infections caused by Haemophilus
influenzae, Klebsiella spp., or Mycoplasma pneumoniae; treatment of upper respiratory tract
infections caused by Streptococcus pneumoniae; respiratory infections caused by Staphylococcus
aureus (doxycycline is not the drug of choice in the treatment of any type of staphylococcal
infection).
Rickettsial infections: Treatment of Rocky Mountain spotted fever, typhus fever and the typhus
group, Q fever, rickettsialpox, and tick fevers caused by Rickettsiae.
Sexually transmitted infections
Note: The CDC sexually transmitted disease guidelines recommend dual antimicrobial therapy be
used for uncomplicated gonorrhea due to N. gonorrhea resistance concerns; ceftriaxone is the
preferred cephalosporin and doxycycline is an alternative option for the second antimicrobial only
in cases of azithromycin allergy (CDC).
Skin and skin structure infections (Avidoxy only): Treatment of skin and skin structure infections
caused by Staphylococcus aureus (doxycycline is not the drug of choice in the treatment of any
type of staphylococcal infection).
Vincent infection: Treatment of Vincent infection caused by Fusobacterium fusiforme when
penicillin is contraindicated.

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Yaws: Treatment of yaws caused by Treponema pallidum subspecies pertenue when penicillin is
contraindicated.
Zoonotic infections
Dosage Dosing: Adult
Regimen Note: Doxycycline is available as hyclate, monohydrate, and calcium salts. All doses are expressed
as doxycycline base.
Usual dosage range:
Oral: IR and most ER formulations: 100 to 200 mg/day in 1 to 2 divided doses. Note: 120 mg of
modified polymer coated tablet (Doryx MPC) is equivalent to 100 mg conventional delayed-
release tablet.
Dosing: Pediatric
Note: Doxycycline is available as hyclate, monohydrate, and calcium salts. All doses are expressed
as doxycycline base.
General dosing:
Children and Adolescents: Oral, IV: 2.2 mg/kg/dose every 12 hours, maximum dose: 100 mg/dose.
Note: Use of doxycycline in children <8 years should be reserved for severe, potentially life-
threatening infections, or when better alternatives are unavailable

Dosage Dosing: Renal Impairment:

adjustment No dosage adjustment necessary
Dosing: Hepatic Impairment: Adult
Severe hepatic impairment require caution. Specific dosage adjustments have not been studied

Contra- o Hypersensitivity to doxycycline, other tetracyclines, or any component of the formulation

indications o Periostat, Apprilon [Canadian products]: Additional contraindications: Use in infants and
children <8 years of age or during second or third trimester of pregnancy; breast-feeding

Adverse Drug Cardiovascular: Hypertension (3%)

Reactions Central nervous system: Anxiety (2%), pain (2%)
Endocrine & metabolic: Increased lactate dehydrogenase (2%), increased serum glucose (1%)
Gastrointestinal: Diarrhea (5%), upper abdominal pain (2%), abdominal distention (1%),
abdominal pain (1%), xerostomia (1%)
Hepatic: Increased serum aspartate aminotransferase (2%)
Infection: Fungal infection (2%), influenza (2%)
Neuromuscular & skeletal: Back pain (1%)
Respiratory: Nasopharyngitis (5%), sinusitis (3%), nasal congestion (2%), sinus headache (1%
Monitoring CBC, renal and liver function tests periodically with prolonged therapy. When used as part of
Parameters alternative treatment for gonococcal infection, test of cure 7 days after dose
Drug Risk X: Avoid combination
Interactions Aminolevulinic Acid (Systemic) Methoxyflurane Cholera Vaccine BCG (Intravesical) Retinoic Acid
Derivatives Strontium Ranelate Sodium Picosulfate
Risk D: Consider therapy modification
Antacids Bismuth Subcitrate Bismuth Subsalicylate Calcium Salts Fosphenytoin Carbamazepine
Iron Preparations Magnesium Salts Multivitamins/Minerals (With AE, No Iron) Sucralfate
Sucroferric Oxyhydroxide Typhoid Vaccine
Pregnancy and Pregnancy factor D
Lactation there is not likely to be harm in short-term use of doxycycline during lactation. avoid prolonged
(>21 days) or repeat courses during nursing. Monitor the infant for rash and for possible effects
on the gastrointestinal flora, such as diarrhea or candidiasis (thrush, diaper rash).

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Administration Administration: Oral
In general, administer with meals to decrease GI upset; however, some manufacturer labeling
recommends administration on an empty stomach. Administer capsule and tablet with at least
glass of water and have patient sit up for at least 30 minutes or 1 to 2 hours after taking to
reduce the risk of esophageal irritation and ulceration.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ concerns related to adverse effects:
Precautions • GI inflammation/ulceration: Esophagitis and ulcerations (sometimes severe) may occur; patients
with dysphagia and/or retrosternal pain may require assessment for esophageal lesions.
• Hepatotoxicity: Rarely occurs; if symptomatic, assess LFTs and discontinue drug.
• Hypersensitivity syndromes: Severe skin reactions (eg, exfoliative dermatitis, erythema
multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with
eosinophilia and systemic symptoms [DRESS]) have been reported. Discontinue therapy for
serious hypersensitivity reactions.
• Increased BUN: May be associated with increases in BUN secondary to antianabolic effects; this
does not occur with use of doxycycline in patients with renal impairment.
• Intracranial hypertension: Intracranial hypertension (pseudotumor cerebri) has been reported;
headache, blurred vision, diplopia, vision loss, and/or papilledema may occur. Women of
childbearing age who are overweight or have a history of intracranial hypertension are at greater
risk. Intracranial hypertension typically resolves after discontinuation of treatment; however,
permanent visual loss is possible. If visual symptoms develop during treatment, prompt
ophthalmologic evaluation is warranted. Intracranial pressure can remain elevated for weeks after
drug discontinuation; monitor patient until stable.
• Photosensitivity: May cause photosensitivity; discontinue at first sign of skin erythema. Use skin
protection and avoid prolonged exposure to sunlight and ultraviolet light.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C.
difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2
months postantibiotic treatment.
• Tissue hyperpigmentation: May induce hyperpigmentation in many organs, including nails,
bone, skin (diffuse pigmentation as well as over sites of scars and injury), eyes, thyroid, visceral
tissue, oral cavity (adult teeth, mucosa, alveolar bone), sclerae, and heart valves independently of
time or amount of drug administration.
Disease-related concerns
• Oral candidiasis: Safety and effectiveness have not been established for treatment of
periodontitis in patients with coexistent oral candidiasis; use with caution in patients with a
history or predisposition to oral candidiasis.
Special populations:
• Pediatric: May cause tissue hyperpigmentation, tooth enamel hypoplasia, or permanent tooth
discoloration (more common with long-term use, but observed with repeated, short courses)
when used during tooth development (last half of pregnancy, infancy, and childhood ≤8 years of
age). Recommended in prevention and treatment of anthrax, treatment of tickborne rickettsial
diseases, and Q fever.
Other warnings/precautions:
• Appropriate use: Acne: The American Academy of Dermatology acne guidelines recommend
doxycycline as adjunctive treatment for moderate and severe acne and forms of inflammatory
acne that are resistant to topical treatments. Concomitant topical therapy with benzoyl peroxide
or a retinoid should be administered with systemic antibiotic therapy (eg, doxycycline) and
continued for maintenance after the antibiotic course is completed.
• Limitations of use: Malaria prophylaxis: Doxycycline does not completely suppress asexual blood
stages of Plasmodium strains; does not suppress P. falciparum's sexual blood stage gametocytes.

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Patients completing a regimen may still transmit the infection to mosquitoes outside endemic
areas.
Storage Capsule, tablet: Store at 20°C to 25°C; excursions permitted between 15°C and 30°C. Protect
from light and moisture.
Refer to manufacturer PIL if there are specific considerations.

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8. Fosfomycin
Watch Group

Generic Name Fosfomycin

Dosage Granules for Oral Solution: 3gm

form/strengths
Route of oral
administration
Pharmacologic Antibiotic, Miscellaneous
category ATC: J01XX01
Indications Cystitis, acute uncomplicated: Treatment of uncomplicated urinary tract infections (acute
cystitis) in women due to susceptible strains of Escherichia coli and Enterococcus faecalis.
Dosage Dosing: Adult
Regimen Cystitis, acute uncomplicated or acute simple cystitis (infection limited to the bladder without
signs/symptoms of upper tract, prostate, or systemic infection), treatment: Oral: 3 g as a single
dose
Dosing: Pediatric
Urinary tract infection, uncomplicated: Limited data available: Note: Oral formulation should
not be used for pyelonephritis or perinephric abscess.
Children <12 years: Oral: 2 g as a single dose.
Children ≥12 years and Adolescents: Oral: 3g as a single dose

Dosage Dosing: Altered Kidney Function: Adult

adjustment Oral: No dosage adjustment necessary for any degree of kidney dysfunction (expert opinion).
However, elimination is significantly prolonged in patients with CrCl <50 mL/minute; monitor
closely for adverse effects and tolerability, particularly with prolonged therapy.
Dosing: Hepatic Impairment: Adult
Oral: There are no dosage adjustments needed.
Contra- Hypersensitivity to fosfomycin or any component of the formulation
indications
Adverse Drug 1% to 10%:
Reactions Central nervous system: Headache (4% to 10%), pain (2%), dizziness (1% to 2%)
Dermatologic: Skin rash (1%)
Gastrointestinal: Diarrhea (9% to 10%), nausea (4% to 5%), abdominal pain (2%), dyspepsia (1%
to 2%)
Genitourinary: Vaginitis (6% to 8%), dysmenorrhea (3%)
Neuromuscular & skeletal: Back pain (3%), weakness (1% to 2%)
Respiratory: Rhinitis (5%), pharyngitis (3%)
Monitoring No monitoring data needed.
Parameters
Drug Risk X: Avoid combination
Interactions BCG (Intravesical) Cholera Vaccine
Risk D: Consider therapy modification
Sodium Picosulfate Typhoid Vaccine
Pregnancy and Pregnancy Category B - No proven risk in humans. This drug should be used during pregnancy
Lactation only if clearly needed and the benefit outweighs the risk.
Due to the potential for serious adverse reactions in the breastfed infant, a decision should be
made whether to discontinue breastfeeding or to discontinue the drug, taking into account the

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importance of treatment to the mother.

Administration Administration: Oral

Oral: Oral packet: Do not administer in its dry form; must be mixed with water prior to
administration. May be administered without regard to meals. Pour contents of 3 g packet into
90 to 120 mL of water (not hot) and stir to dissolve; the resultant concentration is 25 to 33.3
mg/mL. Measure appropriate volume for desired dose and take immediately. Discard any
remaining solution.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Hypersensitivity: Hypersensitivity reactions, including anaphylactic shock, have been reported
(rare). Discontinue use and institute supportive measures at the first sign(s) of a hypersensitivity
reaction.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection,
including Clostridioides difficile-associated diarrhea (CDAD) and pseudomembranous colitis;
CDAD has been observed >2 months postantibiotic treatment.

Storage Oral packet: Store at 25°C; excursions are permitted between 15°C and 30°C
Refer to manufacturer PIL if there are specific considerations.

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9. Lincomycin
Watch Group

Generic Name Lincomycin

Dosage Lincomycin 300 mg / ml ampoules

form/strengths
Route of I.V ,I.M
administration
Pharmacologic Antibiotic, Lincosamide
category ATC: J01FF02
Indications -Treatment of serious infections caused by susceptible strains of streptococci, pneumococci, and
staphylococci.
-Use should be reserved for patients with penicillin allergy or other patients for whom a
penicillin is inappropriate.
Dosage -Adult Dose:
Regimen -Serious Bacterial infection:
IM: 600 mg every 12 to 24 hours
IV: 600 mg to 1 g every 8 to 12 hours (maximum dose: 8 g daily)
-Pediatric Dose:
-Serious Bacterial infection: Infants, Children, and Adolescents:
-IM: 10 mg/kg/dose every 12 to 24 hours.
-IV: 10 to 20 mg/kg/day in divided doses every 8 to 12 hours
Dosage -Adult:
adjustment -Renal Impairment:
-Mild to moderate impairment: no dosage adjustments availabla.
-Severe impairment: Use with caution; decrease dose by 70% to 75%
-Hepatic impairment:
-No dosage adjustments available; use with caution
Contra- -Hypersensitivity to lincomycin, clindamycin, or any component of the formulation.
indications
Adverse Drug -Frequency not defined:
Reactions Gastrointestinal: Colitis, severe colitis
Monitoring -Change in bowel frequency or consistency (eg, diarrhea)
Parameters -Baseline serum creatinine and liver function tests (LFTs)
-Periodical renal function and LFTs, complete blood cell count (CBC) with differential in case of
prolonged therapy.
Drug Risk X: Avoid combination
Interactions BCG (Intravesical), Cholera Vaccine, Erythromycin (Systemic), Mecamylamine
Risk D: Consider therapy modification
Sodium Picosulfate, Typhoid Vaccine
Pregnancy and Pregnancy category C
Lactation -Crosses the placenta at term and can be detected in cord blood and the amniotic fluid. No
effects on the newborn were observed.
- May also contain benzyl alcohol, which may cross the placenta.
Animal reproduction studies have shown an adverse effect on the fetus and there are no
adequate and well-controlled studies in humans, but potential benefits may warrant use of the
drug in pregnant women despite potential risks.
Excreted into human milk but The effects in the nursing infant are unknown.

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Administration -Adult:
- IM:
Injection as deep IM into large muscle mass.
-I. V: Dilute with compatible solution (eg, D5W) to a final concentration of 6 to 10 mg/mL.
Each gram of lincomycin for IV administration should be diluted with at least 100 mL of a
compatible solution (eg, D5W)
Administer as an intermittent infusion over at least 1 hour per gram
-Pediatric:
Same as adult but administer as an intermittent infusion over ≥1 hour
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Colitis: [US Boxed Warning]: C. difficile-associated diarrhea (CDAD) has been reported. May
range in severity from mild to severe (and possibly fatal). Lincomycin therapy should be reserved
for serious infections for which less toxic antimicrobial agents are inappropriate.
• Hypersensitivity reactions: Hypersensitivity reactions, including anaphylaxis and severe
cutaneous adverse reactions (including Stevens-Johnson syndrome [SJS], toxic epidermal
necrolysis [TEN], acute generalized exanthematous pustulosis [AGEP], and erythema
multiforme), have been reported. Discontinue use and institute appropriate therapy if allergic
reaction occurs.
• Superinfection: Prolonged use may result in bacterial or fungal superinfection, particularly
yeasts. Concomitant antimonilial infection treatment should be given in patients with preexisting
monilial infections.
Disease-related concerns:
• Allergies: Use with caution in patients with significant allergies.
• Asthma: Use with caution in patients with a history of asthma.
• Gastrointestinal disease: Use with caution in patients with a history of gastrointestinal disease
(particularly colitis).
• Hepatic impairment: Use with caution in patients with hepatic impairment; half-life may be
prolonged 2-fold.
• Renal impairment: Use with caution in patients with renal impairment; half-life may be
prolonged; dosage adjustment necessary with severe impairment.
Special populations:
• Elderly: Use with caution in the elderly; monitor closely for bowel changes.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts
of benzyl alcohol have been associated with a potentially fatal toxicity ("gasping syndrome") in
neonates; avoid or use dosage forms containing benzyl alcohol with caution in neonates. See
manufacturer’s labeling.
Other warnings/precautions:
• Administration: Do not use undiluted as an IV bolus.
• Appropriate use: Generally reserved for use when treatment with other antibiotics is
inappropriate. Not appropriate for use in the treatment of meningitis due to inadequate
penetration into the cerebrospinal fluid.
Storage -Store at 20°C to 25°C.
-Once diluted in dextran 6% in NS, D5NS, D10NS, D5W, D10W, or Ringer's, may store for 24
hours at room temperature.
Refer to manufacturer PIL if there are specific considerations.

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10. Linezolid
Reserve Group

Generic Name Linezolid

Dosage Oral suspension 100mg/5ml

form/strengths Tablets 200mg, 600mg
Vial 600mg
Route of IV, oral
administration
Pharmacologic Antibiotic, Oxazolidinone
category ATC: J01XX08
Indications Enterococcal infections (vancomycin-resistant): Treatment of vancomycin-
resistant Enterococcus faecium infections, including cases with concurrent bacteremia.

Pneumonia:
Treatment of community-acquired pneumonia caused by Streptococcus pneumoniae, including
cases with concurrent bacteremia, or Staphylococcus aureus (methicillin-susceptible isolates
only).
Treatment of hospital-acquired or health care-associated pneumonia caused by S.
aureus (methicillin-susceptible and methicillin-resistant isolates) or S. pneumoniae.

Skin and skin structure infections:

Complicated: Treatment of complicated skin and skin structure infections, including diabetic foot
infections, without concomitant osteomyelitis.
Uncomplicated: Treatment of uncomplicated skin and skin structure infections caused by S.
aureus (methicillin-susceptible isolates) or S. pyogenes.
Dosage Adult Dosing:
Regimen General dose: IV/Oral: 600mg/12 hr

Pediatric Patients
General Dosage for Neonates
Oral or IV
neonates <7 days of age: 10 mg/kg every 12 hours; may consider 10 mg/kg every 8 hours in
those with inadequate response.
All neonates ≥7 days of age: 10 mg/kg every 8 hours
General Dosage for Infants and Children
Oral or IV
infants and children less than 12 years: 10 mg/kg every 8 hours adolescents ≥12 years of age
:600 mg every 12 hours

Note: Linezolid is not a preferred agent for the treatment of infections requiring prolonged
therapy as the risk of serious hematologic and neurologic toxicity increases after >2 weeks and
>4 weeks of therapy, respectively.
Dosage Dosing: Renal Impairment:
adjustment Mild to severe impairment: No dosage adjustment necessary.
The two primary metabolites accumulate in patients with renal impairment but the clinical
significance is unknown; use with caution. Consider therapeutic drug monitoring in this
population

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Hemodialysis patients: Administer linezolid doses after dialysis session.
Dosing: Hepatic Impairment: Adult
Mild to moderate impairment: No dosage adjustment necessary.
Severe impairment (Child-Pugh class C): Dosage adjustments has not been studied.
Contra- Hypersensitivity to linezolid or any component of the formulation; concurrent use or within 2
indications weeks of MAO inhibitors
Adverse Drug >10%:
Reactions Gastrointestinal: Diarrhea (8% to 11%)
Hematologic & oncologic: Decreased white blood cells, decreased platelet count
1% to 10%:
Central nervous system: Headache, dizziness, vertigo
Dermatologic: Skin rash, pruritus
Endocrine & metabolic: Increased amylase, increased lactate dehydrogenase
Gastrointestinal: Vomiting, nausea, increased serum lipase, loose stools, abdominal pain, oral
candidiasis, dysgeusia, tongue discoloration
Genitourinary: Vulvovaginal candidiasis
Hematologic & oncologic: Anemia, decreased neutrophils, thrombocytopenia, eosinophilia
Hepatic: Increased serum ALT, increased serum bilirubin, increased serum AST, increased serum
alkaline phosphatase, abnormal hepatic function tests
Infection: Fungal infection
Renal: Increased blood urea nitrogen, increased serum creatinine
Monitoring Weekly CBC, peripheral sensory and visual function with extended therapy (≥3 months) or in
Parameters patients with new onset neuropathic or visual symptoms, regardless of therapy length; in
patients with renal impairment, monitor for hematopoietic (eg, anemia, leukopenia,
thrombocytopenia) and neuropathic (eg, peripheral neuropathy, optic neuritis) adverse events
when administering for extended periods. Periodic serum bicarbonate with extended therapy.
Consider monitoring lactic acid in patients with renal dysfunction
Drug Risk X: Avoid combination
Interactions Alcohol (Ethyl) Amphetamines Atomoxetine Atropine BCG (Intravesical) Buprenorphine
Buspirone Carbamazepine Cholera Vaccine Codeine Cyclobenzaprine Cyproheptadine
Dapoxetine Atomoxetine Atropine BCG (Intravesical) Bezafibrate Buprenorphine Buspirone
Carbamazepine Cholera Vaccine Codeine Cyclobenzaprine Cyproheptadine Dapoxetine
Deutetrabenazine Dexmethylphenidate Dextromethorphan Dihydrocodeine Diethylpropion
Dipyrone Droxidopa Epinephrine (Oral Inhalation) Fenfluramine Guanethidine Hydromorphone
Indoramin Isometheptene Levodopa-Containing Products Levomethadone Levonordefrin
Maprotiline Meptazinol Mequitazine Methadone Methyldopa Methylene Blue Methylphenidate
Metoclopramide Mianserin Monoamine Oxidase Inhibitors Morphine Nefazodone
Levonordefrin Maprotiline Meptazinol Mequitazine Methadone Methyldopa Methylene Blue
Methylphenidate Metoclopramide Mianserin Monoamine Oxidase Inhibitors Morphine
Nefazodone Nefopam Normethadone Opicapone Opium Oxycodone Oxymorphone Ozanimod
Pheniramine Pholcodine Pizotifen Reboxetine Selective Serotonin Reuptake Inhibitors Triptans
Serotonin/Norepinephrine Reuptake Inhibitors Solriamfetol Sufentanil Tapentadol
Tetrabenazine Tetrahydrozoline Tianeptine Tricyclic Antidepressants Tryptophan Valbenazine
Risk D: Consider therapy modification
Benzhydrocodone COMT Inhibitors Deferiprone DOPamine HYDROcodone Iohexol Iomeprol
Iopamidol Lithium Remifentanil Reserpine Ropeginterferon Alfa-2b Serotonergic Opioids Sodium
Picosulfate Sympathomimetics Typhoid Vaccine
Pregnancy and pregnancy category C
Lactation Animal reproduction studies have shown an adverse effect on the fetus and there are no

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adequate and well-controlled studies in humans, but potential benefits may warrant use of the
drug in pregnant women despite potential risks.
Use of this drug is not a reason to discontinue breastfeeding if it is required by the mother;
alternate therapy may be preferred, especially if the nursing infant is premature or younger
than 1 month.

Administration Administration: IV
Administer intravenous infusion over 30 to 120 minutes. When the same intravenous line is
used for sequential infusion of other medications, flush line with D5W, NS, or LR before and after
infusing linezolid. The yellow color of the injection may intensify over time without affecting
potency.
Administration: Oral
Administer without regard to meals.
Oral suspension: Invert gently to mix prior to administration, do not shake.
Single-use containers of linezolid injection for IV infusion should be administered without
further dilution. Do not use the containers in series connections; do not introduce additives into
the solution.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Lactic acidosis
• Myelosuppression: may be dependent on duration of therapy (generally >2 weeks of
treatment). Weekly CBC monitoring is recommended; Thrombocytopenia is the most
frequently observed blood dyscrasia.
• Peripheral and optic neuropathy (with vision loss)
• Serotonin syndrome: Symptoms of agitation, confusion, hallucinations, hyper-reflexia,
myoclonus, shivering, and tachycardia may occur with concomitant proserotonergic drugs,
agents which reduce linezolid's metabolism, or in patients with carcinoid syndrome. Avoid
use in such patients unless clinically appropriate and under close monitoring for
signs/symptoms of serotonin syndrome or neuroleptic malignant syndrome-like reactions.
• Superinfection: Prolonged use
Disease-related concerns:
• Carcinoid syndrome: Use with caution and closely monitor for serotonin syndrome in
patients with carcinoid syndrome.
• Diabetes mellitus: Hypoglycemic episodes have been reported; Dose
reductions/discontinuation of concurrent hypoglycemic agents or discontinuation of linezolid
may be required.
• Hypertension
• Hyperthyroidism
• Pheochromocytoma: closely monitor blood pressure in patients with pheochromocytoma
• Seizure disorder
Special populations:
• Pediatric: It is not recommend to use linezolid for empiric treatment of pediatric CNS
infections since therapeutic linezolid concentrations are not consistently achieved or
maintained in the CSF of patients with ventriculoperitoneal shunts.
Other warnings/precautions:
• Appropriate use: Unnecessary use may lead to the development of resistance to linezolid;
consider alternatives before initiating outpatient treatment.

Storage • Infusion: Store at 25°C. Protect from light and freezing. Keep infusion bags in overwrap until
ready for use.

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• Oral suspension: Store at 25°C; following reconstitution store at room temperature and use
suspension within 21 days. Protect from light.
• Tablet: Store at 25°C. Protect from light and moisture.
• Refer to manufacturer PIL if there are specific considerations.

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11. Metronidazole
Access Group
Generic Name Metronidazole

Dosage form/ Suppository 1gm

strengths Vaginal suppository 500mg
Vaginal gel 0.75%
Oral suspension 125mg/5ml, 200mg/5ml
Tablets 250mg, 500mg
Vial 500mg
Route of IV, Oral, rectal, intravaginal
administration
Pharmacologic Amebicide; Antiprotozoal, Nitroimidazole
category
Indications Amebiasis, Anaerobic bacterial infections (caused by Bacteroides spp., including the B.
fragilis group), Surgical prophylaxis (colorectal surgery), Trichomoniasis
Dosage Dosing: Adult
Regimen Amebiasis, intestinal (acute dysentery) or extraintestinal (liver abscess): Oral: 500 to 750 mg
every 8 hours for 7 to 10 days
Intra-abdominal infection: Oral, IV: 500 mg every 8 hours as part of an appropriate combination
regimen. Duration of therapy is for 4 to 7 days following adequate source control
Intracranial abscess (brain abscess, intracranial epidural abscess): IV: 7.5 mg/kg (usually 500 mg)
every 6 to 8 hours for 6 to 8 weeks
Pelvic inflammatory disease (PID):
Mild to moderate PID: Oral: 500 mg twice daily for 14 days
Skin and soft tissue infection:in combination with other appropriate agents
Necrotizing infection: IV: 500 mg every 6 hours
Surgical site infection, incisional (eg, intestinal or GU tract; axilla or perineum), warranting
anaerobic coverage: IV: 500 mg every 8 hours
Surgical prophylaxis:
IV: 500 mg within 60 minutes prior to surgical incision in combination with other antibiotics.
Trichomoniasis (index case and sex partner):
Initial treatment: Oral: 500 mg twice daily for 7 days.
Persistent or recurrent infection (ie, treatment failure of nitroimidazole [eg,
metronidazole]): Oral: 500 mg twice daily for 7 days
Dosing: Pediatric
Note: Some clinicians recommend using adjusted body weight in obese children. Dosing weight =
IBW + 0.45 (TBW-IBW)
General dosing, susceptible infection: Infants, Children, and Adolescents:
Oral: 15 to 50 mg/kg/day in divided doses 3 times daily; maximum daily dose: 2,250 mg/day.
IV: 22.5 to 40 mg/kg/day in divided doses 3 or 4 times daily; maximum daily dose: 4,000 mg/day.

Dosage Dosing: Renal Impairment:

adjustment No dosage adjustment necessary however, monitor closely for adverse effects due to
accumulation of metabolites, particularly with prolonged courses of therapy
Dosing: Hepatic Impairment:
Mild or moderate impairment (Child-Pugh class A or B): No dosage adjustment necessary; use with

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caution and monitor for adverse events.
Severe impairment (Child-Pugh class C):
Tablets, injection: Reduce dose by 50%
Contra- Hypersensitivity to metronidazole, nitroimidazole derivatives, or any component of the
indications formulation; pregnant patients (first trimester) with trichomoniasis; use of disulfiram within the
past 2 weeks; use of alcohol or propylene glycol-containing products during therapy or within 3
days of therapy discontinuation
Active neurological disorders; history of blood dyscrasia; hypothyroidism; hypoadrenalism
Adverse Drug >10%:
Reactions Central nervous system: Headache (18%)
Gastrointestinal: Nausea (10% to 12%)
Genitourinary: Vaginitis (15%)

Monitoring Monitor CBC with differential at baseline, during, and after prolonged or repeated courses of
Parameters therapy. Monitor LFTs in patients with Cockayne syndrome. Closely monitor elderly patients and
patients with severe hepatic impairment or ESRD for adverse reactions. Observe patients carefully
if neurologic symptoms occur and consider discontinuation of therapy.
Drug Risk X: Avoid combination
Interactions Alcohol BCG (Intravesical) Carbocisteine Cholera Vaccine: Disulfiram Dronabinol Mebendazole
Products Containing Propylene Glycol
Risk D: Consider therapy modification
Busulfan Lopinavir Sodium Picosulfate Typhoid Vaccine Vitamin K Antagonists
Risk C: Monitor therapy
BCG Vaccine (Immunization) Fluorouracil Products: Fosphenytoin Lactobacillus and Estriol Lithium
Mycophenolate Phenobarbital Phenytoin Primidone Tipranavir Tolbutamide Vecuronium
Pregnancy and Pregnancy Category B
Lactation If metronidazole is given, breastfeeding should be withheld for 12 to 24 hours after a single 2 g
dose. Use of lower maternal doses may provide lower concentrations of metronidazole in breast
milk and use can be considered in patients who are breastfeedin
Administration IV: Infuse intravenously over 30 to 60 minutes. Avoid contact of drug solution with equipment
containing aluminum.
Oral: Administer with food to minimize stomach upset.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Carcinogenic: [US Boxed Warning]: Possibly carcinogenic based on animal data. Reserve use
for conditions described in Use; unnecessary use should be avoided.
• CNS effects: Severe neurological disturbances, including aseptic meningitis (may occur within
hours of a dose), cerebellar symptoms (ataxia, dizziness, dysarthria), convulsive seizures,
encephalopathy, optic neuropathy, and peripheral neuropathy (usually of sensory type and
characterized by numbness or paresthesia of an extremity) have been reported.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C.
difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed
>2 months postantibiotic treatment. Candidiasis infection (known or unknown) may be more
prominent during metronidazole treatment, antifungal treatment required.
Disease-related concerns:
• Blood dyscrasias: Use with caution in patients with or history of blood dyscrasias;
agranulocytosis, leukopenia, and neutropenia have occurred. Monitor CBC with differential at
baseline, during and after treatment.

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• Cockayne syndrome: Severe hepatotoxicity/acute hepatic failure (has been fatal) has been
reported with systemic metronidazole in patients with Cockayne syndrome; onset is rapid after
initiation of treatment. Use metronidazole only after risk vs benefit assessment and if there are
no appropriate alternatives in patients with Cockayne syndrome. Obtain LFTs prior to treatment
initiation, within the first 2 to 3 days of initiation, frequently during therapy, and after treatment
is complete. Discontinue treatment if elevated LFTs occur and monitor until LFTs return to
baseline.
• Hepatic impairment: Use with caution in patients with hepatic impairment due to potential
accumulation; dosage adjustment recommended in patients with severe hepatic impairment.
• Renal impairment: Use with caution in patients with severe renal impairment or ESRD due to
potential accumulation. Accumulated metabolites may be rapidly removed by hemodialysis;
supplemental doses may be needed.
• Seizure disorder: Use with caution in patients with a history of seizure disorder.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or
frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult
drug interactions database for more detailed information.
Dosage-form specific issues:
• Injection: Use injection with caution in patients with heart failure, edema, or other sodium-
retaining states, including corticosteroid treatment due to high sodium content. In patients
receiving continuous nasogastric secretion aspiration, sufficient metronidazole may be removed
in the aspirate to cause a reduction in serum levels.

Storage Oral: Store at 15°C to 25°C. Protect the tablets from light.
Injection: Store at 20°C to 25°C. Protect from light. Avoid excessive heat. Do not refrigerate. Do
not remove unit from overwrap until ready for use. Discard unused solution.
Refer to manufacturer PIL if there are specific considerations.

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Access Group
12. Nitrofurantoin
Generic Name Nitrofurantoin

Dosage Tablets 100mg

form/strengths Capsules 50mg, 100mg, 100mg retard
Route of Oral
administration
Pharmacologic Antibiotic, Miscellaneous
category ATC: J01XE01
Indications Urinary Tract Infections (UTIs)

• Cystitis, acute uncomplicated, treatment

• Cystitis, uncomplicated, prophylaxis for recurrent infection

Dosage Adults
Regimen Urinary Tract Infections (UTIs)
Oral
50–100 mg 4 times daily given for 7 days or for ≥3 days after urine becomes sterile.
If used for long-term suppressive therapy: states 50–100 mg once daily at bedtime may be
adequate.
Dual-release capsules: 100 mg every 12 hours for 7 days
Cystitis, uncomplicated, prophylaxis for recurrent infection
Continuous prophylaxis:
Oral: 50 to 100 mg once daily at bedtime.
Postcoital prophylaxis: Females with cystitis temporally related to sexual intercourse:
Oral: 50 to 100 mg as a single dose taken within 2 hours of sexual intercourse

Dosage
Pediatric Patients
Urinary Tract Infections (UTIs) in Children ≥1 Month of Age
Oral
Capsules containing macrocrystals or suspension containing microcrystals: 5–7 mg/kg daily in 4
divided doses given for 7 days or for ≥3 days after urine becomes sterile.
If used for long-term suppressive therapy: 1 mg/kg daily given as a single dose or in 2 equally
divided doses may be adequate.
Urinary Tract Infections (UTIs) in Children >12 Years of Age
Oral
Dual-release capsules: 100 mg every 12 hours for 7 days.
UTI, prophylaxis: Infants, Children, and Adolescents: Oral: 1 to 2 mg/kg/day in a single dose (at
bedtime) or divided twice daily; maximum daily dose: 100 mg/day.
Dosage Dosing: Renal Impairment:
adjustment Contraindicated in those with anuria, oliguria, or significant renal impairment
CrCl ≥60 mL/minute: No dosage adjustment necessary.
CrCl <60 mL/minute: Use is contraindicated.
Dosing: Hepatic Impairment:
There are no dosage adjustments available. Nitrofurantoin is associated with hepatotoxicity and
should be used cautiously in patients with hepatic impairment.

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Contra- • Anuria, oliguria, or significant impairment of renal function (creatinine clearance [CrCl] <60
indications mL/minute or clinically significant elevated serum creatinine)
• previous history of cholestatic jaundice or hepatic dysfunction associated with prior
nitrofurantoin use; hypersensitivity to drug or any component of the formulation.
• Because of the possibility of hemolytic anemia caused by immature erythrocyte enzyme
systems (glutathione instability), the drug is contraindicated in pregnant patients at term (38
to 42 weeks gestation), during labor and delivery, or when the onset of labor is imminent; also
contraindicated in neonates younger than 1 month of age

Adverse Drug 1% to 10%:

Reactions Central nervous system: Headache (6%)
Endocrine & metabolic: Increased serum phosphate (1% to 5%)
Gastrointestinal: Nausea (8%), flatulence (2%)
Hematologic & oncologic: Decreased hemoglobin (1-5%), eosinophilia (1- 5%)
Hepatic: Increased serum alanine aminotransferase (1% to 5%), increased serum aspartate
aminotransferase (1% to 5%)

Monitoring Liver function

Parameters
Drug Risk X: Avoid combination
Interactions BCG (Intravesical) Cholera Vaccine Magnesium Trisilicate Norfloxacin
Risk D: Consider therapy modification
Sodium Picosulfate Typhoid Vaccine
Risk C: Monitor therapy
BCG Vaccine Dapsone Eplerenone Lactobacillus and Estriol Local Anesthetics Nitric Oxide
Probenecid Prilocaine Sodium Nitrite
Pregnancy and Pregnancy Risk Factor B
Lactation World Health Organization states that nitrofurantoin is compatible with breastfeeding for healthy
full-term infants with monitoring for adverse reactions (eg, jaundice, hemolysis). However,
patients taking nitrofurantoin should avoid breastfeeding premature neonates or neonates <1
month of age.

Administration Administration: Oral

Administer with meals to improve absorption and decrease adverse effects
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Hepatic reactions: Rare, but severe and sometimes fatal hepatic reactions (eg, cholestatic
jaundice, hepatitis, hepatic necrosis) have been associated with use (onset may be insidious);
discontinue immediately if hepatitis occurs. Monitor liver function tests periodically. Use is
contraindicated in patients with a history of nitrofurantoin associated cholestatic jaundice or
hepatic dysfunction.
• Optic neuritis: Postmarketing cases of optic neuritis have been reported.
• Peripheral neuropathy: Has been associated with peripheral neuropathy (rare); risk may be
increased in patients with anemia, renal impairment (CrCl <60 mL/minute), diabetes, vitamin B
deficiency, debilitating disease, or electrolyte imbalance; use caution.
• Pulmonary toxicity: Acute, subacute, or chronic (usually after 6 months of therapy) pulmonary
reactions (possibly fatal) have been observed; if these occur, discontinue therapy immediately.
Monitor closely for malaise, dyspnea, cough, fever, radiologic evidence of diffuse interstitial
pneumonitis or fibrosis.

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• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C.
difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2
months post antibiotic treatment.
Disease-related concerns:
• Hemolytic anemia: Use caution in patients with G6PD deficiency; may be at increased risk for
hemolytic anemia. Discontinue therapy if occurs.
• Renal impairment: Urinary nitrofurantoin concentrations are variable in patients with impaired
renal function. The Beers Criteria recommends avoiding use in geriatric patients ≥65 years with a
CrCl <30 mL/minute (Beers Criteria.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or
frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult
drug interactions database for more detailed information.
• Sedatives: Effects may be potentiated when used with other sedative drugs or ethanol.
Special populations:
• Elderly: Use in elderly patients, particularly females receiving long-term prophylaxis for
recurrent UTIs, has also been associated with an increased risk of hepatic and pulmonary toxicity
and peripheral neuropathy. Monitor closely for toxicities during use.
• Pediatric: Use is contraindicated in children <1 month of age (at increased risk for hemolytic
anemia).

Storage Capsules: Store at controlled room temperature, 15°C to 30°C. Dispense in a tight container using
a child-resistant closure.
Refer to manufacturer PIL if there are specific considerations.

