Jane S. Ricciuti, RPh, MS


October 23, 2002

In This Article

Antilipemic Agents

(lovastatin) Tablets

Manufacturer: Merck & Co, Inc

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 9/20/02)

Revised Warnings: This supplemental new drug application changes wording on the approved labeling. The changes strengthen the warnings for the potential of Mevacor to cause myopathy/rhabdomyolysis.

The label sections affected include "Clinical Pharmacology," "Warnings," "Precautions," and "Dosage and Administration."

Inhibitors of CYP3A4 can raise the plasma levels of HMG-CoA reductase inhibitor activity and increase the risk of myopathy.

The risk of myopathy/rhabdomyolysis is increased by concomitant use of lovastatin with the following agents:

Potent inhibitors of CYP3A4: clarithromycin, cyclosporine, erythromycin, itraconazole, ketoconazole, nefazodone, protease inhibitors, or large quantities of grapefruit juice (> 1 quart daily), particularly with higher doses of lovastatin.

  • Other drugs: The risk of myopathy/rhabdomyolysis is increased when either amiodarone or verapamil is used concomitantly with higher doses of a closely related member of the HMG-CoA reductase inhibitor class.

  • Dosing: There is a dose-response relationship to myopathy/rhabdomyolysis. Dosing adjustments should be made for patients who are concomitantly taking Mevacor with cyclosporine, gemfibrozil, other fibrates, or lipid-lowering doses of amiodarone, niacin, or verapamil.

    Mevacor (lovastatin) Labeling

    Mevacor (lovastatin) Letter

    Mevacor (lovastatin)


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