Medication Monitor

Generic Name (Trade Name—Company)
June 9, 2011


(Zocor and generics—Merck and others)
Dosing, drug interactions subjects of FDA action

Simvastatin dosage restrictions have been announced by FDA, along with additional contraindications concerning use of the drug with certain other medications or above certain doses with other drugs. Simvastatin 80 mg should be used only in patients who have been taking this dose for 12 months or more without evidence of myopathy, FDA said. Simvastatin 80 mg should not be started in new patients, including patients already taking lower doses of the drug, the agency added. FDA said simvastatin should never be used with posaconazole, and it moved three drugs from a "do not exceed simvastatin 10 mg" category to an absolute contraindication (gemfibrozil, cyclosporine, and danazol). Dosing limits for simvastain were lowered for amiodaraone, verapamil, and diltiazem (now 10 mg daily) and added for amlodipine and ranolazine (Ranexa—Gilead) (20 mg daily).