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Watch Group
13. Oxytetracycline
Generic Name Oxytetracycline

Dosage Capsules 250 mg

form/strengths Topical ointment 3.330 gm/100g
Route of Oral ,Topical
administration
Pharmacologic Tetracycline antibiotic
category ATC (Topical): D06AA03
ATC (Systemic): J01AA06
Indications -Treatment of infections caused by oxytetracycline-sensitive organisms including:
-Respiratory tract infections: Pneumonia, whooping cough and other lower respiratory tract
infections due to susceptible strains of Streptococcus pneumoniae, Haemophilus influenzae,
Klebsiella pneumoniae and other organisms. Mycoplasma pneumoniae pneumonia. Treatment of
chronic bronchitis (including the prophylaxis of acute exacerbations).
-Urinary tract infections: caused by susceptible strains of the Klebsiella species. Enterobacter
species, Escherichia coli, Streptococcus faecalis and other organisms.
-Sexually transmitted diseases: Infections due to Chlamydia trachomatis including uncomplicated
urethral, endocervical or rectal infections. Non-gonococcal urethritis caused by Ureaplasma
urealyticum. Oxytetracycline is also indicated in chancroid, granuloma inguinale and
lymphogranuloma venereum. Oxytetracycline is an alternative drug in the treatment of
gonorrhoea and syphilis.
-Skin Infections: Acne vulgaris when antibiotic therapy is considered necessary and severe
rosacea.
-Ophthalmic infections: Trachoma, although the infectious agent, as judged by
immunofluorescence, is not always eliminated. Inclusion conjunctivitis may be treated with oral
oxytetracycline alone or in combination with topical agents.
-Rickettsial infections: Rocky Mountain spotted fever, typhus group, Q fever and Coxiella
endocarditis and tick fevers.
-Other infections: Stagnant loop syndrome. Psittacosis, brucellosis (in combination with
streptomycin), cholera, bubonic plague, louse and tick-borne relapsing fever, tularaemia,
glanders, melioidosis and acute intestinal amoebiasis (as an adjunct to amoebicides).
Dosage Oral:
Regimen Adults (including the elderly) and children over 12 years:
-Skin infections: 250-500mg daily in single or divided doses should be administered for at least 3
months in the treatment of acne vulgaris and severe rosacea.
-Streptococcal infections: A therapeutic dose of oxytetracycline should be administered for at
least 10 days
-Brucellosis: 500mg four times daily accompanied by streptomycin.
- Sexually transmitted diseases: 500mg four times daily for 7 days in the following infections:
uncomplicated gonococcal infections (except anorectal infections in men); uncomplicated
urethra; endocervical or rectal infection caused by Chlamydia trachomatis; non-gonoccocal
urethritis caused by Ureaplasma urealyticum.
-Acute epididymo-orchitis caused by Chlamydia trachomatis, or Neisseria gonorroeae: 500mg
four times daily for 10 days
-Primary and Secondary syphilis: 500mg four times daily for 15 days.
Dosage -Renal impairment:

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adjustment -In general, the drug contraindicated in renal impairment
-only if use of this class of drug is deemed absolutely essential. Total dosage should be decreased
by reduction of recommended individual doses and/or by extending time intervals between doses
-Hepatic Impairment:
Avoid in high doses
Contra- -children below 12 years
indications -Known hypersensitivity to any of the tetracyclines or any of ingredients in the formulation
- Renal or hepatic impairment
-Systemic lupus erythematosus
-Pregnancy and breastfeeding women
-Porphyria
-Patients receiving vitamin A or retinoid therapy.
Adverse Drug Gastrointestinal irritations ,nausea, abdominal discomfort, vomiting, diarrhoea, anorexia and
Reactions dysphagia ,Pseudomembranous colitis, intestinal overgrowth of resistant organisms ,glossitis,
rectal and vaginal irritation, tooth discolouration, pancreatitis , Hepatotoxicity (hepatitis, jaundice
and hepatic failure), fatty liver degeneration , macropapular and erythematous rashes, photo-
erythema, urticaria, angioneurotic oedema, anaphylaxis, anaphylactoid purpura, pericarditis,
exacerbation of systemic lupus erythematosus , Renal dysfunction.
Monitoring -Renal, hepatic, and hematologic function test
Parameters -Temperature, WBC, cultures and sensitivity
-Appetite, mental status
Drug Risk D: Consider therapy modification
Interactions Antacids , Calcium Salts , Iron Preparations , Magnesium Dimecrotate , Magnesium Salts ,
Multivitamins/Minerals (with ADEK, Folate, Iron , Zinc Salts)
Pregnancy and Product should not be used in pregnancy unless absolutely essential. Tetracyclines cross the
Lactation placenta and may have toxic effects on foetal tissues, particularly on skeletal development. The
use of tetracycline compounds during pregnancy has been associated with reports of maternal
liver toxicity.
Tetracyclines are contraindicated during breastfeeding because of possible staining of infants'
dental enamel or bone deposition of tetracyclines although milk levels are low and absorption by
the infant is inhibited by the calcium in breastmilk. .
Administration -Best taken on an empty stomach (1 hour before food or two hours after).
- If gastric irritation occurs, tablets should be taken with food.
- Tablets should be taken well before going to bed.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ -Drug shouldn’t be administered in the following patients:
Precautions -Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or
glucose-galactose malabsorption
-Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption
or sucrase-isomaltase insufficiency
-Photosensitivity reactions may occur in hypersensitive persons and such patients should be
warned to avoid direct exposure to natural or artificial sunlight and to discontinue therapy at the
first sign of skin discomfort.
Storage -Store below 25°C.
Refer to manufacturer PIL if there are specific considerations.

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Watch Group
14. Rifaximin
Generic Name Rifaximin

Dosage Tablets 200mg, 550mg

form/strengths
Route of Oral
administration
Pharmacologic Rifamycin
category ATC: A07AA11
Indications Hepatic encephalopathy: Reduction in the risk of overt hepatic encephalopathy recurrence in
adults.
Irritable bowel syndrome without constipation: Treatment of moderate to severe irritable bowel
syndrome without constipation in adults.
Travelers' diarrhea: Treatment of travelers' diarrhea caused by noninvasive strains
of Escherichia coli in adults and pediatric patients ≥12 years of age.
Limitations of use: Rifaximin should not be used in patients with diarrhea complicated by fever or
blood in the stool or diarrhea caused by pathogens other than E. coli.
Dosage Dosage
Regimen adult Patients
Irritable bowel syndrome, moderate to severe, without constipation (alternative
agent): Note: Reserve for patients, particularly those with bloating, who have failed other
therapies.
Oral: 550 mg 3 times daily for 14 days
Travelers’ diarrhea:
Treatment, moderate to severe (alternative agent): Note: Avoid in patients with fever or bloody
diarrhea
Oral: 200 mg 3 times daily for 3 days
Hepatic Encephalopathy
Reduction of Risk of Recurrence of Overt Hepatic Encephalopathy
Oral: 550 mg twice daily.
Treatment of Hepatic Encephalopathy
Oral: 600–1200 mg daily (usually in 3 divided doses) for 7–21 days has been used
Dosage
Pediatric Patients
Travelers’ Diarrhea Caused by Noninvasive Strains of E. coli
Treatment
Oral: Adolescents ≥12 years of age: 200 mg 3 times daily for 3 days.
If diarrhea worsens or persists >24–48 hours after drug initiated, discontinue and consider
alternative anti-infective
Dosage Dosing: Renal Impairment: Adult
adjustment There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
Dosing: Hepatic Impairment: Adult
No dosage adjustment necessary. Use with caution in severe impairment (Child-Pugh class C);
however, systemic absorption is limited and pharmacokinetic parameters are highly variable
Contra- Hypersensitivity to rifaximin, other rifamycin antibiotics, or any component of the formulation
indications
Adverse Drug >10%:

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Reactions Cardiovascular: Peripheral edema (15%)
Central nervous system: Dizziness (13%), fatigue (12%)
Hepatic: Ascites (11%)
Gastrointestinal: Nausea (14%; irritable bowel syndrome with diarrhea)
Central nervous system: Headache, depression (7%)
Dermatological: Pruritus (9%), skin rash (5%)
Gastrointestinal: Abdominal pain (>2% to 9%), pseudomembranous colitis (<5%; travelers' diarrhea
or irritable bowel syndrome with diarrhea <2%)
Hematologic & oncologic: Anemia (8%)
Hepatic: Increased serum ALT (irritable bowel syndrome with diarrhea 2%)
Neuromuscular & skeletal: Muscle spasm (9%), arthralgia (6%), increased creatine phosphokinase
(<5%; travelers' diarrhea or irritable bowel syndrome with diarrhea <2%)
Respiratory: Nasopharyngitis (7%), dyspnea (6%), epistaxis (>2% to 5%)
Miscellaneous: Fever (6%)
Monitoring Hypersensitivity reactions, temperature, blood in stool, change in symptoms; monitor changes in
Parameters mental status in hepatic encephalopathy
Drug Risk X: Avoid combination
Interactions Lasmiditan BCG (Intravesical)
Risk D: Consider therapy modification
Sodium Picosulfate
Risk C: Monitor therapy
BCG Vaccine Erdafitinib Lactobacillus and Estriol Lumacaftor and Ivacaftor P-glycoprotein/ABCB1
Inhibitors
Pregnancy and Pregnancy Category C
Lactation Adverse events have been observed in some animal reproduction studies. Due to the limited oral
absorption of rifaximin in patients with normal hepatic function, exposure to the fetus is expected
to be low.
It is not known if rifaximin is excreted in human milk. According to the manufacturer, the decision
to breast-feed during therapy should take into account the risk of exposure to the infant and the
benefits of treatment to the mother. Because of the limited oral absorption of rifaximin in patients
with normal hepatic function, exposure to the nursing infant is expected to be low.
Administration Oral: Administer with or without food.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Hypersensitivity: Hypersensitivity reactions (eg, exfoliative dermatitis, rash, urticaria, flushing,
angioneurotic edema, pruritus, anaphylaxis) have occurred; these events have occurred as early as
within 15 minutes of drug administration.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection,
including Clostridioides (formerly Clostridium) difficile-associated diarrhea (CDAD) and
pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
Disease-related concerns:
• Diarrhea: Appropriate use: Avoid use in diarrhea with fever and/or blood in the stool and in the
treatment of diarrhea due to pathogens other than Escherichia coli, including Campylobacter
jejuni, ShigellaI spp., and Salmonella spp. (efficacy has not been established). Consider alternative
therapy if symptoms persist or worsen after 24 to 48 hours of treatment.
• Hepatic impairment: Efficacy for prevention of encephalopathy has not been established in
patients with a Model for End-Stage Liver Disease (MELD) score >25; use caution in patients with
severe hepatic impairment (Child-Pugh class C).
Concurrent drug therapy issues:

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• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency
adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug
interactions database for more detailed information.
Storage Store at 20°C to 25°C; excursions permitted to 15°C to 30°C
Refer to manufacturer PIL if there are specific considerations.

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15. Secnidazole
Access Group

Generic Name Secnidazole

Dosage Tablets: 500 mg, 1gm

form/strengths
Route of Oral
administration
Pharmacologic Antiprotozoal, Nitroimidazole
category ATC: P01AB07
Indications Bacterial vaginosis: Treatment of bacterial vaginosis in adult females.
Trichomoniasis: Treatment of trichomoniasis caused by Trichomonas vaginalis in adults; treat
partners of infected patients simultaneously to prevent reinfection.
Dosage Dosing: Adult
Regimen Bacterial vaginosis: Oral: 2 g single dose.
Trichomoniasis: Oral: 2 g as a single dose; sexual partners should be treated at the same time.
Dosage Dosing: Renal Impairment: Adult
adjustment There are no dosage adjustments needed.
Dosing: Hepatic Impairment: Adult
There are no dosage adjustments needed.
Contra- Hypersensitivity to secnidazole, other nitroimidazole derivatives, or component of formulation.
indications
Adverse Drug 1% to 10%:
Reactions Gastrointestinal: Diarrhea (3%), nausea (4%)
Genitourinary: Vulvovaginal candidiasis (3% to 10%)
Nervous system: Headache (4%)
Postmarketing: Gastrointestinal: Dysgeusia
Monitoring Monitor for adverse reactions.
Parameters
Drug Risk X: Avoid combination
Interactions Alcohol (Ethyl) BCG (Intravesical) Cholera Vaccine Products Containing Ethanol Products
Containing Propylene Glycol
Risk D: Consider therapy modification
Sodium Picosulfate Typhoid Vaccine
Pregnancy and Adverse events were not observed in animal reproduction studies. Information related to the
Lactation use of secnidazole in pregnancy is limited.
It is not known if secnidazole is present in breast milk.
Due to the potential for adverse events, breastfeeding should be avoided during therapy and for
96 hours after the last dose.
Administration Administration: Oral: Administer without regard to timing of meals
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Carcinogenic: Carcinogenicity has been observed in mice and rats with nitroimidazole agents
that are structurally similar to secnidazole in animal studies; it is unknown whether secnidazole
is associated with carcinogenicity in humans. Avoid chronic use.
Disease-related concerns:
• Candidiasis: Vulvovaginal candidiasis may occur; antifungal treatment may be necessary if
patient is symptomatic.

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Other warnings/precautions:
• Ethanol use: Abdominal pain, diarrhea, dizziness, headache, nausea, and vomiting have been
reported with secnidazole and concomitant alcohol consumption; avoid alcoholic beverages or
products containing ethanol or propylene glycol during therapy and for at least 2 days after
therapy completion.
Storage Store at 20°C to 25°C; excursions permitted to 15°C to 30°C.
Refer to manufacturer PIL if there are specific considerations.

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Access Group
16. Sulfamethoxazole and Trimethoprim
Generic Name Sulfamethoxazole and Trimethoprim

Dosage Oral suspension Sulfamethoxazole 200 mg/5m, Trimethoprim 40 mg/5ml

form/strengths Tablets 400/80mg, 800/160mg
Route of Oral
administration
Pharmacologic Antibiotic, Miscellaneous; Antibiotic, Sulfonamide Derivative
category ATC: J01EE01
Indications Oral:
Treatment of urinary tract infections (UTIs) due
to Escherichia coli, Klebsiella and Enterobacter spp, Morganella morganii, Proteus mirabilis, and Pro
teus vulgaris;
acute otitis media; acute exacerbations of chronic obstructive pulmonary disease due to susceptible
strains of Haemophilus influenzae or Streptococcus pneumoniae;
treatment and prophylaxis of Pneumocystis pneumonia (PCP);
traveler's diarrhea due to enterotoxigenic E. coli;
treatment of shigellosis caused by Shigella flexneri or Shigella sonnei.
Dosage Dosing: Adult
Regimen General dosing guidelines:
Oral: 1 to 2 double-strength tablets every 12 to 24 hours. Note: Serum creatinine and potassium
concentrations should be monitored in outpatients receiving high-dose therapy (>5 mg/kg/day
[TMP component]).
Dosing: Pediatric
Note: Dosage recommendations are based on the trimethoprim (TMP) component:
General dosing, susceptible infection: Infants ≥2 months, Children, and Adolescents: Oral, IV: 6 to
12 mg TMP/kg/day in divided doses every 12 hours; maximum single dose: 160 mg TMP/dose

Dosage Renal Impairment

adjustment Oral
Adults with Clcr 15–30 mL/minute: Reduce dose to ~50% of usual dose.
Adults with Clcr <15 mL/minute: Reduce dose to ~25 to 50% of usual dose. Use with caution and
appropriate monitoring.

Dosing: Renal Impairment: Pediatric

Infants ≥2 months, Children, and Adolescents: Oral:
CrCl >30 mL/minute: No adjustment required.
CrCl 15 to 30 mL/minute: Administer 50% of recommended dose.
CrCl <15 mL/minute: Use is not recommended.

Dosing: Hepatic Impairment:

• There are no dosage adjustments needed. Use with caution; use is contraindicated in cases of
marked hepatic damage.
Contra- Hypersensitivity to any sulfa drug, trimethoprim, or any component of the formulation; history of
indications drug induced-immune thrombocytopenia with use of sulfonamides or trimethoprim; megaloblastic
anemia due to folate deficiency; infants <2 months, infants <4 weeks; marked hepatic damage or
severe renal disease (if patient not monitored); concomitant administration with dofetilide
Additional contraindications: Blood dyscrasias; pregnancy; breastfeeding; premature infants; acute

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porphyria.

Adverse Drug Frequency not defined:

Reactions Cardiovascular: Allergic myocarditis, periarteritis nodosa (rare)
Central nervous system: Apathy, aseptic meningitis, ataxia, chills, depression, fatigue, hallucination,
headache, insomnia, nervousness, peripheral neuritis, seizure, vertigo
Endocrine & metabolic: Hyperkalemia (generally at high dosages), hypoglycemia (rare),
hyponatremia
Gastrointestinal: Abdominal pain, anorexia, diarrhea, glottis edema, kernicterus (in neonates),
nausea, pancreatitis, pseudomembranous colitis, stomatitis, vomiting
Genitourinary: Crystalluria, diuresis (rare), nephrotoxicity (in association with cyclosporine), toxic
nephrosis (with anuria and oliguria)
Hematologic & oncologic: Agranulocytosis, anaphylactoid purpura (IgA vasculitis; rare), aplastic
anemia, eosinophilia, hemolysis (with G6PD deficiency), hemolytic anemia, hypoprothrombinemia,
leukopenia, megaloblastic anemia, methemoglobinemia, neutropenia, thrombocytopenia
Hepatic: Cholestatic jaundice, hepatotoxicity (including hepatitis, cholestasis, and hepatic necrosis),
hyperbilirubinemia, increased transaminases
Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction, serum sickness
Neuromuscular & skeletal: Arthralgia, myalgia, rhabdomyolysis (mainly in AIDS patients), systemic
lupus erythematosus (rare), weakness
Ophthalmic: Conjunctival injection, injected sclera, uveitis
Otic: Tinnitus
Renal: Increased blood urea nitrogen, increased serum creatinine, interstitial nephritis, renal failure
Respiratory: Cough, dyspnea, pulmonary infiltrates
Miscellaneous: Fever
Monitoring CBC, serum potassium, creatinine, BUN
Parameters
Drug Risk X: Avoid combination
Interactions Aminolevulinic Acid Amodiaquine BCG (Intravesical) Cholera Vaccine Dofetilide
Fexinidazole Leucovorin Calcium Mecamylamine Methenamine Metronidazole Potassium P-
Aminobenzoate Procaine
Risk D: Consider therapy modification
Chloroprocaine Methotrexate Phenytoin Procainamide Sodium Picosulfate Typhoid Vaccine Vitamin
K Antagonists
Risk C: Monitor therapy
Amantadine Aminolevulinic Acid Androgens Angiotensin Ii Receptor Blockers Angiotensin-
Converting Enzyme Inhibitors Antidiabetic Agents Azathioprine
Cyclosporine Dapsone Dexketoprofen Digoxin Eplerenone Hypoglycemia-Associated Agents
Lactobacillus And Estriol Lamivudine Local Anesthetics Mercaptopurine Metformin Porfimer
Prilocaine Prothionamide Rifampin Salicylates Sodium Nitrite
Pregnancy and Avoidance of sulfamethoxazole/trimethoprim during the third trimester is recommended by some
Lactation guidelines.
Administration Administration: Oral
Administer without regard to meals. Administer with food, water, or milk to minimize gastric
irritation. Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Blood dyscrasias: Fatalities associated with severe reactions including agranulocytosis, aplastic
anemia, and other blood dyscrasias have occurred; discontinue use at first sign of rash or signs of
serious adverse reactions.
• Dermatologic reactions: Fatalities associated with severe reactions including Stevens-Johnson

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syndrome and toxic epidermal necrolysis have occurred; discontinue use at first sign of rash.
• Hepatic necrosis: Fatalities associated with hepatic necrosis have occurred; discontinue use at
first sign of rash or signs of serious adverse reactions.
• Hyperkalemia: May cause hyperkalemia; potential risk factors for trimethoprim-induced
hyperkalemia include high dosage (20 mg/kg/day of trimethoprim), renal impairment, older age,
hypoaldosteronism, and concomitant use of medications causing or exacerbating hyperkalemia.
• Hypoglycemia: May cause hypoglycemia, particularly in malnourished, or patients with renal or
hepatic impairment.
• Hyponatremia: Severe and symptomatic hyponatremia may occur, particularly in patients treated
for Pneumocystis jirovecii pneumonia (PCP).
• Sulfonamide (“sulfa”) allergy: Traditionally, concerns for cross-reactivity have extended to all
compounds containing the sulfonamide structure (SO2NH2).
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C.
difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2
months postantibiotic treatment.
• Thrombocytopenia: Immune mediated thrombocytopenia may occur. Severe cases which may be
life-threatening or fatal have been reported. Thrombocytopenia usually resolves within 1 week
following discontinuation of therapy.
Disease-related concerns:
• Asthma/allergies: Use with caution in patients with allergies or asthma.
• Hepatic impairment: Use with caution in patients with hepatic impairment.
• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment
recommended. Maintain adequate hydration to prevent crystalluria.
• Thyroid dysfunction: Use with caution in patients with thyroid dysfunction.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency
adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug
interactions database for more detailed information.
• Leucovorin: Avoid concomitant use when treating Pneumocystis jirovecii pneumonia (PCP) in
patients with HIV; may increase risk of treatment failure and death.
Special populations:
• AIDS patients: Incidence of adverse effects appears to be increased in patients with AIDS.
• Elderly: Use with caution in elderly patients; greater risk for more severe adverse reactions,
including hyperkalemia associated with trimethoprim use. Elderly patients are at an increased risk
for severe and potentially life-threatening hyperkalemia when trimethoprim is used concomitantly
with medications known to cause or exacerbate hyperkalemia, such as spironolactone, ACE
inhibitors, or ARBs.
• G6PD deficiency: Use with caution in patients with G6PD deficiency; hemolysis may occur (dose-
related).
• Patients with potential for folate deficiency: Use with caution in patients with potential folate
deficiency (malnourished, chronic anticonvulsant therapy, or elderly).
• Porphyria: Use with caution in patients with porphyria.
• Slow acetylators: May be more prone to adverse reactions
Storage Store at controlled room temperature of 15°C to 25°C. Protect from light
Refer to manufacturer PIL if there are specific considerations.

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17. Tedizolid
Reserve Group

Generic Name Tedizolid

Dosage Tablets: 200mg

form/strengths
Route of Oral
administration
Pharmacologic Antibiotic, Oxazolidinone
category ATC: J01XX11
Indications Skin and soft tissue infections: Treatment of adults and pediatric patients ≥12 years of age with
acute bacterial skin and soft tissue infections caused by susceptible isolates of the following
gram-positive microorganisms
Dosage Dosing: Adult
Regimen Skin and soft tissue infection (alternative agent):
Note: Reserve for patients with or at risk for methicillin-resistant S. aureus infection who cannot
receive preferred agents.
Oral: 200 mg once daily. Total duration of therapy is ≥5 days; may extend up to 14 days
depending on severity and clinical response
Dosing: Pediatric
Skin and skin structure infections: Children ≥12 years and Adolescents: Oral: 200 mg once daily
for 6 days

Dosage Dosing: Renal Impairment: Adult

adjustment No dosage adjustment necessary.
Dosing: Hepatic Impairment: Adult
No dosage adjustment necessary.
Contra- Hypersensitivity to Tedizolid or any component of the formulation
indications
Adverse Drug 1% to 10%:
Reactions Cardiovascular: Flushing (<2%), hypertension (<2%), palpitations (<2%), phlebitis (adolescents:
3%), tachycardia (<2%)
Dermatologic: Dermatitis (<2%), pruritus (<2%), urticaria (<2%)
Endocrine & metabolic: Increased gamma-glutamyl transferase (<2%)
Gastrointestinal: Clostridioides difficile colitis (<2%), diarrhea (4%), nausea (7%), oral candidiasis
(<2%), vomiting (1% to 3%)
Genitourinary: Vulvovaginal infection (fungal: <2%)
Hematologic & oncologic: Anemia (<2%), decreased platelet count (<112,000/mm 3: 1% to 2%),
decreased white blood cell count (<2%)
Hepatic: Increased serum alanine aminotransferase (≤3%), increased serum aspartate
aminotransferase (≤3%), increased serum transaminases (≤3%)
Hypersensitivity: Hypersensitivity reaction (<2%)
Local: Injection site reaction (≤4%)
Nervous system: Dizziness (2%), facial nerve paralysis (<2%), headache (5%), hypoesthesia (<2%),
insomnia (<2%), paresthesia (<2%), peripheral neuropathy (1%)
Ophthalmic: Asthenopia (<2%), blurred vision (<2%), visual impairment (<2%), vitreous opacity
(<2%)
Miscellaneous: Infusion related reaction (≤4%)

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Monitoring Baseline complete blood count (CBC) with differential
Parameters
Monitor for improvement in infection, new opportunistic infections, development of severe
diarrhea.
Drug Risk X: Avoid combination
Interactions BCG (Intravesical) Cholera Vaccine Cladribine Dipyrone Fexinidazole Pazopanib Rimegepant
Topotecan
Risk D: Consider therapy modification
Alpelisib Berotralstat Deferiprone Iohexol Iomeprol Iopamidol Sodium Picosulfate Typhoid
Vaccine Ubrogepant
Pregnancy and Adverse events were observed in animal reproduction studies.
Lactation No information is available on the use of tedizolid during breastfeeding. Tedizolid is 70 to 90%
bound in maternal plasma, so large amounts are not expected to appear in breastmilk. If
tedizolid is required by the mother, it is not a reason to discontinue breastfeeding, but because
there is no published experience with tedizolid during breastfeeding, an alternate drug may be
preferred, especially while nursing a newborn or preterm infant.
Administration Administration: Oral
Administer with or without food.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C.
difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2
months postantibiotic treatment.
Disease-related concerns:
• Neutropenia: Not recommended for use in patients with neutrophil counts <1000 cells/mm3.
Alternative therapies should be considered when treating patients with neutropenia and acute
bacterial skin and skin structure infections

Storage Store at 20°C to 25°C; excursions are permitted between 15°C and 30°C.
Refer to manufacturer PIL if there are specific considerations.

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18. Teicoplanin Watch Group

Generic Name Teicoplanin

Dosage Powder for solution for I.M or I.V Injection 200mg, 400mg
form/strengths
Route of IV IM
administration
Pharmacologic A glycopeptide antibacterial
category ATC: J01XA02
Indications Indicated for use in serious gram+ve infections; serious staphylococcal infections in patients
sensitive or unresponsive to penicillins and cephalosporins; CAPD (continuous ambulatory
peritoneal dialysis) related peritonitis; prophylaxis in orthopaedic surgery at risk of Gram-positive
infection
Dosage Adult Dosing
Regimen • The usual loading dose is 400 mg (equivalent to about 6 mg/kg) intravenously or
intramuscularly, given every 12 hours for the first 3 doses, followed by 6 mg/kg once daily.
• In more severe infections: 800 mg (equivalent to about 12 mg/kg) may be given intravenously
every 12 hours for the first 3 to 5 doses, followed by 12 mg/kg intravenously or
intramuscularly once daily. The duration of therapy should not exceed 4 months.

• For the prophylaxis of Gram-positive infection in high-risk patients undergoing surgical

procedures who are unable to receive penicillin, teicoplanin may be given in a single
intravenous dose of 400 mg at induction of anaesthesia; a dose of 800 mg has been
recommended for those undergoing skeletal stabilisation and definitive soft-tissue closure.

• For CAPD-associated peritonitis, teicoplanin may be added to the dialysis solution at a

concentration of 20 mg/litre; this dose should be given in each bag of solution in the first
week, in alternate bags in the second week, and in the overnight dwell bag only during the
third week. Patients should be given an initial loading dose of 400 mg intravenously.

Pediatric Dosing:
• IV for neonates (1-2month): a single loading dose of 16 mg/kg is followed by maintenance
doses of 8 mg/kg once daily IV

• for children from 1-2 month of age: IV: a loading dose of 10 mg/kg (maximum 400 mg) is given
every 12 hours for three doses followed by maintenance doses of 6 mg/kg (maximum 400 mg)
once daily;
in severe infections, maintenance doses of 10 mg/kg once daily are recommended

Dosage Dosage adjustments in Renal disease:

adjustment Doses of teicoplanin should be adjusted in patients with renal impairment, though reduction is
not required until the fourth day of treatment.
Teicoplanin should be given in usual IV or IM doses for the first 3 days of therapy, thereafter the
dose is adjusted according to creatinine clearance (CrCl):
CrCl 30 to 80 mL/minute: half the maintenance dose given daily or the maintenance dose given
every 2 days
CrCl less than 30 mL/minute and for haemodialysed patients: one-third initial dose given daily or
initial dose given every 3 days.

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Contra- Hypersensetivity to any of the drug components
indications
Adverse Drug Fever, rash and pruritus, and occasional bronchospasm and anaphylaxis
Reactions erythema and flushing of the upper body have occurred.
Other hypersensitivity reactions have included rigors, angioedema, and, rarely, severe skin
reactions including exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, and
toxic epidermal necrolysis.
gastrointestinal disturbances, dizziness, headache, thrombocytopenia (especially at high doses),
leucopenia, neutropenia, eosinophilia
Disturbances in liver enzyme values, and thrombophlebitis
abscess at the injection site.
Rare cases of agranulocytosis have occurred.
Renal impairment and ototoxicity have been reported

Monitoring Renal and auditory function should be monitored during prolonged therapy in patients with pre-
Parameters existing renal impairment, and in those receiving other ototoxic or nephrotoxic drugs, although
opinions conflict as to whether increased risk of nephrotoxicity exists with combined therapy with
drugs such as the aminoglycosides. In general, periodic blood counts and liver- and renal-function
tests are advised during treatment
Drug To be used with caution in conjunction with or sequentially with drugs of known nephrotoxic
Interactions or ototoxic potential particularly streptomycin, neomycin, kanamycin, gentamicin, amikacin,
tobramycin, cephaloridine, colistin.

Pregnancy and Pregnancy Category X

Lactation Limited data indicate that teicoplanin is poorly excreted into breastmilk. Because teicoplanin is
not orally absorbed it is unlikely to adversely affect the breastfed infant.
Administration • Given intravenously, as a bolus dose or by infusion over 30 minutes, or by intramuscular
injection.
• In children: after the loading doses have been given, the intramuscular route may be
considered in children aged 1 month and over.
• Refer to manufacturer PIL if there are specific considerations.
Warnings/ • Prolonged use of teicoplanin may result in overgrowth of non-susceptible organisms.
Precautions Repeated evaluation of patient’s condition is essential.
• Hypersensitivity
Although there have been occasional reports of cross-sensitivity to teicoplanin in patients
hypersensitive to vancomycin, the majority of reports suggest that cross-sensitivity is very rare
and teicoplanin can usually be used in patients intolerant of vancomycin

Storage • Store at a temperature of 2 -8 o C. Protect from light.

• Refer to manufacturer PIL if there are specific considerations.

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Access Group
19. Tetracycline
Generic Name Tetracycline

Dosage Topical ointment 3%

form/strengths Capsule 250mg
Eye Ointment 1%
Route of Oral topical
administration
Pharmacologic Antibiotic, Tetracycline Derivative
category ATC (Topical): D06AA04
ATC (systemic): J01AA07
ATC (Ophthalmic): S01AA09, S03AA02
Indications Acute intestinal amebiasis: Adjunctive therapy in acute intestinal amebiasis caused
by Entamoeba histolytica.
Acne: Adjunctive therapy for the treatment of severe acne.
Actinomycosis: Treatment of actinomycosis caused by Actinomyces species when penicillin is
contraindicated.
Anthrax: Treatment of anthrax due to Bacillus anthracis when penicillin is contraindicated.
Campylobacter: Treatment of infections caused by Campylobacter fetus.
Cholera: Treatment of cholera caused by Vibrio cholerae.
Clostridium: Treatment of infections caused by Clostridium spp. when penicillin is
contraindicated.
Gram-negative infections: Treatment of infections caused by Escherichia coli, Klebsiella
aerogenes (formerly Enterobacter aerogenes), Shigella spp., Acinetobacter spp., Klebsiella spp.,
and Bacteroides spp.
Listeriosis: Treatment of listeriosis due to Listeria monocytogenes when penicillin is
contraindicated.
Ophthalmic infections: Treatment of inclusion conjunctivitis or trachoma caused by Chlamydia
trachomatis.
Relapsing fever: Treatment of relapsing fever due to Borrelia spp.
Respiratory tract infection: Treatment of respiratory tract infections caused by Haemophilus
influenzae (upper respiratory tract only), Klebsiella spp. (lower respiratory tract
only), Mycoplasma pneumoniae (lower respiratory tract only), Streptococcus pneumoniae,
or Streptococcus pyogenes.
Rickettsial infections: Treatment of Rocky Mountain spotted fever, typhus group infections, Q
fever, and rickettsialpox caused by Rickettsiae.
Sexually transmitted diseases: Treatment of lymphogranuloma venereum or uncomplicated
urethral, endocervical, or rectal infections caused by C. trachomatis; chancroid caused
by Haemophilus ducreyi; granuloma inguinale (donovanosis) caused by Klebsiella granulomatis;
syphilis caused by Treponema pallidum, when penicillin is contraindicated.
Limitations of use: Tetracycline is not a recommended alternative for uncomplicated gonorrhea
according to the Centers for Disease Control and Prevention (CDC) sexually transmitted diseases
guidelines.
Skin and skin structure infections: Treatment of skin and skin structure infections caused
by Staphylococcus aureus or S. pyogenes.
Urinary tract infections: Treatment of urinary tract infections caused by susceptible gram-
negative organisms (eg, E. coli, Klebsiella spp.).

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Vincent infection: Treatment of Vincent infection caused by Fusobacterium fusiforme when
penicillin is contraindicated.
Yaws: Treatment of yaws caused by Treponema pertenue when penicillin is contraindicated.
Zoonotic infections: Treatment of psittacosis (ornithosis) due to Chlamydophila psittaci; plague
due to Yersinia pestis; tularemia due to Francisella tularensis; brucellosis due to Brucella spp. (in
conjunction with an aminoglycoside); bartonellosis due to Bartonella bacilliformis.
Dosage Dosing: Adult
Regimen Usual dosage range: Oral: 250 to 500 mg 4 times daily or 500 mg twice daily.
Acne vulgaris (moderate to severe, inflammatory):
Note: Use as an adjunct to topical acne therapy.
Oral: Initial dose: 1 g daily in divided doses; reduce gradually to 125 to 500 mg/day once
improvement is noted (alternate day or intermittent therapy may be adequate in some patients).
Use the shortest possible duration to minimize risk of adverse effects and development of
bacterial resistance; re-evaluate at 3 to 4 months
Cholera (Vibrio cholerae), treatment (adjunctive therapy for severely ill patients):
Oral: 500 mg 4 times daily for 3 days
Syphilis, penicillin-allergic patients: Note: Limited data support use of alternatives to penicillin,
and close serologic and clinical follow up is warranted.
Early syphilis (primary, secondary, and early latent): Oral: 500 mg 4 times daily for 14 days.
Latent syphilis (late latent): Oral: 500 mg 4 times daily for 28 days.
Tularemia (Francisella tularensis) (mild): Oral: 500 mg 4 times daily for at least 14 days
Skin Infections
If tetracycline hydrochloride is used for the prevention or treatment of superficial infections of
the skin, a small amount of the ointment should be applied to the cleansed affected area 2–3
times daily.
Dosing: Pediatric
General dosing: Children ≥8 years and Adolescents: Oral: 6.25 to 12.5 mg/kg/dose 4 times daily;
maximum dose: 500 mg/dose
Dosage Dosing: Renal Impairment:
adjustment CrCl more than 90 mL/minute: no dosage adjustment needed.
CrCl 51 to 90 mL/minute: extend dosing interval to every 8 to 12 hours.
CrCl 10 to 50 mL/minute: extend dosing interval to every 12 to 24 hours.
CrCl less than 10 mL/minute: extend dosing interval to every 24 hours.
Dosing: Hepatic Impairment:
Dose adjustment of tetracycline may be required in patients with hepatic impairment due to
potential for reduced excretion and a prolonged half-life.
Contra- Hypersensitivity to any of the tetracyclines or any component of the formulation.
indications
Adverse Drug Frequency not defined:
Reactions Cardiovascular: Pericarditis
Central nervous system: Bulging fontanel, idiopathic intracranial hypertension
Dermatologic: Erythematous rash, maculopapular rash, skin photosensitivity, urticaria
Endocrine & metabolic: Growth retardation (fibula)
Gastrointestinal: Anorexia, diarrhea, dysphagia, enterocolitis, epigastric distress, glossitis,
melanoglossia, nausea, vomiting
Genitourinary: Inflammatory anogenital lesion (with monilial overgrowth)
Hematologic & oncologic: Henoch-Schonlein purpura
Hepatic: Hepatic failure, hepatotoxicity
Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction
Immunologic: Serum sickness-like reaction

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Neuromuscular & skeletal: Exacerbation of systemic lupus erythematosus

Monitoring Renal, hepatic, and hematologic function test, temperature, WBC, cultures and sensitivity,
Parameters appetite, mental status
Drug Risk X: Avoid combination
Interactions Retinoic Acid Derivatives Methoxyflurane Mecamylamine BCG (Intravesical
Risk D: Consider therapy modification
Antacids Bismuth Subcitrate Bismuth Subsalicylate Calcium Salts CYP3A4 Inducers Dabrafenib
Enzalutamide Iron Preparations Lanthanum Magnesium Salts Mitotane Multivitamins/Minerals
Quinapril Sodium Picosulfate Sucralfate Typhoid Vaccine Zinc Salts
Pregnancy and Pregnancy Risk Factor D
Lactation As a class, tetracyclines have generally been avoided in nursing women due to theoretical
concerns that they may permanently stain the teeth of the breastfeeding infant. Some sources
note that breastfeeding can continue during tetracycline therapy but recommend use of
alternative medications when possible.
Administration Administration: Oral
Administer on an empty stomach (ie, 1 hour prior to, or 2 hours after meals) to increase total
absorption and with adequate amount of fluid to reduce risk of esophageal irritation and
ulceration. Administer at least 1 to 2 hours prior to, or 4 hours after antacid because aluminum
and magnesium cations may chelate with tetracycline and reduce its total absorption.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Increased BUN: May be associated with increases in serum urea nitrogen (BUN) secondary to
antianabolic effects; use caution in patients with renal impairment.
• Intracranial hypertension (eg, pseudotumor cerebri): Intracranial hypertension (headache,
blurred vision, diplopia, vision loss, and/or papilledema) has been associated with use. Women of
childbearing age who are overweight or have a history of intracranial hypertension are at greater
risk. Concomitant use of isotretinoin (known to cause pseudotumor cerebri [PTC]) and
tetracycline should be avoided. Intracranial hypertension typically resolves after discontinuation
of treatment; however, permanent visual loss is possible. If visual symptoms develop during
treatment, prompt ophthalmologic evaluation is warranted. Intracranial pressure can remain
elevated for weeks after drug discontinuation; monitor patients until they stabilize.
• Photosensitivity: May cause photosensitivity; discontinue if skin erythema occurs. Use skin
protection and avoid prolonged exposure to sunlight; do not use tanning equipment.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection,
including Clostridioides (formerly Clostridium) difficile-associated diarrhea (CDAD) and
pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
Disease-related concerns:
• Hepatic impairment: Hepatotoxicity has been reported rarely; risk may be increased in patients
with preexisting hepatic or renal impairment.
• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment
recommended.
Special populations:
• Pediatric: May cause tissue hyperpigmentation, enamel hypoplasia, or permanent tooth
discoloration; use of tetracyclines should be avoided during tooth development (children <8 years
of age) unless other drugs are not likely to be effective or are contraindicated.
Other warnings/precautions:
• Appropriate use: Acne: The American Academy of Dermatology acne guidelines recommend
tetracycline as adjunctive treatment for moderate and severe acne and forms of inflammatory
acne that are resistant to topical treatments. Concomitant topical therapy with benzoyl peroxide

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or a retinoid should be administered with systemic antibiotic therapy (eg, tetracycline) and
continued for maintenance after antibiotic course is completed
Storage Store at 20°C to 25°C; protect from light.
Refer to manufacturer PIL if there are specific considerations.

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Access Group
20. Thiamphenicol
Generic Name Thiamphenicol

Dosage Capsule 250mg

form/strengths Tablets 250mg
Powder for Solution for Injection 750mg
Oral Solution 250mg
Route of IV, IM, Oral
administration
Pharmacologic Antibacterial: Chloramphenicol
category ATC: J01BA02
Indications Treatment of susceptible infections, including sexually transmitted diseases, gonorrhoea

Dosage The usual oral dose is 1.5 g daily in divided doses; up to 3 g daily has been given initially in severe
Regimen infections.
Equivalent doses, expressed in terms of thiamphenicol base, may be given by intramuscular or
intravenous injection as the more water soluble glycinate hydrochloride; 1.26 g of thiamphenicol
glycinate hydrochloride is equivalent to about 1 g of thiamphenicol. A maximum daily dose of 1 g
has been suggested for elderly patients. Doses should also be reduced in patients with renal
impairment
For the treatment of gonorrhoea, oral doses of thiamphenicol have ranged from 2.5 g daily for 1 or
2 days through to 2.5 g on the first day followed by 2 g daily on each of 4 subsequent days. The
single daily dose may be most appropriate for male patients with uncomplicated gonorrhoea.
Administration in children
In children, oral doses may range from 30 to 100 mg/kg daily according to age and severity of
infection. Similar doses may also be given by intramuscular or intravenous injection.
Dosage Administration in renal impairment
adjustment Doses of thiamphenicol should be reduced in patients with renal impairment according to
creatinine clearance (CC). For the oral preparation, suggested reduced doses are:
CC 30 to 60 mL/minute: 500 mg twice daily
CC 10 to 30 mL/minute: 500 mg once daily
Alternatively, for parenteral use the following doses have been suggested:
CC 50 to 75 mL/minute: 500 mg every 12 hours
CC 25 to 50 mL/minute: 500 mg every 18 hours
CC 20 mL/minute: 500 mg every 24 hours
CC 10 mL/minute: 500 mg every 48 hours
Administration in hepatic impairment:
no adjustments needed
Contra- Hypersensetivity
indications
Adverse Drug Thiamphenicol is probably more liable to cause dose-dependent reversible depression of the bone
Reactions marrow than chloramphenicol, particularly in the elderly or in those with impaired renal function,
but it is not usually associated with aplastic anaemia. Thiamphenicol also appears to be less likely
to cause the 'grey syndrome' in neonates.
Doses of thiamphenicol should be reduced in patients with renal impairment. It is probably not
necessary to reduce doses in patients with hepatic impairment.

