Label Changes for:

PrandiMet (repaglinide/metformin HCl fixed-dose combination) tablet

May 2010

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

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – May 2010

CONTRAINDICATIONS

  • PrandiMet is contraindicated in: Patients receiving gemfibrozil

WARNINGS AND PRECAUTIONS

Drug Interactions
  • Gemfibrozil significantly increased repaglinide exposure. Therefore, patients should not take PrandiMet with gemfibrozil
  • Drugs that inhibit OATP1B1 (e.g., cyclosporine) may have the potential to increase plasma concentrations of repaglinide
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