Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, ZOCOR¹ 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:

• Reduce the risk of total mortality by reducing CHD deaths.
• Reduce the risk of non-fatal myocardial infarction and stroke.
• Reduce the need for coronary and non-coronary revascularization procedures.

Hyperlipidemia

ZOCOR is indicated to:

• Reduce elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hyperlipidemia (Fredrickson type IIa, heterozygous familial and nonfamilial) or mixed dyslipidemia (Fredrickson type IIb).
• Reduce elevated TG in patients with hypertriglyceridemia (Fredrickson type lV hyperlipidemia).
• Reduce elevated TG and VLDL-C in patients with primary dysbetalipoproteinemia (Fredrickson type lll hyperlipidemia).
• 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 HeFH, 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.

Limitations of Use

ZOCOR has not been studied in conditions where the major abnormality is elevation of chylomicrons (i.e., hyperlipidemia Fredrickson types I and V).

Recommended Dosing

The dosage range is 5-80 mg/day. In patients with CHD or at high risk of CHD, ZOCOR can be started simultaneously with diet. 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 CHD, 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.

Patients with Homozygous Familial Hypercholesterolemia

The recommended dosage is 40 mg/day in the evening or 80 mg/day in 3 divided doses of 20 mg, 20 mg, and an evening dose of 40 mg. ZOCOR should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.

Adolescents (10-17 years of age) with Heterozygous Familial Hypercholesterolemia

The recommended usual starting dose is 10 mg once a day in the evening. The recommended dosing range is 10-40 mg/day; the maximum recommended dose is 40 mg/day. Doses should be individualized according to the recommended goal of therapy [see NCEP Pediatric Panel Guidelines² and Clinical Studies]. Adjustments should be made at intervals of 4 weeks or more.

Patients with Renal Impairment

Because ZOCOR does not undergo significant renal excretion, modification of dosage should not be necessary in patients with mild to moderate renal impairment. However, caution should be exercised when ZOCOR is administered to patients with severe renal impairment; such patients should be started at 5 mg/day and be closely monitored [See WARNINGS and PRECAUTIONS and CLINICAL PHARMACOLOGY].

Coadministration with Other Drugs

• Concomitant Lipid-Lowering Therapy
• ZOCOR may be used concomitantly with bile acid sequestrants.

Combination therapy with gemfibrozil increases simvastatin exposure. Therefore, if ZOCOR is used in combination with gemfibrozil, the dose of ZOCOR should not exceed 10 mg/day [See WARNINGS and PRECAUTIONS: DRUG INTERACTIONS and CLINICAL PHARMACOLOGY]. Patients taking Cyclosporine or Danazol

• ZOCOR therapy should begin with 5 mg/day and should not exceed 10 mg/day [See WARNINGS and PRECAUTIONS and DRUG INTERACTIONS].

Patients taking Amiodarone or Verapamil

• The dose of ZOCOR should not exceed 20 mg/day [See WARNINGS and PRECAUTIONS, DRUG INTERACTIONS, and CLINICAL PHARMACOLOGY].

Dosage Forms And Strengths

• Tablets ZOCOR 5 mg are buff, oval, film-coated tablets, coded MSD 726 on one side and ZOCOR 5 on the other.
• Tablets ZOCOR 10 mg are peach, oval, film-coated tablets, coded MSD 735 on one side and plain on the other.
• Tablets ZOCOR 20 mg are tan, oval, film-coated tablets, coded MSD 740 on one side and plain on the other.
• Tablets ZOCOR 40 mg are brick red, oval, film-coated tablets, coded MSD 749 on one side and plain on the other.
• Tablets ZOCOR 80 mg are brick red, capsule-shaped, film-coated tablets, coded 543 on one side and 80 on the other.

Storage and Handling

No. 8360 — Tablets ZOCOR 5 mg are buff, oval, film-coated tablets, coded MSD 726 on one side and ZOCOR 5 on the other. They are supplied as follows:

NDC 0006-0726-31 unit of use bottles of 30
NDC 0006-0726-54 unit of use bottles of 90
NDC 0006-0726-82 bottles of 1000.

No. 8146 — Tablets ZOCOR 10 mg are peach, oval , film-coated tablets, coded MSD 735 on one side and plain on the other. They are supplied as follows:

NDC 0006-0735-31 unit of use bottles of 30
NDC 0006-0735-54 unit of use bottles of 90
NDC 0006-0735-82 bottles of 1000.

No. 8147 — Tablets ZOCOR 20 mg are tan, oval , film-coated tablets, coded MSD 740 on one side and plain on the other. They are supplied as follows:

NDC 0006-0740-31 unit of use bottles of 30
NDC 0006-0740-54 unit of use bottles of 90
NDC 0006-0740-82 bottles of 1000.

No. 8148 — Tablets ZOCOR 40 mg are brick red, oval, film-coated tablets, coded MSD 749 on one side and plain on the other. They are supplied as follows:

NDC 0006-0749-31 unit of use bottles of 30
NDC 0006-0749-54 unit of use bottles of 90
NDC 0006-0749-82 bottles of 1000.

No. 6577 — Tablets ZOCOR 80 mg are brick red, capsule-shaped, film-coated tablets, coded 543 on one side and 80 on the other. They are supplied as follows:

NDC 0006-0543-31 unit of use bottles of 30
NDC 0006-0543-54 unit of use bottles of 90
NDC 0006-0543-28 unit dose packages of 100
NDC 0006-0543-82 bottles of 1000.

Storage

Store between 5-30°C (41-86°F)

Storage of 1,000 count bottles

Dispense in a tightly-closed container.

REFERENCES

² National Cholesterol Education Program (NCEP): Highlights of the Report of the Expert Panel on Blood Cholesterol Levels in Children and Adolescents. Pediatrics. 89(3):495-501. 1992.

Manufactured for: By: MERCK SHARP & DOHME LTD., Cramlington, Northumberland, UK NE23 3JU. Issued June 2008. FDA revision date: 6/11/2008

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