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Monitoring CBC, Kideny functions
Parameters
Drug Although thiamphenicol is not metabolised in the liver and might not be expected to be affected
Interactions by drugs that induce hepatic enzymes, it is reported to inhibit hepatic microsomal enzymes and
may affect the metabolism of other drugs.
Pregnancy Category C
An alternate drug is preferred to chloramphenicol during breastfeeding, especially while nursing a
newborn or preterm infant.
Administration Oral, IV or IM
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Thiamphenicol is probably more liable to cause dose-dependent reversible depression of the bone
Precautions marrow than chloramphenicol, particularly in the elderly or in those with impaired renal function,
but it is not usually associated with aplastic anaemia. Thiamphenicol also appears to be less likely
to cause the 'grey syndrome' in neonates.
Doses of thiamphenicol should be reduced in patients with renal impairment. It is probably not
necessary to reduce doses in patients with hepatic impairment.

Storage Refer to manufacturer PIL if there are specific considerations.

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21. Tigecycline Reserve Group

Generic Name Tigecycline

Dosage Lyophilized Powder for Reconstitution for I.V Infusion: 50mg

form/strengths
Route of IV
administration
Pharmacologic Antibiotic, Glycylcycline
category ATC: J01AA12
Indications Intra-abdominal infection: Treatment of complicated intra-abdominal infections in patients ≥18
years of age caused by susceptible organisms.

Pneumonia, community acquired: Treatment of community-acquired bacterial pneumonia in

patients ≥18 years of age caused by susceptible organisms.

Skin and skin structure infections, complicated: Treatment of complicated skin and skin
structure infections in patients ≥18 years of age caused by susceptible organisms.

Limitations of use: Not indicated for treatment of diabetic foot infections. Not indicated for
treatment of hospital-acquired or ventilator-associated pneumonia.
Dosage Dosing: Adult
Regimen Note: Given the increased mortality risk associated with tigecycline, reserve for use in situations
when alternative treatments are not suitable.
Intra-abdominal infection (alternative agent):
Note: Not recommended for routine empiric use. Reserve use for patients with or at risk for
certain multidrug-resistant organisms (eg, K. pneumoniae carbapenemase-producing
Enterobacteriaceae, Acinetobacter baumannii).
IV: 100 mg once, then 50 mg every 12 hours. Total duration of therapy is 4 to 5 days.
Pneumonia, community-acquired (alternative agent for patients unable to tolerate beta-
lactams or fluoroquinolones): Inpatients without risk factors for Pseudomonas aeruginosa; not
recommended for routine empiric use.
IV: 100 mg as a single dose, then 50 mg every 12 hours. Total duration (which may include oral
step-down therapy) is a minimum of 5 days; patients should be clinically stable with normal vital
signs before therapy is discontinued.
Skin/skin structure infection, complicated: IV: Initial: 100 mg as a single dose; Maintenance
dose: 50 mg every 12 hours for 5 to 14 days.
Dosing: Pediatric
General dosing, susceptible infection: Limited data available:
Note: Use should be reserved for situations when no effective alternative therapy is available;
should not be used in pediatric patients <8 years due to adverse effects on tooth development,
unless no alternatives are available.
Dosage Dosing: Renal Impairment: Adult
adjustment No dosage adjustment necessary for any degree of kidney dysfunction
Dosing: Hepatic Impairment: Adult
Mild-to-moderate hepatic impairment (Child-Pugh class A or B): No dosage adjustment
necessary.

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Severe hepatic impairment (Child-Pugh class C): Initial: 100 mg single dose; Maintenance: 25 mg
every 12 hours.
Dosing: Renal and hepatic Impairment: Pediatric
There are no pediatric specific recommendations; data is insufficient.
Contra- Hypersensitivity to tigecycline or any component of the formulation. Hypersensitivity to
indications tetracycline class of antibiotics

Adverse Drug >10%: Gastrointestinal: Diarrhea (12%), nausea (24% to 35%), vomiting (16% to 20%)
Reactions 1% to 10%:
Cardiovascular: Phlebitis (3%), septic shock, thrombophlebitis
Dermatologic: Pruritus, skin rash (3%)
Endocrine & metabolic: Hypocalcemia, hypoglycemia, hyponatremia (2%), increased amylase
(3%)
Gastrointestinal: Abdominal pain (6%), abnormal stools, anorexia, dysgeusia, dyspepsia (2%)
Genitourinary: Leukorrhea, vaginitis, vulvovaginal candidiasis
Hematologic & oncologic: Anemia (5%), eosinophilia, hypoproteinemia (5%), increased INR,
prolonged partial thromboplastin time, prolonged prothrombin time, thrombocytopenia
Hepatic: Hyperbilirubinemia (2%), increased serum alanine aminotransferase (5%), increased
serum alkaline phosphatase (3%), increased serum aspartate aminotransferase (4%), jaundice
Hypersensitivity: Hypersensitivity reaction
Infection: Abscess (2%), infection (7%), sepsis
Local: Inflammation at injection site, injection site phlebitis, injection site reaction, pain at
injection site, swelling at injection site
Nervous system: Chills, dizziness (3%), headache (6%)
Neuromuscular & skeletal: Asthenia (3%)
Renal: Increased blood urea nitrogen (3%), increased serum creatinine
Respiratory: Pneumonia (2%)

Monitoring Hepatic function (periodically); coagulation parameters (including aPTT, PTT, fibrinogen) at
Parameters baseline and regularly during therapy. Observe for signs and symptoms of anaphylaxis during
administration.
Drug Risk X: Avoid combination
Interactions Aminolevulinic Acid (Systemic) BCG (Intravesical) Cholera Vaccine Mecamylamine
Methoxyflurane Retinoic Acid Derivatives
Risk D: Consider therapy modification
Sodium Picosulfate Typhoid Vaccine
Pregnancy and pregnancy category D
Lactation Tigecycline may cause fetal harm when administered to a pregnant woman
Although oral bioavailability is low and exposure to the breastfed infant is expected to be
limited, breastfeeding is not recommended if maternal therapy is required for >3 weeks due to
the potential risk of tooth discoloration and inhibition of bone growth in the infant.
Administration Administration: IV
Infuse over 30 to 60 minutes through dedicated line or via Y-site. If the same IV line is used for
sequential infusion of several drugs, flush line with NS, D5W, or LR before and after Tigecycline
administration.
Preparation for Administration:
Add 5.3 mL NS, D5W, or LR to each 50 mg vial. Swirl gently to dissolve. Resulting solution is 10
mg/mL. Reconstituted solution must be further diluted to allow IV administration. Transfer to
100 mL IV bag for infusion (final concentration should not exceed 1 mg/mL). Reconstituted

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solution should be yellow-orange; discard if not this color.
Refer to manufacturer PIL if there are specific considerations.
Warnings Concerns related to adverse effects:
/Precautions • Anaphylactic/Hypersensitivity reactions: May cause life-threatening anaphylaxis. Due to
structural similarity with tetracyclines, avoid use in patients with known hypersensitivity to
tetracycline-class antibiotics.
• Antianabolic effects: May be associated with antianabolic effects observed with the
tetracycline class (including increased BUN, azotemia, acidosis, and hyperphosphatemia).
• Coagulopathy: May be associated with abnormalities of blood coagulation parameters,
including prolongation of PT and aPTT and decreased fibrinogen that may be dose- and/or time-
dependent, in particular in patients with renal and hepatic impairment; discontinue use when
suspected.
• Hepatotoxicity: Abnormal liver function tests (increased total bilirubin, prothrombin time,
transaminases) have been reported. Isolated cases of significant hepatic dysfunction and hepatic
failure have occurred. Closely monitor for worsening hepatic function in patients who develop
abnormal liver function tests during therapy. Adverse hepatic effects may occur after drug
discontinuation.
• Pancreatitis: Acute pancreatitis (including fatalities) has been reported, including patients
without known risk factors; discontinue use when suspected.
• Photosensitivity: May be associated with photosensitivity due to structural similarities with
tetracyclines.
• Pseudotumor cerebri: May be associated with pseudotumor cerebri due to structural
similarities with tetracyclines.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C.
difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2
months postantibiotic treatment.
• Treatment-related mortality: [US Boxed Warning]: In a meta analysis of Phase 3 and 4 clinical
trials, an increase in all-cause mortality has been observed in tigecycline-treated patients versus
comparator-treated patients. The cause of the mortality risk difference (0.6% [95% CI 0.1, 1.2])
has not been established. Use should be reserved for situations in which alternative treatments
are not suitable. In general, deaths were the result of worsening infection, complications of
infection, or underlying comorbidity.
Disease-related concerns:
• Hepatic impairment: Use with caution in patients with hepatic impairment; dosage adjustment
recommended in severe hepatic impairment.
• Intra-abdominal infections: Avoid use as monotherapy for patients with intestinal perforation
(in the small sample of available cases, sepsis/septic shock occurred more frequently than
patients treated with imipenem/cilastatin comparator).
Special populations:
• Pediatric: Safety and efficacy in children and adolescents <18 years of age have not been
established due to increased mortality observed in trials of adult patients. Use only if no
alternative antibiotics are available. Because of effects on tooth development (yellow-gray-
brown discoloration), use in patients <8 years of age is not recommended.
Other warnings/precautions:
• Appropriate use: Do not use for diabetic foot infections; non-inferiority was not demonstrated
in studies. Do not use for healthcare-acquired pneumonia (HAP) or ventilator-associated
pneumonia (VAP); increased mortality and decreased efficacy have been reported in HAP and
VAP trials.

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Storage Store intact vials at 20°C to 25°C; excursions are permitted between 15°C and 30°C.
Reconstituted solutions may be stored at room temperature (not to exceed 25°C) for up to 6
hours in the vial or up to 24 hours if further diluted in NS, D5W, or LR.
Alternatively, may be stored at 2°C to 8°C for up to 48 hours following immediate transfer of the
reconstituted solution into NS or D5W.
Refer to manufacturer PIL if there are specific considerations.

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22. Vancomycin
Watch Group

Generic Name Vancomycin

Dosage Powder for Solution for I.V Infusion 100mg, 500mg, 1gm, 10gm
form/strengths Hard Gelatin Capsules 250 mg
Route of Oral, IV
administration
Pharmacologic A glycopeptide antibacterial
category ATC (Oral): S01AA28
ATC (systemic): J01XA01
Indications
Clostridioides (formerly Clostridium) difficile infection (oral): in adults and pediatric patients
<18 years of age.

Endocarditis (injection):
Treatment of diphtheroid endocarditis in combination with either rifampin, an
aminoglycoside, or both in early-onset prosthetic valve endocarditis caused by diphtheroids.
Enterococcal: Treatment of endocarditis caused by enterococci (eg, Enterococcus
faecalis), in combination with an aminoglycoside.
Staphylococcal: Treatment of staphylococcal endocarditis.
Streptococcal: Treatment of endocarditis due to Streptococcus viridans or Streptococcus
bovis, as monotherapy or in combination with an aminoglycoside.

Enterocolitis (oral): Treatment of enterocolitis caused by Staphylococcus aureus (including

methicillin-resistant strains) in adults and pediatric patients <18 years of age.

Staphylococcal infections (injection): Treatment of serious or severe infections (eg,

bloodstream infections, bone infections, lower respiratory tract infections, skin and skin
structure infections) caused by susceptible strains of methicillin-resistant (beta-lactam-
resistant) staphylococci; empiric therapy of infections when methicillin-resistant staphylococci
are suspected.
Dosage Dosing: Adult
Regimen General Adult Dosage:
Oral: Ineffective for treating systemic infections:
125 to 500 mg 4 times daily.
Treatment of Life-threatening Systemic Infections
• Intermittent infusion: 15 to 20 mg/kg/dose (rounded to the nearest 250 mg) every 8 to 12
hours initially; for serious MRSA infections, adjust based on therapeutic monitoring.
Early and frequent monitoring for dosage adjustments is recommended, especially when
empiric doses exceed 4 g/day
Loading dose: Seriously ill patients with documented/suspected MRSA infection: A loading
dose of 20 to 35 mg/kg (based on actual body weight; maximum: 3 g/dose) may be
considered to rapidly achieve target concentrations. After administration of the loading
dose, initiate the maintenance dose 8 hours after the start of the loading dose).
• Continuous infusion: Note: May be considered for critically ill patients who are unable to
achieve AUC target with intermittent infusion dosing. Loading dose: 15 to 20 mg/kg,
followed by a maintenance continuous infusion dose of 30 to 40 mg/kg/day (up to 60

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mg/kg/day) to achieve a target steady state concentration of 20 to 25 mg/L

Pediatric Patients
General dosing, susceptible infection: Infants, Children, and Adolescents: IV: Initial: 45 to 60
mg/kg/day divided every 6 to 8 hours; dose and frequency should be individualized based on
serum concentrations monitoring; doses require adjustment in renal impairment.
Neonates: Manufacturer recommends 15 mg/kg initially, followed by 10 mg/kg every 12
hours in neonates <1 week of age and 10 mg/kg every 8 hours in neonates 1 week to 1 month
of age.
MRSA infection, serious; treatment:
Infants ≥3 months and Children <12 years: IV: Initial: 60 to 80 mg/kg/day in divided doses
every 6 hours; initial maximum daily dose: 3,600 mg/day.
Children ≥12 years and Adolescents: IV: Initial: 60 to 70 mg/kg/day in divided doses every 6 to
8 hours; initial maximum daily dose: 3,600 mg/day.

Dosage Dosing: Renal Impairment: Adult

adjustment Oral: There are no dosage adjustments provided in the manufacturer's labeling. However,
dosage adjustment unlikely due to low systemic absorption.
IV:
Note: Initial IV dosing in nonobese patients should be based on actual body weight;
subsequent dosing should generally be adjusted based on therapeutic monitoring
Altered kidney function:
Intermittent infusion:

Suggested loading Suggested initial Suggested

CrCl
dose (when maintenance dosing
(mL/minute)
applicable) dose interval
>90 to <130 25 to 30 mg/kg 15 to 20 mg/kg 8 to 12 hours
50 to 90 20 to 25 mg/kg 15 to 20 mg/kg 12 hours
15 to <50 20 to 25 mg/kg 10 to 15 mg/kg 24 hours

IV: Note: Vancomycin levels should be monitored in patients with any renal impairment:
Pediatric:
The following adjustments have been recommended
Note: Renally-adjusted dose recommendations are based on IV doses of 10 mg/kg/dose
every 6 hours or 15 mg/kg/dose every 8 hours.
GFR 30 to 50 mL/minute/1.73 m2: 10 mg/kg/dose every 12 hours.
GFR 10 to 29 mL/minute/1.73 m2: 10 mg/kg/dose every 18 to 24 hours.
GFR <10 mL/minute/1.73 m2: 10 mg/kg/dose; redose based on serum concentrations.
Continuous renal replacement therapy (CRRT): 10 mg/kg/dose every 12 to 24 hours; monitor
serum concentrations.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling

Contra- Hypersensitivity to vancomycin or any component of the formulation

indications
Adverse Drug Adverse Reactions (Significant): Considerations
Reactions Anaphylaxis
Clostridioides difficile infection

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Drug-induced immune thrombocytopenia
Hypersensitivity reactions (delayed)
Nephrotoxicity
Neutropenia/pancytopenia
Ototoxicity
Vancomycin infusion reaction

IV:
Frequency not defined:
Cardiovascular: Chest pain, flushing, hypotension, shock, vasculitis
Dermatologic: Bullous dermatitis, erythema of skin, exfoliative dermatitis, pruritus, Stevens-
Johnson syndrome, toxic epidermal necrolysis
Gastrointestinal: Clostridioides difficile colitis
Hematologic & oncologic: Agranulocytosis, eosinophilia, leukopenia, neutropenia (reversible),
pancytopenia, thrombocytopenia
Hypersensitivity: Anaphylaxis, hypersensitivity reaction, red man syndrome
Local: Injection site phlebitis, irritation at injection site, pain at injection site
Nervous system: Chills, dizziness, malaise, vertigo
Neuromuscular & skeletal: Myalgia
Otic: Hearing loss, ototoxicity, tinnitus
Renal: Increased blood urea nitrogen, increased serum creatinine, interstitial nephritis, renal
tubular necrosis
Respiratory: Dyspnea, wheezing
Miscellaneous: Fever
Oral:
>10%:
Endocrine & metabolic: Hypokalemia
Gastrointestinal: Abdominal pain, nausea
1% to 10%:
Cardiovascular: Peripheral edema
Gastrointestinal: Diarrhea, flatulence, vomiting
Genitourinary: Urinary tract infection
Nervous system: Fatigue, headache
Neuromuscular & skeletal: Back pain
Renal: Nephrotoxicity
Miscellaneous: Fever

Monitoring IV: Periodic renal function tests, CBC, pregnancy test prior to use for formulation containing
Parameters PEG 400 and NADA excipients, serum trough vancomycin concentrations in select patients
(eg, aggressive dosing, life-threatening infection, seriously ill, unstable renal function,
concurrent nephrotoxins, prolonged courses).
AUC monitoring: Frequency of AUC monitoring should be based on clinical judgement;
frequent or daily monitoring may be appropriate for hemodynamically unstable patients;
hemodynamically stable patients may only require once-weekly monitoring
Reference Range
IV:
Target concentrations:
• Intermittent infusion:
AUC/minimum inhibitory concentration determined by broth microdilution (MICBMD): 400
to 600, assuming MICBMD of 1 mg/L. When MICBMD is >1 mg/L, probability of attaining an

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AUC/MIC target of ≥400 is low with conventional dosing; higher doses may risk
unnecessary toxicity. When MICBMD is <1 mg/L, decreasing the dose to achieve the
AUC/MIC target is not recommended

Trough: 10 to 20 mg/L; target within this range depends on site and severity of infection,
as well as clinical response. The American Thoracic Society (ATS)/Infectious Diseases
Society of America (IDSA) guidelines for hospital-acquired pneumonia and the IDSA
meningitis guidelines also recommend trough concentrations of 15 to 20 mg/L
• Continuous infusion: Target steady-state concentration: 20 to 25 mg/L.
Concentrations associated with toxicity: Serum concentration >80 mg/L

Oral therapy: Serum sample monitoring is not typically required; systemic absorption of
enteral vancomycin may occur in patients with mucosal disruption due to colitis, especially in
patients with renal failure. Monitoring serum vancomycin levels may be considered for
patients with renal failure who have severe colitis and require a prolonged course of enteral
vancomycin
Drug Risk X: Avoid combination
Interactions BCG (Intravesical) Cholera Vaccine
Risk D: Consider therapy modification
Bile Acid Sequestrants Colistimethate Sodium Picosulfate Typhoid Vaccine

Pregnancy and IV vancomycin injection is as category C.

Lactation Vancomycin is present in breast milk following IV administration. Limited information
indicates that vancomycin produces low levels in milk and because vancomycin is poorly
absorbed orally, it is not likely to reach the bloodstream of the infant or cause any adverse
effects in breastfed infants. No special precautions are required.

Administration Administration: IV
Administer vancomycin with a final concentration not to exceed 5 mg/mL by IV intermittent
infusion over at least 60 minutes (recommended infusion period of ≥30 minutes for every 500
mg administered, in adult patients in need of fluid restriction, a concentration up to 10 mg/mL
may be used, but risk of infusion-related reactions is increased. Not for IM administration.
If a maculopapular rash appears on the face, neck, trunk, and/or upper extremities
(vancomycin infusion reaction [formerly “red man syndrome”]), slow the infusion rate to over
11/2 to 2 hours and increase the dilution volume. Hypotension, shock, and cardiac arrest (rare)
have also been reported with too rapid of infusion. Administration of antihistamines prior to
infusion may prevent or minimize this reactionIrritant; ensure proper needle or catheter
placement prior to and during infusion. Avoid extravasation.
Extravasation management: If extravasation occurs, stop infusion immediately and
disconnect (leave cannula/needle in place); gently aspirate extravasated solution
(do NOT flush the line); remove needle/cannula; elevate extremity. Information conflicts
regarding the use of dry cold or dry warm compresses; however, dry warm compresses may
be of benefit in increasing local blood flow to enhance drug removal from the extravasation
site. Intradermal hyaluronidase may be considered for refractory cases
Administration: Oral
Reconstituted powder for injection (not premixed solution) may be diluted and used for oral
administration; common flavoring syrups may be added to improve taste. The unflavored,
diluted solution may also be administered via nasogastric tube.
Preparation for Administration: Adult
IV: Reconstitute 500 mg and 1 g vials with a compatible diluent to a final concentration of 50

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mg/mL. Reconstituted solution must be further diluted with at least 100 mL of a compatible
diluent per 500 mg of vancomycin prior to parenteral administration.
Preparation for Administration: Pediatric
Parenteral: Reconstitute vials with SWFI to a final concentration of 50 mg/mL (see
manufacturer's labeling for specific details). Further dilute the reconstituted solution in a
compatible diluent (eg, D5W, NS) to a final concentration ≤5 mg/mL. In fluid restricted
patients, a concentration of 10 mg/mL may be used, but the risk of infusion reactions
increases.
Oral Solution
Using a vial of vancomycin powder for injection (reconstituted to 50 mg/mL), add the
appropriate volume for the dose to 30 mL of water and administer orally or via NG tube. For
oral administration, common flavoring syrups may be added to improve taste.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Extravasation and thrombophlebitis: If thrombophlebitis occurs, slow infusion rates, dilute
solution (eg, 2.5 to 5 g/L) and rotate infusion sites.
• Nephrotoxicity
• Neutropenia: Prolonged therapy and use of concomitant drugs that causes neutropenia
may increase the risk; monitor leukocyte counts periodically in these patients.
• Ototoxicity: It has been most frequently reported in older patients, patients receiving
excessive doses, those who have underlying hearing loss, or those receiving concomitant
ototoxic drugs (eg, aminoglycosides). Ototoxicity may be transient or permanent;
discontinue treatment if signs of ototoxicity occur.
• Superinfection: Prolonged use.
Disease-related concerns:
• Inflammatory bowel disease: in case of oral vancomycin (multiple doses) for the treatment
of C. difficile-associated diarrhea. consider monitoring serum trough concentrations,
especially with renal insufficiency, severe colitis, and concurrent enteral vancomycin
administration.
• Pregnancy: [US Boxed Warning]: The formulation of vancomycin injection containing the
excipients, polyethylene glycol (PEG 400) and N-acetyl D-alanine (NADA), is not
recommended for use during pregnancy. PEG 400 and NADA have caused fetal
malformations in animal reproduction studies. If use of vancomycin is needed during
pregnancy, use other available formulations of vancomycin.
• Renal impairment: Use with caution in patients with renal impairment or those receiving
other nephrotoxic drugs; dosage modification required and close monitoring is
recommended in patients with preexisting renal impairment and those at high risk for renal
impairment. Accumulation may occur after multiple oral doses of vancomycin in patients
with renal impairment; consider monitoring serum concentrations in this circumstance.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist.
Other warnings/precautions:
• Appropriate use: Oral vancomycin is only indicated for the treatment of CDI or
enterocolitis due to S. aureus and is not effective for systemic infections; parenteral
vancomycin is not effective for the treatment of enterocolitis.
• Infusion reactions: Rapid IV administration (eg, over <60 minutes) may result in
hypotension, flushing, erythema, urticaria, pruritus, wheezing, dyspnea, and, rarely, cardiac
arrest. Reactions usually cease promptly after infusion is stopped. Frequency of infusion
reactions may increase with concomitant administration of anesthetics. If used in
conjunction with anesthesia, complete the vancomycin infusion prior to anesthesia

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induction.

Storage Vials: Store intact vials at 20°C to 25°C.

Reconstitute vial using an appropriate diluent; recommendations may vary by product.
Capsules: Store at 20°C to 25°C; excursions permitted to 15°C to 30°C.
Refer to manufacturer PIL if there are specific considerations.

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Penicillins
1. Amoxicillin Access Group

Generic Name Amoxicillin

Dosage Powder for Oral suspension 125mg/5ml, 200mg/5ml, 250mg/5ml, 400mg/5ml

form/strengths Capsule 250mg, 500mg
Tablet 125mg, 875mg, 1g,
Extended Release Tablets: 775 mg
Powder for injection 250mg, 500mg, 1g
Oral drops 100mg/ml
Route of Oral, IV
administration
Pharmacologic Antibiotic, Penicillin
category J01CA04
Indications Ear, nose, and throat infections (pharyngitis/tonsillitis, otitis media)
Genitourinary tract infections
Helicobacter pylori eradication
Lower respiratory tract infections (including pneumonia)
Rhinosinusitis, acute bacterial:
Skin and skin structure infections.
Dosage Adult Dosing: Usual dosage range:
Regimen Oral:
Immediate release: 500 mg to 1 g every 8 to 12 hours.
Extended release: 775 mg once daily.
• Helicobacter pylori eradication: Oral:
o Different regimens containing Amoxicillin 1 g twice daily with different agents e.g
clarithromycin 500 mg twice daily, a standard-dose or double-dose proton pump
inhibitor, metronidazole or tinidazole 500 mg twice daily or levofloxacin 500 mg once
daily. regimen is for 10 to 14 days.
o High-dose dual therapy (salvage regimen): Amoxicillin 750 mg 4 times daily or 1 g 3
times daily; in combination with a standard-dose or double-dose proton pump inhibitor
3 to 4 times daily for 14 days
• Otitis media, acute (alternative agent): Oral: 500 mg every 8 hours. Some experts use 1 g
every 8 hours for patients at high risk of severe infection or resistant Streptococcus
pneumoniae. Duration is 5 to 7 days for mild to moderate infection and 10 days for severe
infection
• Pneumonia, community acquired, outpatient empiric therapy (patients without
comorbidities or risk factors for antibiotic resistant pathogens):
Oral: 1 g 3 times daily; some experts prefer use of amoxicillin in combinations. Duration is
for a minimum of 5 days.
• Rhinosinusitis, acute bacterial:
Oral: 500 mg every 8 hours or 875 mg every 12 hoursfor 5 to 7 days
• Skin and soft tissue infection:
Erysipelas, mild: Oral: 500 mg 3 times or 875 mg every 12 hours for 5 days, for up to 14 days
Erysipeloid, localized cutaneous: Oral: 500 mg 3 times daily for 5 to 10 days
• Streptococcal pharyngitis (group A):
Oral: 500 mg twice daily or 1 g once daily for 10 days.
Extended release: 775 mg once daily for 10 days.

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• Urinary tract infection:
Note: Not recommended for empiric therapy.
Oral: 500 mg every 8 hours for 4 to 7 days.

Dosing: Pediatric:
− General dosing, susceptible infection:
Mild to moderate infection:
Infants ≤3 months: Oral: 30 mg/kg/day divided into 2 doses.
Infants >3 months, Children, and Adolescents:
Oral: 20 to 40 mg/kg/day in divided doses every 8 hours (maximum dose: 500 mg/dose) or 25 to
45 mg/kg/day in divided doses every 12 hours (maximum dose: 875 mg/dose).
Severe infection (as step-down therapy): Infants, Children, and Adolescents: Oral: 80 to
90mg/kg/day in divided doses every 12 hours; maximum dose: 500 mg/dose for most indications.
Dosage Renal Impairment: Adult
adjustment Oral:
If the normal recommended dose is 250 to 500 mg every 8 hours
GFR >30 mL/minute: No dosage adjustment necessary.
GFR 10 to 30 mL/minute: 250 to 500 mg every 12 hours
GFR <10 mL/minute: 250 to 500 mg every 12 to 24 hours
Hemodialysis, intermittent: 250 to 500 mg every 12 to 24 hours
Peritoneal dialysis: 250 to 500 mg every 12 hours
If the normal recommended dose is 1 g every 8 hours
GFR >30 mL/minute: No dosage adjustment necessary.
GFR 10 to 30 mL/minute: 1 g every 12 hours
GFR <10 mL/minute: 500 mg every 12 hours
Hemodialysis, intermittent: 500 mg every 12 hours
Peritoneal dialysis: 500 mg every 12 hours

Avoid extended release 775 mg tablet and immediate release 875 mg tablet in patients with GFR
<30 mL/minute or patients requiring hemodialysis

Renal Impairment in pediatrics

The following guidelines have been used by some clinicians: Oral:
Immediate release: Infants, Children, and Adolescents:
Mild to moderate infection: Dosing based on 25 to 50 mg/kg/day divided every 8 hours:
GFR >30 mL/minute/1.73 m2: No adjustment required
GFR 10 to 29 mL/minute/1.73 m2: 8 to 20 mg/kg/dose every 12 hours
GFR <10 mL/minute/1.73 m2: 8 to 20 mg/kg/dose every 24 hours
Hemodialysis: Moderately dialyzable (20% to 50%); ~30% removed by 3-hour hemodialysis: 8
to 20 mg/kg/dose every 24 hours; give after dialysis
Peritoneal dialysis: 8 to 20 mg/kg/dose every 24 hours
Severe infection (high dose): Dosing based on 80 to 90 mg/kg/day divided every 12 hours:
GFR >30 mL/minute/1.73 m2: No adjustment required
GFR 10 to 29 mL/minute/1.73 m2: 20 mg/kg/dose every 12 hours; do not use the 875 mg
tablet
GFR <10 mL/minute/1.73 m2: 20 mg/kg/dose every 24 hours; do not use the 875 mg tablet
Hemodialysis: Moderately dialyzable (20% to 50%); ~30% removed by 3-hour hemodialysis:
20 mg/kg/dose every 24 hours; give after dialysis
Peritoneal dialysis: 20 mg/kg/dose every 24 hours
Extended release: Children ≥12 years and Adolescents: CrCl <30 mL/minute: Not recommended

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Dosing: Hepatic Impairment:
There are no dosage adjustments needed.
Contra- Serious hypersensitivity to amoxicillin or to other beta-lactams, or any component of the
indications formulation
Adverse Drug Adverse Reactions (Significant): Considerations
Reactions Antibiotic-associated (non–Clostridioides difficile) diarrhea
Clostridioides difficile diarrhea
Hypersensitivity reactions (immediate and delayed)
1% to 10%:
CNS: Headache (1%)
Gastrointestinal: Diarrhea (2%), nausea (1%), vomiting (1%)
Genitourinary: Vulvovaginal infection (2%)
Monitoring Obtain CBC with differential, renal function tests, and liver function tests periodically with
Parameters prolonged therapy. Screen patients for history of renal impairment, liver impairment, or active
mononucleosis. Assess for signs of anaphylaxis during first dose. Assess for signs and symptoms of
opportunistic infections
Drug Risk X: Avoid combination:
Interactions BCG (Intravesical), Cholera Vaccine
Risk D: Consider therapy modification:
Typhoid Vaccine, Sodium Picosulfate
Risk C: Monitor therapy:
Acemetacin, Allopurinol, Aminoglycosides, BCG Vaccine (Immunization), Dichlorphenamide.
Lactobacillus and Estriol. Methotrexate, Mycophenolate, Probenecid, Tetracyclines, warfarin

May interfere with urinary glucose tests

Pregnancy Pregnancy Risk Factor B
Amoxicillin is present in breast milk. In general, antibiotics that are present in breast milk may
cause non-dose-related modification of bowel flora. Monitor infants for GI disturbances, such as
thrush or diarrhea.
Administration Oral:
Immediate release: May be administered on an empty or full stomach; may be mixed with
formula, milk, cold drink, or juice; administer dose immediately after mixing; shake
suspension well before use
Extended release: Administer within 1 hour of finishing a meal; do not chew or crush tablet.
N.B. Hypersensitivity test must be done before using injection form of this medicine.
Refer to manufacturer PIL if there are specific considerations.
Warnings/Preca • Anaphylactic/hypersensitivity reactions: Serious and occasionally severe or fatal.
utions • Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C.
difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed
>2 months postantibiotic treatment.
Disease-related concerns:
• Infectious mononucleosis: A high percentage of patients with infectious mononucleosis
develop an erythematous rash during amoxicillin therapy; avoid use in these patients.
Geriatric Considerations
Resistance to amoxicillin has been a problem in patients on frequent antibiotics or in nursing
homes. Alternative antibiotics may be necessary in these populations. Adjust dose based on
renal function.
- May be administered on an empty or full stomach;

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Storage Store at room temperature.
Reconstituted oral suspension remains stable for 14 days at room temperature or refrigerated
(refrigeration preferred).
Refer to manufacturer PIL if there are specific considerations.

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2. Amoxicillin and Clavulanic acid
Access Group

Generic Name Amoxicillin and Clavulanate

Dosage Tablet (film coated, dispersible or chewable): 125/31.25 mg, 200/28.5 mg, 250/62.5 mg,
form/strengths 250/125mg, 500/125 mg, 652.78/50.4 mg, 875/125 mg, 875/148.9 mg
Powder for Oral Suspension: 50/12.5 mg, 125/31.25 mg, 200/28.5 mg, 200/30 mg, 250/62.5
mg, 400/57 mg, 400/60 mg, 600/42.9 mg, 1000/125 mg
Powder for injection: 500/100 mg, 1000/200 mg
Route of Oral, IV
administration
Pharmacologic Antibiotic, Penicillin
category ATC: J01CR02
Indications Oral:
Otitis media, acute
Pneumonia
Rhinosinusitis, acute bacterial
Skin and skin structure infections.
Urinary tract infections

IV:
Treatment of severe upper respiratory infections, chronic bronchitis (acute exacerbation),
CAP, cystitis, pyelonephritis, skin and soft tissue infections, osteomyelitis, intra-abdominal
infections, and female genital infections caused by susceptible organisms in adults and
pediatric patients; surgical prophylaxis in procedures involving the GI tract, pelvic cavity, head
and neck, or biliary tract in adults.
Dosage Adult:
Regimen Usual dosing range:
Oral:
Immediate release: 500 mg every 8 to 12 hours or 875 mg every 12 hours;
IV: 1 g every 8 hours or 2 g every 8 to 12 hours
Duration: 5 to 7 days for mild to moderate infection and 10 days for severe infection
• Otitis media(acute); community acquired (mild); Community acquired (outpatient with
comorbidities, as part of an appropriate combination regimen): Oral:
Immediate release: 875 mg twice daily or 500 mg every 8 hours.
• Rhinosinusitis, acute bacterial: Oral
Standard dose: Immediate release: 500 mg every 8 hours or 875 mg every 12 hours for 5
to 7 days
• Urinary tract infection (UTI) (alternative agent)
o acute simple cystitis:
Oral: Immediate release: 500 mg twice daily
o Complicated UTI (including pyelonephritis):
Oral: 875 mg twice daily for 10 to 14 days
Note: Oral therapy should follow appropriate parenteral therapy.
Pediatric
• Children weighing <40 kg should not receive film-coated tablets containing 250 mg of
amoxicillin since this preparation contains a high dose of clavulanic acid.
• The oral suspension containing 125 mg of amoxicillin/5 mL is the only preparation
recommended for use in neonates and infants <12 weeks (3 months) of age.

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Frequency of dosing generally based on ratio of amoxicillin to clavulanate:
• 2:1 formulation is dosed 3 times daily amoxicillin/clavulanate (250 mg/ 125 mg): should
only be used in patients ≥40 kg, due to the amoxicillin to clavulanate ratio.

• 4:1 formulation is dosed 3 times daily amoxicillin/clavulanate (125 mg/ 31.25 mg; 250
mg/ 62.5 mg; 500 mg/ 125 mg).

• 7:1 formulation is dosed 2 times daily amoxicillin/clavulanate (200 mg/ 28.5 mg; 400
mg/ 57 mg; 875 mg/ 125 mg).

• 14:1 formulation is dosed 2 times daily amoxicillin/clavulanate (600 mg/ 42.9 mg).

General dosing, susceptible infection:

Note: Dosing determined by formulations amoxicillin/clavulanate ratio:
Infants, Children, and Adolescents: Oral:

4:1 formulation: 20 to 40 mg amoxicillin/kg/day in divided doses 3 times daily; maximum

daily dose: 1,500 mg/day.

7:1 formulation: 25 to 45 mg amoxicillin/kg/day in divided doses twice daily; maximum

daily dose: 1,750 mg/day.

14:1 formulation: 90 mg amoxicillin/kg/day in divided doses twice daily; maximum daily

dose: 4,000 mg/day.

IV dosing:
5:1 formulation:
Infants <3 months or weighing <4 kg: IV: 25 mg amoxicillin/kg/dose every 12 hours.
Infants ≥3 months weighing ≥4 kg, Children, and Adolescents: IV: 25 mg
amoxicillin/kg/dose every 8 hours; maximum dose: 1,000 mg amoxicillin/dose.

Dosage Dosing: Renal Impairment: Adult

adjustment Oral: Note: Renally adjusted dose recommendations are based on the amoxicillin 250
mg/clavulanate 125 mg and amoxicillin 500 mg/clavulanate 125 mg tablets. Avoid IR 875 mg
tablet.
CrCl ≥30 mL/minute: No dosage adjustment necessary.
CrCl 10 to <30 mL/minute: 250 to 500 mg every 12 hours.
CrCl <10 mL/minute; Hemodialysis, intermittent (thrice weekly):
250 to 500 mg every 12 to 24 hours
Peritoneal dialysis: 250 to 500 mg every 12 hours

IV: Note: Dose based on amoxicillin component.

CrCl ≥30 mL/minute: No dosage adjustment necessary.
CrCl 10 to 30 mL/minute: Initial: 1 g followed by 500 mg every 12 hours.
CrCl <10 mL/minute; Hemodialysis, intermittent (thrice weekly):
Initial: 1 g followed by 500 mg every 12 to 24 hours (expert opinion).
Peritoneal dialysis: Initial: 1 g followed by 500 mg every 12 hours

Dosing: Renal Impairment: Pediatric

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Oral:
o Mild to moderate infection: Dosing based on
20 to 40 mg amoxicillin/kg/day divided every 8 hours
or 25 to 45 mg amoxicillin/kg/day divided every 12 hours:
GFR >30 mL/minute/1.73 m2: No adjustment required.
GFR 10-29 mL/minute/1.73 m2: 8- 20 mg amoxicillin/kg/dose every 12 hours.
GFR <10 mL/minute/1.73 m2: 8-20 mg amoxicillin/kg/dose every 24 hours.
Hemodialysis: 8-20 mg amoxicillin/kg/dose every 24 hours; given after dialysis.
Peritoneal dialysis: 8-20 mg amoxicillin/kg/dose every 24 hours.
o Severe infection (high dose): do not use the 875 mg tablet. Dosing based on 80 to
90 mg amoxicillin/kg/day divided every 12 hours:
CrCl >30 mL/minute/1.73 m2: No adjustment required.
CrCl 10-29 mL/minute/1.73 m2: 20 mg amoxicillin/kg/dose every 12 hours.
CrCl <10 mL/minute/1.73 m2: 20 mg amoxicillin/kg/dose every 24 hours.
Hemodialysis: 20 mg amoxicillin/kg/dose every 24 hours; give after dialysis.
Peritoneal dialysis: 20 mg amoxicillin/kg/dose every 24 hours; do not use the 875 mg tablet.
IV:
5:1 formulation: preferred formulation in case of kidney impairment.
o Infants, Children, and Adolescents weighing <40 kg:
CrCl >30 mL/minute: No dosage adjustment necessary.
CrCl 10 to 30 mL/minute: 25 mg amoxicillin/kg every 12 hours.
CrCl <10 mL/minute: 25 mg amoxicillin/kg every 24 hours.
Hemodialysis: 25 mg amoxicillin/kg every 24 hours; give an additional dose of 12.5 mg
amoxicillin/kg at the end of each dialysis session.
o Children and Adolescents weighing ≥40 kg:
CrCl >30 mL/minute: No dosage adjustment necessary.
CrCl 10 to 30 mL/minute: 1,000 mg amoxicillin followed by 500 mg amoxicillin every 12 hours.
CrCl <10 mL/minute: 1,000 mg amoxicillin followed by 500 mg amoxicillin every 24 hours.
Hemodialysis: 1,000 mg amoxicillin followed by 500 mg amoxicillin every 24 hours; give an
additional 500 mg at the end of each dialysis session.
Dosing: Hepatic Impairment: Adult, pediatric
There are no dosage adjustments available. Use caution and monitor liver function during
therapy.
Contra- Hypersensitivity to amoxicillin, clavulanic acid, other beta-lactam antibacterial drugs (eg,
indications penicillins, cephalosporins), or any component of the formulation; history of cholestatic
jaundice or hepatic dysfunction with amoxicillin/clavulanate potassium therapy.

