Clarithromycin

What it is and how it works

Mechanism of Action Clarithromycin is a macrolide antimicrobial drug .

Mechanism class: Cytochrome P450 3A4 Inhibitors · Cytochrome P450 3A Inhibitors · P-Glycoprotein Inhibitors

Indications

Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in the following: Acute Bacterial Exacerbation of Chronic Bronchitis in Adults Acute Maxillary Sinusitis Community-Acquired Pneumonia Pharyngitis/Tonsillitis Uncomplicated Skin and Skin Structure Infections Acute Otitis Media in Pediatric Patients Treatment and Prophylaxis of Disseminated Mycobacterial Infections Helicobacter pylori Infection and Duodenal Ulcer Disease in Adults Limitations of Use To reduce the development of drug-resistant bacteria and maintain the effectiveness of clarithromycin tablets and other antibacterial drugs, clarithromycin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Dosage and administration (summary)

Adults : Clarithromycin tablets 250 mg or 500 mg every 12 hours for 7 to 14 days H. pylori eradication (in combination with lansoprazole/amoxicillin, omeprazole/amoxicillin, or omeprazole): Clarithromycin tablets 500 mg every 8 or 12 hours for 10 to 14 days. See full prescribing information (FPI) for additional information. Pediatric Patients : Clarithromycin tablets 15 mg/kg/day divided every 12 hours for 10 days Mycobacterial Infections : Clarithromycin tablets 500 mg every 12 hours.

Contraindications

Hypersensitivity to clarithromycin or any macrolide drug Cisapride and pimozide History of cholestatic jaundice/hepatic dysfunction with use of clarithromycin Colchicine in renal or hepatic impairment Lomitapide, lovastatin, and simvastatin Ergot alkaloids (ergotamine or dihydroergotamine) Lurasidone Hypersensitivity Clarithromycin tablets are contraindicated in patients with a known hypersensitivity to clarithromycin, erythromycin, or any of the macrolide antibacterial drugs .

Warnings and precautions

Severe Acute Hypersensitivity Reactions: Discontinue clarithromycin if occurs QT Prolongation : Avoid clarithromycin in patients with known QT prolongation or receiving drugs known to prolong the QT interval, ventricular arrhythmia ( torsades de pointes ), hypokalemia /hypomagnesemia, significant bradycardia, or taking Class IA or III antiarrhythmics Hepatotoxicity : Discontinue if signs and symptoms of hepatitis occur Serious adverse reactions can occur due to drug interactions of clarithromycin with colchicine, some lipid-lowering agents, some calcium channel blockers, and other drugs Risk o…

Pregnancy

Pregnancy 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. If pregnancy occurs while taking clarithromycin, the patient should be apprised of the potential hazard to the fetus .

Storage and supply

Clarithromycin Tablets USP, 250 mg are light yellow colored, oval shaped, biconvex film-coated tablets, with ‘D’ debossed on one side and ‘62’ on the other side. Bottles of 60 NDC 57237-044-60 Clarithromycin Tablets USP, 500 mg are light yellow colored, oval shaped, biconvex film-coated tablets, with ‘D’ debossed on one side and ‘63’ on the other s…

Source: Clarithromycin (Clarithromycin) — US FDA prescribing information, 2024-01-05, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.