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