Adverse Drug >10%: Gastrointestinal: Diarrhea (3% to 34%; incidence varies upon dose and regimen used)
Reactions 1% to 10%:
Dermatologic: Diaper rash, skin rash, urticaria
Gastrointestinal: Abdominal distress, loose stools, nausea, vomiting
Genitourinary: Vaginitis
Infection: Candidiasis, vaginal mycosis

Monitoring Assess patient at beginning and throughout therapy for infection; with prolonged therapy,
Parameters monitor renal, hepatic, and hematologic function periodically; in patients with hepatic
impairment, monitor liver function tests at regular intervals; monitor for signs of anaphylaxis
during first dose
Drug Risk X: Avoid combination:
Interactions BCG (Intravesical), Cholera Vaccine,

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Risk D: Consider therapy modification:
Tolvaptan, Typhoid Vaccine, Sodium Picosulfate:
Risk C: Monitor therapy:
Allopurinol, Acemetacin, Aminoglycosides, BCG Vaccine (Immunization),
Dichlorphenamide, Lactobacillus and Estriol, Methotrexate, Mycophenolate, Probenecid,
Teriflunomide, Tetracyclines, Vitamin K Antagonists

Pregnancy and Pregnancy Risk Factor B

Lactation Amoxicillin is present in breast milk following administration amoxicillin/clavulanate.
amoxicillin/clavulanate is considered compatible with caution during breastfeeding when
used in usual recommended doses. Monitor infants for GI disturbances, such as thrush and
diarrhea
Administration Administration: IV
Administer by slow IV injection over 3 to 4 minutes (1 g dose only) or as an infusion over
30 to 40 minutes.
Administration: Oral
Administer around-the-clock to promote less variation in peak and trough serum levels.
Administer with food to increase absorption and decrease stomach upset; shake
suspension well before use.
Administration: Pediatric
Oral: Can be given without regard to meals. Administer at the start of a meal to
decrease the frequency or severity of GI side effects; may mix with milk, formula, or
juice; shake suspension well before use.
IV: Administer as an infusion over 30 to 40 minutes. In infants ≥3 months, children, and
adolescents, 5:1 formulation (500/100 mg and 1,000/200 mg) may also be administered
by slow IV injection over 3 to 4 minutes.

Preparation for Administration:

• Oral: Reconstitute powder for oral suspension with appropriate amount of water as
specified. Shake vigorously until suspended.
• IV:
500 mg vial: Reconstitute with 10 mL of SWFI; within 15 minutes, further dilute to 50 mL
in a compatible solution (eg, SWFI, NS).
1 g or 2 g vial: Reconstitute with 20 mL SWFI; within 15 minutes, further dilute in a
compatible solution (eg, SWFI, NS) to a final concentration of 10 to 20 mg amoxicillin/mL
(ie, 1,000 to 2,000 mg in 100 mL for larger patients).
N.B. Hypersensitivity test must be done before using injection form of this medicine.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Anaphylactic/hypersensitivity reactions: Serious and occasionally severe or fatal
hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin
therapy, especially with a history of beta-lactam hypersensitivity, or history of sensitivity
to multiple allergens.
• Diarrhea: Incidence of diarrhea is higher than with amoxicillin alone.
• Hepatic effects: Although rarely fatal, hepatic dysfunction (eg, cholestatic jaundice,
hepatitis) has been reported. Patients at highest risk include those with serious
underlying disease or concomitant medications. Hepatic toxicity is usually reversible.
Monitor LFTs at regular intervals in patients with hepatic impairment.
• Prolonged therapy: Monitor renal, hepatic, and hematopoietic function if therapy
extends beyond approved duration times.

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• Superinfection: Prolonged use may result in fungal or bacterial superinfection,
including Clostridioides (formerly Clostridium) difficile-associated diarrhea (CDAD) and
pseudomembranous colitis; CDAD has been observed >2 months postantibiotic
treatment.
Disease-related concerns:
• Hepatic impairment: Use with caution in patients with hepatic impairment and
monitor LFTs at regular intervals.
• Infectious mononucleosis: A high percentage of patients with infectious
mononucleosis have developed rash during therapy; ampicillin-class antibiotics not
recommended in these patients.
• Renal impairment: Dosage adjustment recommended in patients with CrCl ≤30
mL/minute.

Storage • Powder for oral suspension: Store dry powder at or below 25°C. Reconstituted oral
suspension should be kept in refrigerator. Discard unused suspension after 10 days
(consult manufacturer's labeling). Unit-dose antibiotic oral syringes are stable under
refrigeration for 24 hours.
• Tablet: Store at or below 25°C. Dispense in original container.
• IV: Store intact vials at 15°C to 30°C. Solutions diluted for infusion should be used
within 1 hour if stored at 25°C or within 4 hours if stored at 4°C; recommendations
may vary based on solution used for dilution, refer to manufacturer’s PIL for detailed
information.
• Refer to manufacturer PIL if there are specific considerations.

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Access Group
3. Ampicillin
Generic Name Ampicillin

Dosage Capsules: 250mg, 500mg

form/strengths Oral suspension: 125mg/5ml, 250mg/5ml
Vial: 250 mg, 500 mg, 1g
Route of Oral, IV, IM
administration
Pharmacologic Antibiotic, Penicillin
category ATC: J01CA01
Indications Oral:
GI tract infections: Treatment of GI tract infections. Note: Ampicillin is not recommended by
CDC as a first-line agent for shigellosis, salmonellosis (nontyphoid), or Salmonella
enterica species (typhoid fever) due to development of resistance.
GU tract infections: Treatment of GU tract infections. Note: Ampicillin is not recommended
by the CDC as a first-line agent in the treatment of gonorrhea.
Respiratory tract infections: Treatment of respiratory tract infections.
Injection:
Bloodstream infection
Endocarditis, treatment: caused by susceptible gram-positive organisms
GI infections: Treatment of GI infections. Note: Ampicillin is not recommended as a first-line
agent for shigellosis, salmonellosis (nontyphoid), or S. enterica species (typhoid fever) due to
development of resistance.
Meningitis, bacterial
Respiratory tract infections
Urinary tract infections.
Dosage Adult Dosing
Regimen • Endocarditis:
12 g daily (by continuous IV infusion or in 6 equally divided IV doses) in conjunction with IM or
IV gentamicin (1 mg/kg every 8 hours). Treatment with both drugs generally should be
continued for 4–6 weeks

• Meningitis and Other CNS Infections

IV, then IM
150–200 mg/kg daily in divided doses every 3–4 hours. Use IV initially, may switch to IM after 3
days.
• Respiratory Tract Infections
Oral
250 mg 4 times daily.
IV or IM
Adults weighing <40 kg: 25–50 mg/kg daily in divided doses every 6–8 hours.
Adults weighing ≥40 kg: 250–500 mg every 6 hours.
• Septicemia
IV or IM
150–200 mg/kg daily
• Urinary Tract Infections (UTIs)
Oral
500 mg 4 times daily.1

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IV or IM
Adults weighing <40 kg: 50 mg/kg daily in divided doses every 6–8 hours.2
Adults weighing ≥40 kg: 500 mg every 6 hours

Dosing: Pediatric
General dosing, susceptible infection: Infants, Children, and Adolescents:
Mild to moderate infection:
Oral: 50 to 100 mg/kg/day divided every 6 hours; maximum daily dose: 2,000 mg/day.
IM, IV: 50 to 200 mg/kg/day divided every 6 hours; maximum daily dose: 8 g/day.
Severe infection (eg, meningitis, endocarditis): IM, IV: 300 to 400 mg/kg/day divided every 4 to
6 hours; maximum daily dose: 12 g/day.

Dosage Dosing: Renal Impairment, Adult: IV:

adjustment Note: The following recommendations are based primarily on expert opinion.
Ampicillin Dose Adjustments in Altered Kidney Function
If usual recommended
If usual recommended
CrCl (mL/minute) dose is 1 to 2 g every 6
dose is 2 g every 4 hours
hours
50 to <130 1 to 2 g every 6 hours 2 g every 4 hours
30 to <50 1 to 2 g every 8 hours 2 g every 6 hours
15 to <30 1 to 2 g every 12 hours 2 g every 8 hours
<15 1 to 2 g every 24 hours 2 g every 12 hours
Hemodialysis,
intermittent 1 to 2 g every 24 hours 2 g every 12 hours
c
(thrice weekly)
Peritoneal
1 to 2 g every 24 hours 2 g every 12 hours
dialysis

Dosing: Renal Impairment: Pediatric

Infants, Children, and Adolescents: The following adjustments have been recommended.
Note: Renally adjusted dose recommendations are based on IM, IV doses of 100 to 200
mg/kg/day divided every 6 hours: IM, IV:
GFR 30 to 50 mL/minute/1.73 m2: 35 to 50 mg/kg/dose every 6 hours
GFR 10 to 29 mL/minute/1.73 m2: 35 to 50 mg/kg/dose every 8 to 12 hours
GFR <10 mL/minute/1.73 m2: 35 to 50 mg/kg/dose every 12 hours
Intermittent hemodialysis: 35 to 50 mg/kg/dose every 12 hours
Peritoneal dialysis (PD): 35 to 50 mg/kg/dose every 12 hours
Continuous renal replacement therapy (CRRT): 35 to 50 mg/kg/dose every 6 hours
Dosing: Hepatic Impairment:
There are no dosage adjustments needed

Contra- Hypersensitivity (eg, anaphylaxis) to ampicillin, any component of the formulation, or other
indications penicillins; infections caused by penicillinase-producing organisms

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Adverse Drug Frequency not defined.
Reactions Central nervous system: Brain disease (penicillin-induced), glossalgia, seizure, sore mouth
Dermatologic: Erythema multiforme, exfoliative dermatitis, skin rash, urticaria
Note: Appearance of a rash should be carefully evaluated to differentiate (if possible)
nonallergic ampicillin rash from hypersensitivity reaction. Incidence is higher in patients with
viral infection, Salmonella infection, lymphocytic leukemia, or patients that have hyperuricemia.
Gastrointestinal: Diarrhea, enterocolitis, glossitis, melanoglossia, nausea, oral candidiasis,
pseudomembranous colitis, stomatitis, vomiting
Hematologic & oncologic: Agranulocytosis, anemia, eosinophilia, hemolytic anemia, immune
thrombocytopenia, leukopenia
Hepatic: Increased serum AST
Hypersensitivity: Anaphylaxis
Immunologic: Serum sickness-like reaction
Renal: Interstitial nephritis (rare)
Respiratory: Stridor
Miscellaneous: Fever
Monitoring With prolonged therapy, monitor renal, hepatic, and hematologic function periodically; observe
Parameters signs and symptoms of anaphylaxis during first dose
Drug Risk X: Avoid combination:
Interactions BCG (Intravesical), Cholera Vaccine
Risk D: Consider therapy modification:
Chloroquine, Sodium Picosulfate, Typhoid Vaccine,
Risk C: Monitor therapy:
Allopurinol, Aminoglycosides, Atenolol, BCG Vaccine (Immunization), Dichlorphenamide,
Lactobacillus and Estriol, Methotrexate, Mycophenolate, Probenecid, Tetracyclines, Vitamin
K Antagonists (eg, warfarin)
Pregnancy and Pregnancy Risk Factor B
lacatation Ampicillin is considered compatible with breastfeeding when used in usual recommended doses.
Monitor infants for GI disturbances, such as thrush or diarrhea.
Administration Administration: Oral
Administer around-the-clock to promote less variation in peak and trough serum levels.
Administer on an empty stomach with a full glass of water (ie, 30 minutes prior to or 2 hours
after meals) to increase total absorption.
Administration: IM
Inject deep IM into a large muscle mass
Administration: IV
Direct IV bolus: Administer over 3 to 5 minutes (125 to 500 mg) or over 10 to 15 minutes (1 to
2 g). More rapid infusion may cause seizures.
Infusion: Rapid infusion may cause seizures. Adjust rate of infusion so that the total dose is
administered before admixture stability expires.
Preparation for Administration:
IM: Dissolve contents of vial in sterile water for injection or bacteriostatic water for injection;
final concentration for IM injection is 125 mg/mL or 250 mg/mL. Solutions for IM injection
should be freshly prepared and used within 1 hour.
IV:
Direct IV use: Dissolve contents of 125 mg, 250 mg, or 500 mg vial in 5 mL SWFI or
bacteriostatic water for injection. Alternatively, dissolve contents of 1 g or 2 g vial in 7.4 or
14.8 mL SWFI or bacteriostatic water for injection, respectively.
Intermittent infusion: Minimum volume: Concentration should not exceed 30 mg/mL due to
concentration-dependent stability restrictions. Usual diluent: 500 mg/50 mL NS; 1 g/50 mL NS;
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2 g/100 mL NS.
N.B. Hypersensitivity test must be done before using injection form of this medicine.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Hypersensitivity/anaphylactoid reactions: Serious and occasionally severe or fatal
hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin therapy,
especially with a history of beta-lactam hypersensitivity or a history of sensitivity to multiple
allergens. Serious anaphylactoid reactions require emergency treatment and airway
management. Appropriate treatments must be readily available.
• Rash: Appearance of a rash should be carefully evaluated to differentiate a nonallergic
ampicillin rash from a hypersensitivity reaction; rash occurs in 5% to 10% of children and is a
generalized dull red, maculopapular rash, generally appearing 3 to 14 days after the start of
therapy. It normally begins on the trunk and spreads over most of the body. It may be most
intense at pressure areas, elbows, and knees.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection,
including Clostridioides (formerly Clostridium) difficile-associated diarrhea (CDAD) and
pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment
Geriatric Considerations
Resistance to ampicillin has been a problem in patients on frequent antibiotics or in nursing
homes. Alternative antibiotics may be necessary in these populations. Adjust dose for renal
function.
Warnings: Additional Pediatric Considerations
Ampicillin has been shown to prolong the bleeding time in neonates in 2 prospective studies
Storage • Capsules: Store at 20°C to 25°C.
• Oral suspension: Store dry powder at 20°C to 25°C. Once reconstituted, oral suspension is
stable for 14 days under refrigeration.
• Vials: Store intact vials at 20°C to 25°C.
• Solutions for IM or direct IV should be used within 1 hour.
• Stability of parenteral admixture in NS at 25°C is 8 hours (concentrations up to 30
mg/mL) and at 4°C is 24 hours (concentration of 30 mg/mL) or 48 hours (concentrations
up to 20 mg/mL). Protect from freezing.
• Refer to manufacturer PIL if there are specific considerations.

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4. Ampicillin and sulbactam Access Group
Generic Name Ampicillin and Sulbactam

Dosage Powder for Injection: 2000/1000mg, 1000/500mg, 500/250mg, 250/125 mg

form/strengths
Route of IM, IV
administration
Pharmacologic Antibiotic, Penicillin
category ATC: J01CR01
Indications Treatment of skin and skin structure, intra-abdominal, and gynecological infections caused by
susceptible bacteria; spectrum is that of ampicillin plus organisms producing beta-lactamases
such as Staphylococcus aureus, Haemophilus influenzae, Escherichia
coli, Klebsiella, Acinetobacter, Enterobacter, and anaerobes.
Dosage Dosing: Adult
Regimen Note: Adult dosage recommendations are expressed as total grams of ampicillin/sulbactam.
Usual dosage range: IM, IV: 1.5 to 3 g every 6 hours (maximum: ampicillin/sulbactam 12 g daily);
for the treatment of infections caused by Acinetobacter spp., higher doses have been described.

Dosing: Pediatric
General dosing, susceptible infection: Infants, Children, and Adolescents:
Mild to moderate infection:
IV: 100 to 200 mg ampicillin/kg/day divided every 6 hours; maximum dose: 2,000 mg
ampicillin/dose. may also be administered IM
Severe infection (eg, meningitis, resistant Streptococcus pneumonia):
IV: 200 to 400 mg ampicillin/kg/day divided every 6 hours; maximum dose: 2,000 mg
ampicillin/dose; may also be administered IM
Surgical prophylaxis: Children and Adolescents: IV: 50 mg ampicillin/kg/dose within 60 minutes
prior to procedure; may repeat in 2 hours if lengthy procedure or excessive blood loss; maximum
dose: 2,000 mg ampicillin/dose

Dosage Dosing: Renal Impairment: Adult

adjustment Note: Renally adjusted dose recommendations are based on a usual recommended dose of 1.5 to
3 g every 6 hours.
Altered kidney function: IV:
CrCl ≥30 mL/minute: No dosage adjustment necessary.
CrCl 15 to 29 mL/minute: 1.5 to 3 g every 12 hours.
CrCl 5 to 14 mL/minute: 1.5 to 3 g every 24 hours.
Hemodialysis, intermittent (thrice weekly): Dialyzable (39% to 63%):
IV: 1.5 to 3 g every 12 to 24 hours; administer after dialysis when scheduled dose falls on dialysis
days.
Peritoneal dialysis: IV: 1.5 g every 12 hours or 3 g every 24 hours.
CRRT: Drug clearance is dependent on the effluent flow rate, filter type, and method of renal
replacement.
CVVH/CVVHD/CVVHDF: IV: 3 g every 8 to 12 hours.
PIRRT (eg, sustained, low-efficiency diafiltration): Drug clearance is dependent on the effluent
flow rate, filter type, and method of renal replacement. Appropriate dosing requires
consideration of adequate drug concentrations (eg, site of infection) and consideration of initial
loading doses. Close monitoring of response and adverse reactions (eg, neurotoxicity) due to drug
accumulation is important.

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IV: Initial: 3 g followed by 1.5 to 3 g every 8 to 12 hours. Where possible, give one dose after
PIRRT session.

Dosing: Renal Impairment: Pediatric

Children and Adolescents: IV:
CrCl ≥30 mL/minute/1.73 m2: No dosage adjustment required.
CrCl 15 to 29 mL/minute/1.73 m2: Administer every 12 hours.
CrCl 5 to 14 mL/minute/1.73 m2: Administer every 24 hours.
Dosing: Hepatic Impairment: Pediatric
There are no dosage adjustments needed
Contra- Hypersensitivity (eg, anaphylaxis or Stevens-Johnson syndrome) to ampicillin, sulbactam, or to
indications other beta-lactam antibacterial drugs (eg, penicillins, cephalosporins), or any component of the
formulations; history of cholestatic jaundice or hepatic dysfunction associated with
ampicillin/sulbactam
Adverse Drug >10%: Local: Pain at injection site (IM; 16%)
Reactions 1% to 10%:
Cardiovascular: Thrombophlebitis (3%), phlebitis (1%)
Dermatologic: Skin rash (<2%)
Gastrointestinal: Diarrhea (3%)
Local: Pain at injection site (IV; 3%)

Monitoring With prolonged therapy, monitor hematologic, renal, and hepatic function; monitor for signs of
Parameters anaphylaxis during first dose. In patients with preexisting hepatic impairment, monitor hepatic
function at regular intervals
Drug Risk X: Avoid combination
Interactions BCG (Intravesical), Cholera Vaccine
Risk D: Consider therapy modification
Chloroquine, Sodium Picosulfate, Typhoid Vaccine,
Risk C: Monitor therapy:
Acemetacin, Allopurinol, Aminoglycosides, Atenolol, BCG Vaccine (Immunization),
Dichlorphenamide, Lactobacillus and Estriol, Methotrexate, Mycophenolate, Probenecid,
Tetracyclines, Vitamin K Antagonists (eg, warfarin)
Pregnancy and Pregnancy category B
Lactation Ampicillin and sulbactam are present in breast milk. Ampicillin is considered compatible with
breastfeeding when used in usual recommended doses. In general, antibiotics that are present in
breast milk may cause nondose-related modification of bowel flora. Monitor infants for GI
disturbances
Administration Administration:
Parenteral:
IM: Administer by deep IM injection. Administer within 1 hour of preparation.
IV: Administered by slow IV injection over 10 to 15 minutes or by intermittent IV infusion over
15 to 30 minutes
Ampicillin and gentamicin should not be mixed in the same IV tubing.
Concurrent Y-site administration with aminoglycosides should be avoided (penicillins have
been shown to inactivate aminoglycosides in vitro, while amikacin has shown greater stability
against inactivation)

Preparation for Administration: Adult

Direct IV administration and IV infusion: Reconstitute with sterile water for injection (SWFI).

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Sodium chloride 0.9% (NS) is the diluent of choice for IV infusion use.
IM administration: Reconstitute with SWFI or 0.5% or 2% lidocaine hydrochloride injection.
Preparation for Administration: Pediatric
IV: Use within several hours after preparation. Reconstitute with SWFI. Further dilute with a
compatible solution; sodium chloride 0.9% (NS) is the diluent of choice; final concentration
should not exceed (30 mg/mL of ampicillin and 15 mg/mL of sulbactam)
IM: Reconstitute with SWFI or lidocaine (0.5% or 2%) to a final concentration of 375 mg/mL (ie,
250 mg/mL of ampicillin and 125 mg/mL of sulbactam). Administer within 1 hour of
preparation.
N.B. Hypersensitivity test must be done before using injection form of this medicine.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions Anaphylactoid/hypersensitivity reactions: Serious and occasionally severe or fatal
hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin
therapy, especially with a history of beta-lactam hypersensitivity or a history of sensitivity to
multiple allergens. If an allergic reaction occurs, discontinue and institute appropriate
therapy.

• Hepatic dysfunction: Hepatitis and cholestatic jaundice have been reported (including
fatalities). Toxicity is usually reversible. Monitor hepatic function at regular intervals in
patients with hepatic impairment.

• Rash: Appearance of a rash should be carefully evaluated to differentiate a nonallergic

ampicillin rash from a hypersensitivity reaction; rash occurs in 5% to 10% of children and is a
generalized dull red, maculopapular rash, generally appearing 3-14 days after the start of
therapy. It normally begins on the trunk and spreads over most of the body. It may be most
intense at pressure areas, elbows, and knees.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C.

difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been
observed >2 months postantibiotic treatment.
Storage • Prior to reconstitution, store at 20°C to 25°C.
• IM: Concentration of 375 mg/mL (250 mg ampicillin/125 mg sulbactam) should be used
within 1 hour after reconstitution.
• Intermittent IV infusion: Refer to manufacturer's labeling for specific storage instructions
after reconstitution and dilution (varies by concentration and diluent)
• Refer to manufacturer PIL if there are specific considerations.

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5. Benzylpenicillin [Penicillin G] Access Group

Generic Name Benzylpenicillin [Penicillin G]

Dosage Vial 1 M.I.U

form/strengths
Route of IV, IM
administration
Pharmacologic Antibiotic, Penicillin
category ATC: J01CE01
Indications Anthrax: Treatment of anthrax caused by Bacillus anthracis.
Actinomycosis, severe or extensive: Treatment of actinomycosis (cervicofacial disease and
thoracic and abdominal disease) caused by Actinomyces israelii.
Bloodstream infection: Treatment of bloodstream infection caused
by Streptococcus spp., Listeria monocytogenes, Neisseria meningitidis, and Pasteurella
multocida.
Botulism, wound: Treatment of botulism caused by Clostridium spp. as an adjunctive agent
following antitoxin administration.
Diphtheria: Treatment of diphtheria caused by Corynebacterium diphtheriae as an adjunctive
agent following antitoxin administration.
Endocarditis, treatment: Treatment of endocarditis caused by Streptococcus spp.
and Erysipelothrix rhusiopathiae.
Meningitis, bacterial: Treatment of meningitis caused by L. monocytogenes, N. meningitidis, P.
multocida, and Streptococcus spp.
Neurosyphilis (including ocular and otosyphilis): Treatment of syphilis (congenital and
neurosyphilis) caused by Treponema pallidum.
Odontogenic infection: Treatment of pyogenic odontogenic infection, including severe
infections of the oropharynx, caused by Fusobacterium spp. and spirochetes.
Rat bite fever: Treatment of rat bite fever (including Haverhill fever) caused by Spirillum
minus or Streptobacillus moniliformis.
Tetanus: Treatment of tetanus caused by Clostridium tetani as an adjunctive agent following
tetanus immune globulin and vaccine administration.
Toxic shock syndrome: Treatment of toxic shock syndrome caused by Streptococcus spp
Dosage Dosing: Adult
Regimen Note: For ease of outpatient administration, the total daily dose may be administered as a 24-
hour continuous infusion

Actinomycosis, severe or extensive: IV: 10 to 20 million units/day as a continuous infusion or

in divided doses every 4 to 6 hours for 4 to 6 weeks followed by appropriate long-term oral
therapy.
Bloodstream infection:
− Pathogen-directed therapy for Listeria monocytogenes: IV: 24 million units/day in divided
doses every 4 hours; use in combination with gentamicin for nonpregnant patients.
Duration should be individualized usually continued for at least 2 weeks;
− Pathogen directed therapy for beta-hemolytic streptococci: IV: 18 to 24 million units/day
in divided doses every 4 hours. Duration of therapy is generally 14 days; some experts
suggest a shorter course (eg, 10 days) for patients with rapid clearance of bacteremia
and clinical improvement.

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− Pathogen-directed therapy for group D streptococci (Streptococcus bovis/Streptococcus
equinus complex) (alternative agent): IV: 12 to 24 million units/day in divided doses
every 4 hours. Duration of therapy is 14 days.
Botulism, wound (adjunctive agent following antitoxin administration): IV: 18 to 20 million
units/day in divided doses every 4 to 6 hours in combination with wound debridement;
duration depends on extent of the wound.
Diphtheria (adjunctive agent following antitoxin administration) (alternative agent): IV: 2 to
3 million units/day in divided doses every 4 to 6 hours for 10 to 12 days
Endocarditis, treatment:
12–24 million units daily in divided doses every 4 hours for 4-6 weeks. In case of relatively
resistant strains, taken in conjunction with gentamicin (3–6 mg/kg daily IV in divided doses
every 8 hours given concomitantly during first 2 weeks of penicillin G treatment)
Meningitis, bacterial:
Pathogen-directed therapy for Cutibacterium acnes, L. monocytogenes, Neisseria meningitidis
(with MIC <0.1 mcg/mL), Streptococcus agalactiae, or Streptococcus pneumoniae (with MIC
≤0.06 mcg/mL): IV: 4 million units every 4 hours. For treatment of L. monocytogenes, use as
part of an appropriate combination regimen. Treatment duration is 7 to 21 days, depending
on causative pathogen(s) and clinical response.
Neurosyphilis (including ocular and otosyphilis): Note: Penicillin desensitization and
treatment is recommended in patients with a history of severe penicillin allergy.
IV: 18 to 24 million units/day as a continuous infusion or in divided doses every 4 hours for 10
to 14 days.
Odontogenic infection, pyogenic (alternative agent): IV: 2 to 4 million units every 4 to 6 hours
in combination with metronidazole; total duration (including oral step-down therapy) is 7 to
14 days
Rat bite fever:
Uncomplicated infection: IV: 200,000 units every 4 hours; if patient clinically improves, may
switch to an oral antibiotic after 5 to 7 days to complete a 14-day course.
Serious invasive infection (including bacteremia, meningitis, endocarditis, and other focal
organ involvement): IV: 12 to 18 million units/day as a continuous infusion or in divided doses
every 4 to 6 hours; may increase dose to 24 million units/day in patients with an isolate that is
not highly penicillin-susceptible (eg, MIC >0.1 mcg/mL). Treatment duration is 4 weeks.
Tetanus (Clostridium tetani infection) (adjunctive agent following tetanus immune globulin
and vaccine administration) (alternative agent): IV: 2 to 4 million units every 4 to 6 hours for
7 to 10 days.
Toxic shock syndrome, streptococcal: IV: 4 million units every 4 hours in combination with
clindamycin. Duration of therapy depends on extent and severity of infection and response to
treatment; treat patients who are bacteremic for ≥14 days.
Dosing: Pediatric
General dosing, susceptible infection (non-CNS):
Infants, Children and Adolescents, IM, IV:
Mild to moderate infections: 100,000–150,000 units/kg daily in 4 divided doses.
Severe infections: 200,000–300,000 units/kg daily in 4–6 divided doses. maximum daily dose:
24 million units/day.
Anthrax, systemic; treatment:
− Non-CNS infection; preferred agent for penicillin-susceptible strains: Infants, Children, and
Adolescents: IV: 400,000 units/kg/day in divided doses every 4 hours; maximum dose: 4
million units/dose; use in combination with clindamycin, linezolid, doxycycline, or rifampin
for ≥14 days until clinical stability is achieved; treatment must be followed by prophylaxis
for a total antibiotic course of 60 days.

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− Meningitis; preferred agent for penicillin-susceptible strains: Infants, Children, and
Adolescents: IV: 400,000 units/kg/day in divided doses every 4 hours; maximum dose: 4
million units/dose; use in combination with a fluoroquinolone plus linezolid, clindamycin,
rifampin, or chloramphenicol for ≥2 to 3 weeks until clinical stability is achieved; treatment
must be followed by prophylaxis for a total antibiotic course of 60 days.
Clostridial myonecrosis (gas gangrene): Infants, Children, and Adolescents: IV: 250,000 to
400,000 units/kg/day in divided doses every 4 to 6 hours with or without clindamycin.
Diphtheria: Infants, Children, and Adolescents: IM, IV: 150,000 to 250,000 units/kg/day in
divided doses every 6 hours for 7 to 10 days for 14 days.
Endocarditis, bacterial; treatment: Children and Adolescents: IV: 200,000 to 300,000
units/kg/day in divided doses every 4 hours; maximum daily dose: 24 million units/day; treat
for at least 4 weeks; longer durations may be necessary; may use in combination with
gentamicin for some resistant organisms.
Note: For endocarditis from rat-bite fever/haverhill fever, a lower dose of 150,000 to 250,000
units/kg/day in divided doses every 4 hours is recommended; maximum daily dose: 20 million
units/day.
Lyme disease: Infants, Children, and Adolescents: IV: 200,000 to 400,000 units/kg/day in
divided doses every 4 hours; maximum daily dose: 24 million units/day.
Meningitis: Note: Dosing varies based on organism being treated.
Group B streptococcus: Infants: IV: 450,000 to 500,000 units/kg/day divided every 6 hours.
S. pneumoniae: Infants, Children, and Adolescents: IV: 250,000 to 400,000 units/kg/day
divided every 4 to 6 hours.
Other susceptible organisms (including health care-associated ventriculitis/meningitis):
Infants, Children, and Adolescents: IV: 300,000 to 400,000 units/kg/day divided every 4 to 6
hours; maximum daily dose: 24 million units/day.
Meningococcal disease: Infants, Children, and Adolescents: IV: 300,000 units/kg/day in
divided doses every 4 to 6 hours; maximum daily dose: 12 million units/day.
Pneumonia, community-acquired (CAP): Infants >3 months and Children:
Empiric treatment or S. pneumoniae (moderate to severe; MICs to penicillin ≤2.0 mcg/mL): IV:
200,000 to 250,000 units/kg/day divided every 4 to 6 hours.
Alternate dosing (AAP recommendation): IV: 250,000 to 400,000 units/kg/day divided
every 4 to 6 hours; maximum daily dose: 24 million units/day.
Group A Streptococcus (moderate to severe): IV: 100,000 to 250,000 units/kg/day divided
every 4 to 6 hours.
Skin and soft tissue necrotizing infections due to Clostridium species: Infants, Children, and
Adolescents: IV: 60,000 to 100,000 units/kg/dose every 6 hours; use in combination with
clindamycin and continue until patient has clinically improved, and patient is afebrile for 48 to
72 hours.
Streptococcal skin infections, including skin and soft tissue necrotizing infections: Infants,
Children, and Adolescents: IV: 60,000 to 100,000 units/kg/dose every 6 hours; maximum dose:
4 million units/dose; use in combination with clindamycin for necrotizing infections and
continue until patient has clinically improved, and patient is afebrile for 48 to 72 hours.
Syphilis:
Congenital: Infants and Children: IV: 50,000 units/kg/dose every 4-6 hours for 10 days.
Neurosyphilis (including ocular syphilis):
Infants and Children: IV: 50,000 units/kg/dose every 4 to 6 hours for 10 to 14 days; maximum
daily dose: 24 million units/day.
Adolescents: IV: 3 to 4 million units every 4 hours or as a continuous infusion for 10 to 14 days;
maximum daily dose: 24 million units/day.
Tetanus; treatment: Infants, Children, and Adolescents: IV: 100,000 units/kg/day in divided

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doses every 4 to 6 hours for 7 to 10 days; maximum daily dose: 12 million units/day.

Dosage Dosing: Renal Impairment:

adjustment Uremic patients with CrCl >10 mL/minute/1.73 m2: Administer a usual recommended dose
followed by 50% of the usual recommended dose every 4 to 5 hours.
CrCl <10 mL/minute/1.73 m2: Administer a normal dose followed by 50% of the normal dose
every 8 to 10 hours.
Dosing: Hepatic Impairment:
There are no dosage adjustments needed.

Contra- Hypersensitivity to any penicillin or any component of the formulation

indications Documentation of allergenic cross-reactivity for beta-lactams (eg, penicillins and
cephalosporins) is limited. However, because of similarities in chemical structure and/or
pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Adverse Drug Frequency not defined:

Reactions Cardiovascular: Local thrombophlebitis, localized phlebitis
Central nervous system: Coma (high doses), hyperreflexia (high doses), myoclonus (high
doses), seizure (high doses)
Dermatologic: Exfoliative dermatitis, maculopapular rash, skin rash
Endocrine & metabolic: Electrolyte disorder (high doses)
Gastrointestinal: Clostridioides difficile associated diarrhea, Clostridioides difficile colitis
Hematologic & oncologic: Neutropenia, positive direct Coombs test (rare, high doses)
Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction (immediate and
delayed), serum sickness-like reaction
Immunologic: Jarisch-Herxheimer reaction
Local: Pain at injection site
Renal: Acute interstitial nephritis (high doses), renal tubular disease (high doses)

Monitoring Periodic electrolyte, hepatic, renal, cardiac and hematologic function tests during
Parameters prolonged/high-dose therapy; observe for signs and symptoms of anaphylaxis during first
dose. In older adults, especially those with decreased renal function, monitor for seizure
activity.

Drug Risk X: Avoid combination

Interactions BCG (Intravesical) Cholera Vaccine
Risk D: Consider therapy modification
Sodium Picosulfate Typhoid Vaccine
Probenecid Teriflunomide Tetracyclines Vitamin K Antagonists (eg, warfarin)
Pregnancy and Pregnancy Category B
Lactation Penicillin is considered compatible with breastfeeding when used in usual recommended
doses. Monitor infants for GI disturbances, such as thrush or diarrhea.
Administration Administration:
Parenteral:
IM: Administer IM by deep injection in the upper outer quadrant of the buttock.
Administer injection around-the-clock to promote less variation in peak and trough levels.
IV: Usually administered by intermittent infusion. The potassium or sodium content of the
dose should be considered when determining the infusion rate.
− Intermittent IV: Infuse over 15 to 30 minutes

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− Continuous IV infusion: Daily dose may be administered as a continuous infusion
over 24 hours, or smaller increments (eg, 24-hour dose divided into two 12-hour
infusions)
N.B. Hypersensitivity test must be done before using injection form of this medicine.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Anaphylactic/hypersensitivity reactions: Serious and occasionally severe or fatal
hypersensitivity (anaphylactic) reactions have been reported, especially in patients with a
history of beta-lactam hypersensitivity (including cephalosporins) or history of sensitivity to
multiple allergens. Use with caution in asthmatic patients. If a serious reaction occurs,
discontinue treatment and institute supportive measures.
• Neurovascular damage: Avoid intra-arterial administration or injection into or near major
peripheral nerves or blood vessels since such injections may cause severe and/or permanent
neurovascular damage.
• Severe cutaneous adverse reactions: Severe cutaneous adverse reactions (SCAR) (eg,
Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and
systemic symptoms, acute generalized exanthematous pustulosis) have been reported;
discontinue immediately if SCAR is suspected.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C.
difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed
>2 months postantibiotic treatment.
Disease-related concerns:
• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment
recommended. In the presence of concomitant hepatic impairment, further dosage
adjustment may be needed.
• Seizure disorders: Use with caution in patients with a history of seizure disorder; high levels,
particularly in the presence of renal impairment, may increase risk of seizures.
Special populations:
• Neonates: Neonates may have decreased renal clearance of penicillin and require frequent
dosage adjustments depending on age.
Other warnings/precautions:
• Electrolyte imbalance: Product contains sodium and potassium; high doses of IV therapy
may alter serum levels. If high doses (eg, >10 million units) are used, administer at a slower
rate (eg, >30 minutes for intermittent IV infusion).
Storage Penicillin G powder for injection should be stored at 25°C. Once reconstituted, it is
recommended to be used immediately
Store at temperature not exceeding 30 °C, protect from light.
Refer to manufacturer PIL if there are specific considerations.

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6. Cloxacillin
Access Group

Generic Name Cloxacillin

Dosage In combinations: capsule, suspension

form/strengths
Route of Oral
administration
Pharmacologic Antibiotic, Penicillin
category ATC: J01CF02
Indications Bacterial infections: Treatment of bacterial infections including endocarditis, pneumonia,
bone and joint infections, skin and soft-tissue infections, and sepsis that are caused by
susceptible strains of penicillinase-producing staphylococci.

