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GlaxoSmithKline Obtains Exclusive U.S. OTC Marketing Rights to MEVACOR(R) (lovastatin) from Merck & Co., Inc.
Date:11/26/2007

n patients receiving concomitant medication with other fibrates or Greater Than or Equal To 1 g/day of niacin. Caution should be used when prescribing other fibrates or lipid-lowering doses (Greater Than or Equal To 1 g/day) of niacin with lovastatin, as these agents can cause myopathy when given alone. The benefit of further alterations in lipid levels by the combined use of lovastatin with other fibrates or niacin should be carefully weighed against the potential risks of these combinations.

Cyclosporine or danazol, with higher doses of lovastatin: The dose of lovastatin should not exceed 20 mg daily in patients receiving concomitant medication with cyclosporine or danazol. The benefits of the use of lovastatin in patients receiving cyclosporine or danazol should be carefully weighed against the risks of these combinations.

Amiodarone or verapamil: The dose of lovastatin should not exceed 40 mg daily in patients receiving concomitant medication with amiodarone or verapamil. The combined use of lovastatin at doses higher than 40 mg daily with amiodarone or verapamil should be avoided unless the clinical benefit is likely to outweigh the increased risk of myopathy. 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.

Prescribing recommendations for interacting agents are summarized in Table VI (see also CLINICAL PHARMACOLOGY, Pharmacokinetics; PRECAUTIONS, Drug Interactions; DOSAGE AND ADMINISTRATION).

Table VI

Drug Interactions Associated with Increased

Risk of Myopathy/Rhabdomyolysis

Interacting Agents Prescribing Recommendations

Itraconazole Avoid lovastatin

Ketoconazole

Erythromycin

Clarithromycin

Telithromycin

HIV protease inh
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SOURCE GlaxoSmithKline
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