ZOCOR

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Generic Name for ZOCOR Simvastatin 5mg, 10mg, 20mg, 40mg, 80mg; tabs. Legal Classification: Rx Pharmacological Class for ZOCOR HMG-CoA reductase inhibitor. Manufacturer of ZOCOR Merck & Co., Inc.

Indications for ZOCOR

Adjunct to diet when response to nondrug therapy is inadequate: primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Types lla and llb) to reduce elevated total-C, LDL-C, apo B and TG, and to increase HDL-C; hypertriglyceridemia (Type IV) or primary dysbetalipoproteinemia (Type III); adjunct to or when other lipid-lowering treatments for homozygous familial hypercholesterolemia are not available, to reduce total-C and LDL-C. In patients with coronary heart disease (CHD), diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease to reduce: risk of total mortality by reducing CHD death, risk of non-fatal MI and stroke, risk for undergoing myocardial revascularization procedures. Adjunct to diet to reduce total-C, LDL-C, and apo B in patients 10–17 years of age (≥1yr post-menarche) with heterozygous familial hypercholesterolemia if  LDL-C remains ≥190mg/dL, or if LDL-C remains ≥160mg/dL with either family history of premature cardiovascular disease (CVD) or if patient has at least 2 other CVD risk factors.

Adult dose for ZOCOR

≥17yrs: Initially 20–40mg once daily in the PM; if patient is high risk of CHD event: initially 40mg/day; range 5–80mg/day; monitor lipids after 4 weeks and periodically thereafter. Concomitant fibrates (eg, gemfibrozil), niacin ≥1g/day: avoid; if used, max simvastatin 10mg/day. Concomitant cyclosporine: initially simvastatin 5mg/day, max 10mg/day. Concomitant amiodarone, verapamil: max simvastatin 20mg/day. Severe renal insufficiency: initially 5mg/day, monitor closely. Homozygous familial hypercholesterolemia: 40mg once daily in the PM or 80mg/day in 3 divided doses (20mg twice daily + 40mg in the PM).

Children's dosing for ZOCOR

<10yrs: not recommended. 10–17yrs: initially 10mg once daily in the PM, may increase at 4 week intervals; range 10–40mg/day; max 40mg/day.

Contraindications for ZOCOR

Active liver disease. Unexplained, persistent elevated serum transaminases. Pregnancy (Cat.X). Nursing mothers.

Warnings/Precautions for ZOCOR

Monitor liver function at baseline, then as needed (test before increasing dose to 80mg/day, then after 3 months, and semiannually for 1^st year); discontinue if AST or ALT levels of ≥3xULN persist. History of liver disease. Substantial alcohol consumption. Discontinue if myopathy or markedly elevated creatine kinase (>10xULN) levels occur. Severe renal insufficiency.

Interactions for ZOCOR

Due to increased myopathy risk: suspend simvastatin if itraconazole, ketoconazole, erythromycin, clarithromycin must be used; avoid other concomitant potent CYP3A4 inhibitors (eg, HIV protease inhibitors, nefazodone, grapefruit juice >1 quart daily); avoid gemfibrozil, other fibrates, niacin ≥1g/day, reduce max simvastatin dose if these must be used; reduce max simvastatin dose if amiodarone or verapamil must be used; reduce initial and max simvastatin doses if cyclosporine must be used. Monitor digoxin, oral anticoagulants.

Adverse Reactions for ZOCOR

Elevated serum transaminases, myopathy, rhabdomyolysis.

How is ZOCOR supplied?

Tabs 5mg, 40mg, 80mg—30, 60, 90, 1000
10mg—30, 90, 1000, 10000
20mg—30, 60, 90, 1000, 10000

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