Label Changes for:
Prandin (repaglinide) Tablets
March 2012
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2012
PRECAUTIONS
Drug Interactions
- Deferasirox: Co-administration of deferasirox (30 mg/kg/day for 4 days) and repaglinide (single dose of 0.5 mg) resulted in an increase in repaglinide systemic exposure (AUC) to 2.3-fold ofontrol and an increase in Cmax of 62%
June 2009
CONTRAINDICATIONS
Prandin is contraindicated in patients with:
- Co-administration of gemfibrozil.
PRECAUTIONS
Drug-Drug Interactions
- Repaglinide appears to be a substrate for active hepatic uptake transporter (organic anion transporting protein OATP1B1). Drugs that inhibit OATP1B1 (e.g. cyclosporine) may likewise have the potential to increase plasma concentrations of repaglinide.
ADVERSE REACTIONS
Infrequent Adverse Events (<1% of Patients)
- Changes in blood glucose levels may result in blurred vision and visual disturbances, especially at the initiation of treatment with hypoglycemic agents.
