Generic Name and Formulations:
Simvastatin 5mg, 10mg, 20mg, 40mg, 80mg; tabs.
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 (HoFH) 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. Limitations of use: not studied in conditions where major abnormality is elevation of chylomicrons (eg, hyperlipidemia Fredrickson types I and V).
≥17yrs: Initially 10–20mg once daily in the PM; if patient is high risk of CHD event: initially 40mg/day; range 5–40mg/day; monitor lipids after 4 weeks and periodically thereafter. Concomitant verapamil, diltiazem, dronedarone: max simvastatin 10mg/day. Concomitant amiodarone, amlodipine, ranolazine: max simvastatin 20mg/day. Severe renal insufficiency: initially 5mg/day, monitor closely. HoFH: 40mg once daily in the PM. Concomitant lomitapide: reduce simvastatin dose by 50%; max 20mg/day (or 40mg/day for those previously taken 80mg/day chronically). Chinese patients taking niacin ≥1g/day or niacin-containing products: use caution with simvastatin doses >20mg/day. Restrict 80mg/day dose to chronic users (≥12mos) without evidence of muscle toxicity; if currently tolerating simvastatin 80mg and need to start a contraindicated drug or is associated with a simvastatin dose cap: switch to an alternative statin with less potential drug interaction. If patients unable to achieve their LDL-C goal using simvastatin 40mg: do not titrate to 80mg dose, switch to alternative regimen that provides greater LDL-C lowering. See full labeling.
<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.
Concomitant strong CYP3A4 inhibitors (eg, itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone), gemfibrozil, cyclosporine, danazol. Active liver disease. Unexplained, persistent elevated serum transaminases. Pregnancy (Cat.X). Nursing mothers.
Increased risk of myopathy/rhabdomyolysis with simvastatin 80mg doses including predisposing factors (eg, age ≥65yrs, female gender, uncontrolled hypothyroidism). Discontinue if markedly elevated CPK (>10xULN) levels occur or myopathy diagnosed or suspected. Temporarily withhold if acute or serious condition predisposing to the development of renal failure secondary to rhabdomyolysis occurs. Monitor liver function prior to initation and repeat as clinically indicated. Interrupt therapy if serious liver injury with clinical symptoms and/or hyperbilirubinemia or jaundice occurs; do not restart if alternate etiology not found. History of liver disease. Substantial alcohol consumption. Severe renal insufficiency. Women of childbearing potential who needs treatment: use effective contraception; discontinue if pregnancy occurs.
See Contraindications. Avoid concomitant grapefruit juice >1 quart daily. Caution with other fibrates, niacin ≥1g/day or niacin-containing products (esp. Chinese patients), or lomitapide (in HoFH patients). Reduce max simvastatin dose if amiodarone, dronedarone, verapamil, diltiazem, amlodipine, ranolazine must be used. Caution with colchicine. Monitor digoxin, oral anticoagulants.
HMG-CoA reductase inhibitor.
Upper respiratory infection, headache, abdominal pain, constipation, nausea, elevated serum transaminases, myopathy, rhabdomyolysis; increased HbA1c and fasting serum glucose, rare: cognitive impairment, non-fatal hepatic failure, immune-mediated necrotizing myopathy.
Tabs 5mg—30; 10mg, 20mg, 40mg, 80mg—30, 90