HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ZOCOR safely and effectively. See full prescribing information for ZOCOR.

ZOCOR (simvastatin) Tablets
Initial U.S. Approval: 1991
INDICATIONS AND USAGE
ZOCOR® is an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to:

Reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal myocardial infarction, stroke, and the need for revascularization procedures in patients at high risk of coronary events. (1.1)
Reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia. (1.2)
Reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbeta-lipoproteinemia. (1.2)
Reduce total-C and LDL-C in adult patients with homozygous familial hypercholesterolemia. (1.2)
Reduce elevated total-C, LDL-C, and Apo B in boys and postmenarchal girls, 10 to 17 years of age with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. (1.2, 1.3)
Limitations of Use

ZOCOR has not been studied in Fredrickson Types I and V dyslipidemias. (1.4)

DOSAGE AND ADMINISTRATION
Dose range is 5 to 40 mg/day. (2.1)
Recommended usual starting dose is 10 or 20 mg once a day in the evening. (2.1)
Recommended starting dose for patients at high risk of CHD is 40 mg/day. (2.1)
Due to the increased risk of myopathy, including rhabdomyolysis, use of the 80-mg dose of ZOCOR should be restricted to patients who have been taking simvastatin 80 mg chronically (e.g., for 12 months or more) without evidence of muscle toxicity. (2.2)
Patients who are currently tolerating the 80-mg dose of ZOCOR who need to be initiated on an interacting drug that is contraindicated or is associated with a dose cap for simvastatin should be switched to an alternative statin with less potential for the drug-drug interaction. (2.2)
Due to the increased risk of myopathy, including rhabdomyolysis, associated with the 80-mg dose of ZOCOR, patients unable to achieve their LDL-C goal utilizing the 40-mg dose of ZOCOR should not be titrated to the 80-mg dose, but should be placed on alternative LDL-C-lowering treatment(s) that provides greater LDL-C lowering. (2.2)
Adolescents (10-17 years of age) with HeFH: starting dose is 10 mg/day; maximum recommended dose is 40 mg/day. (2.5)
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg; 10 mg; 20 mg; 40 mg; 80 mg (3)

CONTRAINDICATIONS
Concomitant administration of strong CYP3A4 inhibitors. (4, 5.1)
Concomitant administration of gemfibrozil, cyclosporine, or danazol. (4, 5.1)
Hypersensitivity to any component of this medication. (4, 6.2)
Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels. (4, 5.2)
Women who are pregnant or may become pregnant. (4, 8.1)
Nursing mothers. (4, 8.3)
WARNINGS AND PRECAUTIONS
Patients should be advised of the increased risk of myopathy including rhabdomyolysis with the 80-mg dose. (5.1)
Skeletal muscle effects (e.g., myopathy and rhabdomyolysis): Risks increase with higher doses and concomitant use of certain medicines. Predisposing factors include advanced age (≥65), female gender, uncontrolled hypothyroidism, and renal impairment. Rare cases of rhabdomyo