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Label Changes for:

Biaxin Filmtab (clarithromycin tablets, USP)Biaxin XL Filmtab (clarithromycin extended-release tablets)Biaxin Granules (clarithromycin for oral suspension, USP)

May 2011

Changes have been made to the CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – May 2011

 

CONTRAINDICATIONS

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

WARNINGS

Hepatotoxicity
  • Hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice, has been reported with clarithromycin. This hepatic dysfunction may be severe and is usually reversible. In some instances, hepatic failure with fatal outcome has been reported and generally has been associated with serious underlying diseases and/or concomitant medications. Discontinue clarithromycin immediately if signs and symptoms of hepatitis occur.

ADVERSE REACTIONS

Postmarketing Experience
  • Adverse reactions related to hepatic dysfunction have been reported in postmarketing experience with clarithromycin.
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