ZOCOR SUMMARY
ZOCOR®
(SIMVASTATIN)
TABLETS
ZOCOR1 (simvastatin) is a lipid-lowering agent that is derived synthetically from a fermentation product of
Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding (beta)-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol.
Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol.
In patients with CHD or at high risk of CHD, ZOCOR can be started simultaneously with diet.
Reductions in Risk of CHD Mortality and Cardiovascular Events
In patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, ZOCOR is indicated to:
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Reduce the risk of total mortality by reducing CHD deaths.
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Reduce the risk of non-fatal myocardial infarction and stroke.
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Reduce the need for coronary and non-coronary revascularization procedures.
Patients with Hypercholesterolemia Requiring Modifications of Lipid Profiles
ZOCOR is indicated to:
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Reduce elevated total-C, LDL-C, Apo B, and TG, and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson types IIa and IIb4).
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Treat patients with hypertriglyceridemia (Fredrickson type IV hyperlipidemia).
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Treat patients with primary dysbetalipoproteinemia (Fredrickson type III hyperlipidemia).
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Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.
Adolescent Patients with Heterozygous Familial Hypercholesterolemia (HeFH)
ZOCOR is indicated as an adjunct to diet to reduce total-C, LDL-C, and Apo B levels in adolescent boys and girls who are at least one year post-menarche, 10-17 years of age, with heterozygous familial hypercholesterolemia, if after an adequate trial of diet therapy the following findings are present:
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LDL cholesterol remains >/=190 mg/dL; or
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LDL cholesterol remains >/=160 mg/dL and
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There is a positive family history of premature cardiovascular disease (CVD) or
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Two or more other CVD risk factors are present in the adolescent patient
The minimum goal of treatment in pediatric and adolescent patients is to achieve a mean LDL-C <130 mg/dL. The optimal age at which to initiate lipid-lowering therapy to decrease the risk of symptomatic adulthood CAD has not been determined.
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