Limitations of use: Exhibits good activity against Staphylococcus aureus; has activity
against many streptococci, but is less active than penicillin and is generally not used in
clinical practice to treat streptococcal infections. Not effective against methicillin-
resistant staphylococci.
Dosage Dosing: Adult
Regimen Susceptible infections:
Oral: 250 to 500 mg every 6 hours (maximum adult dose: 6 g/day)
Note: Dose and duration of therapy can vary depending on infecting organism, severity of
infection, and clinical response of patient. Treat severe staphylococcal infections for at least
14 days; endocarditis and osteomyelitis require an extended duration of therapy for 4 to 6
weeks.
Dosing: Pediatric
Susceptible infections: Oral:
Children ≤20 kg: 25 to 50 mg/kg/day in divided doses every 6 hours
Children and Adolescents >20 kg: Refer to adult dosing.
Dosage Dosing: Renal Impairment: Adult
adjustment No dosage adjustment necessary.
Dosing: Hepatic Impairment: Adult
There are no dosage adjustments necessary
Contra- Hypersensitivity to cloxacillin, other penicillins, cephalosporins, or any component of the
indications formulation
Adverse Drug Frequency not defined
Reactions Cardiovascular: Hypotension, thrombophlebitis
Central nervous system: Confusion, lethargy, myoclonus, seizure (high doses and/or renal
failure), twitching
Dermatologic: Pruritus, skin rash, urticaria
Gastrointestinal: Abdominal pain, diarrhea, epigastric distress, flatulence, hairy tongue,
loose stools, melanoglossia, nausea, oral candidiasis, pseudomembranous colitis,
stomatitis, vomiting
Genitourinary: Hematuria, proteinuria
Hematologic & oncologic: Agranulocytosis, anemia, bone marrow depression, eosinophilia,
granulocytopenia, hemolytic anemia, immune thrombocytopenia, leukopenia, neutropenia,
thrombocytopenia
Hepatic: Increased serum alkaline phosphatase, increased serum ALT & AST, hepatotoxicity
Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction (immediate and

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delayed)
Immunologic: Serum sickness-like reaction
Neuromuscular & skeletal: Laryngospasm
Renal: Interstitial nephritis, renal insufficiency, renal tubular disease
Respiratory: Bronchospasm, laryngeal edema, sneezing, wheezing
Miscellaneous: Fever
Monitoring Observe for signs and symptoms of anaphylaxis during first dose; CBC with differential
Parameters (prior to initiating therapy and weekly thereafter), periodic urinalysis, BUN, creatinine,
hepatic function
Drug Risk X: Avoid combination
Interactions BCG (Intravesical) Cholera Vaccine
Risk D: Consider therapy modification
Sodium Picosulfate Typhoid Vaccine
Pregnancy and Pregnancy category B
Lactation Cloxacillin is considered compatible with breastfeeding when used in usual recommended
doses. Monitor infants for GI disturbances, such as thrush or diarrhea.
Administration Administration: Oral
Administer with water 1 hour before or 2 hours after meals.
Powder for oral solution: Prior to mixing, store powder at room temperature not
exceeding 25°C. Refrigerate oral solution after reconstitution; discard after 14 days.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Anaphylactoid/hypersensitivity reactions: Serious and occasionally severe or fatal
hypersensitivity (anaphylactoid) reactions have been reported in patients on penicillin
therapy, especially with a history of beta-lactam hypersensitivity, history of sensitivity to
multiple allergens, or previous IgE-mediated reactions (eg, anaphylaxis, angioedema,
urticaria). Use with caution in asthmatic patients.
• Hematologic effects: Penicillin use has been associated with hematologic disorders (eg,
agranulocytosis, neutropenia, thrombocytopenia) believed to be a hypersensitivity
phenomenon. Reactions are most often reversible upon discontinuing therapy.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection,
including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD
has been observed >2 months postantibiotic treatment.
Disease-related concerns:
• Renal impairment: Use with caution in patients with renal impairment; rate of
elimination is reduced.
• Seizure disorders: Use with caution in patients with a history of seizure disorder; high
serum levels, particularly in the presence of renal impairment, may increase risk for
seizures.
Special populations:
• Neonates: May have decreased renal clearance of cloxacillin; frequent evaluation of
serum levels and of clinical status for adverse effects as well as frequent dosage
adjustments may be necessary in this patient population.
Storage Capsule: Store at room temperature not exceeding 25°C
Refer to manufacturer PIL if there are specific considerations.

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7. Flucloxacillin
Access Group

Generic Name Flucloxacillin

Dosage In cominations: Capsule, tablet, oral suspension & vial.

form/strengths
Route of IV, IM & oral
administration
Pharmacologic Antibiotic, Penicillin
category ATC: J01CF05
Indications Flucloxacillin is an isoxazolyl penicillin used primarily for the treatment of infections due to
staphylococci resistant to benzylpenicillin. These include bone and joint infections,
endocarditis, pneumonia, skin infections (including soft-tissue infections), and toxic shock
syndrome. Flucloxacillin is used in children, often to treat ear infections and chest infections.

Dosage Adult dosing:

Regimen Flucloxacillin is given parenterally and orally as the sodium or magnesium salt. All doses are
expressed as flucloxacillin; 1.18 g of flucloxacillin magnesium and 1.09 g of flucloxacillin
sodium are each equivalent to about 1 g of flucloxacillin.
The usual adult dose orally or by intramuscular injection is 250 mg four times daily
Flucloxacillin is given intravenously in a dose of 0.25 to 1 g four times daily by slow injection
over 3 to 4 minutes or by intravenous infusion.
All systemic doses may be doubled in severe infections. Up to 8 g daily in 3 or 4 divided doses
may be given for osteomyelitis; in endocarditis a dose of 8 g daily in 4 divided doses may be
given to patients weighing up to 85 kg, and 12 g daily in 6 divided doses may be used in those
weighing more. In severe renal impairment a reduction in dosage may be necessary.
Administration in children
Flucloxacillin may be given to neonates and children for the treatment of infections caused by
susceptible organisms and may be given orally, by intramuscular or slow intravenous injection,
or by intermittent intravenous infusion over 30 to 60 minutes.
In the UK, the BNFC suggests the following:
For infections due to beta-lactamase-producing staphylococci including in otitis externa,
pneumonia, impetigo, and cellulitis:
neonates: 25 mg/kg orally orintravenously, given twice daily for those under 7 days of age, 3
times daily for those 7 to 20 days of age, and 4 times daily for those 21 to 28 days of age;
intravenous doses may be doubled for severe infection
children from 1 month to 1 year of age: 62.5 to 125 mg; 2 to 9 years, 125 to 250 mg; 10 years
and older, 250 to 500 mg; all doses to be givenorally 4 times daily
or children from 1 month of age: 12.5 to 25 mg/kg intramuscularly (to a maximum of 500 mg)
or intravenously (to a maximum of 1 g) every 6 hours; intravenous dose may be doubled for
severe infection
For osteomyelitis, cerebral abscess, and staphylococcal meningitis:
neonates: 50 to 100 mg/kg intravenously, given every 12 hours for those under 7 days of age,
every 8 hours for those 7 to 20 days of age, and every 6 hours for those 21 to 28 days of age
children from 1 month of age: 50 mg/kg (maximum 2 g) intravenously every 6 hours
For endocarditis:
children from 1 month of age: 50 mg/kg (maximum 2 g) intravenously every 6 hours
For prevention of staphylococcal lung infection in cystic fibrosis:
for primary prevention, flucloxacillin is given orally to neonates and children up to 3 years of
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for secondary prevention in children from 1 month of age an oral dose of 50 mg/kg (to a
maximum of 1 g) twice daily is given
For thetreatment of staphylococcal lung infection in cystic fibrosis, infants and children from
1 month of age may be given an oral dose of 100 mg/kg (to a maximum of 4 g) daily in 3 or 4
divided doses; alternatively, it may be given intravenously in a dose of 50 mg/kg (to a
maximum of 2 g) every 6 hours.
Dosage In children with severe renal impairment (creatinine clearance less than 10 mL/min), the
adjustment normal dose should be given no more frequently than every 8 hours
Contra- Hypersensitivity reaction to flucloxacillin
indications
Adverse Drug Hepatitis and cholestatic jaundice
Reactions
Monitoring Liver enzymes
Parameters
Drug • Probenecid, Anticoagulants (warfarin), Hormonal contraceptives
Interactions • Other antibacterials such as chloramphenicol and tetracyclines and may be
incompatible in vitro with other drugs, including some other antibacterials.
Pregnancy and Maternal use of penicillins has generally not resulted in an increased risk of adverse fetal
Lactation effects. Use during pregnancy only if potential benefits outweigh possible risks.
Flucloxacillin is considered compatible with breastfeeding when used in usual recommended
doses. Monitor infants for GI disturbances, such as thrush or diarrhea.
Administration • Oral: Take flucloxacillin on an empty stomach. This means 30 to 60 minutes before a meal
or snack, or at least 2 hours after.
• Swallow flucloxacillin capsules whole with a drink of water. Do not chew or break them.
N.B. Hypersensitivity test must be done before using injection form of this medicine.
• Refer to manufacturer PIL if there are specific considerations.
Warnings/ Hepatitis and cholestatic jaundice have been reported occasionally with flucloxacillin and may
Precautions be delayed in onset for up to 2 months after treatment has been stopped; older patients and
those receiving flucloxacillin for more than 2 weeks are at greater risk.
Effects on metabolism
Use of flucloxacillin, often with paracetamol, has been associated with accumulation of
pyroglutamic acid resulting in pyroglutamic aciduria (5–oxoprolinuria) and high-anion gap
metabolic acidosis
Porphyria
The Drug Database for Acute Porphyria, compiled by the Norwegian Porphyria Centre (NAPOS)
and the Porphyria Centre Sweden, classifies flucloxacillin as possibly porphyrinogenic; it should
be used only when no safer alternative is available and precautions should be considered in
vulnerable patients.
Storage • Capsules: Store in original package at controlled room temperature; protect from moisture
• Oral suspension: Store at ≤25°C prior to reconstitution. After reconstitution, store in
refrigerator at 2°C to 8°C.
• Solution for injection: Store below ≤25°C prior to reconstitution. Protect from light.
• Refer to manufacturer PIL if there are specific considerations.

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Access Group
8. Penicillin G Benzathine

Generic Name Penicillin G Benzathine

Dosage Vial 1.2M IU

form/strengths
Route of IM
administration
Pharmacologic Antibiotic, Penicillin
category ATC: J01CE08
Indications Acute glomerulonephritis: Prophylaxis (secondary) in patients with a history of acute
glomerulonephritis

Respiratory tract infections: Treatment of mild to moderate upper respiratory tract

infections (including pharyngitis) caused by streptococci susceptible to low, prolonged serum
concentrations of penicillin G

Rheumatic fever and chorea: Prophylaxis (secondary) of rheumatic fever and/or chorea

Rheumatic heart disease: Prophylaxis (secondary) in patients with rheumatic heart disease

Syphilis and other venereal diseases: Treatment of syphilis, yaws, bejel, and pinta
Dosage Adult Usual dosage range: IM: 1.2 to 2.4 million units as a single dose
Regimen • Streptococcus (group A):
Pharyngitis, acute treatment: IM: 1.2 million units as a single dose
Secondary prophylaxis for rheumatic fever (prevention of recurrent attacks): IM: 1.2 million
units once every 21 to 28 days. Duration depends on risk factors and presence of valvular
heart disease.
IM: 600,000 units every 2 weeks
Secondary prophylaxis of glomerulonephritis: IM: 1.2 million units every 4 weeks or 600,000
units twice monthly
• Syphilis (CDC):
Primary, Secondary, Early Latent (<1-year duration): IM: 2.4 million units as a single dose
Late Latent, Latent with unknown duration, or Tertiary Syphilis (with normal CSF
examination): IM: 2.4 million units once weekly for 3 doses
Neurosyphilis (including Ocular Syphilis): Not indicated for initial treatment; aqueous
penicillin G IV is preferred initial therapy. Following penicillin G IV initial treatment, may
consider administration of penicillin G benzathine 2.4 million units IM once weekly for 3
weeks to provide a comparable total duration of therapy as for latent syphilis.

Dosing: Pediatric
• Group A streptococcal (Streptococcus pyogenes) infection:
Pharyngitis, treatment (primary prevention of rheumatic fever): Note: Empiric treatment is
generally not recommended; treatment should be prescribed only when testing confirms
presence of Group A Streptococcus.
Infants, Children, and Adolescents: IM:
≤27 kg: 600,000 units as a single dose.
>27 kg: 1.2 million units as a single dose.

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Rheumatic fever, secondary prevention: Note: Duration varies based on risk factors and
presence of residual heart disease.
Infants, Children, and Adolescents: IM:
≤27 kg: 600,000 units every 3 to 4 weeks.
>27 kg: 1.2 million units every 3 to 4 weeks.
Note: Every-4-week administration is recommended in the US where rheumatic fever
incidence is low; every 3 weeks should be used to maintain desirable serum drug
concentrations in patients who have had a breakthrough episode despite every-4-week
dosing and in areas where incidence of acute rheumatic fever remains high.
Chronic carriers of Group A Streptococcus, treatment: Limited data available: Note: Antibiotic
therapy is generally not recommended for chronic S. pyogenes carriage; however, it may be
considered in certain cases.
Infants, Children, and Adolescents: IM:
≤27 kg: 600,000 units as a single dose in combination with oral rifampin for 4 days.
>27 kg: 1.2 million units as a single dose in combination with oral rifampin for 4 days.
• Syphilis: Note: Not recommended for the initial treatment of neurosyphilis (CDC).
Congenital; patients with no clinical manifestations and normal cerebrospinal fluid
(CSF): Limited data available: Infants and Children: IM: 50,000 units/kg/dose once weekly
for up to 3 weeks; maximum dose: 2.4 million units/dose.
Primary, secondary, or early latent (<1-year duration): Infants, Children, and Adolescents:
IM: 50,000 units/kg once; maximum dose: 2.4 million units/dose.
Re-treatment of primary, secondary, or early latent disease after failure of previous
therapy: Infants, Children, and Adolescents: 50,000 units/kg/dose once weekly for 3 weeks;
maximum dose: 2.4 million units/dose. Note: If CSF examination positive, treat as
neurosyphilis.
Late latent (>1 year or unknown duration): Infants, Children, and Adolescents: IM: 50,000
units/kg/dose once weekly for 3 weeks; maximum dose: 2.4 million units/dose (CDC).
Dosage Dosing: Renal Impairment:
adjustment Penicillin G is rapidly eliminated via renal tubular excretion and clearance is significantly
delayed in patients with decreased renal function. Specific dosage adjustment
recommendations are not available.
Dosing: Hepatic Impairment:
No dosage adjustment is needed in patients with hepatic impairment; patients with both
hepatic and renal impairment may need dosage adjustment.
Geriatric Considerations
Not indicated as single drug therapy for neurosyphilis, but may be given 1 time/week for 3
weeks following IV treatment with Penicillin G (Parenteral/Aqueous). No adjustment for
renal function or age is necessary.
Contra- Hypersensitivity to penicillin(s) or any component of the formulation
indications
Adverse Drug Cardiovascular: Cerebrovascular accident, hypersensitivity angiitis, hypotension,
Reactions palpitations, pulmonary embolism, syncope, tachycardia, vasodilation, vasospasm,
vasodepressor syncope
Central nervous system: Anxiety, coma, confusion, dizziness, drowsiness, euphoria, fatigue,
headache, localized warm feeling, nervousness, neurologic abnormality (neurogenic
bladder), numbness of extremities, pain, seizure, transverse myelitis
Dermatologic: Diaphoresis, gangrene of skin and/or other subcutaneous tissues, pallor,
pruritus, skin mottling, skin or other tissue necrosis (Nicolau syndrome), skin ulceration at
injection site

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Gastrointestinal: Blood in stool, Clostridioides difficile associated diarrhea, intestinal
necrosis, nausea, vomiting
Genitourinary: Hematuria, impotence, priapism, proteinuria
Hematologic & oncologic: Lymphadenopathy
Hepatic: Increased serum aspartate aminotransferase
Hypersensitivity: Anaphylaxis, hypersensitivity reaction
Immunologic: Jarisch-Herxheimer reaction
Local: Abscess at injection site, atrophy at injection site, bleeding at injection site, bruising at
injection site, cellulitis at injection site, localized edema (at injection site), inflammation at
injection site, injection site reaction (neurovascular damage), pain at injection site, residual
mass at injection site, tissue necrosis at injection site
Neuromuscular & skeletal: Arthropathy, asthenia, exacerbation of arthritis, periosteal
disease, rhabdomyolysis, tremor
Ophthalmic: Blindness, blurred vision
Renal: Increased blood urea nitrogen, increased serum creatinine, myoglobinuria, renal
failure syndrome
Respiratory: Apnea, cyanotic extremities, dyspnea, hypoxia, pulmonary hypertension
Monitoring Observe for signs and symptoms of anaphylaxis during first dose
Parameters
Drug Risk X: Avoid combination
Interactions BCG (Intravesical), Cholera Vaccine,
Risk D: Consider therapy modification
Bacillus clausii, Tolvaptan, Typhoid Vaccine, Sodium Picosulfate:
Risk C: Monitor therapy:
Acemetacin, Aminoglycosides, BCG Vaccine (Immunization), Dichlorphenamide,
Lactobacillus and Estriol, Methotrexate, Mycophenolate, Probenecid, Sodium
Benzoate,Teriflunomide, Tetracyclines, Vitamin K Antagonists

Pregnancy and This drug should be used during pregnancy only if clearly needed
Lactation Penicillin G is the drug of choice for treatment of syphilis during pregnancy
Penicillin G benzathine is considered compatible with breastfeeding when used in usual
recommended doses. Monitor infants for GI disturbances, such as thrush or diarrhea.
Administration Administration: IM only
Warm to room temperature before administration to lessen the pain associated with
injection. Administer by deep IM injection at a slow, steady rate in the dorsogluteal region
(upper outer quadrant of the buttock) or the ventrogluteal region.
Do not inject near an artery or a nerve; permanent neurological damage or gangrene may
result. When doses are repeated, rotate the injection site.
Do not administer IV, intra-arterially, or SubQ. inadvertent IV administration has resulted
in thrombosis, severe neurovascular damage, cardiac arrest, and death.
N.B. Hypersensitivity test must be done before using injection form of this medicine.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Hypersensitivity reactions: Serious and occasionally severe or fatal hypersensitivity
(anaphylactic) reactions have been reported in patients on penicillin therapy, especially with
a history of beta-lactam hypersensitivity (including cephalosporins), history of sensitivity to
multiple allergens, or previous IgE-mediated reactions (eg, anaphylaxis, angioedema,
urticaria). Serious anaphylactic reactions require immediate emergency treatment with
epinephrine, oxygen, intravenous steroids and airway management (including intubation) as
indicated.

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• Severe cutaneous adverse reactions: Severe cutaneous adverse reactions (SCAR) (eg,
Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and
systemic symptoms, acute generalized exanthematous pustulosis) have been reported;
discontinue immediately if SCAR is suspected.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection,
including Clostridioides (formerly Clostridium) difficile-associated diarrhea (CDAD) and
pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment
• Not for IV use; cardiopulmonary arrest and death have occurred from inadvertent IV
administration. Administer by deep IM injection only. Quadriceps femoris fibrosis and
atrophy have been reported after repeated IM injections of penicillin preparations into the
anterolateral thigh. Injection into or near an artery or nerve could result in severe
neurovascular damage or permanent neurological damage.
• Prolonged use: Extended duration of therapy or use associated with high serum
concentrations (eg, in renal insufficiency) may be associated with an increased risk for some
adverse reactions (neutropenia, hemolytic anemia, serum sickness)

Storage Store at 2°C to 8°C; do not freeze.

Refer to manufacturer PIL if there are specific considerations.

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9. Phenoxymethylpenicillin
Access Group

Generic Name Phenoxymethylpenicillin

Dosage Tablets 1MU, 1.5MU

form/strengths
Route of Oral
administration
Pharmacologic Antibiotic, Penicillins (penicillin V)
category ATC: J01CE02
Indications Erysipelas: Treatment of mild infection or step-down therapy after initial parenteral
therapy.
Odontogenic infection (acute simple gingivitis): Treatment of odontogenic infection, in
conjunction with dental care for infections involving gum tissue.
Pneumococcal infections: Treatment of mild to moderately severe pneumococcal
respiratory tract infections, including otitis media.
Streptococcus, group A: Secondary prophylaxis for rheumatic fever (prevention of
secondary attacks).
Streptococcus, group A pharyngitis: Initial treatment of pharyngitis caused by group
A Streptococcus.
Dosage Adults
Regimen Odontogenic infection: Acute simple gingivitis:
Oral: 500 mg every 6 to 8 hours for 5 to 7 days in combination with metronidazole
Skin and soft tissue infection:
Erysipelas, treatment of mild infection or step-down therapy after initial parenteral
therapy: Oral: 500 mg every 6 hours; total duration is 5 days, with extension to 14 days for
slow response, severe infection, or immunosuppression
Streptococcus, group A:
Pharyngitis: Oral: 500 mg 2 to 3 times daily for 10 days.
Secondary prophylaxis in patients with rheumatic fever (prevention of recurrent attacks)
(alternative agent): Oral: 250 mg twice daily. Duration depends on risk factors, age, and
presence of valvular disease

Dosing: Pediatric
General dosing: Infants, Children, and Adolescents:
Mild to moderate infection: Oral: 25 to 50 mg/kg/day in divided doses every 6 hours;
maximum daily dose: 2,000 mg/day
Group A streptococcal infection:
Pharyngitis, acute treatment (primary prevention of rheumatic fever):
Children <27 kg: Oral: 250 mg 2 to 3 times daily for 10 days.
Children ≥27 kg and Adolescents: Oral: 500 mg 2 to 3 times daily for 10 days; in
adolescents, 250 mg 4 times daily has also been suggested.
Pneumonia, community-acquired; Group A Streptococcus, mild infection or step-down
therapy:
Infants, Children, and Adolescents: Oral: 50 to 75 mg/kg/day in divided doses 4 times daily

Dosage Dosing: Renal Impairment: Adult

adjustment Use with caution; excretion is prolonged in patients with renal impairment. No dosage

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adjustments needed.
Dosing: Hepatic Impairment: Adult
There are no dosage adjustments needed.

Contra- Known hypersensitivity to any penicillin.

indications
Adverse Drug Adverse GI effects (e.g., nausea, vomiting, epigastric distress, diarrhea, black hairy tongue),
Reactions hypersensitivity reactions (e.g., fever, eosinophilia, rash, urticaria, serum sickness-like
reactions)
Monitoring Periodic renal and hematologic function tests during prolonged therapy; monitor for signs
Parameters of anaphylaxis during first dose

Drug Risk X: Avoid combination

Interactions BCG (Intravesical) Cholera Vaccine
Risk D: Consider therapy modification
Fexinidazole Sodium Picosulfate Typhoid Vaccine
Pregnancy and Pregnancy Category B
Lactation Penicillin V is considered compatible with breastfeeding when used in usual recommended
doses.
Administration Take on an empty stomach 1 hour before or 2 hours after meals, to enhance absorption.
Do not use for initial treatment of severe infections. Should not be relied on in patients with
nausea, vomiting, gastric dilatation, cardiospasm, or intestinal hypermotility.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Anaphylactic/hypersensitivity reactions: Serious and occasionally severe or fatal
hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin
therapy, especially with a history of beta-lactam hypersensitivity or history of sensitivity to
multiple allergens.). Use with caution in asthmatic patients. If a serious reaction occurs,
treatment with supportive care measures and airway protection should be instituted
immediately.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C.
difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been
observed >2 months postantibiotic treatment.
Disease-related concerns:
• Renal impairment: Use with caution in patients with severe renal impairment.
• Seizure disorders: Use with caution in patients with a history of seizure disorder; high
levels, particularly in the presence of renal impairment, may increase risk of seizures.
Storage Store at 20–25°C. Refer to manufacturer PIL if there are specific considerations.

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10. Piperacillin and Tazobactam
Watch Group

Generic Name Piperacillin and Tazobactam

Dosage Vial 4.5gm

form/strengths
Route of Intravenous
administration
Pharmacologic Antibiotic, Penicillin
category ATC: J01CR05
Indications Intra-abdominal infections: Treatment of appendicitis complicated by rupture or abscess and
peritonitis in adults and pediatric patients ≥2 months of age.
Pelvic infections: Treatment of postpartum endometritis or pelvic inflammatory disease in
adults.
Pneumonia, community-acquired: Treatment of moderate severity community-acquired
pneumonia in adults.
Pneumonia, hospital-acquired (nosocomial): Treatment of moderate to severe hospital-acquired
(nosocomial) pneumonia in adults and pediatric patients ≥2 months of age.
Skin and skin structure infections: Treatment of skin and skin structure infections, including
cellulitis, cutaneous abscesses, and ischemic/diabetic foot infections in adults
Dosage Dosing: Adult
Regimen Note: Adult doses are expressed as the combined amount of piperacillin and tazobactam.
Infusion method: Dosing is presented based on the traditional infusion method over 30 minutes,
unless otherwise specified
Usual dosage range:
Traditional infusion method (over 30 minutes): IV:
Mild to moderate infections: 3.375 g every 6 hours.
Severe infections: 4.5 g every 6 to 8 hours.
For coverage of Pseudomonas aeruginosa: 4.5 g every 6 hours. Usual maximum dose: 18 g/day.
Dosing: Pediatric
General dosing, susceptible infection: Severe infection:
Traditional dosing:
• Neonates ≤30 weeks: 100 mg/kg (of piperacillin) every 8 hours.
• Infants ≥2 months, Children, and Adolescents: IV: 240 to 300 mg piperacillin/kg/day divided in
3 to 4 doses; maximum daily dose: 16 g/day
Dosage Dosing: Renal Impairment: Adult
adjustment CrCl (mL/minute) If the usual
If the usual recommended dose
recommended dose is
is 4.5 g every 6 hours
3.375 g every 6 hours
Extended infusion
100 to <130 Extended infusion preferred
preferred
40 to <100 (usual
3.375 g every 6 hours 4.5 g every 6 hours
recommended dose)
4.5 g every 8 hours or 3.375 g
20 to <40 2.25 g every 6 hours
every 6 hours
4.5 g every 12 hours or 2.25 g
<20 2.25 g every 8 hours
every 6 hours

Dosing: Renal Impairment: Pediatric

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Note: Dosage recommendations are based on the piperacillin component. Dosing based on a
usual dose of 200 to 300 mg piperacillin kg/day in divided doses every 6 hours.
GFR >50 mL/minute/1.73 m2: No adjustment required
GFR 30 to 50 mL/minute/1.73 m2: 35 to 50 mg piperacillin/kg/dose every 6 hours
GFR <30 mL/minute/1.73 m2: 35 to 50 mg piperacillin/kg/dose every 8 hours
Intermittent hemodialysis (IHD): Hemodialysis removes 30% to 40% of a piperacillin/tazobactam
dose: 50 to 75 mg piperacillin/kg/dose every 12 hours
Peritoneal dialysis (PD): Peritoneal dialysis removes 21% of tazobactam and 6% of piperacillin: 50
to 75 mg piperacillin/kg/dose every 12 hours
Continuous renal replacement therapy (CRRT): 35 to 50 mg piperacillin/kg/dose every 8 hours

Dosing: Hepatic Impairment:

No dosage adjustment necessary.
Contra- Hypersensitivity to penicillins, cephalosporins, beta-lactamase inhibitors, or any component of
indications the formulation

Adverse Drug >10%: Gastrointestinal: Diarrhea (11%)

Reactions 1% to 10%:
Dermatologic: Pruritus, skin rash
Gastrointestinal: Abdominal pain, Clostridioides difficile colitis, constipation, dyspepsia, nausea,
vomiting
Infection: Candidiasis
Nervous system: Headache, insomnia, rigors
Miscellaneous: Fever
Monitoring Creatinine, BUN, CBC with differential, PT, PTT, serum electrolytes, LFTs, urinalysis; signs of
Parameters bleeding; monitor for signs of anaphylaxis during first dose
Drug Risk X: Avoid combination
Interactions BCG (Intravesical) Cholera Vaccine
Risk D: Consider therapy modification
Probenecid Sodium Picosulfate Typhoid Vaccine
Risk C: Monitor therapy
Acemetacin Aminoglycosides BCG Vaccine (Immunization) Dichlorphenamide Flucloxacillin
Immune Checkpoint Inhibitors Lactobacillus and Estriol Methotrexate Mycophenolate
Tetracyclines Vancomycin Vecuronium Vitamin K Antagonists (eg, warfarin)
Pregnancy and pregnancy category B
lactation Piperacillin/tazobactam is considered compatible with breastfeeding in women when used for
the treatment of airway diseases
Administration Administration: IV
Administer by IV infusion over 30 minutes.
Preparation for Administration:
Single-dose vial: After initial reconstitution, further dilute in D5W or NS to a volume of 50 to 150
mL
4.5 g vial: Reconstitute 4.5 g vial with 20 mL of diluent (eg, D5W, NS, SWFI) to yield a final volume
of 23.15 mL, resulting in a final concentration of piperacillin 172.8 mg/mL .
N.B. Hypersensitivity test must be done before using injection form of this medicine.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Anaphylactoid/hypersensitivity reactions
• CNS effects: May cause neuromuscular excitability and seizures. Risk is increased at higher

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doses, particularly in the presence of renal impairment and in patients with seizure
disorders; monitor closely.
• Dermatologic effects: Serious skin reactions have been reported.
• Electrolyte abnormalities: Sodium content (2.84 mEq per gram of piperacillin) should be
considered in patients requiring sodium restriction. Assess electrolytes periodically in
patients with low potassium reserves, especially those receiving cytotoxic therapy or
diuretics.
• Hematologic effects: Prothrombin time, platelet aggregation, and clotting time
abnormalities. Discontinue if thrombocytopenia or bleeding occurs.
Leukopenia/neutropenia may occur; appears to be reversible.
• Nephrotoxicity: especially when given in combination with vancomycin
• Superinfection: in prolonged use
Disease-related concerns:
• Cystic fibrosis: An increased frequency of fever and rash has been reported in patients
with cystic fibrosis receiving piperacillin.
• Renal impairment: Use with caution in patients with renal impairment or in hemodialysis
patients. Dosage adjustment recommended.
Special populations:
• Critically ill patients: may delay renal recovery as compared to other beta-lactam
antibacterial drugs; consider alternative treatment options in critically ill patients. If
alternative treatment options are inadequate or unavailable, closely monitor renal function.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist.

Storage Vials: Store intact vials at 20°C to 25°C.

after reconstitution: Use immediately
Discard any unused portion after 24 hours if stored at 20°C to 25°C or after 48 hours if
stored at 2°C to 8°C.
Refer to manufacturer PIL if there are specific considerations.

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11. Sultamicillin
Access Group

Generic Name Sultamicillin

Dosage Tablets: 375 mg, 750 mg

form/strengths Oral Suspension: 250 mg/5ml
Route of Oral
administration
Pharmacologic Antibiotic, Penicillin
category ATC J01CR04
Indications Treatment of susceptible bacterial infections including skin and skin structure infections, upper
and lower respiratory tract infections, urinary tract infections, pyelonephritis, and gonococcal
infections.
Dosage − Infants, Children, and Adolescents <30 kg: 25 to 50 mg/kg/day in 2 divided doses
Regimen − Children ≥30 kg, Adolescents, and Adults: Oral: Usual range: 375 to 750 mg every 12 hours;
2.25 g as a single dose in combination with probenecid has been reported for treatment of
uncomplicated gonorrhea.
Dosage Renal impairment:
adjustment Severe impairment of renal function (creatinine clearance ≤30 ml/min): The dose of sultamicillin
in such patients should be administered less frequently
Hepatic impairment:
No adjustments needed.
Contra- The use of sultamicillin is contraindicated in individuals with a history of an allergic reaction to
indications any of the penicillins.
Adverse Drug 1-10%:
Reactions Headache, Diarrhea, Vomiting, Abdominal pain, Nausea, Rash, Pruritus.
Monitoring monitor adverse effects or hypersensitivity reactions.
Parameters
Drug Risk X: Avoid Combination
Interactions Bacteriostatic drugs (chloramphenicol, erythromycin, sulfonamides and tetracyclines)
Risk D: Consider Therapy Modification
Anticoagulants Estrogen-containing oral contraceptives
Pregnancy and safety for use in human pregnancy has not been established. Therefore, sultamicillin should be
Lactation used during pregnancy only if the potential benefits outweigh the potential risk.
The use of sultamicillin during lactation is not recommended
Administration Oral without regards to food.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ • Serious and occasionally fatal hypersensitivity reactions (including anaphylactoid and severe
Precautions cutaneous adverse reactions) have been reported in patients receiving therapy with
betalactams. If an allergic reaction occurs, sultamicillin (sulbactam sodium/ampicillin sodium)
must be discontinued immediately and appropriate alternative therapy instituted. Serious
anaphylactic reactions require immediate emergency treatment with adrenaline. Oxygen,
intravenous steroids, and airway management, including intubation, should be administered
as indicated.
• Severe skin reactions, such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome
(SJS), dermatitis exfoliative, erythema multiforme, and acute generalized exanthematous

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pustulosis (AGEP) have been reported in patients on ampicillin/sulbactam therapy. If a severe
skin reaction occurs, ampicillin/sulbactam should be discontinued and appropriate therapy
should be initiated
• Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all
antibacterial agents, including sultamicillin, and may range in severity from mild diarrhea to
fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon, leading
to overgrowth of C. difficile.
• Drug induced liver injury such as cholestatic hepatitis and jaundice have been associated with
the use of ampicillin/sulbactam. Patients should be advised to contact their doctor if signs and
symptoms of hepatic disease develop
Storage Store below 30°C. The reconstituted oral suspension must be stored under refrigeration and
discarded after 14 days.
Refer to manufacturer PIL if there are specific considerations.

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Quinolones
Watch Group
1. Ciprofloxacin
Generic Name Ciprofloxacin

Dosage form/ Tablets 250mg, 500mg, 750mg

strengths Extended Release Tablets: 500 mg, 1g
Eye ointment 0.3%
Ear or eye drops 3mg/ml
Vial 200mg, 400mg
Route of Oral, Opthalmic, IV
administration
Pharmacologic Antibiotic, Fluoroquinolone
action Systemic ATC: J01MA02
Ophthalmic ATC: S03AA07
Indications Systemic:
• Children and Adolescents: Treatment of complicated urinary tract infections and
pyelonephritis due to E. coli. Note: Although effective, ciprofloxacin is not the drug of
first choice in children.
• Infants, Children, Adolescents, and Adults: Prophylaxis to reduce incidence or
progression of disease following inhalation exposure to Bacillus anthracis; prophylaxis
and treatment of plague (Yersinia pestis).
• Adults: Treatment of the following infections when caused by susceptible bacteria:
Urinary tract infections; acute uncomplicated cystitis in females, chronic bacterial
prostatitis, bone and joint infections, complicated intra-abdominal infections (in
combination with metronidazole), infectious diarrhea, typhoid fever (Salmonella
typhi), hospital-acquired (nosocomial) pneumonia
Ophthalmic:
Bacterial conjunctivitis: Ointment or solution
Corneal ulcers: Solution

Dosage Note: Extended-release tablets and immediate-release formulations are not interchangeable.
Regimen Unless otherwise specified, oral dosing reflects the use of immediate-release formulations.

Intra-abdominal infection (including perforated appendix, appendiceal abscess, acute

diverticulitis, acute cholecystitis), community-acquired: Note: For empiric therapy, usually
administered in combination with metronidazole.
Oral: 500 mg every 12 hours
IV: 400 mg every 12 hours
Duration: Duration of therapy is for 4 to 7 days following adequate source control
Osteomyelitis:
Oral:
Treatment: 500 to 750 mg every 12 hours; when treating P. aeruginosa, 750 mg every 12
hours for ≥6 weeks
Chronic suppression in presence of retained infected orthopedic hardware: 250 to 500 mg
every 12 hours.
IV: 400 mg every 12 hours; when treating P. aeruginosa, 400 mg every 8 hours for ≥6 weeks
Plague (Yersinia pestis) infection (alternative agent):
Note: Consult public health officials for event-specific recommendations:
Postexposure prophylaxis: Oral: 500 mg twice daily for 7 days.

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Treatment: Note: Duration of therapy is 10 to 14 days.
Oral: 500 to 750 mg every 12 hours
IV: 400 mg every 8 to 12 hours.
Pneumonia, as a component of empiric therapy or pathogen-specific therapy for P.
aeruginosa in hospitalized patients: Note: For empiric therapy, must be used in combination
with other appropriate agents.
Oral: 750 mg every 12 hours
IV: 400 mg every 8 hours.
Duration of therapy: 7 days; may be individualized based on patient-specific factors and
response to therapy
Salmonella species, GI infection:
Nontyphoidal, severe (nonbacteremic) illness or any severity in patients at high risk for
invasive disease: Oral: 500 mg twice daily for 3 to 14 days (7 to 14 days in patients with HIV
with a CD4 count ≥200 cells/mm3). Note: Immunosuppressed patients (eg, patients with HIV
and CD4 count <200 cells/mm3) require a longer duration of treatment (eg, weeks to months)
and may require a higher dose (eg, 750 mg twice daily).
Nontyphoidal bloodstream infection: IV: 400 mg twice daily for 14
days. Note: Immunosuppressed patients (eg, patients with HIV with CD4 count <200
cells/mm3) and those with an extraintestinal focus of infection require a longer duration of
treatment (eg, weeks or months).
Typhoid fever (Salmonella typhi and paratyphi): Severe disease or mild to moderate infection
in patients at high risk of developing invasive disease. Note: Use only if MIC ≤0.06 mcg/mL as
the incidence of fluoroquinolone-resistant strains is increasing (Humphries 2012).
Oral: 500 mg every 12 hours for 7 to 10 days.
IV: 400 mg every 12 hours for 7 to 10 days.
Septic arthritis (without prosthetic material) (alternative agent): Note: Use in combination
with an aminoglycoside for initial treatment if P. aeruginosa suspected.
Oral: 500 to 750 mg twice daily.
IV: 400 mg every 12 hours.
Duration of therapy: 3 to 4 weeks (in the absence of osteomyelitis), including oral step-down
therapy.
Urinary tract infection:
Acute uncomplicated or simple cystitis in females: Note: Use is discouraged due to safety
concerns and significant Escherichia coli resistance; reserve for those who have no alternative
treatment options.
Oral, immediate release: 250 mg every 12 hours for 3 days.
Oral, extended release: 500 mg every 24 hours for 3 days.
Acute pyelonephritis or other complicated UTI: Note: If the prevalence of fluoroquinolone
resistance is >10%, an initial dose of a long-acting parenteral antimicrobial, such as
ceftriaxone, ertapenem, or a consolidated 24-hour dose of an aminoglycoside is
recommended for outpatients.
Oral, immediate release: 500 mg every 12 hours for 5 to 7 days.
Oral, extended release: 1 g every 24 hours for 5 to 7 days.
IV (inpatient): 400 mg every 12 hours for a total of 5 to 7 days.
Dosing: Pediatric
Note: In pediatric patients, ciprofloxacin is not routinely first-line therapy, but after
assessment of risks and benefits, can be considered a reasonable alternative for some
situations [eg, anthrax, resistance (cystic fibrosis)].
General dosing, susceptible infection: Infants, Children, and Adolescents:
Mild to moderate infections: Oral, immediate release: 10 mg/kg/dose twice daily; maximum

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dose: 500 mg/dose.
Severe infections:
Oral, immediate release: 15 to 20 mg/kg/dose twice daily; maximum dose: 750 mg/dose.
IV: 10 mg/kg/dose every 8 to 12 hours; maximum dose: 400 mg/dose.

Ophthalmic:
Bacterial conjunctivitis: Ophthalmic:
Solution: Instill 1 to 2 drops into the conjunctival sac every 2 hours while awake for 2 days and
then every 4 hours while awake for the next 5 days.
Ointment: Apply a 1/2 inch ribbon into the conjunctival sac 3 times/day for the first 2 days,
followed by a 1/2 inch ribbon applied twice daily for the next 5 days.
Corneal ulcer

Corneal ulcer: Ophthalmic:

Solution: Instill 2 drops into affected eye:
every 15 minutes for the first 6 hours, then every 30 minutes for the remainder of the first
day. On day 2, instill 2 drops every hour. On days 3 to 14, instill 2 drops every 4 hours.
Treatment may continue after day 14 if re-epithelialization has not occurred.

Dosage Renal impairment systemic dosing

adjustment
Oral,
Oral, immediate
CrCl (mL/minute) extended IV
release
release

1 g every 24
CrCl >50 to <130 500-750/12hr 400 mg every 8 to 12 hours
hours

250 to 500 mg every No adjustment

CrCl 30 to 50 No adjustment needed
12 hoursb needed

500 mg every 24 500 mg every 200c to 400 mg every 12 to 24

CrCl <30
hoursb 24 hours hours

Hemodialysis,
250d to 500 mg 500 mg every
intermittent 200c to 400 mg every 24 hours
every 24 hoursb 24 hours
(thrice weekly)e

250d to 500 mg 500 mg every

Peritoneal dialysis 200c to 400 mg every 24 hours
every 24 hoursb 24 hours
b
For severe infections, 750 mg may be administered at the intervals noted above.
c
Consider administering a loading dose of 400 mg × 1 if utilizing 200 mg every 24 hours.
d
Consider administering a loading dose of 500 mg × 1 if utilizing 250 mg every 24
hours.
e
Minimally dialyzable (<10%); when scheduled dose falls on a dialysis day, administer
post dialysis.

