Monograph Details
|
|
Cardiovascular System
> Hyperlipoproteinemias
|
|
ZOCOR |
| Manufacturer |
|
Merck & Co., Inc. |
| Legal Classification |
|
Rx
|
| Pharmacological Class |
|
HMG-CoA reductase inhibitor. |
| Generic Name |
|
Simvastatin 5mg, 10mg, 20mg, 40mg, 80mg; tabs. |
| Indications |
|
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. |
| Children |
|
<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. |
| Adults |
|
≥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). |
| Contraindications |
|
Active liver disease. Unexplained, persistent elevated serum transaminases. Pregnancy (Cat.X). Nursing mothers. |
| Precautions |
|
Monitor liver function at baseline, then as needed (test before increasing dose to 80mg/day, then after 3 months, and semiannually for 1st 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 |
|
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 |
|
Elevated serum transaminases, myopathy, rhabdomyolysis. |
| How Supplied |
Tabs 5mg, 40mg, 80mg—30, 60, 90, 1000
10mg—30, 90, 1000, 10000
20mg—30, 60, 90, 1000, 10000 |
| Additional Resources |
|
• Related Prescribing Note |
|
|
|
|
