Clarithromycin (7 brand names, 6 dosage forms, 1 route)
Available dosage forms: TABLET, TABLET, EXTENDED RELEASE, FOR SUSPENSION, CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS, CAPSULE, TABLET, CAPSULE, DELAYED RELEASE, CAPSULE, TABLET, TABLET.
Routes of administration: ORAL.
Brand Names
- BIAXIN
- BIAXIN XL
- CLARITHROMYCIN
- LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN (COPACKAGED)
- OMECLAMOX-PAK
- PREVPAC (COPACKAGED)
- VOQUEZNA TRIPLE PAK
Adverse Reactions
The following serious adverse reactions are described below and elsewhere in the labeling: • Acute Hypersensitivity Reactions [see Warnings and Precautions (5.1)] • QT Prolongation [see Warnings and Precautions (5.2)] • Hepatotoxicity [see Warnings and Precautions (5.3)] • Serious Adverse Reactions Due to Concomitant Use with Other Drugs [see Warnings and Precautions (5.4)] • Clostridium difficileAssociated Diarrhea [see Warnings and Precautions (5.6)] • Exacerbation of Myasthenia Gravis [see Warnings and Precautions (5.8)]
Drug Interactions
Co-administration of clarithromycin is known to inhibit CYP3A, and a drug primarily metabolized by CYP3A may be associated with elevations in drug concentrations that could increase or prolong both therapeutic and adverse effects of the concomitant drug. Clarithromycin should be used with caution in patients receiving treatment with other drugs known to be CYP3A enzyme substrates, especially if the CYP3A substrate has a narrow safety margin (e.g., carbamazepine) and/or the substrate is extensively metabolized by this enzyme. Adjust dosage when appropriate and monitor serum concentrations of drugs primarily metabolized by CYP3A closely in patients concurrently receiving clarithromycin. Table 8: Clinically Significant Drug Interactions with Clarithromycin Drugs That Are Affected By Clarithromycin Drug(s) with Pharmacokinetics Affected by Clarithromycin Recommendation Comments Antiarrhythmics: Disopyramide Quinidine Dofetilide Amiodarone Sotalol Procainamide Digoxin Not Recommended Use With Caution Disopyramide, Quinidine: There have been postmarketing reports of torsades de pointesoccurring with concurrent use of clarithromycin and quinidine or disopyramide. Electrocardiograms should be monitored for QTc prolongation during coadministration of clarithromycin with these drugs [see Warnings and Precautions (5.2)] . Serum concentrations of these medications should also be monitored. There have been spontaneous or published reports of CYP3A based interactions of clarithromycin with disopyramide and quinidine. There have been postmarketing reports of hypoglycemia with the concomitant administration of clarithromycin and disopyramide. Therefore, blood glucose levels should be monitored during concomitant administration of clarithromycin and disopyramide. Digoxin: Digoxin is a substrate for P-glycoprotein (Pgp) and clarithromycin is known to inhibit Pgp. When clarithromycin and digoxin are co-administered, inhibition of Pgp by clarithromycin may lead to increased exposure of
Mechanism of Action
Clarithromycin is a macrolide antimicrobial drug [see Microbiology (12.4)] .
Overdosage
Overdosage of clarithromycin can cause gastrointestinal symptoms such as abdominal pain, vomiting, nausea, and diarrhea. Treat adverse reactions accompanying overdosage by the prompt elimination of unabsorbed drug and supportive measures. As with other macrolides, clarithromycin serum concentrations are not expected to be appreciably affected by hemodialysis or peritoneal dialysis.