Zocor

[simvastatin]

Concomitant Lipid-Lowering Therapy

In controlled clinical studies in which simvastatin was administered concomitantly with cholestyramine, no adverse reactions peculiar to this concomitant treatment were observed. The adverse reactions that occurred were limited to those reported previously with simvastatin or cholestyramine. The combined use of simvastatin at doses exceeding 10 mg/ day with gemfibrozil should be avoided (see WARNINGS,
Myopathy/ Rhabdomyolysis).

Adolescent Patients (ages 10-17 years)

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In a 48-week controlled study in adolescent boys and girls who were at least 1 year post-menarche, 10-17 years of age with heterozygous familial hypercholesterolemia (n= 175), the safety and tolerability profile of the group treated with ZOCOR (10-40 mg daily) was generally similar to that of the group treated with placebo, with the most common adverse experiences observed in both groups being upper respiratory infection, headache, abdominal pain, and nausea. (see CLINICAL PHARMACOLOGY, Clinical Studies in Adolescents, and PRECAUTIONS, Pediatric Use).

Drug Interactions

CYP3A4 Interactions

Simvastatin is metabolized by CYP3A4 but has no CYP3A4 inhibitory activity; therefore it is not expected to affect the plasma concentrations of other drugs metabolized by CYP3A4. Potent inhibitors of CYP3A4 (below) increase the risk of myopathy by reducing the elimination of simvastatin.
See WARNINGS, Myopathy/ Rhabdomyolysis, and CLINICAL PHARMACOLOGY, Pharmacokinetics.

Itraconazole
Ketoconazole
Erythromycin
Clarithromycin
HIV protease inhibitors
Nefazodone
Cyclosporine
Large quantities of grapefruit juice (> 1 quart daily)

Interactions with lipid-lowering drugs that can cause myopathy when given alone See WARNINGS, Myopathy/ Rhabdomyolysis.

The risk of myopathy is increased by gemfibrozil (see DOSAGE AND ADMINISTRATION) and to a lesser extent by other fibrates and niacin (nicotinic acid) ( 1 g/ day).

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