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.

 

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