Biaxin (Clarithromycin) - Drug Interactions, Contraindications, Overdosage, etc

DRUG INTERACTIONS

BIAXIN drug label information in our database does not contain a dedicated section on drug interactions. Please check subsections of WARNINGS AND PRECAUTIONS as well as other sources.

OVERDOSAGE

Overdosage of clarithromycin can cause gastrointestinal symptoms such as abdominal pain, vomiting, nausea, and diarrhea.

Adverse reactions accompanying overdosage should be treated 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.

CONTRAINDICATIONS

Clarithromycin is contraindicated in patients with a known hypersensitivity to clarithromycin or any of its excipients, erythromycin, or any of the macrolide antibiotics.

Clarithromycin is contraindicated in patients with a history of cholestatic jaundice/hepatic dysfunction associated with prior use of clarithromycin.

Concomitant administration of clarithromycin and any of the following drugs is contraindicated: cisapride, pimozide, astemizole, terfenadine, and ergotamine or dihydroergotamine (see Drug Interactions). There have been post-marketing reports of drug interactions when clarithromycin and/or erythromycin are coadministered with cisapride, pimozide, astemizole, or terfenadine resulting in cardiac arrhythmias (QT prolongation, ventricular tachycardia, ventricular fibrillation, and torsades de pointes) most likely due to inhibition of metabolism of these drugs by erythromycin and clarithromycin. Fatalities have been reported.

Concomitant administration of clarithromycin and colchicine is contraindicated in patients with renal or hepatic impairment.

Clarithromycin should not be given to patients with history of QT prolongation or ventricular cardiac arrhythmia, including torsades de pointes.

Clarithromycin should not be used concomitantly with HMG-CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (lovastatin or simvastatin), due to the increased risk of myopathy, including rhabdomyolysis. (see WARNINGS).

For information about contraindications of other drugs indicated in combination with BIAXIN, refer to the CONTRAINDICATIONS section of their package inserts.

REFERENCES

1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically - 9th edition. Approved Standard. CLSI Document M07-A9, CLSI. 950 West Valley Rd, Suite 2500, Wayne, PA 19087, 2012.
2. CLSI. Performance Standards for Antimicrobial Susceptibility Testing, 22^nd Informational Supplement, CLSI Document M100-S22, 2012.
3. CLSI. Performance Standards for Antimicrobial Disk Susceptibility Tests, 11th edition. Approved Standard CLSI Document M02-A11, 2012.
4. CLSI. Methods for Antimicrobial Dilution and Disk Diffusion Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria - 2^nd edition. CLSI document M45-A2, 2010.
5. Chaisson RE, et al. Clarithromycin and Ethambutol with or without Clofazimine for the Treatment of Bacteremic Mycobacterium avium Complex Disease in Patients with HIV Infection. AIDS. 1997;11:311-317.
6. Kemper CA, et al. Treatment of Mycobacterium avium Complex Bacteremia in AIDS with a Four-Drug Oral Regimen. Ann Intern Med. 1992;116:466-472.

SPL UNCLASSIFIED

Filmtab - Film-sealed tablets, Abbott

Biaxin Filmtab 250 mg and 500 mg and Biaxin XL 500 mg

Mfd. by Abbott Pharmaceuticals PR Ltd., Barceloneta, PR 00617

Biaxin Granules for Oral Suspension, 125 mg/5 mL and 250 mg/5 mL

Mfd. by Abbott Laboratories, North Chicago, IL  60064

For Abbott Laboratories, North Chicago, IL 60064, U.S.A.

Revised: 07/2012