Clarithromycin
کلاریترومایسین
🦠 Antiinfectives For Systemic UseMacrolide
Market / country: 🇺🇸 USA
Biaxin (US)
🧮 Dose calculator
Streptococcal pharyngitis / tonsillitis · Regimen source: FDA Clarithromycin susp · 2.4FDA Clarithromycin susp · 8.4
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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 suspFDA Clarithromycin tab
- MedlinePlus (NIH)ClarithromycinLansoprazole, 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)✅ PresentFDA Clarithromycin susp · 3FDA Clarithromycin susp · 2.4FDA Clarithromycin susp · 8.4FDA Clarithromycin tab · 2.2, Table 1FDA Clarithromycin susp · 1.6FDA Clarithromycin susp · 4.1FDA Clarithromycin susp · 4.2FDA Clarithromycin susp · 4.3FDA Clarithromycin susp · 4.4FDA Clarithromycin susp · 4.5FDA Clarithromycin susp · 5.1FDA Clarithromycin susp · 5.2FDA Clarithromycin susp · 5.3FDA Clarithromycin susp · 5.4FDA Clarithromycin susp · 5.6FDA Clarithromycin susp · 5.8FDA Clarithromycin susp · 2.6FDA Clarithromycin susp · 8.1FDA Clarithromycin susp · 8.2FDA Clarithromycin susp · 8.5FDA Clarithromycin susp · 8.3FDA 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)✅ PresentDarooyab · G-362/Clarithromycin
- Clinical review⚠ Unverified