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Clarithromycin

کلاریترومایسین

⚠ Unverified

🦠 Antiinfectives For Systemic UseMacrolide

🤰 Pregnancy:Use with caution 🤱 Breastfeeding:Use with caution 👶 Children:Use with caution 👴 Older adults:Use with caution ⚥ Females & males of reproductive potential:Use with caution 🇮🇷 Registered in Iran ⛔ 6 contraindications 🇺🇸 FDA approved generic (ANDA) ANDA065283 ATC J01FA09

Market / country: 🇺🇸 USA

Biaxin (US)

🧮 Dose calculator

Disease / regimen

Streptococcal pharyngitis / tonsillitis · Regimen source: FDA Clarithromycin susp · 2.4 FDA Clarithromycin susp · 8.4

Formulation

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🛡️ Safety & information

Contraindications

⛔ Hypersensitivity to clarithromycin, erythromycin or any macrolide. FDA Clarithromycin susp · 4.1
⛔ Concomitant cisapride or pimozide (fatal arrhythmias). FDA Clarithromycin susp · 4.2
⛔ History of cholestatic jaundice/hepatic dysfunction with clarithromycin. FDA Clarithromycin susp · 4.3
⛔ With colchicine in renal or hepatic impairment. FDA Clarithromycin susp · 4.4
⛔ With lomitapide, lovastatin or simvastatin. FDA Clarithromycin susp · 4.5
⛔ Safety and effectiveness established only from 6 months. FDA Clarithromycin susp · 8.4

Warnings

• Severe acute hypersensitivity reactions FDA Clarithromycin susp · 5.1
• QT prolongation FDA Clarithromycin susp · 5.2
• Hepatotoxicity FDA Clarithromycin susp · 5.3
• Serious adverse reactions with concomitant drugs FDA Clarithromycin susp · 5.4
• Clostridium difficile-associated diarrhea FDA Clarithromycin susp · 5.6
• Exacerbation of myasthenia gravis FDA Clarithromycin susp · 5.8

Renal adjustment

• eGFR < 30: CrCl <30 mL/min: reduce dose by 50%. FDA Clarithromycin susp · 2.6

Formulations

125 mg / 5 mL — suspension 🇺🇸 USA FDA Clarithromycin susp · 3
250 mg / 5 mL — suspension 🇺🇸 USA FDA Clarithromycin susp · 3

👥 Special populations

🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Clarithromycin susp · 8.1
“Risk Summary Based on findings from animal studies, clarithromycin is not recommended for use in pregnant women except in clinical circumstances where no alternative therapy is appropriate.”
🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Clarithromycin susp · 8.2
“Risk Summary Based on limited human data, clarithromycin and its active metabolite 14-OH clarithromycin are present in human milk at less than 2% of the maternal weight-adjusted dose ( see Data ).”
👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Clarithromycin susp · 8.4
“The safety and effectiveness of clarithromycin for oral suspension have been established for the treatment of the following conditions or diseases in pediatric patients 6 months and older.”
👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Clarithromycin susp · 8.5
“Elderly patients may be more susceptible to development of torsades de pointes arrhythmias than younger patients [ see Warnings and Precautions ( 5.3 ) ].”
⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Clarithromycin susp · 8.3
“Males Administration of clarithromycin resulted in testicular atrophy in rats, dogs and monkeys [see Nonclinical Toxicology ( 13.1 )] .”

🔗 Reference links

FDA (approval record)ANDA065283
DailyMed (FDA label)FDA Clarithromycin susp FDA Clarithromycin tab
MedlinePlus (NIH)Clarithromycin Lansoprazole, Clarithromycin, and Amoxicillin
WHO ATC/DDDJ01FA09
Darooyab (Iran)Clarithromycin

🇮🇷 Registered in Iran Darooyab · G-362/Clarithromycin

Dosage forms with Iranian generic codes, per Darooyab.

01838 · CLARITHROMYCIN 125MG/5ML SUSP · سوسپانسیون کلاریترومایسین ۱۲۵ میلی‌گرم / ۵ میلی‌لیتر
01837 · CLARITHROMYCIN 250MG TAB · قرص کلاریترومایسین ۲۵۰ میلی‌گرم
13464 · CLARITHROMYCIN 250MG/5ML 100ML SUSP · سوسپانسیون کلاریترومایسین ۲۵۰ میلی‌گرم / ۵ میلی‌لیتر ۱۰۰ میلی‌لیتر
09300 · CLARITHROMYCIN 250MG/5ML 60ML SUSP · سوسپانسیون کلاریترومایسین ۲۵۰ میلی‌گرم / ۵ میلی‌لیتر ۶۰ میلی‌لیتر
02034 · CLARITHROMYCIN 500MG TAB · قرص کلاریترومایسین ۵۰۰ میلی‌گرم
50194 · CLARITHROMYCIN GRANULE, FOR SUSPENSION ORAL 250 mg · سوسپانسیون خوراکی کلاریترومایسین ۲۵۰ میلی‌گرم
51903 · CLARITHROMYCIN POWDER, FOR SUSPENSION ORAL 125 mg/5 mL 60 mL · سوسپانسیون خوراکی کلاریترومایسین ۱۲۵ میلی‌گرم / ۵ میلی‌لیتر ۶۰ میلی‌لیتر
52002 · CLARITHROMYCIN POWDER, FOR SUSPENSION ORAL 250 mg/5 mL 100 mL · سوسپانسیون خوراکی کلاریترومایسین ۲۵۰ میلی‌گرم / ۵ میلی‌لیتر ۱۰۰ میلی‌لیتر

📚 Reference status for this drug

Shows which sources have references recorded for this drug and which do not.

FDA label (DailyMed)✅ Present
FDA Clarithromycin susp · 3 FDA Clarithromycin susp · 2.4 FDA Clarithromycin susp · 8.4 FDA Clarithromycin tab · 2.2, Table 1 FDA Clarithromycin susp · 1.6 FDA Clarithromycin susp · 4.1 FDA Clarithromycin susp · 4.2 FDA Clarithromycin susp · 4.3 FDA Clarithromycin susp · 4.4 FDA Clarithromycin susp · 4.5 FDA Clarithromycin susp · 5.1 FDA Clarithromycin susp · 5.2 FDA Clarithromycin susp · 5.3 FDA Clarithromycin susp · 5.4 FDA Clarithromycin susp · 5.6 FDA Clarithromycin susp · 5.8 FDA Clarithromycin susp · 2.6 FDA Clarithromycin susp · 8.1 FDA Clarithromycin susp · 8.2 FDA Clarithromycin susp · 8.5 FDA Clarithromycin susp · 8.3 FDA Clarithromycin susp · SPL approval / marketing category
UK SmPC (eMC / MHRA)❌ Not present
Published guideline❌ Not present
Licensed reference (medical school)❌ Not present
Iranian leaflet (IFDA)❌ Not present
Pharmacy website (secondary, unreliable)✅ Present
Darooyab · G-362/Clarithromycin
Clinical review⚠ Unverified