Infants, Children, and Adolescents:

The following guidelines have been used by some clinicians for IV and oral immediate

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formulations on 10-15mg/kg/dose every 12 hours:
GFR ≥30 mL/minute/1.73 m2: No dosage adjustment necessary
GFR 10 to 29 mL/minute/1.73 m2: 10 to 15 mg/kg/dose every 18 hours
GFR <10 mL/minute/1.73 m2: 10 to 15 mg/kg/dose every 24 hours
Hemodialysis/peritoneal dialysis (PD) (after dialysis on dialysis days): Minimally dialyzable
(<10%): 10 to 15 mg/kg/dose every 24 hours
CRRT: 10 to 15 mg/kg/dose every 12 hours
Oral, extended release: Adolescents ≥18 years:
CrCl ≥30 mL/minute: No dosage adjustment necessary
CrCl <30 mL/minute: 500 mg every 24 hours
Hemodialysis/peritoneal dialysis (PD) (administer after dialysis on dialysis days): 500 mg
every 24 hours

Dosing: Hepatic Impairment: Adult& Pediatrics

There are no dosage adjustments needed. Use with caution in severe impairment.

Contra- Hypersensitivity to ciprofloxacin, any component of the formulation, or other quinolones;

indications concurrent administration of tizanidine
Adverse Drug Adverse Reactions (Significant): Considerations
Reactions Aortic aneurysm/aortic dissection
CNS effects/neuroexcitation
Clostridioides (formerly Clostridium) difficile infection
Glucose regulation/dysglycemia
Hepatotoxicity
Hypersensitivity reactions (immediate and delayed)
Myasthenia gravis
Peripheral neuropathy
Phototoxicity/photoallergy
QT prolongation
Tendonitis/tendon rupture

>10%: Neuromuscular & skeletal: Musculoskeletal signs and symptoms (children: 9% to 22%)
1% to 10%:
Dermatologic: Skin rash (1% to 2%)
Gastrointestinal: Abdominal pain (children: 3%; adults: <1%), diarrhea (2% to 5%), dyspepsia
(1% to 3%), nausea (3% to 4%), vomiting (1% to 5%)
Genitourinary: Vulvovaginal candidiasis (2%)
Local: Injection site reactions (IV: >1%)
Nervous system: Dizziness (oral: 2%; IV: <1%), drowsiness, headache (oral: 1% to 3%; IV: >1%),
insomnia, nervousness, neurological signs and symptoms (IV: children: 3%), restlessness (IV:
>1%; oral: <1%)
Respiratory: Asthma (children: 2%)
Miscellaneous: Fever (children: 2%; adults: <1%)

Monitoring Monitoring Parameters

Parameters CBC, renal and hepatic function during prolonged therapy, altered mental status, signs and
symptoms of tendonitis; signs and symptoms of disordered glucose regulation

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Drug Risk X: Avoid combination
Interactions Agomelatine, Aminolevulinic Acid, BCG (Intravesical), Cholera Vaccine, Lomitapide,
Meptazinol, Nadifloxacin, Pimozide, Tizanidine
Risk D: Consider therapy modification
Clozapine, Erlotinib, some Iron Preparations, Lanthanum, Magnesium Salts,
Multivitamins/Minerals (with ADEK, Folate, Iron), Pirfenidone, Rasagiline, Sevelamer,
Sodium Picosulfate, Sucralfate, Theophylline Derivatives, Tolvaptan, Triazolam, Typhoid
Vaccine, Zinc Salts Except: Zinc Chloride, Zolpidem
Pregnancy and Use during pregnancy only if potential benefits justify potential risks to fetus and mother.
Lactation Animal studies (rats and mice) using oral ciprofloxacin did not reveal evidence of harm to the
fetus
In general, quinolone antibiotics should be avoided in breastfeeding women if alternative
agents are available. Based on adverse outcomes observed in animal studies, breastfeeding
should be discontinued during therapy and for 2 days after the last ciprofloxacin dose if used
for indications other than treating maternal B. anthracis. Mothers may express and discard
milk during this time.
Administration Administration: IV
Administer by slow IV infusion over 60 minutes into a large vein (reduces risk of venous
irritation)
Administration: Oral
• Administering 2 hours after meals is preferable. May administer with most foods to
minimize GI upset; avoid antacid use; maintain proper hydration and urine output.
• Administer orally at least 2 hours before or 6 hours after antacids or other products
containing calcium, iron, or zinc. Separate oral administration from drugs that may
impair absorption
• May be administered with meals containing dairy products (calcium content <800 mg),
but not with dairy products alone.
• Extended release: Do not crush, split, or chew.

Preparation for Administration:

Injection, vial: May be diluted with NS, D5W, SWFI, D10W, D51/4NS, D51/2NS, LR to a
final concentration not to exceed 2 mg/mL
Refer to manufacturer PIL if there are specific considerations.
Warnings/ • Fluoroquinolones, including ciprofloxacin, have been associated with disabling and
Precautions potentially irreversible serious adverse reactions (e.g., tendinitis and tendon rupture,
peripheral neuropathy, CNS effects) that have occurred together. Discontinue
immediately and avoid use of fluoroquinolones, including ciprofloxacin, in patients who
have experienced any of these serious adverse reactions
• Fluoroquinolones, including ciprofloxacin, may exacerbate muscle weakness in patients
with myasthenia gravis. Avoid in patients with known history of myasthenia gravis.
• Because of risk of serious adverse reactions, use ciprofloxacin for treatment of acute
bacterial sinusitis, acute bacterial exacerbations of chronic bronchitis, or uncomplicated
urinary tract infections (UTIs) only when no other treatment options available
•Altered cardiac conduction: Fluoroquinolones may prolong QTc interval; avoid use in
patients with a history of or at risk for QTc prolongation, torsades de pointes, uncorrected
electrolyte disorders (hypokalemia or hypomagnesemia), cardiac disease (heart failure,
myocardial infarction, bradycardia) or concurrent administration of other medications
known to prolong the QT interval (including Class Ia and Class III antiarrhythmics,
cisapride, erythromycin, antipsychotics, and tricyclic antidepressants.

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•Aortic aneurysm and dissection: Fluoroquinolones have been associated with aortic
aneurysm ruptures or dissection within 2 months following use, particularly in elderly
patients. Fluoroquinolones should not be used in patients with a known history of aortic
aneurysm or those at increased risk, including patients with peripheral atherosclerotic
vascular diseases, hypertension, genetic disorders involving blood vessel changes (eg,
Marfan syndrome, Ehlers-Danlos syndrome), and elderly patients, unless no other
treatment options are available. Longer treatment duration (eg, >14 days) may increase
risk
•Crystalluria: Rarely, crystalluria has occurred; urine alkalinity may increase the risk.
Ensure adequate hydration during therapy.
•Glucose regulation: Fluoroquinolones have been associated with disturbances in glucose
regulation, including hyperglycemia and hypoglycemia. These events have occurred most
often in patients receiving concomitant oral hypoglycemic agents or insulin. Severe cases
of hypoglycemia, including coma and death, have been reported. Diabetic patients should
be monitored closely for signs/symptoms of disordered glucose regulation. Discontinue if
a hypoglycemic reaction occurs and immediately initiate appropriate therapy.
•Hepatotoxicity: Hepatocellular, cholestatic, or mixed liver injury has been reported,
including hepatic necrosis, life-threatening hepatic events, and fatalities. Acute liver injury
can be rapid onset (range: 1 to 39 days) and is often associated with hypersensitivity. The
pattern of injury can be hepatocellular, cholestatic, or mixed. Most fatalities occurred in
patients >55 years of age. Discontinue immediately if signs/symptoms of hepatitis
(abdominal tenderness, dark urine, jaundice, pruritus) occur. Additionally, temporary
increases in transaminases or alkaline phosphatase, or cholestatic jaundice may occur
(highest risk in patients with previous liver damage.
•Hypersensitivity reactions: Severe hypersensitivity reactions, including anaphylaxis, have
occurred with fluoroquinolone therapy. The spectrum of these reactions can vary widely;
reactions may present as typical allergic symptoms (eg, itching, urticaria, rash, edema)
after a single dose, or may manifest as severe idiosyncratic dermatologic (eg, Stevens-
Johnson, toxic epidermal necrolysis), vascular (eg, vasculitis), pulmonary (eg,
pneumonitis), renal (eg, nephritis), hepatic (eg, hepatitis, jaundice, hepatic failure or
necrosis), and/or hematologic (eg, anemia, cytopenias) events, usually after multiple
doses. Prompt discontinuation of drug should occur if skin rash or other symptoms arise.

•Photosensitivity/phototoxicity: Avoid excessive sunlight and take precautions to limit

exposure (eg, loose fitting clothing, sunscreen); may cause moderate-to-severe
phototoxicity reactions which may appear as exaggerated sunburn reactions. Discontinue
use if phototoxicity occurs.
-Peripheral neuropathy: Fluoroquinolones have been associated with an increased risk of
peripheral neuropathy; may occur soon after initiation of therapy and may be
irreversible; discontinue immediately if symptoms of sensory or sensorimotor neuropathy
occur. Avoid use in patients who have previously experienced peripheral neuropathy.
-Psychiatric reactions: Fluoroquinolones have been associated with an increased risk of
psychiatric reactions, including toxic psychosis, hallucinations, or paranoia; may also
cause nervousness, agitation, delirium, attention disturbances, insomnia, anxiety,
nightmares, memory impairment, confusion, depression, and suicidal thoughts or actions.
Use with caution in patients with a history of or risk factor for mental illness. Reactions
may appear following the first dose; discontinue if reaction occurs and institute
appropriate therapy.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including
C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been

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observed >2 months postantibiotic treatment.

Storage • Vial: Store between 5°C to 30°C; avoid freezing. Protect from light. Diluted solutions of 0.5
to 2 mg/mL are stable for up to 14 days refrigerated or at room temperature.
• Tablet: Store between 20°C to 25°C; excursions are permitted between 15°C and 30°C.
• Refer to manufacturer PIL if there are specific considerations.

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2. Gatifloxacin
Watch Group

Generic Name Gatifloxacin

Dosage Eye drops 0.3%, 0.5%

form/strengths
Route of Ophthalmic
administration
Pharmacologic Fluoroquinolone; Antibiotic, Ophthalmic
action ATC: S01AE06

Indications Conjunctivitis: Treatment of bacterial conjunctivitis

Dosage
Regimen Dosing: Adult, Pediatric
Bacterial conjunctivitis: Ophthalmic:
• 0.3% solution
Days 1 and 2: Instill 1 drop into affected eye(s) every 2 hours while awake (maximum: 8
times/day).
Days 3 to 7: Instill 1 drop into affected eye(s) 4 times/day while awake.
• 0.5% solution
Day 1: Instill 1 drop into affected eye(s) every 2 hours while awake (maximum: 8 times/day)
Days 2 to 7: Instill 1 drop into affected eye(s) 2 to 4 times/day while awake
Dosage Dosing: Renal Impairment:
adjustment There are no dosage adjustments needed.
Dosing: Hepatic Impairment:
There are no dosage adjustments needed.
Contra- Hypersensitivity to gatifloxacin, other quinolones, or any component of the formulation
indications
Adverse Drug 1% to 10%:
Reactions Ophthalmic: Conjunctival hemorrhage, conjunctival irritation, conjunctivitis (worsening),
decreased visual acuity, dry eye syndrome, eye discharge, eye irritation, eye pain, eye redness,
eyelid edema, increased lacrimation, keratitis, papillary conjunctivitis

Monitoring Assess for signs of bacterial superinfection. Educate patients to report immediately to prescriber
Parameters vision changes, eye pain, severe eye irritation, signs of Stevens-Johnson syndrome/toxic
epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or
irritated eyes; or sores in mouth, throat, nose, or eyes), or eye or eyelid edema. Educate patients
about change in taste side effect.
Drug Ophthalmic: There are no known significant interactions.
Interactions
Pregnancy and Systemic concentrations of gatifloxacin following ophthalmic administration are below the limit
Lactation of quantification. pregnancy category C.
It is not known if gatifloxacin is excreted in breast milk. The decision to continue or discontinue
breast-feeding during therapy should take into account the risk of infant exposure, the benefits
of breast-feeding to the infant, and benefits of treatment to the mother.

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Administration Administration:
Ophthalmic:
For topical ophthalmic use only. Avoid touching tip of applicator to eye, fingers, or other
surfaces.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Hypersensitivity reactions: Hypersensitivity reactions, including anaphylactic reactions,
angioedema (including pharyngeal, laryngeal, or facial edema), dyspnea, urticaria, and itching,
have been reported (even following a single dose) with topical ophthalmic gatifloxacin. Rare
cases of Stevens-Johnson syndrome were also reported. If an allergic reaction occurs, discontinue
use.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection. If superinfection
is suspected, institute appropriate alternative therapy.
• QTc Interval Prolongation
• Disturbances in Blood Glucose
• Tendon Effects
• Peripheral neuropathy
Special populations:
• Contact lens wearers: Contact lenses should not be worn during treatment of ophthalmic
infections.
Dosage form specific issues:
• Appropriate use: For topical ophthalmic use only. Do not inject ophthalmic solution
subconjunctivally or introduce directly into the anterior chamber of the eye (may cause corneal
endothelial cell injury).

Storage Store between 15°C to 25°C; protect from freezing.

Refer to manufacturer PIL if there are specific considerations.

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3. Levofloxacin
Watch Group

Generic Name Levofloxacin

Dosage Vial 500mg, 750mg

form/strengths Tablets 250mg, 500mg, 750mg
Eye drops 0.5% (5mg/ml)

Route of IV, Oral, Ophthalmic solution

administration
Pharmacologic Antibiotic, Fluoroquinolone
al action Systemic ATC: J01MA12
Ophthalmic ATC: S01AE05
Indications Treatment of community-acquired pneumonia, including multidrug-resistant strains
of Streptococcus pneumoniae (MDRSP); nosocomial pneumonia; chronic obstructive pulmonary
disease, acute exacerbation; rhinosinusitis, acute bacterial (ABRS); prostatitis (chronic bacterial);
urinary tract infection (uncomplicated or complicated); acute pyelonephritis; skin or skin
structure infections (uncomplicated or complicated); inhalational anthrax (postexposure) to
reduce incidence or disease progression; prophylaxis and treatment of plague (pneumonic and
septicemic) due to Yersinia pestis
Limitations of use: Because fluoroquinolones have been associated with disabling and potentially
irreversible serious adverse reactions (eg, tendinopathy and tendon rupture, peripheral
neuropathy, CNS effects), reserve levofloxacin for use in patients who have no alternative
treatment options for acute exacerbation of chronic bronchitis, acute bacterial sinusitis, and
uncomplicated urinary tract infections.
Dosage Conventional dosing:
Regimen Adult: Oral/IV :500-750 mg once daily
Pediatric:
Note: In pediatric patients, fluoroquinolones are not routinely first-line therapy, but after
assessment of risks and benefits, can be considered a reasonable alternative for situations where
no safe and effective substitute is available (eg, multidrug resistance) or in situations where the
only alternative is parenteral therapy and levofloxacin offers an oral therapy option.
Oral, IV
6 months to <5 years: 8 to 10 mg/kg/dose twice daily
≥5 years: 10 mg/kg/dose once daily;
maximum dose: 750 mg/day

Bacterial conjunctivitis: Ophthalmic: Adult, pediatric

Treatment day 1 and day 2: Instill 1 to 2 drops into affected eye(s) every 2 hours while awake, up
to 8 times daily
Treatment day 3 through day 7: Instill 1 to 2 drops into affected eye(s) every 4 hours while
awake, up to 4 times daily
Note:
Dosages of oral and IV levofloxacin are identical.
Safety of levofloxacin given for >28 days in adults and >14 days in pediatric patients not studied,

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Dosage Renal impairment: Adult
adjustment
Usual Daily Clcr (mL/min) Dosage for Renal Impairment
Dosage for
Normal Renal
Function (Clcr ≥
50 mL/min)
20–49 Dosage adjustment not required
10–19 Uncomplicated UTIs: Dosage adjustment
not required.
250 mg
Other infections: 250 mg once every 48
hours
Hemodialysis or Information not available
CAPD patients
20–49 Initial 500-mg dose, then 250 mg once
every 24 hours
10–19 Initial 500-mg dose, then 250 mg once
500 mg every 48 hours
Hemodialysis or Initial 500-mg dose, then 250 mg once
CAPD patients every 48 hours; supplemental doses not
required after dialysis
20–49 750 mg once every 48 hours
10–19 Initial 750-mg dose, then 500 mg once
every 48 hours
750 mg
Hemodialysis or Initial 750-mg dose, then 500 mg once
CAPD patients every 48 hours; supplemental doses not
required after dialysis

Dosing: Renal Impairment: Pediatric

Infants, Children, and Adolescents: IV, Oral: The following adjustments have been
recommended. Note: Renally adjusted dose recommendations are based on doses of 5 to 10
mg/kg/dose every 12 hours in ages ≤5 years and 5 to 10 mg/kg/dose every 24 hours in ages
>5 years.
GFR ≥30 mL/minute/1.73 m2: No adjustment necessary
GFR 10 to 29 mL/minute/1.73 m2: 5 to 10 mg/kg/dose every 24 hours
GFR <10 mL/minute/1.73 m2: 5 to 10 mg/kg/dose every 48 hours
Intermittent hemodialysis: 5 to 10 mg/kg/dose every 48 hours; not removed by
hemodialysis; supplemental levofloxacin doses are not required
Peritoneal dialysis (PD): 5 to 10 mg/kg/dose every 48 hours; not removed by peritoneal
dialysis; supplemental levofloxacin doses are not required
Continuous renal replacement therapy (CRRT): 10 mg/kg/dose every 24 hours
• No dosage adjustment for hepatic impairment.
Contra- Hypersensitivity to levofloxacin, any component of the formulation, or other quinolones
indications
Adverse Drug Adverse Reactions (Significant): Considerations
Reactions Aortic aneurysm/aortic dissection
CNS effects/neuroexcitation

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Clostridioides difficile infection
Glucose regulation/dysglycemia
Hepatotoxicity
Hypersensitivity reactions (immediate and delayed)
Myasthenia gravis
Peripheral neuropathy
Phototoxicity/photoallergy
QT prolongation
1% to 10%:
Cardiovascular: Chest pain (1%), edema (1%)
Dermatologic: Pruritus (1%), skin rash (2%)
Gastrointestinal: Abdominal pain (2%), constipation (3%), diarrhea (5%), dyspepsia (2%), nausea
(7%), vomiting (2%)
Genitourinary: Vaginitis (1%)
Infection: Candidiasis (1%)
Local: Injection site reaction (1%)
Nervous system: Dizziness (3%), headache (6%), insomnia (4%)
Respiratory: Dyspnea (1%)
Monitoring Evaluation of organ system functions (renal, hepatic, and hematopoietic) is recommended
Parameters periodically during therapy; the possibility of crystalluria should be assessed; WBC and signs of
infection, altered mental status, signs and symptoms of tendonitis; signs and symptoms of
disordered glucose regulation
Drug Risk X: Avoid combination
Interactions Aminolevulinic Acid Amiodarone BCG (Intravesical) Antacids Cholera Vaccine Fexinidazole
Nadifloxacin Pimozide QT-prolonging Class IA Antiarrhythmics QT-prolonging Class III
Antiarrhythmics Strontium Ranelate
Risk D: Consider therapy modification
Antacids: Exception: Sodium Bicarbonate Calcium Salts Delamanid Didanosine Domperidone Iron
Preparations Lanthanum Methadone Magnesium Salts Multivitamins/Minerals (with ADEK,
Folate, Iron) Multivitamins/Minerals (with AE, No Iron) QT-prolonging Kinase Inhibitors QT-
prolonging Miscellaneous Agents Quinapril Sevelamer Sodium Picosulfate Sucralfate Typhoid
Vaccine Zinc Salts
Pregnancy and Pregnancy risk factor C
Lactation When administered orally or IV, levofloxacin enters breast milk. The amount of levofloxacin
available systemically following topical application of the ophthalmic drops is significantly less in
comparison to oral or IV doses. Caution be exercised when administering levofloxacin ophthalmic
drops to nursing women.
Administration Administration: IV
Infuse 250 to 500 mg IV solution over 60 minutes; infuse 750 mg IV solution over 90 minutes. Too
rapid of infusion can lead to hypotension.
Avoid administration through an intravenous line with a solution containing multivalent cations
(eg, magnesium, calcium). Maintain adequate hydration of patient to prevent crystalluria or
cylindruria.
Administration: Oral
Tablets may be administered without regard to meals. Maintain adequate hydration of patient to
prevent crystalluria.
Administer at least 2 hours before or 2 hours after antacids containing magnesium or aluminum,
sucralfate, metal cations (eg, iron), multivitamin preparations with zinc, or didanosine
chewable/buffered tablets or the pediatric powder for solution.
Preparation for Administration:

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Solution for injection: Single-use vials must be further diluted in compatible solution (eg, D5W,
NS) to a final concentration of 5 mg/mL prior to infusion.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Altered cardiac conduction
• Aortic aneurysm and dissection: Fluoroquinolones have been associated with aortic
aneurysm ruptures or dissection within 2 months following use, particularly in elderly patients.
• Glucose regulation: including hyperglycemia and hypoglycemia. Diabetic patients should be
monitored closely.
• Hepatotoxicity: Unrelated to hypersensitivity, severe hepatotoxicity (including acute hepatitis
and fatalities) has been reported. Elderly patients may be at greater risk.
• Hypersensitivity reactions: Severe hypersensitivity reactions, including anaphylaxis, have
occurred with quinolone therapy.
• Phototoxicity: Avoid excessive sunlight and take precautions to limit exposure (eg, loose-
fitting clothing, sunscreen)
• Serious adverse reactions: [US Boxed Warning]: Fluoroquinolones are associated with
disabling and potentially irreversible serious adverse reactions that may occur together,
including tendinitis and tendon rupture, peripheral neuropathy, and CNS effects. Discontinue
levofloxacin immediately and avoid use of fluoroquinolones in patients who experience any of
these serious adverse reactions. Patients of any age or without preexisting risk factors have
experienced these reactions; may occur within hours to weeks after initiation.
- CNS effects: May occur following the first dose; discontinue immediately and avoid further
use of fluoroquinolones in patients who experience these reactions.
Avoid use in patients who have previously experienced peripheral neuropathy.
- Psychiatric reactions: Use with caution in patients with a history of or risk factor for
depression. Reactions may occur following the first dose; discontinue if reaction occurs and
institute appropriate therapy.
- Tendinitis/tendon rupture: risk may be increased with concurrent corticosteroids, solid organ
transplant recipients, and in patients >60 years of age, but has also occurred in patients
without these risk factors. Discontinue at first sign of tendon pain, swelling, inflammation or
rupture.
• Superinfection: Prolonged use
Disease-related concerns:
• Myasthenia gravis: [US Boxed Warning]: May exacerbate muscle weakness related to
myasthenia gravis; avoid use in patients with known history of myasthenia gravis.
• Renal impairment: dosage adjustment required. May increase risk of tendon rupture.
• Rheumatoid arthritis: Use with caution. may increase risk of tendon rupture.
Special populations:
• Elderly: Adverse effects (eg, hepatotoxicity, tendon rupture, QT changes, aortic dissection)
may be increased in the elderly.
• G6PD deficiency: Hemolytic reactions may (rarely) occur with quinolone use in patients with
latent or actual G6PD deficiency.
• Pediatric: Safety of use in pediatric patients for >14 days of therapy has not been studied;
increased incidence of musculoskeletal disorders (eg, arthralgia, tendon rupture) has been
observed in children.
Other warnings/precautions:
• Appropriate use: [US Boxed Warning]: Reserve use of levofloxacin for treatment of acute
bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, or uncomplicated urinary
tract infection for patients who have no alternative treatment options because of the risk of
disabling and potentially serious adverse reactions (eg, tendinitis and tendon rupture,

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peripheral neuropathy, CNS effects).

Storage • Vial: Store at room temperature. Protect from light.

• Diluted solution (5 mg/mL) is stable in NS, D5W, D5NS, D5LR or sodium lactate for 72 hours
when stored at room temperature; stable for 14 days when stored under refrigeration.
• Premixed: Store at ≤25°C; do not freeze. Brief exposure to 40°C does not adversely affect the
product. Protect from light.
• Tablet, oral solution: Store at 25°C; excursions permitted to 15- 30°C.
• Refer to manufacturer PIL if there are specific considerations.

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4. Lomefloxacin
Watch Group

Generic Name Lomefloxacin

Dosage -Ophthalmic Solution, eye drops: 3 mg/ml

form/strengths -Film coated tablets : 400 mg
Route of Oral ,Ophthalmic
administration
Pharmacologic Antibiotic, Quinolone
category Systemic ATC: J01MA07
Opthalmic ATC: S01AE04
Indications -Tablets:
1-Treatment of adults with mild to moderate infections caused by susceptible strains of the
designated microorganisms in the following conditions:
a-Lower respiratory tract:
-Acute Bacterial Exacerbation of Chronic Bronchitis caused by Haemophilus, influenzae or
Moraxella catarrhalis
b-Urinary tract:
-Uncomplicated Urinary Tract Infections (cystitis) caused by Escherichia coli, Klebsiella
pneumoniae, Proteus mirabilis, or Staphylococcus saprophyticus
-Complicated Urinary Tract Infections caused by Escherichia coli, Klebsiellapneumoniae, Proteus
mirabilis, Pseudomonas aeruginosa, Citrobacter diversus, or Enterobacter cloacae
2-Prevention of infection in the following situations:
-Transrectal prostate biopsy
-Transurethral surgical procedures
-Ophthalmic Solution:
-Bacterial infections, including conjunctivitis, blepharitis, blepharoconjunctivitis which are due to
Lomefloxacin susceptible germs and Staphylococcus aureus- induced corneal ulcers.
Dosage -Oral Dosing Adults:
Regimen -Treatment:
1-Acute bacterial exacerbation of chronic bronchitis: 400 mg once daily for 10 days
2-Uncomplicated cystitis in females caused by E coli: 400 mg once daily for 3 days
3-Uncomplicated cystitis caused by K pneumoniae, P mirabilis, or S Saprophyticus: 400 mg once
daily for 10 days
4-Complicated UTI: 400 mg once daily for 14 days
-Prevention:
-Transrectal prostate biopsy: 400 mg single dose 1–6 hours prior to procedure
-Transurethral surgical procedures: 400 mg single dose 2–6 hours prior to procedure
-Ophthalmic solution:
-Adults and children (above 1 year of age):
-Initial:5 drops within 20 minutes or 1 drop every hour during 6-10 hours.
-Maintenance: 1 drop to be instilled 2-3 times daily into the lower conjunctival sac.
Duration of the treatment: 7 to 9 days.
Dosage -Oral:
adjustment -Renal impairment:
-Creatinine clearance > 10 mL/min/1.73 m2 but < 40 mL/min/1.73 m2:
initial loading dose of 400 mg followed by daily maintenance doses
of 200 mg once daily for the duration of treatment.
-Hepatic impairment:

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-No dosage adjustment needed.

Contra- -History of hypersensitivity to lomefloxacin or any member of the quinolone group

indications
Adverse Drug -Headache (3.6%), nausea (3.5%), photosensitivity (2.3%), dizziness (2.1%), diarrhea (1.4%), and
Reactions abdominal pain (1.2%)

Monitoring No needed data

Parameters
Drug -Tablets:
Interactions Antacids and sucralfate, Probenecid
-Opthalamic:
Preparations containing heavy metals, such as zinc , Bacteriostatic ophthalmic antibiotics
Pregnancy and pregnancy category C
Lactation Contraindicated (Use only if no other alternatives)
Lactation: No Human Data—Probably Compatible
Administration -Tablets:
Administered orally without regard to meals. Sucralfate and antacids containing magnesium or
aluminum should not be taken within 4 hours before or 2 hours after taking lomefloxacin.
-Ophthalamic:
-Administered without regard to meals.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Tablets:
Precautions -Drug should be administered 12 hours before exposure to direct or indirect sunlight (including
exposure through glass and exposure through sunscreens and sunblocks) and artificial ultraviolet
light (eg, sunlamps)
-Drug should be discontinued l at the first signs or symptoms of phototoxicity reaction such as a
sensation of skin burning, redness, swelling, blisters, rash, itching, or dermatitis
patient who has experienced a phototoxic reaction should avoid re-exposure to sunlight and
artificial ultraviolet light until he has completely
recovered from the reaction.
-Patient should drink fluids liberally.
-Caution before operating an automobile or machinery or engaging in activities requiring mental
alertness and coordination as drug causes dizziness and lightheadedness
- Treatment should be discontinued and physician informed if patient experience pain,
inflammation, or rupture of a tendon, and to rest and refrain from exercise until diagnosis of
tendinitis or tendon rupture has been confidently excluded
-Caution in patients with history of convulsion
- Should be avoided in patients with known prolongation of the QT interval, patients with
uncorrected hypokalemia, and patients receiving class IA (quinidine, procainamide), or class III
(amiodarone, sotalol) antiarrhythmic agents.

-Ophthalmic:
-Intensive exposure to sunlight or UV radiation should be avoided
Storage Store at (15° to 25°C).
Refer to manufacturer PIL if there are specific considerations.

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Watch Group
5. Moxifloxacin
Generic Name Moxifloxacin

Dosage Tablets 400mg,

form/strengths Ophthalmic solution 0.5%
Vial 400mg
Route of Oral, ophthalmic, IV
administration
Pharmacologic Antibiotic, Fluoroquinolone;
action Systemic ATC: J01MA14
Ophthalmic ATC: S01AE07
Indications Treatment of mild to moderate community-acquired pneumonia, including multidrug-
resistant Streptococcus pneumoniae (MDRSP); acute bacterial exacerbation of chronic
bronchitis; acute bacterial rhinosinusitis; complicated and uncomplicated skin and skin
structure infections; complicated intra-abdominal infections; prophylaxis and treatment of
plague, including pneumonic and septicemic plague, due to Yersinia pestis.

Limitations of use: Because fluoroquinolones have been associated with disabling and
potentially irreversible serious adverse reactions (eg, tendinopathy and tendon rupture,
peripheral neuropathy, CNS effects), reserve use of moxifloxacin for acute exacerbation of
chronic bronchitis or acute sinusitis for patients who have no alternative treatment options.

Bacterial conjunctivitis: Treatment of bacterial conjunctivitis caused by susceptible

organisms
Dosage Dosing: Adult
Regimen Oral, IV: 400 mg once daily
Duration: Individualize based on rapidity of culture conversion, extent of disease, and
patient-specific factors, including clinical response and toxicity
Bacterial conjunctivitis: Ophthalmic:
Instill 1 drop into affected eye(s) 2-3 times daily for 7 days.

Dosing: Pediatric
Note: In pediatric patients, fluoroquinolones are not routinely first-line therapy, but after
assessment of risks and benefits, can be considered a reasonable alternative for situations
where no safe and effective substitute is available (eg, multidrug resistance), limited data
available about dosing.

Dosage Dosing: Renal Impairment: Adult

adjustment No dosage adjustment necessary.
Dosing: Hepatic Impairment:
No dosage adjustment necessary; however, use with caution in this patient population
secondary to the risk of QT prolongation.

Contra- Hypersensitivity to moxifloxacin, other quinolone antibiotics, or any component of the

indications formulation

Adverse Drug 1% to 10%:

Reactions Central nervous system: Headache (4%), dizziness (3%), insomnia (2%)
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Endocrine & metabolic: Decreased serum glucose (≥2%), hyperchloremia (≥2%), increased
serum albumin (≥2%), hypokalemia (1%)
Gastrointestinal: Nausea (7%), diarrhea (6%), decreased amylase (≥2%), constipation (2%),
vomiting (2%), abdominal pain (1% to 2%), dyspepsia
Hematologic & oncologic: Decreased basophils (≥2%), decreased red blood cells (≥2%),
eosinopenia (≥2%), increased MCH (≥2%), increased neutrophils (≥2%), leukocytosis (≥2%),
prolonged prothrombin time (≥2%), anemia (1%)
Hepatic: Decreased serum bilirubin (≥2%), increased serum bilirubin (≥2%), increased serum
alanine aminotransferase (1%)
Immunologic: Increased serum globulins (≥2%)
Renal: Increased ionized serum calcium (≥2%)
Respiratory: Hypoxia (≥2%)
Miscellaneous: Fever (1%)

Monitoring WBC, signs of infection, signs/symptoms of disordered glucose regulation, ECG in patients
Parameters with liver cirrhosis

Drug • Risk X: Avoid combination

Interactions Aminolevulinic Acid BCG (Intravesical) Cholera Vaccine Nadifloxacin Pimozide QT-
prolonging Agents Strontium Ranelate
• Risk D: Consider therapy modification
Delamanid Didanosine Iron Preparations Lanthanum Magnesium Salts
Multivitamins/Minerals (with ADEK, Folate, Iron) Quinapril Sevelamer Sodium Picosulfate
Sucralfate Typhoid Vaccine Zinc Salts
• Risk C: Monitor therapy
Agents with Blood Glucose Lowering Effects Amisulpride Amphetamines BCG Vaccine
(Immunization Corticosteroids Haloperidol Heroin Hydroxychloroquine Lactobacillus and
Estriol: Methylphenidate Mycophenolate Nonsteroidal Anti-Inflammatory Agents
Ondansetron Pentamidine Porfimer QT-prolonging Agents Varenicline Verteporfin
Vitamin K Antagonists
Pregnancy and Pregnancy Category C
Lactation It is not known if moxifloxacin is present in breast milk.

According to the manufacturer, the decision to breastfeed during therapy should consider
the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of
treatment to the mother. Use of fluoroquinolone antibiotics should be avoided if alternative
agents are available
Administration IV: Infuse over 60 minutes; do not infuse by rapid or bolus intravenous infusion.
Oral: Administer without regard to meals. Administer at least 4 hours before or 8 hours after
products containing magnesium, aluminum, iron, or zinc, including antacids, sucralfate,
multivitamins, and didanosine (buffered tablets for oral suspension or the pediatric powder
for oral solution).
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Altered cardiac conduction: Fluoroquinolones may prolong QTc interval; avoid use in
patients with known QTc prolongation, ventricular arrhythmias including torsades de
pointes, proarrhythmic conditions (eg, clinically significant bradycardia, acute myocardial
ischemia), uncorrected hypokalemia, hypomagnesemia, or concurrent administration of

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other medications known to prolong the QT interval (including Class Ia and Class III
antiarrhythmics, cisapride, erythromycin, antipsychotics, and tricyclic antidepressants).
• Aortic aneurysm and dissection: Fluoroquinolones have been associated with aortic
aneurysm ruptures or dissection within 2 months following use, particularly in elderly
patients.
• Glucose regulation: Fluoroquinolones have been associated with disturbances in glucose
regulation, including hyperglycemia and hypoglycemia.
• Hepatotoxicity: Fulminant hepatitis potentially leading to liver failure (including fatalities)
has been reported with use; patients should be advised to discontinue treatment and
promptly report signs/ symptoms of hepatitis (eg, abdominal pain, jaundice, dark urine, pale
stools).
• Hypersensitivity reactions: Severe hypersensitivity reactions, including anaphylaxis, have
occurred with quinolone therapy. The spectrum of these reactions can vary widely; reactions
may present as typical allergic symptoms (eg, itching, urticaria, rash, edema) after a single
dose, or may manifest as severe idiosyncratic dermatologic (eg, Stevens-Johnson, toxic
epidermal necrolysis), vascular (eg, vasculitis), pulmonary (eg, pneumonitis), renal (eg,
nephritis), hepatic (eg, hepatic failure or necrosis), and/or hematologic (eg, anemia,
cytopenias) events, usually after multiple doses. Prompt discontinuation of drug should occur
if skin rash or other symptoms arise.
• Photosensitivity: Avoid excessive sunlight and take precautions to limit exposure (eg, loose
fitting clothing, sunscreen); may rarely cause moderate to severe phototoxicity reactions.
Discontinue use if phototoxicity occurs.
• Serious adverse reactions: [US Boxed Warning]: Fluoroquinolones are associated with
disabling and potentially irreversible serious adverse reactions that may occur together,
including tendinitis and tendon rupture, peripheral neuropathy, and CNS effects. Discontinue
moxifloxacin immediately and avoid use of fluoroquinolones in patients who experience any
of these serious adverse reactions. Patients of any age or without pre-existing risk factors
have experienced these reactions; may occur within hours to weeks after initiation.
- CNS effects: Fluoroquinolones have been associated with an increased risk of CNS effects
including seizures, increased intracranial pressure (including pseudotumor cerebri),
lightheadedness, dizziness, and tremors.
- Peripheral neuropathy
- Psychiatric reactions: Fluoroquinolones have been associated with an increased risk of
psychiatric reactions, including toxic psychosis, hallucinations, or paranoia; may also cause
nervousness, agitation, delirium, attention disturbances, insomnia, anxiety, nightmares,
memory impairment, confusion, depression, and suicidal thoughts or actions.
- Tendinitis/tendon rupture: Fluoroquinolones have been associated with an increased risk of
tendonitis and tendon rupture in all ages
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C.
difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been
observed >2 months postantibiotic treatment.
Disease-related concerns:
• Cardiovascular disease: Use with caution in patients with significant bradycardia or acute
myocardial ischemia.
• Diabetes: Use with caution in patients with diabetes mellitus; glucose regulation may be
altered.
• Hepatic impairment: Use with caution in patients with mild, moderate, or severe hepatic
impairment or liver cirrhosis; may increase the risk of QT prolongation.
• Myasthenia gravis: [US Boxed Warning]: May exacerbate muscle weakness related to
myasthenia gravis; avoid use in patients with known history of myasthenia gravis. Cases of

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severe exacerbations, including the need for ventilatory support, and deaths have been
reported.
• Rheumatoid arthritis: Use with caution in patients with rheumatoid arthritis; may increase
risk of tendon rupture.
Special populations:
• Elderly: Adverse effects (eg, tendon rupture, QT changes) may be increased in elderly
patients.
• G6PD deficiency: Hemolytic reactions may (rarely) occur with quinolone use in patients
with latent or actual G6PD deficiency.
• Pediatric: Efficacy of systemically administered moxifloxacin (oral, intravenous) have not
been established in pediatric patients.
Other warnings/precautions:
• Appropriate use: [US Boxed Warning]: Reserve use of moxifloxacin for treatment of acute
bacterial sinusitis or acute bacterial exacerbation of chronic bronchitis for patients who have
no alternative treatment options because of the risk of disabling and potentially serious
adverse reactions (eg, tendinitis and tendon rupture, peripheral neuropathy, CNS effects).
Storage Store at 25°C; excursions are permitted between 15°C and 30°C. Avoid high humidity. Do not
refrigerate infusion solution; discard unused portion.
Opthalmic: Store at 2°C to 25°C
Refer to manufacturer PIL if there are specific considerations.

