Zocor

[simvastatin]

ZOCOR ® (simvastatin) 9556645

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:
1. LDL cholesterol remains 190 mg/ dL; or
2. LDL cholesterol remains 160 mg/ dL and
There is a positive family history of premature cardiovascular disease (CVD) or 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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DOSAGE AND ADMINISTRATION

The patient should be placed on a standard cholesterol-lowering diet. In patients with CHD or at high risk of CHD, ZOCOR can be started simultaneously with diet. The dosage should be individualized according to the goals of therapy and the patient's response. (For the treatment of adult dyslipidemia, see NCEP Treatment Guidelines. For the reduction in risks of major coronary events, see CLINICAL PHARMACOLOGY, Clinical Studies in Adults.) The dosage range is 5-80 mg/ day (see below).

The recommended usual starting dose is 20 to 40 mg once a day in the evening. For patients at high risk for a CHD event due to existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, the recommended starting dose is 40 mg/ day. Lipid determinations should be performed after 4 weeks of therapy and periodically thereafter. See below for dosage recommendations in special populations (i. e., homozygous familial hypercholesterolemia, adolescents and renal insufficiency) or for patients receiving concomitant therapy (i. e., cyclosporine, amiodarone, verapamil, or gemfibrozil).

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