The U.S. Food and Drug Administration (FDA) is notifying the public that it has revised the dose limitation for the cholesterol-lowering drug simvastatin from 10 mg to 20 mg when it is co-administered with the cardiac drug amiodarone. In June 2011, FDA previously recommended that the dose limitation for simvastatin be decreased from 20 mg to 10 mg, and has now reconsidered that recommendation.
In patients who are taking both simvastatin and amiodarone, the dose of simvastatin should not exceed 20 mg per day. The simvastatin drug labels (Zocor and generics, Vytorin) have been updated to reflect this correction.
For more information please visit: simvastatin update:
Drug Safety and Availability > FDA Drug Safety Communication: Revised dose limitation for Zocor (simvastatin) when taken with amiodarone
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