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6. Norfloxacin
Watch Group

Generic Name Norfloxacin

Dosage -Tablets: 400 mg

form/strengths -Ophthalmic solution: 15 mg/5ml
Route of Oral, Ophthalmic
administration
Pharmacologic Antibiotic, Fluoroquinolone
category ATC systemic: J01MA06
ATC: Ophthalmic: S01AE02
Indications -Tablets:
Uncomplicated and complicated urinary tract infections caused by susceptible gram-negative
and gram-positive bacteria
-Opthalmic solution:
Treatment of conjunctivitis caused by susceptible strains
Dosage -Tablets: Adult dosing
Regimen -Prostatitis: Oral: 400 mg every 12 hours for 4 to 6 weeks
-Urinary tract infection:
-Cystitis, acute uncomplicated or acute simple cystitis: Oral: 400 mg twice daily for 3 days
(females) or 5 days (males)
-Complicated (including pyelonephritis): Oral: 400 mg twice daily for 5 to 7 days

-Ophthalmic solution:
-Adults and pediatric ≥1 year : one or two drops to be instilled in each eye 4 times/day for 7 days
Dosage -Oral:
adjustment -Renal Impairment:
CrCl ≤30 mL/minute/1.73 m2: 400 mg once daily
-Hepatic Impairment:
- Norfloxacin is eliminated primarily through biliary and renal excretion and is only moderately
metabolized in the liver. Cases of hepatitis have been reported with norfloxacin. Specific dosage
adjustment are not available
Contra- -Tablets & Ophthalmic solution:
indications -Hypersensitivity to norfloxacin, quinolones, or any component of the formulation
-Tablets only:
- History of tendonitis or tendon rupture associated with quinolone use
Adverse Drug -Oral:
Reactions 1 – 10%:
-Gastrointestinal: Nausea (2%)
-Nervous system: Dizziness (1%), headache (2%)
-Ophthalmic:
-Local burning ,discomfort ,bitter taste following instillation ,conjunctival hyperemia ,
photophobia,corneal deposits , chemosis
Monitoring -Tablets:
Parameters -CBC, Renal and hepatic function
-Ophthalmic solution:
Response of bacteria to drug

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Drug -Tablets:
Interactions Risk X: Avoid combination
Aminolevulinic Acid, BCG (Intravesical), Cholera Vaccine, Nadifloxacin, Nitrofurantoin, Strontium
Ranelate
Risk D: Consider therapy modification
Antacids, Calcium Salts, Delamanid, Didanosine, Iron Preparations, Lanthanum, Magnesium
Salts, Multivitamins/Minerals, Sevelamer, Sodium Picosulfate, Sucralfat, Typhoid Vaccine, Zinc.
Pregnancy and Pregnancy Category C
Lactation It is not known if concentrations would be detectable after a higher dose than 200 mg or
multiple doses. Due to the potential for serious adverse reactions in the nursing infant, the
manufacturer recommends a decision be made whether to discontinue nursing or to discontinue
the drug, taking into account the importance of treatment to the mother.
Administration -Tablets:
- Administer on an empty stomach with water (at least 1 hour before or 2 hours after meals,
milk, or other dairy products).
-Hold antacids, sucralfate, or multivitamins/supplements containing iron, zinc, magnesium, or
aluminum for at least 2 hours before or after giving norfloxacin; do not administer together
Refer to manufacturer PIL if there are specific considerations.
Warnings/ -Tablets:
Precautions -Avoid use in patients with a history of QTc prolongation, uncorrected hypokalemia,
hypomagnesemia, or concurrent administration of other medications known to prolong the QT
interval (including Class Ia and Class III antiarrhythmics, cisapride, erythromycin, antipsychotics,
and tricyclic antidepressants).
-Should not be used in patients with a known history of aortic aneurysm or those at increased
risk, including patients with peripheral atherosclerotic vascular diseases, hypertension, genetic
disorders involving blood vessel changes (eg, Marfan syndrome, Ehlers-Danlos syndrome), and
elderly patients, unless no other treatment options are available
-Patients should be monitored closely for signs/symptoms of disordered glucose regulation.
-Avoid excessive sunlight and take precautions to limit exposure (eg, loose fitting clothing,
sunscreen); may cause moderate-to-severe phototoxicity reactions. Discontinue use if
photosensitivity occurs.
-Use with caution in patients with known or suspected CNS disorder, or risk factors that may
predispose to seizures or lower the seizure threshold.
-Avoid use in patients who have previously experienced peripheral neuropathy
-Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated
diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months
postantibiotic treatment.
-avoid use in patients with known history of myasthenia gravis
-use with caution in patients with renal or hepatic impairment
-Hemolytic reactions may (rarely) occur with fluoroquinolone use in patients with G6PD
deficiency
-Fluoroquinolones have been associated with an increased risk of tendonitis and tendon rupture
in all ages; risk may be increased with concurrent corticosteroids, solid organ transplant
recipients, and in patients >60 years of age, but has also occurred in patients without risk factors
Storage -Tablets: Store at 25°C; excursions permitted to 15°C to 30°C.
-Ophthalmic: Store at 15-30oC. Protect from light
Refer to manufacturer PIL if there are specific considerations.

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Watch Group
7. Ofloxacin
Generic Name Ofloxacin

Dosage Tablets: 200mg, 300mg, 400mg

form/strengths Ophthalmic solution 3mg/ml
Route of Oral, Ophthalmic
administration
Pharmacologic Antibiotic, Fluoroquinolone
action Systemic ATC: J01MA01
Opthalmic ATC: S01AE01
Indications Treatment of:
Community-acquired pneumonia,
Skin and soft tissue infections (uncomplicated),
Urethritis and cervicitis (nongonococcal) due to Chlamydia trachomatis infection,
Pelvic inflammatory disease (acute),
Cystitis (uncomplicated),
Urinary tract infections (complicated),
Prostatitis
Opthalmic: Treatment of Bacterial conjunctivitis and Corneal ulcer
Dosage Dosing: Adult
Regimen usual adult dose: 200 to 400 mg every 12 hours
Cervicitis/urethritis: Oral:
Nongonococcal (due to Chlamydia trachomatis) (alternative agent):
300 mg every 12 hours for 7 days
Pelvic inflammatory disease, outpatient therapy, mild to moderate disease (alternative
agent):
Oral: 400 mg every 12 hours for 10 to 14 days. Guidelines recommend use of a
fluoroquinolone in combination with metronidazole
Skin and soft tissue infection, uncomplicated: Oral: 400 mg every 12 hours. Treat for 5 to 14
days depending on severity and clinical response.
Urinary tract infection:
o Cystitis, acute uncomplicated or acute simple cystitis (infection limited to the bladder
without signs/symptoms of upper tract, prostate, or systemic infection) (alternative
agent):
Note: Use is discouraged due to safety concerns and increasing resistance; reserve for
those who have no alternative treatment options.
Oral: 200 mg every 12 hours for 3 days (females) or 5 days (males).
o Urinary tract infection, complicated (including pyelonephritis):
Note: If the prevalence of fluoroquinolone resistance is >10%, an initial dose of a long-
acting parenteral antimicrobial (eg, ceftriaxone) followed by oral therapy is
recommended for outpatients.
Oral: 200 mg every 12 hours for 5 to 7 days
Dosing: Pediatric
Susceptible infection: Limited data available: Children:
Oral: 15 mg/kg/day divided every 12 hours
Children weighing ≥45 kg and Adolescents: Oral: 300-400 mg twice daily

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Opthalmic Adult, Pediatric
Bacterial conjunctivitis: Ophthalmic: Initial: Instill 1 to 2 drops in affected eye(s) every 2 to 4
hours for the first 2 days (Days 1 and 2); then instill 1 to 2 drops 4 times daily for an
additional 5 days (Days 3 through 7)
Corneal ulcer:
Ophthalmic: Initial: Instill 1 to 2 drops in affected eye(s) every 30 minutes while awake and
every 4 to 6 hours at night for the first 2 days (Days 1 and 2); then instill 1 to 2 drops every
hour while awake for 4 to 6 additional days (Days 3 through 7 to 9); thereafter, 1 to 2 drops 4
times daily until clinical cure is achieved

Dosage Dosing: Renal Impairment: Adult

adjustment Oral: After a normal initial dose, adjust as follows:
CrCl >50 mL/minute: No dosage adjustment necessary.
CrCl 20 to 50 mL/minute: Administer usual recommended dose every 24 hours.
CrCl <20 mL/minute: Administer half the usual recommended dose every 24 hours.
Intermittent hemodialysis (IHD): 100 to 200 mg after dialysis
Peritoneal dialysis: 200 mg every 24 hours
Continuous renal replacement therapy (CRRT): 300 mg every 24 hours
Dosing: Hepatic Impairment: Adult
Use with caution.
Severe impairment (eg, cirrhosis with or without ascites): Maximum dose: 400 mg/day
Dosing: Renal Impairment: Pediatric
There are no specific pediatric recommendations; based on experience in adult patients,
dosing adjustment is suggested.
Dosing: Hepatic Impairment: Pediatric
There are no specific pediatric recommendations; based on experience in adult patients,
dosing adjustment is suggested.
Contra- Hypersensitivity to ofloxacin, other quinolones, or any component of the formulation
indications
Adverse Drug Oral:
Reactions 1% to 10%:
Cardiovascular: Chest pain (1% to 3%)
Central nervous system: Headache (1% to 9%), insomnia (3% to 7%), dizziness (1% to 5%),
fatigue (1% to 3%), drowsiness (1% to 3%), sleep disorder (1% to 3%), nervousness (1% to
3%), pain (trunk)
Dermatologic: Pruritus (≤3%), skin rash (≤3%), genital pruritus (women: 1% to 3%)
Gastrointestinal: Nausea (3% to 10%), diarrhea (1% to 4%), vomiting (1% to 4%), abdominal
cramps (1% to 3%), constipation (1% to 3%), decreased appetite (1% to 3%), dysgeusia (1% to
3%), flatulence (1% to 3%), gastrointestinal distress (1% to 3%), xerostomia (1% to 3%)
Genitourinary: Vaginitis (1% to 5%)
Ophthalmic: Visual disturbance (1% to 3%)
Respiratory: Pharyngitis (1% to 3%)
Miscellaneous: Fever (1% to 3%)
Ophthalmic:
Blurred vision, burning sensation of eyes, conjunctivitis (chemical), eye discomfort, eye pain,
eye pruritus, eye redness, keratitis (chemical), lacrimation, photophobia, stinging of eyes,
swelling of eye, xerophthalmia
Monitoring Monitor CBC, renal and hepatic function periodically if therapy is prolonged; signs and
Parameters symptoms of disordered glucose regulation.

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Drug Oral:
Interactions Risk X: Avoid combination
Aminolevulinic Acid BCG (Intravesical) Cholera Vaccine Fexinidazole Nadifloxacin Strontium
Ranelate
Risk D: Consider therapy modification
Antacids Calcium Salts Delamanid Didanosine Iron Preparation Lanthanum Magnesium Salts
Risk C: Monitor therapy
Agents with Blood Glucose Lowering Effects: Amphetamines BCG
Vaccine Corticosteroids Haloperidol Lactobacillus and Estriol Methylphenidate
Mycophenolate Nonsteroidal Anti-Inflammatory Agents Probenecid QT-prolonging Agents
Theophylline Derivatives Varenicline Verteporfin Vitamin K Antagonists
Pregnancy and Pregnancy Risk Factor C
Lactation Ofloxacin is excreted in breast milk. Due to the potential for serious adverse reactions in the
nursing infant, the manufacturer recommends a decision be made whether to discontinue
nursing or to discontinue the drug, taking into account the importance of treatment to the
mother.
Administration Oral:
Administer with or without food.
Do not take within 2 hours of sucralfate, didanosine, iron, zinc, or antacids containing
magnesium, calcium, or aluminum. drink plenty of fluids to maintain proper hydration and
urine output
Ophthalmic
For ophthalmic use only; not for injection. Avoid touching tip of applicator to eye, fingers, or
other surfaces.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Altered cardiac conduction: Fluoroquinolones may prolong QTc interval; avoid use in
patients with a history of QTc prolongation, uncorrected hypokalemia, hypomagnesemia, or
concurrent administration of other medications known to prolong the QT interval (including
Class Ia and Class III antiarrhythmics, cisapride, erythromycin, antipsychotics, and tricyclic
antidepressants).
• Aortic aneurysm and dissection: Fluoroquinolones have been associated with aortic
aneurysm ruptures or dissection within 2 months following use, particularly in elderly
patients. Fluoroquinolones should not be used in patients with a known history of aortic
aneurysm or those at increased risk, including patients with peripheral atherosclerotic
vascular diseases, hypertension, genetic disorders involving blood vessel changes (eg, Marfan
syndrome, Ehlers-Danlos syndrome), and elderly patients, unless no other treatment options
are available. Longer treatment duration (eg, >14 days) may increase risk.
• CNS effects: Fluoroquinolones have been associated with an increased risk of CNS effects
including seizures, increased intracranial pressure (including pseudotumor cerebri), dizziness,
lightheadedness, and tremors. Use with caution in patients with known or suspected CNS
disorders (eg, severe cerebral arteriosclerosis, epilepsy) or other risk factors that may
predispose to seizures or lower the seizure threshold.
• Glucose regulation: Fluoroquinolones have been associated with disturbances in glucose
regulation, including hyperglycemia and hypoglycemia. These events have occurred most
often in patients receiving concomitant oral hypoglycemic agents or insulin. Severe cases of
hypoglycemia, including coma and death, have been reported. Diabetic patients should be
monitored closely for signs/symptoms of disordered glucose regulation. Discontinue if a
hypoglycemic reaction occurs and immediately initiate appropriate therapy.
• Hypersensitivity reactions: Severe, sometimes fatal, hypersensitivity reactions, including

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anaphylaxis, have occurred with quinolone therapy. The spectrum of these reactions can vary
widely; reactions may present as typical allergic symptoms (eg, itching, urticaria, rash,
edema) after a single dose, or may manifest as severe idiosyncratic dermatologic (eg,
Stevens-Johnson, toxic epidermal necrolysis), vascular (eg, vasculitis), pulmonary (eg,
pneumonitis), renal (eg, nephritis), hepatic (eg, hepatic failure or necrosis), and/or
hematologic (eg, anemia, cytopenias) events, usually after multiple doses. Prompt
discontinuation of drug should occur if skin rash or other symptoms arise.
• Peripheral neuropathy: Peripheral neuropathy has been reported (rare); may occur soon
after initiation of therapy and may be irreversible; discontinue if symptoms of sensory or
sensorimotor neuropathy occur.
• Phototoxicity: Avoid excessive sunlight and take precautions to limit exposure (eg, loose
fitting clothing, sunscreen); may cause moderate to severe phototoxicity reactions.
Discontinue use if photosensitivity occurs.
• Psychiatric reactions: Fluoroquinolones have been associated with an increased risk of
psychiatric reactions, including toxic psychosis or hallucinations; may also cause nervousness,
agitation, confusion, disorientation, delirium, attention disturbances, and memory
impairment. Use with caution in patients with a history of or risk factor for depression;
discontinue if reaction occurs and institute appropriate therapy.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C.
difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been
observed >2 months postantibiotic treatment.
• Tendon inflammation/rupture: [US Boxed Warning]: There have been reports of tendon
inflammation and/or rupture with quinolone antibiotics; risk may be increased with
concurrent corticosteroids, organ transplant recipients, and in patients >60 years of age.
Discontinue at first sign of tendon inflammation or pain. May occur even after
discontinuation of therapy.
Disease-related concerns:
• Hepatic impairment: Use with caution in patients with hepatic impairment.
• Myasthenia gravis: [US Boxed Warning]: May exacerbate muscle weakness related to
myasthenia gravis. Cases of severe exacerbations, including the need for ventilatory support
and deaths have been reported; avoid use in patients with myasthenia gravis.
• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment
required. May increase risk of tendon rupture.
• Rheumatoid arthritis: Use with caution in patients with rheumatoid arthritis; may increase
risk of tendon rupture.
• Seizures: Use with caution in individuals at risk of seizures (CNS disorders or concurrent
therapy with medications which may lower seizure threshold). Potential for seizures,
although very rare, may be increased with concomitant NSAID therapy.
• Syphilis: Since ofloxacin is ineffective in the treatment of syphilis and may mask symptoms,
all patients should be tested for syphilis at the time of gonorrheal diagnosis and 3 months
later. Note: As of April 2007, the CDC no longer recommends the use of fluoroquinolones for
the treatment of uncomplicated gonococcal disease.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or
frequency adjustment, additional monitoring, and/or selection of alternative therapy.
Consult drug interactions database for more detailed information.
Special populations:
• Elderly: Adverse effects (eg, tendon rupture, QT changes) may be increased in the elderly.
• G6PD deficiency: Hemolytic reactions may (rarely) occur with quinolone use in patients
with latent or actual G6PD deficiency

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• Contact lens wearers: Contact lenses should not be worn during treatment of ophthalmic
infections.

Storage Oral: Store at 20°C to 25°C

Ophthalmic: Store 15°C to 25°C
Refer to manufacturer PIL if there are specific considerations.

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Topical
1. Benzyl Benzoate
Generic Name Benzyl Benzoate
Dosage Topical cream: 20 gm/100ml
form/strengths Topical Lotion: 25 ml/100ml
Route of Topical
administration
Pharmacologic Antiparasitic Agent, Topical; Pediculocide; Scabicidal Agent
category ATC: P03AX01

Indications Pediculosis (lice): Treatment of pediculosis (lice)

Scabies: Treatment of scabies.

Dosage Dosing: Adult, Pediatric:

Regimen Note: Dosing recommendations may vary per country (consult product labeling).
Pediculosis (lice): Topical: After washing hair, apply sufficient amount to moisten hair. After 3
to 5 minutes, rinse hair thoroughly and comb with a fine-tooth comb to remove nits. May
repeat application if necessary.
Note: Refer to dilution instructions for use in children
Scabies: Topical: After bathing, apply to moist skin and allow to dry, then reapply. Apply at
night; bathe and remove the drug the next morning. May repeat application in 24 hours if
necessary.
Note: Refer to dilution instructions for use in children
Dosage Dosing: Renal Impairment:
adjustment There are no dosage adjustments needed
Dosing: Hepatic Impairment:
There are no dosage adjustments needed.

Contra- Hypersensitivity to benzyl benzoate or any component of the formulation; application to skin
indications areas that may have greater absorption (eg, wounds, burns)
Adverse Drug Central nervous system: Burning sensation
Reactions Dermatologic: Contact dermatitis, erythematous rash, skin rash
Local: Application site irritation
Hypersensitivity: Hypersensitivity reaction
Ophthalmic: Eye irritation
Respiratory: Nasal mucosa irritation
Monitoring No monitoring data needed.
Parameters
Drug There are no known significant interactions.
Interactions
Pregnancy Category C.
Topical medications have little systemic absorption. When treatment is needed, benzyl
benzoate may be used in pregnant females
Administration Administration: Topical
For topical use only. Do not swallow. Avoid contact with eyes, face, mucous membranes, or
broken skin. Shake well prior to application. Apply to a small test area prior to full application

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to assess hypersensitivity reaction. Dilution is recommended in elderly patients. Wash all
bedding and clothing in between and after applications.
Pediculosis (lice) treatment: Apply only enough solution to moisten the affected area. A towel
may be wrapped around the hair when treating head lice. Use a fine-tooth comb to remove
dead lice and nits.
Scabies treatment: Apply preferably at night after evening bath to moist skin; application
should include intertriginous areas of the body (armpits, abdomen, and buttocks). Allow to
dry, then reapply. Dress or lie down without wiping. Take a bath the following morning to
remove.
Preparation for Administration: Adult
Dilution is not required for adults.
Dilution is recommended prior to application in elderly patients. Mix 1 part solution with 3
parts water.
Preparation for Administration: Pediatric
Dilution is recommended prior to application in infants and children. Dilution instructions may
vary; consult specific product labeling.
Infants: Mix 1 part solution with 3 parts water.
Children: Mix 1 part solution with 1 to 3 parts water
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Hypersensitivity: Use with caution in patients with a history of allergic reaction to other
topical products.
Other warnings/precautions:
• Appropriate use: For topical use only; do not ingest solution. Do not apply to face, eyes, lips,
or mucous membranes. Application is contraindicated on skin areas that may have greater
absorption (eg, wounds, burns).
Storage Store at room temperature; protect from light and moisture.
Refer to manufacturer PIL if there are specific considerations.

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2. Clotrimazole
Generic Name Clotrimazole

Dosage Aerosol 1%
form/strengths Solution 1%
Topical powder 1%
Topical cream 1%
Topical spray 10mg/ml
Vaginal tablets 100mg, 200mg, 500mg
Vaginal cream 2%, 10gm/100gm
Route of Topical, inhalation, intravaginal
administration
Pharmacologic Antifungal Agent, Imidazole Derivative
category ATC (Topical): D01AC01
ATC (Vaginal): G01AF02
Indications Topical cream and solution: Topical treatment of candidiasis due to Candida albicans and tinea
versicolor caused by Malassezia furfur

Topical ointment: Topical treatment of tinea cruris, C. albicans, tinea corporis, and tinea pedis

Vaginal cream: Treatment of vaginal yeast infections and relief of associated external vulvar
itching and irritation

Vaginal tablet: Treatment of vaginal candidiasis

Dosage Dosing: Adult
Regimen Cutaneous candidiasis: Topical:
Cream, solution: Apply to affected area twice daily; if no improvement occurs after 4 weeks of
therapy, re-evaluate diagnosis.
vulvovaginal candidiasis: Intravaginal: Note: A longer duration may be necessary in patients
with complicated infection (ie, recurrent or severe infection, infection with non-albicans
Candida, or infection in an immunocompromised host) (CDC).
Cream (1%): Insert 1 applicatorful of 1% vaginal cream daily (at bedtime) for 7 consecutive
days. May also apply externally twice daily for 7 days as needed for itching and irritation.
Cream 2%: Intravaginal: Insert 1 applicatorful (~5 g) once daily (at bedtime) for 3 days. May also
apply externally twice daily for 7 days, as needed, for itching and irritation.
Vaginal Tablet:
500 mg tablet: Insert 1 vaginal tablet as a single dose (preferably at bedtime)
200 mg tablet: Insert 1 vaginal tablet once daily for 3 consecutive days (preferably at bedtime)
Note: When tablets are used in conjunction with an external cream, apply cream over the
irritated area 1 to 2 times/day as needed for up to 7 consecutive days
Tinea infections:
Tinea corporis/tinea cruris: Topical: Cream 1%, solution 1%: Apply to affected and surrounding
area(s) twice daily until clinical resolution, typically 1 to 4 weeks.
Tinea versicolor: Topical: Cream 1%, solution 1%: Apply to affected area(s) and immediate
surrounding skin twice daily for 2 weeks.

Dosing: Pediatric
Cutaneous candidiasis: Topical ointment: Children ≥2 years and Adolescents: Topical: Apply

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twice daily (morning and night) for 2 weeks.
Tinea corporis, tinea cruris, and tinea pedis: Children ≥2 years and Adolescents: Topical: Apply
twice daily (morning and night). Duration: 2 weeks for tinea cruris; 4 weeks for tinea corporis
and tinea pedis
Vulvovaginal candidiasis: Children ≥12 years and Adolescents: Intravaginal:
Cream (1%): Insert 1 applicatorful of 1% vaginal cream daily (preferably at bedtime) for 7
consecutive days; some patients may require 14 days (CDC). May also apply externally twice
daily for 7 days as needed for itching and irritation.
Cream (2%): Insert 1 applicatorful of 2% vaginal cream daily (preferably at bedtime) for 3
consecutive days. May also apply externally twice daily for 7 days as needed for itching and
irritation.

Dosage Dosing: Renal Impairment: Adult

adjustment There are no dosage adjustments needed.
Dosing: Hepatic Impairment: Adult
There are no dosage adjustments needed.

Contra- Hypersensitivity to clotrimazole or any component of the formulation.

indications Documentation of allergenic cross-reactivity for imidazole antifungals is limited. However,
because of similarities in chemical structure and/or pharmacologic actions, the possibility of
cross-sensitivity cannot be ruled out with certainty.

Adverse Drug Topical, Vaginal:

Reactions 1% to 10%: Genitourinary: Vulvovaginal burning

Monitoring Assess for effectiveness of treatment. Assess for severe skin irritation.
Parameters
Drug Progesterone: Antifungal Agents (Vaginal) may diminish the therapeutic effect of
Interactions Progesterone. Risk X: Avoid combination
Sirolimus: Clotrimazole (Topical) may increase the serum concentration of Sirolimus. Risk C:
Monitor therapy
Tacrolimus (Systemic): Clotrimazole (Topical) may increase the serum concentration of
Tacrolimus (Systemic). Risk C: Monitor therapy
Pregnancy and Pregnancy category B
Lactation It is not known if clotrimazole is present in breast milk following oral administration. Because
clotrimazole has poor oral bioavailability, it is unlikely to adversely affect the breastfed infant.

Administration Administration: Topical

For external use only. Avoid contact with eyes and application to severely cracked or irritated
areas. Cleanse and thoroughly dry area prior to application. Apply a thin layer to affected area.
For treatment of athlete's foot, pay special attention to spaces between the toes; wear well-
fitting, ventilated shoes and change shoes and socks at least once a day.
Administration: Intravaginal
For vaginal use only.
Cream may also be applied externally for itching and irritation of surrounding areas. Do not
use tampons, douches, spermicides, or other vaginal products or have vaginal intercourse
during treatment.
Vaginal tablet [Canadian product]: Should be inserted deep into the vagina to ensure tablet
dissolves completely. If tablet does not dissolve completely within one night, consider use of a

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vaginal cream.
Administration: Pediatric
Topical: For external use only. Apply sparingly and rub gently into the cleansed, affected area;
do not apply to the eye. For tinea pedis, also apply to spaces between the toes. Children under
12 years should be supervised during use.
Vaginal: Wash hands before using. Insert full applicator into vagina gently and expel cream
into vagina. Wash applicator with soap and water following use. Remain lying down for 30
minutes following administration.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ • Local irritation: If irritation/sensitivity develops, discontinue therapy and institute appropriate
Precautions alternative therapy.
Other warnings/precautions:
• Appropriate use: Topical: For external use only; avoid contact with the eyes. Not effective for
treatment of scalp or nails. When used for self-medication, discontinue use and contact a
healthcare provider if there is no improvement in 2 weeks (jock itch) or 4 weeks (athlete's foot,
ringworm).
• Self-medication: Vaginal: When used for self-medication (OTC), consult a health care provider
before use if experiencing vaginal itching and discomfort for the first time, frequent vaginal
yeast infections (eg, monthly, 3 in 6 months), or exposure to HIV. A mild increase in vaginal
itching, burning, or irritation may occur with use; a health care provider should be consulted
before switching to another agent if patient does not experience complete relief. Discontinue
use and contact a health care provider if symptoms do not improve in 3 days or last more than 7
days, or if symptoms of a more serious condition occur (eg, abdominal pain, back/shoulder pain,
fever, chills, nausea, vomiting, foul-smelling vaginal discharge). For vaginal use only; do not use
tampons, douches, spermicides, or other vaginal products or have vaginal intercourse during
treatment.

Storage Recommendations vary. Refer to manufacturer PIL if there are specific considerations.

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3. Econazole
Generic Name Econazole

Dosage Topical Cream, Lotion or spray: 1 %

form/strengths Vaginal Pessary/ovules: 150 mg
Vaginal Cream: 1 gm/100g
Route of Topical, vaginal
administration
Pharmacologic Antifungal Agent, Imidazole Derivative
category ATC (Topical): D01AC03
ATC (Gynecological): G01AF05
Indications Fungal infection:

Cream: Treatment of tinea pedis, tinea cruris, and tinea corporis and in the treatment of
cutaneous candidiasis, and in treatment of tinea versicolor.

Vaginal cream: Treatment of mycotic vulvovaginitis and mycotic balanitis

Vaginal suppository: Treatment of vaginitis due to Candida albicans and other yeasts
Dosage Dosing: Adult
Regimen Cutaneous candidiasis: Topical: Cream: Apply sufficient quantity twice daily (morning and
evening) for 2 weeks
Tinea versicolor: Topical: Cream: Apply sufficient amount to cover affected areas once daily for 2
weeks
Tinea cruris, tinea corporis: Topical: Cream 1%: Apply to affected and surrounding area(s) once
daily until clinical resolution, typically 1 to 3 weeks
Tinea and fungal skin infections: Topical: Apply once daily in the evening for 3 consecutive days.
May repeat 3-day treatment course after 2 weeks if infection not resolved. For prevention of
relapse, may repeat 3-day treatment course at 1 month and 3 months after initial treatment.
Vulvovaginitis: Vaginal:
Cream: Insert 1 applicator full (5 g) and apply topically to affected areas once daily in the evening
for at least 14 days.
Suppository: Insert 1 suppository (150 mg) once daily in the evening for 3 days.
Dosing: Pediatric
Candidiasis cutaneous (including diaper dermatitis): Limited data available: Infants, Children,
and Adolescents: Topical: Cream: Apply sufficient amount to cover affected area twice daily
Tinea corporis, tinea cruris, and tinea versicolor (smaller lesions): Children and Adolescents:
Limited data available: Topical: Cream: Apply sufficient amount to cover affected area once daily
for 4 weeks
Tinea pedis:
Cream: Children and Adolescents: Limited data available: Topical: Apply sufficient amount to
cover affected area once daily for 4 weeks
Vulvovaginitis: Adolescents ≥16 years: Vaginal: Cream or suppository: Refer to adult dosing.

Dosage Dosing: Renal Impairment:

adjustment There are no dosage adjustments needed.
Dosing: Hepatic Impairment:
There are no dosage adjustments needed.

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Contra- Cream, vaginal cream/suppository: Hypersensitivity to econazole, other imidazoles, or any
indications component of the formulation

Adverse Drug 1% to 10%: Dermatologic: Burning sensation of skin, erythema, pruritus, stinging of the skin
Reactions
Monitoring Reassess diagnosis if no clinical improvement after completion of treatment course.
Parameters
Drug Vitamin K Antagonists (eg, warfarin): Econazole may increase the serum concentration of
Interactions Vitamin K Antagonists. Risk C: Monitor therapy
Pregnancy and Pregnancy Category C. avoid use in the first trimester and apply sparingly during the second and
Lactation third trimesters if needed for topical fungal infections
It is not known if econazole is present in breast milk. Consider benefits and risks.
Administration Administration: Topical
For external use only. Not for oral, ophthalmic, or vaginal use. Avoid contact with the eyes.
Cream: For treatment of balanitis, apply to penis, including under the foreskin if applicable.
Avoid contact with latex condoms and diaphragms.
Administration: Intravaginal
Administer in the evening. Wash hands prior to administration.
Cream: Insert into vagina using a vaginal applicator (avoid use of applicator in pregnant
women). Apply additional thin layer of cream to the vulva.
Suppository: Insert high into the vagina
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions • Irritation: Discontinue if sensitivity or irritation occurs.
Other warnings/precautions:
• Appropriate use: For topical use only; avoid contact with eyes, mouth, nose, or other
mucous membranes

Storage Store below 30°C. Refer to manufacturer PIL if there are specific considerations.

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4. Erythromycin and Zinc Acetate
Generic Name Erythromycin and Zinc Acetate

Dosage Paint: Erythromycin - Zinc Acetate: 4 gm/100g-1.2 gm/100g

form/strengths Topical Lotion: 4 gm/100ml-1.2 gm/100ml
Route of Topical
administration
Pharmacologic Acne Products; Antibiotic, Macrolide
category ATC: D10AF52
Indications Acne: Treatment of acne vulgaris

Dosage Dosing: Adult

Regimen Acne: Topical: Apply to affected area twice daily; usual treatment duration is 10 - 12 weeks.
Dosing: Pediatric
Acne: Children ≥12 years and Adolescents: Topical: Apply to affected area twice daily; usual
treatment duration is 10 to 12 weeks.
Dosage Dosing: Renal Impairment: Adult
adjustment There are no dosage adjustments available
Dosing: Hepatic Impairment: Adult
There are no dosage adjustments available.
Contra- Hypersensitivity to erythromycin, other macrolide antibiotics, zinc acetate, or any
indications component of the formulation
Adverse Drug Frequency not defined: Dermatologic: Acute generalized exanthematous pustulosis
Reactions
Monitoring No monitoring data needed.
Parameters
Drug Risk X: Avoid combination
Interactions Clindamycin (Topical)
Pregnancy and Pregnancy category B. There are no data on the excretion of Zinc acetate topical into
Latcation human milk. Elemental zinc is known to be excreted into human milk and may lead to
copper deficiency in the nursing infant.
Administration Administration: Topical
Prior to treatment, thoroughly wash affected area. Unscrew the protective cap, hold the
bottle upside down, and place the pad against the affected area. Spread solution over
affected area and surrounding skin. The amount of solution dispensed may be increased
by pressing the pad of the bottle more firmly against the skin. Blot any excess solution off
with tissues. Make-up may be applied after medication has dried. Avoid contact with the
eyes, nose, mouth, and other mucous membranes.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ Concerns related to adverse effects:
Precautions Allergic reactions: Allergic reactions, including acute generalized exanthematous
pustulosis (AGEP), may occur. Discontinue therapy if an allergic reaction occurs.
Other warnings/precautions:
Appropriate use: For topical use only; not for ophthalmic use. Avoid contact with eyes,
nose, mouth, mucous membranes, or broken skin. Consider alternate therapy in patients
with poor tolerance to macrolide or lincosamide antibiotics.
Storage Store at ≤25°C. Refer to manufacturer PIL if there are specific considerations.

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5. Isoconazole
Generic Name Isoconazole

Dosage Vaginal ovules 300, 600mg

form/strengths Topical cream 1%
Route of Topical, intravaginal
administration
Pharmacologic Imidazole antifungal
category ATC (Topical): D01AC05
ATC (Vaginal): G01AF07
Indications Vaginal: Fungal infections of the vagina: Treatment of fungal vaginal infections, including mixed
infections with gram-positive bacteria
Topical: Superficial fungal infections: Treatment of superficial fungal infections caused by
dermatophytes, yeasts and yeast-like fungi, and molds, including infections on or near the hands,
the interdigital spaces of the feet, and in the inguinal and genital regions
Dosage Vaginal infections it is usually given as a pessary (600 mg) once as a single dose.
Regimen Topical: Superficial fungal infections: Apply to the affected areas once or twice daily for 1-3 weeks
Dosage No adjustments needed
adjustment
Contra- Tuberculous and syphilitic infections in the area to be treated, viral infections (herpes simplex,
indications vaccinia, varicella and smallpox). Pregnancy. Not recommended for use in infants and children
Adverse Drug 1-10%: Local reactions including burning or itching may occur after application of isoconazole.
Reactions Intravaginal preparations of azole antifungals may damage latex contraceptives and additional
contraceptive measures are therefore necessary during local application.
Monitoring Not data needed
Parameters
Drug Warfarin: concomitant use may increase use of plasma levels of warfarin.
Interactions
Pregnancy and Isoconazole is poorly absorbed following application to mucous membranes or intact skin. Use
Lactation during pregnancy and breastfeeding would not be expected to result in significant exposure or
harm. Application to the nipples should be avoided in women who are nursing.
Administration Topical for external use only, vaginal: Avoid administration during menstruation.
Refer to manufacturer PIL if there are specific considerations.
Warnings/ • Not to be used on skin creases due to presence of potent corticosteroid.
Precautions • Prolonged use may lead to skin thinning, loss of elasticity, dilatation of superficial blood vessels,
telangiectasiae and ecchymoses especially when used on face or with occlusive dressings.
• Excessive use on damaged skin may lead to substantial systemic absorption resulting in
depression of the hypothalmus-pituitary adrenal axis especially in children.
• Caution when used near the eye.
Storage Store below 30°C.
Refer to manufacturer PIL if there are specific considerations.

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6. Miconazole
Generic Name Miconazole

Dosage Oral gel 2%

form/strengths Vaginal ovules 400mg, 1200
Vaginal Cream 2%
Vaginal suppository 200mg, 400mg
Topical Cream, gel, powder 2%
Powder or liquid spray
Tincture 2%
Route of Topical , Intravaginal, oral
administration
Pharmacologic Antifungal Agent, Imidazole Derivative;
category ATC (Topical): D01AC02
ATC (Gynecological): G01AF04
Indications Treatment of vulvovaginal candidiasis and a variety of skin and mucous membrane fungal
infections

Treatment of oropharyngeal candidiasis

Dosage Adult Dosing:
Regimen Tinea corporis/tinea cruris: Topical: Aerosol powder (tinea corporis only), cream, ointment,
powder, solution: Apply to affected and surrounding area(s) twice daily until clinical resolution,
typically 1 to 4 weeks
Vulvovaginal candidiasis: Intravaginal: Note: A longer duration may be necessary in patients with
complicated infection (ie, recurrent or severe infection, infection with non-albicans Candida,
infection in an immunocompromised host)
Cream, 2%: Insert 1 applicatorful at bedtime for 7 days
Suppository 200 mg: Intravaginal: Insert 1 suppository once daily (at bedtime) for 3 days
Pediatric dosing:
Tinea cruris: Children ≥2 years and Adolescents: Topical cream, spray, powder, aerosol powder
or solution: Topical: Apply twice daily for 2-4 weeks
Dosage Dosing: Renal Impairment:
adjustment There are no dosage adjustments needed.
Dosing: Hepatic Impairment:
There are no dosage adjustments needed.
Contra- Hypersensitivity to miconazole or any component of the formulation
indications
Adverse Drug Topical: Dermatologic: Allergic contact dermatitis, burning sensation of skin, maceration of skin
Reactions Vaginal:
Gastrointestinal: Abdominal cramps
Genitourinary: Vulvovaginal burning, vulvovaginal irritation, vulvovaginal pruritus
Oral:
>10%: Local: Application site reaction (10% to 12%; including glossalgia, local discomfort, local
pain, local pruritus, localized burning, localized edema, oral mucosa ulcer, toothache)
Monitoring Caution patients with diabetes to test serum glucose regularly; may inhibit the metabolism of
Parameters oral sulfonylureas. Teach patient bleeding precautions.
Drug Risk X: Avoid combination
Interactions Progesterone
Risk D: Consider therapy modification

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Vitamin K Antagonists

Pregnancy and pregnancy risk category C

Lactation Following vaginal administration, small amounts are absorbed systemically.
Based on available data, vaginal use of miconazole is not associated with an increased risk of
adverse pregnancy outcomes. Avoid prolonged use while breastfeeding. use of the gel is not
recommended.
There is minimal systemic absorption following buccal application. Consider benefits and risk.
Administration Oral Gel: Apply after meals. Gel should not be swallowed immediately but allowed to linger in
the mouth for as long as possible.
Refer to manufacturer PIL if there are specific considerations

Warnings/ Concerns related to adverse effects:

Precautions • Hypersensitivity reactions: Hypersensitivity reactions (including anaphylactic reactions) have
been reported. Monitor patients with a history of azole hypersensitivity.
• Skin reactions: Gel: Serious dermatologic reactions including Stevens-Johnson syndrome (SJS)
and toxic epidermal necrolysis (TENs) have been reported with oral gel products. Discontinue use
at the first appearance of skin rash.
Disease-related concerns:
• Hepatic impairment: Although systemic absorption is typically minimal, use with caution in
patients with hepatic impairment. The gel formulation is contraindicated with liver dysfunction.
Special populations:
• Pediatric: Gel: Use with caution in pediatric patients to ensure the gel does not obstruct the
throat. Do not apply to the back of the throat. Divide the dose into smaller portions and observe
the patient for possible choking. Consider the swallowing function of all pediatric patients prior
to use, especially in infants aged 4 to 6 months. Increase lower age limit to 5 to 6 months in
preterm infants or infants exhibiting slow neuromuscular development. Do not apply gel to the
nipple of a breastfeeding woman for administration to an infant.
Storage Store at room temperature.
Refer to manufacturer PIL if there are specific considerations

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7. Mupirocin
Generic Name Mupirocin

Dosage Topical Cream: 20 mg/gm, 2 gm/100g

form/strengths Topical Ointment: 20 mg/gm 2 gm/100g
Route of Topical
administration
Pharmacologic Antibiotic, Topical
category ATC: D06AX09
Indications Impetigo: Treatment of impetigo due to Staphylococcus aureus and Streptococcus
pyogenes (topical ointment).
Secondary skin infection: Treatment of secondarily infected traumatic skin lesions (up to 10
cm in length or 100 cm2 in area) due to susceptible isolates of S. aureus and S.
pyogenes (topical cream).

