Label Changes for:

Verelan PM (verapamil hydrochloride) Extended-Release CapsulesVerelan (verapamil hydrochloride) Sustained-Release Capsules

November 2011

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) – November 2011

 

  • Calan (verapamil hydrochloride) Intravenous Injection and Calan (verapamil hydrochloride) Intravenous Injection Syringe
  • Covera HS (verapamil hydrochloride) Extended Release Tablets
  • Tarka (trandolapril/verapamil hydrochloride) Tablets
  • Verelan PM (verapamil hydrochloride) Extended-Release Capsules
  • Verelan (verapamil hydrochloride) Sustained-Release Capsules

 

 

PRECAUTIONS

Drug Interactions
  • HMG-CoA reductase inhibitors: The use of HMG-CoA reductase inhibitors that are CYP3A4 substrates in combination with verapamil has been associated with reports of myopathy/rhabdomyolysis. Co-administration of multiple doses of 10 mg of verapamil with 80 mg simvastatin resulted in exposure to simvastatin 2.5-fold that following simvastatin alone. Limit the dose of simvastatin in patients on verapamil to 10 mg daily. Limit the daily dose of lovastatin to 40 mg. Lower starting and maintenance doses of other CYP3A4 substrates (e.g., atorvastatin) may be required as verapamil may increase the plasma concentration of these drugs.

 

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