Uses
Prevention of Cardiovascular Events
Adjunct to dietary therapy in patients with CHD or CHD risk equivalents (e.g., diabetes mellitus, peripheral arterial disease, history of stroke or other cerebrovascular disease) to reduce the risk of total mortality by reducing CHD death, to reduce the risk of nonfatal MI and stroke, and to reduce the need for coronary and non-coronary revascularization procedures.
Slowing progression or inducing regression of atherosclerosis† in coronary arteries by reducing intimal-medial wall thickness.
Dyslipidemias
Adjunct to dietary therapy in adults to decrease elevated serum total cholesterol, LDL-cholesterol, apolipoprotein B (apo B), and triglyceride concentrations and to increase HDL-cholesterol concentrations in the management of primary hypercholesterolemia and mixed dyslipidemia, including heterozygous familial hypercholesterolemia and other causes of hypercholesterolemia (e.g., polygenic hypercholesterolemia). May be used in combination or fixed combination with ezetimibe (as Vytorin® tablets) for additive antilipemic effects.
Adjunct to dietary therapy to decrease elevated serum total cholesterol, LDL-cholesterol, and apo B concentrations in the management of heterozygous familial hypercholesterolemia in boys and postmenarchal girls ≥10 years of age who have a serum LDL-cholesterol concentration of ≥190 mg/dL or in those who have a serum LDL-cholesterol concentration of ≥160 mg/dL and either a family history of premature cardiovascular disease or ≥2 cardiovascular risk factors despite an adequate trial of dietary management.
Reduction of elevated serum total and LDL-cholesterol concentrations in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering therapies (e.g., plasma LDL-apheresis) or when such therapies are not available. May be used in combination or fixed combination with ezetimibe (as Vytorin® tablets) for additive antilipemic effects.
Adjunct to dietary therapy for the treatment of patients with primary dysbetalipoproteinemia.
Adjunct to dietary therapy in the management of patients with hypertriglyceridemia.
Reduction of total and LDL-cholesterol concentrations in patients with hypercholesterolemia associated with or exacerbated by diabetes mellitus† (diabetic dyslipidemia), cardiac† or renal† transplantation, or nephrotic syndrome†.
Dosage and Administration
General
- Patients should be placed on a standard lipid-lowering diet before initiation of simvastatin therapy and should remain on this diet during treatment with the drug; in patients with CHD or CHD risk equivalents, initiate simvastatin simultaneously with dietary management.
Monitoring during Antilipemic Therapy
Monitor lipoprotein concentrations periodically to ensure that target LDL-cholesterol goals are achieved and maintained at <100 mg/dL (optional goal: <70 mg/dL) for patients with CHD or CHD risk equivalents; <130 mg/dL (optional goal: <100 mg/dL) for patients with ≥2 risk factors and 10-year risk of 10–20%; <130 mg/dL for patients with ≥2 risk factors and 10-year risk <10%; or <160 mg/dL for patients with 0–1 risk factor.
Administration
Oral Administration
Administer orally in the evening without regard to meals.
Administer simvastatin-ezetimibe fixed-combination preparation (Vytorin®) orally in the evening without regard to meals.
Dosage
Pediatric Patients
Dyslipidemias
Oral
Children ≥10 years of age: 10 mg once daily.
Adjust dosage at intervals of ≥4 weeks until the desired effect on lipoprotein concentrations is observed. Usual dosage range is 10–40 mg daily.
Adults
Dyslipidemias and Prevention of Cardiovascular Events
Oral
Initially, 20–40 mg once daily.
Patients with CHD or CHD risk equivalents: Initially, 40 mg once daily.
Adjust dosage at intervals of no less than 4 weeks until the desired effect on lipoprotein concentrations is observed. Usual dosage range is 5–80 mg daily.
Simvastatin-ezetimibe fixed combination (Vytorin®): Initially, simvastatin 20 mg and ezetimibe 10 mg once daily in the evening. In patients requiring less aggressive LDL-cholesterol lowering, consider lower dosage (simvastatin 10 mg and ezetimibe 10 mg once daily). In patients requiring LDL-cholesterol reductions >55%, give simvastatin 40 mg and ezetimibe 10 mg once daily. Determine serum lipoprotein concentrations 2 weeks after initiation of therapy and adjust dosage as needed. Usual maintenance dosage is simvastatin 10–80 mg and ezetimibe 10 mg once daily.
Homozygous Familial Hypercholesterolemia
Oral
40 mg once daily in the evening or 80 mg daily in 3 divided doses of 20 mg, 20 mg, and an evening dose of 40 mg.
Simvastatin-ezetimibe fixed combination (Vytorin®): Initially, simvastatin 40 or 80 mg and ezetimibe 10 mg once daily in the evening.
Prescribing Limits
Pediatric Patients
Oral
Children ≥10 years of age: Maximum 40 mg once daily.
Special Populations
Dosage in Hepatic Impairment
Use with caution in patients who consume substantial amounts of alcohol and/or have a history of liver disease. Contraindicated in patients with active liver disease or unexplained, persistent increases in serum aminotransferase concentrations.
Dosage in Renal Impairment
Dosage modification is not necessary in patients with mild to moderate impairment. In patients with severe renal impairment, initially, 5 mg once daily. Use with caution; monitor closely.
Simvastatin-ezetimibe fixed combination (Vytorin®): Dosage modification is not necessary in patients with mild to moderate impairment. In patients with severe renal impairment, do not use unless patient already has tolerated treatment with simvastatin at dosage of ≥5 mg daily; in such patients, exercise caution and monitor closely.
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