Dosage Dosing: Adult

Regimen Superficial skin infection:
Impetigo (limited number of lesions): Topical: Ointment: Apply to affected area 2 to 3 times
daily for 5 days.
Secondary skin infection (localized infection of wounds, burns, dermatitis, or other
lesions): Topical: Cream, Ointment: Apply to affected area 2 to 3 times daily, typically for 7
to 14 days depending on severity and clinical response; if no response after 3 to 5 days, re-
evaluate treatment.
Dosing: Pediatric
MRSA or impetigo, treatment; minor skin infection or a limited number of infected
lesions: Infants, Children, and Adolescents: Topical: Cream, Ointment: Apply small amount 3
times daily for 5 to 10 days; patients not showing clinical response after 5 days should be
reevaluated
Dosage Dosing: Renal Impairment:
adjustment There are no dosage adjustments needed.
Dosing: Hepatic Impairment:
There are no dosage adjustments needed.
Contra- Hypersensitivity to mupirocin or any component of the formulation
indications
Adverse Drug 1% to 10%:
Reactions Central nervous system: Headache, localized burning, stinging sensation
Dermatologic: Pruritus, skin rash
Gastrointestinal: Nausea, dysgeusia
Local: Local pain
Respiratory: Rhinitis, respiratory congestion, pharyngitis, cough
Monitoring No monitoring necessary.
Parameters
Drug There are no known significant interactions.
Interactions
Pregnancy and Pregnancy Category B
Lactation It is not known if mupirocin is present in breast milk. Systemic absorption following topical
application is minimal and significant exposure to a breastfeeding infant is not expected.
Administration Administration: Topical
Topical cream, ointment: For external use only; not for use in eyes or on mucous

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membranes (components may be absorbed systemically and cause drying and irritation).
Apply small amount to affected area using gauze pad or cotton swab; area may be covered
with a gauze dressing if desired. In case of accidental contact in or near eyes, rinse well with
water. Wash hands before and after application.
Refer to manufacturer PIL if there are specific considerations
Warnings/ Concerns related to adverse effects:
Precautions • Hypersensitivity: May be associated with systemic allergic reactions, including
anaphylaxis, urticaria, angioedema, and generalized rash. If a systemic reaction occurs,
discontinue use.
• Irritation: If sensitization or local irritation occurs, discontinue use.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C.
difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been
observed >2 months postantibiotic treatment.
Disease-related concerns:
• Renal impairment: Topical ointment and intranasal: Use with caution in patients with
renal impairment (has not been studied).
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large
amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal
toxicity ("gasping syndrome") in neonates; avoid or use dosage forms containing benzyl
alcohol with caution in neonates. See manufacturer's labeling.
• Polyethylene glycol: Potentially toxic amounts of polyethylene glycol contained in some
topical products may be absorbed percutaneously in patients with extensive burns or open
wounds. Do not use polyethylene glycol-based ointments in conditions where absorption of
large quantities of polyethylene glycol is possible, especially in the presence of moderate or
severe renal impairment.
Other warnings/precautions:
• Appropriate use: For external use only. Avoid contact with eyes; in case of accidental
contact in or near eyes, rinse well with water.
- Topical cream and ointment: Not for ophthalmic or nasal use or use on mucosal surfaces.
May cover treated areas with gauze dressing.
• Limitations of use:
- Topical ointment: Should not be used with intravenous (IV) cannulae or at central IV sites
because of the potential to promote fungal infections and antimicrobial resistance.
Storage Topical cream, ointment: Store at or below 25°C. Do not freeze.
Refer to manufacturer PIL if there are specific considerations

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8. Neomycin, Polymyxin B, and Dexamethasone
Generic Name Neomycin, Polymyxin B, and Dexamethasone

Dosage Ophthalmic Suspension: Dexamethasone 1 mg/ml; Neomycin Sulphate 3.5 mg/ml; Polymyxin B
form/strengths Sulphate 6000 I.U./ml
Eye ointment: Dexamethasone 1 mg ; Neomycin Sulphate 5mg ; Polymyxin B Sulphate 6000 I.U.
Route of ophthalmic
administration
Pharmacologic Antibiotic/Corticosteroid, Ophthalmic
category ATC: A07AA51
Indications Inflammatory ocular conditions: Management of corticosteroid-responsive inflammatory ocular
conditions where bacterial infection or a risk of bacterial infection exists
Dosage Dosing: Adult
Regimen Inflammatory ocular conditions: Ophthalmic:
Suspension: Instill 1 to 2 drops into the conjunctival sac of the affected eye(s) 4 to 6 times daily. In
severe disease, drops may be used hourly; frequency should decrease as signs and symptoms
improve.
Ointment: Place 1.25 cm in the conjunctival sac of the affected eye(s) 3 to 4 times daily
Note: If signs and symptoms do not improve after 2 days of treatment, the patient should be
reevaluated.
Dosing: Pediatric
Inflammatory ocular conditions: Ophthalmic: Suspension: Children ≥2 years and Adolescents:
Instill 1 to 2 drops into the conjunctival sac of the affected eye(s) 4 to 6 times daily; in severe
disease, drops may be used hourly and tapered to discontinuation

Dosage Dosing: Renal Impairment:

adjustment There are no dosage adjustments needed.
Dosing: Hepatic Impairment:
There are no dosage adjustments needed.

Contra- Hypersensitivity to neomycin, polymyxin B, dexamethasone, or any component of the

indications formulation; viral disease of the cornea and conjunctiva (including epithelial herpes simplex
keratitis [dendritic keratitis], vaccinia, varicella); mycobacterial ophthalmic infection; fungal
diseases of ocular structures
Canadian labeling: Additional contraindications (not in US labeling): Untreated parasitic
ophthalmic infection
Adverse Drug Frequency not defined:
Reactions Hypersensitivity: Hypersensitivity reaction
Infection: Secondary infection
Ophthalmic: Glaucoma, increased intraocular pressure, optic nerve damage (infrequent),
subcapsular posterior cataract
Miscellaneous: Wound healing impairment
Monitoring Monitor intraocular pressure with use >10 days and in patients with glaucoma; reevaluate if signs
Parameters and symptoms persist beyond 2 days.
Drug CYP3A4 Inhibitors (Strong): May increase the serum concentration of Dexamethasone
Interactions (Ophthalmic). Risk C: Monitor therapy
Nonsteroidal Anti-Inflammatory Agents (Ophthalmic): May enhance the adverse/toxic effect of

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Corticosteroids (Ophthalmic). Healing of ophthalmic tissue during concomitant administration of
ophthalmic products may be delayed. Risk C: Monitor therapy
Pregnancy and Adverse events have been observed with topical corticosteroids in animal reproduction studies. If
Lactation ophthalmic agents are needed during pregnancy, the minimum effective dose should be used in
combination with punctal occlusion to decrease potential exposure to the fetus. Refer to
individual agents.
It is not known if systemic absorption following topical administration results in detectable
quantities in human milk. caution should be exercised when administering neomycin/polymyxin
B/dexamethasone to breastfeeding women. Refer to individual agents.
Administration Administration: Ophthalmic
Note: Contact lenses should not be worn during therapy.
Ointment: Apply into pocket between eyeball and lower lid; patient should look downward
before closing eye. To avoid contamination, do not touch tip of tube to eye or any other surface.
Suspension: Shake well before using. Tilt head back, instill suspension into the conjunctival sac,
and close eye(s). Apply light finger pressure on lacrimal sac for 1 minute following instillation. To
avoid contamination, do not touch dropper to eye or any other surface.
Refer to manufacturer PIL if there are specific considerations
Warnings/ Concerns related to adverse effects:
Precautions • Immunosuppression: Prolonged use of corticosteroids (including ophthalmic preparations) may
increase the incidence of secondary ocular infections (including fungal infections). Acute purulent
ocular infections may be masked or exacerbated with use. Fungal infection should be suspected in
any patient with persistent corneal ulceration who has received corticosteroids.
• Neomycin sensitization: Neomycin may cause cutaneous sensitization. Discontinue use if
hypersensitivity occurs. Cross-sensitivity to other topical or systemic aminoglycosides may occur.
• Ocular effects: Prolonged use of corticosteroids may result in glaucoma; damage to the optic
nerve, defects in visual acuity and fields of vision, corneal and scleral thinning (leading to
perforation), and posterior subcapsular cataract formation may occur. Use following cataract
surgery may delay healing or increase the incidence of bleb formation.
Disease-related concerns:
• Glaucoma: Use with caution in patients with glaucoma.
• Ocular herpes simplex: Use with extreme caution in patients with a history of ocular herpes
simplex; frequent slit lamp microscopy is recommended.
Dosage-forms specific issues:
• Ophthalmic suspension: May contain benzalkonium chloride, which may be absorbed by soft
contact lenses; contact lenses should not be worn during treatment of ophthalmologic infections.
Other warnings/precautions:
• Appropriate use: Never directly introduce (eg, inject) into the anterior chamber. A maximum of
8 g of ointment or 20 mL of suspension should be prescribed initially; reevaluate patients (eg,
intraocular pressure and exams using magnification and fluorescein staining, where appropriate)
prior to additional refills. Use >10 days should include routine monitoring of intraocular pressure.
Inadvertent contamination of multiple-dose ophthalmic bottle dropper and tips has caused
bacterial keratitis.
Storage Store at a temperature ≤ 25°C
Refer to manufacturer PIL if there are specific considerations

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9. Natamycin

Generic Name Natamycin

Dosage Sterile ophthalmic suspension: 50mg/ml

form/strengths
Route of Ophthalmic
administration
Pharmacologic Antifungal Agent, Ophthalmic
category ATC: S01AA10
Indications Ocular fungal infections: Treatment of fungal blepharitis, conjunctivitis, and keratitis caused by
susceptible organisms, including Fusarium solani keratitis.
Dosage Ophthalmic Dosing: Adult
Regimen Fungal blepharitis or conjunctivitis: Instill 1 drop in conjunctival sac 4-6 times daily.
Fungal keratitis: Instill 1 drop in conjunctival sac every 1-2 hours, after 3-4 days reduce to one
drop 6 - 8 times daily; usual course is 2 - 3 weeks or until resolution of active fungal keratitis.
Dosage Dosing: Altered Kidney or Hepatic Functions:
adjustment There are no dosage adjustments needed.
Contra- Hypersensitivity to natamycin or any component of the formulation
indications
Adverse Drug Allergic reaction, chest pain, corneal opacity, dyspnea, eye discomfort, edema, hyperemia,
Reactions irritation and/or pain, foreign body sensation, parasthesia, tearing, vision changes
Monitoring No monitoring data needed.
Parameters
Drug There are no known significant interactions.
Interactions
Pregnancy and pregnancy category C. Animal reproduction studies have not been conducted.
Lactation It is not known if natamycin is excreted in breast milk. Caution should be exercised when
administering natamycin to nursing women.
Administration Administration: Adult
Ophthalmic: For topical ophthalmic use only. Shake well before using. Wash hands before and
after use. Do not touch tip of applicator to eye or other surfaces.
Refer to manufacturer PIL if there are specific considerations
Warnings/ Disease-related concerns:
Precautions • Epithelial ulceration: Suspension may adhere to epithelial ulcers; retention of the suspension in
the fornices occurs regularly.
Special populations:
• Contact lens wearers: Contains benzalkonium chloride, which may be absorbed by soft contact
lenses; remove lenses prior to administration. Contact lenses should not be worn during
treatment of ophthalmologic infections (fungal blepharitis, conjunctivitis, and keratitis).
Other warnings/precautions:
• Appropriate use: For topical ophthalmic use only. Failure to improve (keratitis) after 7 to 10
days of administration suggests infection caused by a microorganism not susceptible to
natamycin; efficacy as a single agent in fungal endophthalmitis has not been established.
Storage Store at 2°C to 24°C; do not freeze. Protect from excessive heat and light.
Refer to manufacturer PIL if there are specific considerations

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10. Terbinafine
Generic Name Terbinafine

Dosage Topical gel, cream or solution: 10 mg/gm

form/strengths Topical Spray: 1 %, 0.888 gm/100g
Topical Aerosol Powder: 1%
Tablets: 250mg
Route of Topical, Oral
administration
Pharmacologic Antifungal Agent
category ATC (Topical): D01AE15
ATC (systemic): D01BA02
Indications Topical: Dermatologic fungal infections: Treatment of tinea pedis (athlete's foot), tinea cruris
(jock itch), and tinea corporis (ringworm).

Systemic use: Onychomycosis: Treatment of onychomycosis of the toenail or fingernail caused

by dermatophytes (tinea unguium).
Dosage Dosing: Adult
Regimen Onychomycosis:
Oral: 250 mg once daily for 6 weeks (fingernail) or 12 weeks (toenail).
Tinea pedis: Topical:
Cream 1%, gel 1%: Apply to affected and surrounding area(s) once or twice daily (cream) or once
daily (gel or spray) until 1 week after clinical resolution, typically for 2 weeks total
Tinea corporis, Tinea cruris: Topical:
Cream, gel, solution (spray): Apply to affected area once daily for 1 week
Dosing: Pediatric
Tinea corporis (ringworm): Children ≥12 years and Adolescents: Topical: Cream, gel: Apply to
affected area once daily for at least 1 week
Tinea cruris (jock itch): Children ≥12 years and Adolescents: Topical: Cream, gel, solution (spray):
Apply to affected area once daily for at least 1 week
Tinea pedis (athlete’s foot): Children ≥12 years and Adolescents: Topical:
Cream: Apply between the toes to affected area twice daily for at least 1 week; apply on the
bottom or sides of feet twice daily for 2 weeks
Gel: Apply to affected area once daily at bedtime for at least 1 week

Dosage CrCl 20 to 50 mL/minute: Administer 50% of the usual dose.

adjustment CrCl <20 mL/minute: Use of alternative agent may be preferred
Dosing: Hepatic Impairment:
use is contraindicated in adults with chronic or active hepatic disease.
Contra- Hypersensitivity to terbinafine or any component of the formulation.
indications
Adverse Drug Topical: 1% to 10%:
Reactions Dermatologic: Burning sensation of skin, contact dermatitis, exfoliation of skin, pruritus, skin
irritation, skin rash, stinging of the skin, xeroderma
Local: Local irritation
Sysytemic:
Adverse Reactions (Significant): Considerations
Hepatotoxicity

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Hypersensitivity reactions (delayed)
Taste & smell disturbances
Thrombotic microangiopathy
>10%: Nervous system: Headache (13%)
1% to 10%:
Dermatologic: Pruritus (3%), skin rash (6%), urticaria (1%)
Gastrointestinal: Diarrhea (6%), dysgeusia (3%; may be severe and result in weight loss, anxiety,
and depression) (See Table 1), dyspepsia (4%)
Hepatic: Increased serum transaminases (3%)
Monitoring Liver function tests at baseline and periodically during treatment; signs/symptoms of liver injury;
Parameters CBC (if used >6 weeks in immunodeficient patients or if clinical signs or symptoms of secondary
infection occur); taste and/or smell disturbances; skin rash, signs/symptoms of hypersensitivity
reaction.
Drug Systemic:
Interactions Risk X: Avoid combination:
Doxorubicin Mequitazine Saccharomyces boulardii
Risk D: Consider therapy modification
Eliglustat Tamoxifen
Pregnancy and Pregnancy Category B
Lactation Systemic therapy is not recommended during pregnancy Breastfeeding during systemic therapy
is not recommended. Systemic absorption is limited following topical application. Breastfeeding
mothers should not apply topical formulations to the breast and infants should avoid contact
with treated skin
Administration Oral: Administer without regard to meals.
Topical: Administration:
For external use only; avoid contact with eyes or mouth. Do not use on nails, scalp, or for
vaginal yeast infections. Wash affected area with soap and water prior to use and dry
completely; wash hands after use. Apply in sufficient quantity.
Spray: Hold 4 to 6 inches from skin during application.
Refer to manufacturer PIL if there are specific considerations
Warnings/ Concerns related to adverse events:
Precautions • Local irritation: If irritation/sensitivity develops, discontinue therapy and institute appropriate
alternative therapy.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol; large amounts
of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity
(“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis,
respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial
hemorrhage), hypotension, and cardiovascular collapse; avoid or use dosage forms containing
benzyl alcohol with caution in neonates. See manufacturer's labeling.
Other warnings/precautions:
• Appropriate use: For topical use only. Not intended for ophthalmologic, oral, or vaginal
administration. Do not use on nails or scalp.
Systemic:
• Hepatic impairment: Use is contraindicated in patients with active or chronic hepatic disease;
clearance is reduced by ~50% in hepatic cirrhosis.
• Renal impairment: Use with caution in patients with renal dysfunction (CrCl ≤50 mL/minute);
clearance is reduced by ~50%.
• Appropriate use: Due to potential toxicity, confirmation of diagnostic testing of nail or skin

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specimens prior to treatment of onychomycosis or dermatomycosis is recommended.

Storage Store at <30°C.

Refer to manufacturer PIL if there are specific considerations

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11. Selenium Sulfide
Generic Name Selenium Sulfide

Dosage Shampoo 0.025 gm (2.5%)

form/strengths Topical Cream/lotion: 2.5 gm

Route of Topical
administration
Pharmacologic Antiseborrheic Agent, Topical
category ATC: D01AE13
Indications Dandruff, scalp seborrhea: Treatment of dandruff and seborrheic dermatitis of the scalp

Tinea versicolor: Treatment of tinea versicolor

Dosage Dandruff, scalp seborrhea: Topical:
Regimen Lotion, shampoo (2.25%): Massage ~5 to 10 mL into wet scalp; leave on scalp for 2 to 3 minutes,
then rinse scalp thoroughly.
Usually 2 applications each week for 2 weeks will be effective. After this, may repeat at less
frequent intervals (eg, once weekly, every 2 to 4 weeks).
Tinea versicolor: Topical:
Apply to affected area with small amounts of water; leave on skin for 10 minutes, then rinse
thoroughly; repeat once every day for 7 days.

Dosage No dosage adjustments needed

adjustment
Contra- Hypersensitivity to selenium sulfide or any component of the formulation.
indications
Adverse Drug Central nervous system: Lethargy
Reactions Dermatologic: Alopecia or hair discoloration, unusual dryness or oiliness of scalp
Gastrointestinal: Vomiting following long-term use on damaged skin, abdominal pain, garlic
breath
Local: Burning, itching, irritation, stinging (transient)
Neuromuscular & skeletal: Tremor
Miscellaneous: Diaphoresis

Monitoring Assess for any broken or irritated skin that may signal that this medication should not be taken
Parameters at this time. Assess for effectiveness of therapy.
Drug There are no known significant interactions.
Interactions
Pregnancy and pregnancy category C
Lactation Animal reproduction studies have not been conducted. Not recommended for use in pregnant
women.
Breastfeeding Considerations
It is not known if selenium sulfide is present in breast milk following topical application. Caution
should be exercised when administering selenium sulfide to breastfeeding women.
Administration Administration: Topical
Shake well before using. For external use only; not for ophthalmic, oral, anal or intravaginal use.
Do not use when acute inflammation or exudation is present or on damaged skin or mucous
membranes. May damage jewelry; remove before treatment.

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Refer to manufacturer PIL if there are specific considerations

Warnings/ Concerns related to adverse effects:

Precautions • Local effects: Skin irritation or sensitization may occur; discontinue use if irritation or
sensitivity occurs.
Other warnings/precautions:
• Appropriate use: For external use only; not for ophthalmic, oral, anal or intravaginal use. Due
to the risk of systemic toxicity, do not use when acute inflammation or exudation is present or
on damaged skin or mucous membranes.

Storage Store at 20°C to 25°C; excursions permitted between 15°C to 30°C. Protect from heat and
freezing.
Refer to manufacturer PIL if there are specific considerations

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12. Silver Sulfadiazine

Access Group

Generic Name Silver Sulfadiazine

Dosage Topical Cream: 1 gm/100g, 10mg/gm

form/strengths Dressing: 1%
Topical Aerosol 1%
Route of Topical
administration
Pharmacologic Antibiotic, Topical
category ATC: D06BA01
Indications Burn treatment: As an adjunct for the prevention and treatment of wound sepsis in
patients with second- and third-degree burns.

Dosage Dosing: Adult

Regimen Burn treatment: Topical: Apply once or twice daily; reapply as needed to areas where the
cream is removed by patient activity as the burned area should be covered with cream at all
times. Continue use until healing has occurred or the burn site is ready for grafting.
Do not discontinue therapy if the possibility of infection exists unless a significant adverse
reaction has occurred.
Dosing: Pediatric
Note: Continue use until healing has occurred or the burn site is ready for grafting. Do not
discontinue therapy if the possibility of infection exists unless a significant adverse reaction
has occurred.
Burn, treatment: Infants >2 months, Children, and Adolescents: Limited data available in
infants and children: Topical: Apply once or twice daily; reapply as needed; burned area
should be covered with cream at all times

Dosage Dosing: Renal Impairment:

adjustment Sulfadiazine may accumulate with renal impairment. Accumulation will depend on the body
surface area involved and the extent of tissue damage.
Dosing: Hepatic Impairment:
Sulfonamides may cause hepatic impairment; use with caution in hepatic disease.
Discontinuation of treatment may be needed if hepatic impairment occurs with treatment
Contra- Hypersensitivity to silver sulfadiazine or any component of the formulation; pregnant
indications women approaching or at term; premature infants or neonates ≤2 months of age.

Adverse Drug Dermatologic: Erythema multiforme, pruritus, skin discoloration, skin photosensitivity, skin
Reactions rash
Hematologic & oncologic: Agranulocytosis, aplastic anemia, hemolytic anemia, leukopenia
Hepatic: Hepatitis
Hypersensitivity: Hypersensitivity reaction (may be related to sulfa component)
Renal: Interstitial nephritis

Monitoring Serum electrolytes, urinalysis, renal function tests, CBC in patients with extensive burns on
Parameters long-term treatment. Serum sulfa concentrations, if clinically indicated.

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Drug There are no known significant interactions.
Interactions
Pregnancy and Pregnancy Category B
Lactation Use is not recommended unless clearly needed, especially in pregnant women approaching
or at term.
Sulfonamides are known to be excreted in human milk and all sulfonamide derivatives are
known to increase the possibility of kernicterus. There is a possibility for serious adverse
reactions in nursing infants from sulfonamides. A decision should be made to discontinue
breastfeeding or discontinue the drug, taking into account the importance of the drug to
the mother.
Administration Administration: Topical
For topical use only; avoid contact with eyes. Apply with a sterile-gloved hand. Burned area
should be covered with cream at all times; reapply to areas where cream has been removed
by patient activity. Dressings may be used if necessary. Reapply immediately after
hydrotherapy.
Refer to manufacturer PIL if there are specific considerations
Warnings/ Concerns related to adverse effects:
Precautions • Sulfonamide allergy: Chemical similarities are present among sulfonamides, sulfonylureas,
carbonic anhydrase inhibitors, thiazides, and loop diuretics (except ethacrynic acid). Use in
patients with sulfonamide allergy is specifically contraindicated in product labeling,
however, a risk of cross-reaction exists in patients with allergy to any of these compounds;
avoid use when previous reaction has been severe.
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C.
difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been
observed >2 months postantibiotic treatment. Fungal proliferation may rarely occur in and
below the eschar.
• Systemic effects: Systemic absorption may be significant and adverse reactions may occur.
Disease-related concerns:
• G6PD deficiency: Use with caution in patients with G6PD deficiency; hemolysis may occur.
• Hepatic impairment: Use with caution in patients with hepatic impairment; sulfadiazine
may accumulate.
• Renal impairment: Use with caution in patients with renal impairment; sulfadiazine may
accumulate.
Dosage form specific issues:
• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are
potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures, and
respiratory depression; use caution.
Other warnings/precautions:
• Appropriate use: For topical use only. Avoid contact with eyes.

Storage Store at 20°C to 25°C.

Refer to manufacturer PIL if there are specific considerations

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13. Sodium Fusidate/ Fusidic acid
Generic Name Sodium Fusidate/ Fusidic acid

Dosage Tablets 250mg

form/strengths Ointment, cream 2%
Dressing 2% 20mg/gm
eye drops 1mg/gm
Oral Suspension 250 mg/5ml
Route of Oral, topical, Opthalmic
administration
Pharmacologic Antibiotic, Miscellaneous; Antibiotic, Topical
category ATC (Topical): D06AX01
ATC (Dressing): D09AA02
ATC (Systemic): J01XC01
ATC (Ophthalmic): S01AA13
Indications Topical: Skin infections: Treatment of primary (eg, impetigo contagiosa, erythrasma) and
secondary (eg, infected wounds, infected burns) skin infections caused by
susceptible Staphylococcus aureus, Streptococcus spp., Corynebacterium minutissimum

Systemic use: For the treatment of susceptible staphylococcal infections, including cutaneous
infections, osteomyelitis, pneumonia, septicemia, wound infections, endocarditis, and
superinfected cystic fibrosis
Dosage Topical Dosing: Adult, Pediatric
Regimen Skin infections: Topical: Apply small amount to affected area 2 to 3 times daily for 7 to 14 days.
If a gauze dressing is used, frequency of application may be reduced to once or twice daily
Oral adult dose
Oral:
Adolescents and Adults:
Suspension: 750 to 1,500 mg 3 times daily.
Tablets: 250 mg twice daily or 500 to 1,000 mg 3 times daily.
Ophthalmic infections/conjunctivitis: Ophthalmic: Instill 1 drop into the conjunctival sac of each
eye every 12 hours for 7 days; reassess if infection has not resolved after 7 days
Dosing in pediatrics:
Children <1 year: Suspension: 50 mg/kg/day administered in 3 divided doses.
Children 1 to 5 years: Suspension: 250 mg 3 times daily.
Children >5 to 12 years:
Suspension: 500 to 1,000 mg 3 times daily.
Tablets: 250 to 500 mg 3 times daily.
Ophthalmic infections/conjunctivitis: Children ≥2 years and Adolescents: Refer to adult dosing.

Dosage Renal impairment:

adjustment No dosage adjustment is needed
Hepatic impairment:
Fusidates should be given with caution to patients with hepatic impairment
Contra- Hypersensitivity to fusidic acid or any component of the formulation
indications
Adverse Drug Frequency not defined:
Reactions
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Central nervous system: Pain (with treatment of deep leg ulcers)
GIT: jaundice and changes in liver function
Blood: There have been occasional reports of granulocytopenia and thrombocytopenia after the
use of fusidic acid systemically. Sideroblastic anaemia has also been reported.UK licensed
product information also states that there have been isolated cases of neutropenia,
agranulocytosis, and pancytopenia
Monitoring periodic monitoring of hepatic function is recommended in patients with hepatic impairment
Parameters and in those receiving high or prolonged oral doses
Drug There are no known significant interactions.
Interactions interaction has been suspected with drugs metabolised by the hepatic cytochrome P450
isoenzyme CYP3A4

Pregnancy and Adverse effects were not observed in animal reproduction studies. Fusidic acid crosses the
Lactation placenta following systemic administration. Systemic absorption following topical application is
minimal.
Fusidic acid is present in breast milk following systemic administration; however, systemic
absorption following topical application is minimal
Administration For topical use only; do not use near the eyes. Crust of impetigo contagiosa does not need to be
removed prior to application of cream or ointment. When indicated, incision and drainage of
infected lesions should precede application of the cream or ointment.
Refer to manufacturer PIL if there are specific considerations
Warnings/ Concerns related to adverse effects:
Precautions • Skin reactions: Excipients in the topical cream and ointment may cause local skin reaction (eg,
contact dermatitis); discontinue use if irritation or sensitization develops.
• Superinfection: Prolonged use may result in superinfection (including fungal infections).
Discontinue use if superinfection occurs; evaluate and treat appropriately.
• Hypersensitivity reactions in the form of rashes and irritation may occur with topical fusidates;
rash is rare after systemic use.
• Fusidic acid competes with bilirubin for binding to albuminin vitro and caution has been advised
if it is given to premature, jaundiced, acidotic, or seriously-ill neonates because of the risk of
kernicterus.
Other warnings/precautions:
• Appropriate use: Do not use topical cream or ointment near the eye; conjunctival irritation
may occur. Supplemental systemic therapy may be necessary for severe or refractory lesions.
• Neonates: Not indicated for use in neonatal conjunctivitis.

Storage Cream, ointment: Store below 30°C. Use ointment within 3 months of first opening the tube
Ophthalmic solution: Store at 2°C to 25°C. Discard each multi-dose tube 28 days after opening.
Refer to manufacturer PIL if there are specific considerations

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14. Permethrin
Generic Name Permethrin

Dosage Topical Cream, Lotion, Ointment, Emulsion: 2.5%, 5%

form/strengths Shampoo 1%
Route of Topical
administration
Pharmacologic Antiparasitic Agent, Pediculocide; Scabicidal Agent
category ATC: P03AC04
Indications Head lice (lotion/cream rinse): Treatment of head lice (Pediculus humanus capitis) and its nits
(eggs).

Scabies (cream): Treatment of scabies (Sarcoptes scabiei) infestation

Dosage Dosing: Adult
Regimen Head lice: Topical: Cream rinse/lotion 1%: Prior to application, wash hair with conditioner-free
shampoo; rinse with water and towel dry. Apply a sufficient amount of lotion or cream rinse to
saturate the hair and scalp (especially behind the ears and nape of neck). Leave on hair for 10
minutes (but no longer), then rinse off with warm water; remove remaining nits with a nit
comb. A single application is generally sufficient; however, may repeat 7 days after first
treatment if lice or nits are still present.
Scabies: Topical: Cream 5%: Thoroughly massage cream (30 g for an average adult) from head
to soles of feet; leave on for 8 to 14 hours before removing (shower or bath); for infants and
the elderly, also apply on the hairline, neck, scalp, temple, and forehead; may repeat if living
mites are observed 14 days after first treatment; one application is generally curative.
Dosing: Pediatric
Head lice: Note: Usual first-line treatment (or pyrethrins) if community resistance is not an
issue; Infants ≥2 months, Children, and Adolescents: Topical: Solution/rinse 1%: After hair has
been washed with shampoo (nonconditioning), rinsed with water, and towel dried, apply a
sufficient volume of permethrin solution/rinse to saturate the hair and scalp; also apply behind
the ears and at the base of the neck; leave on hair for 10 minutes before rinsing off with water;
remove remaining nits. May repeat in 7 to 10 days if live lice or nits observed; optimal time to
repeat is at day 9 based on the life cycle of lice.
Pubic lice: Limited data available: Adolescents: Topical: Solution/rinse 1%: Apply to affected
area, leave on for 10 minutes, then wash off
Scabies: Infants ≥2 months, Children, and Adolescents: Topical: Cream 5%: Apply and massage
in cream from head to toe (average adult requires 30 g); leave on for 8 to 14 hours before
washing off with water; for infants, also apply on the hairline, neck, scalp, temple, and
forehead; may reapply in 14 days if live mites appear.

Dosage Dosing: Renal Impairment:

adjustment There are no dosage adjustments needed.
Dosing: Hepatic Impairment:
There are no dosage adjustments needed.
Contra- Hypersensitivity to any pyrethroid or pyrethrin, or to any component of the formulation.
indications OTC labeling (cream rinse/lotion): When used for self-medication, do not use on infants <2
months of age; near the eyes; inside the nose, ear, mouth, or vagina. Consult health care
provider for use on eyebrows or eyelashes.

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Adverse Drug 1% to 10%:
Reactions Central nervous system: Local discomfort (scalp), localized burning, localized numbness, tingling
of skin
Dermatologic: Pruritus, erythema, skin rash (scalp), stinging of the skin
Local: Localized edema

Monitoring Assess head, hair, and skin surfaces for presence of lice and nits. Teach patient appropriate
Parameters application
Drug There are no known significant interactions.
Interactions
Pregnancy and Pregnancy Risk Factor B
Lactation The amount of permethrin available systemically following topical application is ≤2%.
The CDC considers permethrin as one of the drugs of choice for the treatment of pubic lice
during pregnancy; permethrin is the preferred treatment of scabies during pregnancy and
during breastfeeding. breastfeeding is not expected to result in significant exposure to a
breastfed child.
Administration Administration: Topical
Avoid contact with eyes and mucous membranes during application. Because scabies and lice
are so contagious, use caution to avoid spreading or infecting oneself; wear gloves when
applying. For the treatment of head lice, use as a portion of a whole lice removal program,
which includes washing or dry cleaning all clothing, hats, bedding, and towels recently worn or
used by the patient and washing combs, brushes, and hair accessories in hot water; items that
cannot be washed should be sealed in a plastic bag for ≥4 weeks. Refer to manufacturer’s
labeling for additional information.
Cream 5%: Apply to skin from head to soles of feet. Remove cream after 8 to 14 hours (shower
or bath).
Rinse 1%: Shake well before using. Apply immediately after hair is shampooed (without
conditioner), rinsed, and towel-dried. Apply enough product to saturate hair and scalp
(especially behind ears and on nape of neck). Leave on hair for 10 minutes (but no longer)
before rinsing with warm water. Remove nits with fine-tooth comb. Protect eyes with a
washcloth or towel
Refer to manufacturer PIL if there are specific considerations
Warnings/ Concerns related to adverse effects:
Precautions • Skin irritation: Treatment may temporarily exacerbate the symptoms of itching, redness, and
swelling. Discontinue use if hypersensitivity occurs.
Other warnings/precautions:
• Appropriate use: For external use only. Avoid contact with eyes.
• Ragweed allergy (cream rinse/lotion): May cause difficulty in breathing or an asthmatic
attack.

Storage Store at 20°C to 25°C

Refer to manufacturer PIL if there are specific considerations

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List of content Alphabetically

1 Abacavir (ABC) 97 29 Cefotaxime 254

2 Acyclovir 143 30 Cefoxitin 233
3 Adefovir Dipivoxil 150 31 Cefpodoxime 245
4 Albendazole 20 32 Cefprozil 236
5 Amikacin 1 33 Ceftaroline fosamil 270
6 Amoxicillin 356 34 Ceftazidime 257
7 Amoxicillin and Clavulanic acid 360 35 Ceftazidime and Avibactam 260
8 Amphotericin B 36 36 Ceftolozane and Tazobactam 274
9 Ampicillin 365 37 Ceftriaxone 263
10 Ampicillin and sulbactam 369 38 Cefuroxime 238
11 Anidulafungin 39 39 Cephalexin 225
12 Artemether and lumefantrine 75 40 Cephradine 228
13 Artesunate 78 41 Chloramphenicol 294
14 Artesunate and amodiaquine 80 42 Chloroquine 82
15 Atazanavir (ATV) 114 43 Ciprofloxacin 392
16 Azithromycin 277 44 Clarithromycin 280
17 Aztreonam 291 45 Clindamycin 297
18 Benzyl Benzoate 419 46 Clotrimazole 421
19 Benzylpenicillin [Penicillin G] 372 47 Cloxacillin 377
20 Caspofungin 41 48 Colistimethate 301
21 Cefaclor 230 49 Daclatasvir 153
22 Cefadroxil 219 50 Dapsone 304
23 Cefazolin 221 51 Darunavir and ritonavir (DRV/r)
119
24 Cefdinir 241
52 Diethylcarbamazine 22
25 Cefepime 267
53 Diloxanide 307
26 Cefixime 243
54 Dolutegravir (DTG) 122
27 Cefoperazone 249
55 Doxycycline 308
28 Cefoperazone and Sulbactam 252
56 Econazole 424

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57 Efavirenz (EFV) 111 88 Lomefloxacin 406
58 Entecavir 156 89 Lopinavir and Ritonavir 116
59 Ertapenem 207 90 Mebendazole 29
60 Erythromycin and Zinc Acetate 426 91 Mefloquine 89
61 Erythromycin, 284 92 Meropenem 216
62 Ethambutol 126 93 Metronidazole 320
63 Ethambutol, Isoniazid, Rifampicin, 94 Micafungin 59
and Pyrazinamide 129
95 Miconazole 428
64 Famciclovir 159
96 Moxifloxacin 408
65 Favipiravir 162
97 Mupirocin 430
66 Flubendazole 44
98 Natamycin 434
67 Flucloxacillin 379
99 Neomycin 10
68 Fluconazole 45
100 Neomycin, Polymyxin B, and
69 Fosfomycin 312 Dexamethasone 432
70 Ganciclovir 163 101 Nevirapine (NVP) 109
71 Gatifloxacin 399 102 Niclosamide 30
72 Gentamicin 4 103 Nitrofurantoin 323
73 Griseofulvin 49 104 Norfloxacin 412
74 Hydroxychloroquine 86 105 Nystatin 62
75 Imipenem and Cilastatin 212 106 Ofloxacin 414
76 Isoconazole 427 107 Ombitasvir, Papritaprevir and
Ritonavir 172
77 Isoniazid 131
108 Oseltamivir 175
78 Itraconazole 51
109 Oxytetracycline 326
79 Ivermectin 24
110 Penicillin G Benzathine 381
80 Ketoconazole 55
111 Permethrin 444
81 Lamivudine (3TC) 100
112 Phenoxymethylpenicillin 385
82 Lamivudine and Zidovudine 166
113 Piperacillin and Tazobactam 387
83 Ledipasvir and Sofosbuvir 168
114 Posaconazole 70
84 Levamisole 27
115 Praziquantel 32
85 Levofloxacin 401
116 Pyrantel 34
86 Lincomycin 314
117 Pyrazinamide 134
87 Linezolid 316

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118 Pyrimethamine 92 136 Sulfamethoxazole and Trimethoprim
333
119 Raltegravir 124
137 Sultamicillin 390
120 Ribavirin 179
138 Tedizolid 336
121 Rifampicin 136
139 Teicoplanin 338
122 Rifampicin and Isoniazid 140
140 Tenofovir Alafenamide 197
123 Rifaximin 328
141 Tenofovir disoproxil fumarate (TDF)
124 Roxithromycin 287
104
125 Secnidazole 331
142 Terbinafine 435
126 Selenium Sulfide 438
143 Tetracycline 340
127 Silver Sulfadiazine 440
144 Thiamphenicol 344
128 Simeprevir 185
145 Tigecycline 346
129 Sodium Fusidate/ Fusidic acid 442
146 Tobramycin 17
130 Sofosbuvir 188
147 Triclabendazole 35
131 Sofosbuvir and Velpatasvir 191
148 Valacyclovir 199
132 Sofosbuvir, Velpatasvir and
149 Valganciclovir 203
Voxilaprevir 194
150 Vancomycin 350
133 Spiramycin 289
151 Voriconazole 64
134 Streptomycin 13
152 Zidovudine 107
135 Sulfadoxine and Pyrimethamine 94

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List of Antibiotics in Formulary according to WHO AWaRe list
Acess Watch Reserve
Amikacin Azithromycin Aztreonam
Amoxicillin Cefaclor Ceftaroline fosamil
Amoxicillin and Clavulanate Cefdinir Ceftazidime and Avibactam
Ampicillin Cefepime Ceftolozane and Tazobactam
Ampicillin and Sulbactam Cefixime Colistimethate
Benzylpenicillin [Penicillin G] Cefoperazone Linezolid
Cefadroxil Cefotaxime Tedizolid
Cefazolin Cefoxitin Tigecycline
Cephalexin Cefpodoxime
Cephradine Cefprozil
Chloramphenicol Ceftazidime
Clindamycin Ceftriaxone
Cloxacillin Cefuroxime
Doxycycline Ciprofloxacin
Flucloxacillin Clarithromycin
Gentamicin Ertapenem
Metronidazole Erythromycin
Nitrofurantoin Fosfomycin
Penicillin G Benzathine Gatifloxacin
Phenoxymethylpenicillin Imipenem and Cilastatin
Secnidazole Levofloxacin
Silver Sulfadiazine (topical) Lincomycin
Sulfamethoxazole and Trimethoprim Lomefloxacin
Sultamicillin Meropenem
Tetracycline Moxifloxacin
Thiamphenicol Neomycin
Norfloxacin
Ofloxacin
Oxytetracycline
Piperacillin and Tazobactam
Rifampicin
Rifaximin
Roxithromycin
Spiramycin
Streptomycin
Teicoplanin
Tobramycin
Vancomycin

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References
www.lexicomp.com

www.Drugs.com (AHFS monographs)

www.Accessdata.fda.gov

Uptodate

BNF

WHO aware list

www.whocc.no/atc_ddd_index/

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