Zocor Indications and Dosage
- atherosclerosis
- hypercholesterolemia
- hyperlipoproteinemia
- hypertriglyceridemia
- myocardial infarction prophylaxis
- stroke prophylaxis
Zocor (Simvastatin) Indications and Dosage
For the treatment of hypercholesterolemia, hyperlipoproteinemia, and/or hypertriglyceridemia as and adjunct to dietary control:
- for reduction of elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglyceride concentrations, and to increase HDL-cholesterol in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) or mixed dyslipidemia (Fredrickson types IIa or IIb); or to treat Fredrickson Type IV (hypertriglyceridemia, increased VLDL) or Fredrickson Type III (primary dysbetalipoproteinemia) hyperlipoproteinemias:
Oral dosage:
Adults: Initially, 20 - 40 mg PO once daily in the evening. The dosage range is 5 - 80 mg PO once daily (mean LDL reduction range: 26 - 47%). Dosage is adjusted to achieve the target LDL and lipid goals based on the NCEP guidelines. Adjust dosage based on serum lipid determinations at intervals >= 4 weeks.
Adult patients taking gemfibrozil, danazol, or cyclosporine: Initially, 5 mg PO once daily in the evening. Do not exceed 10 mg/day.
Adult patients taking amiodarone or verapamil: The dosage range is 5 - 20 mg PO once daily in the evening. Do not exceed 20 mg/day. When given with amiodarone or verapamil, simvastatin is associated with a dose-related risk of developing myopathy and/or rhabdomyolysis.
Elderly: See adult dosage. Some elderly patients may be more sensitive to the effects of the usual adult dosage of simvastatin; dosage should be individualized to achieve serum lipoprotein goals. A pharmacokinetic study with simvastatin showed the mean plasma level of HMG-CoA reductase inhibitory activity to be approximately 45% higher in patients aged 70 - 78 compared with patients aged 18 - 30 years. However, long-term therapy with 20 - 80 mg/day PO has been used safely in elderly patients in clinical trials, with no differences in safety compared to younger patients. In the 4S trial and the Heart Protection Study, 23% and 52% of the patients, respectively, were elderly. The were no differences in the cardiovascular or stroke protection benefits of simvastatin between older and younger patients in these large clinical outcome trials.
Adolescents and children >= 10 years, including girls who are at least 1 year post-menarche: 10 mg PO once daily in the evening. The recommended dosage range is 10 - 40 mg/day. Doses > 40 mg/day have not been studied. Dosage adjustments should be made at >= 4 week intervals. Adjust dosage to attain the target LDL and lipid goals. NOTE: Simvastatin may be used as an adjunct to diet in adolescents and children >= 10 years when either: 1) the LDL remains >= 190 mg/dl, or 2) the LDL remains >= 160 mg/dl and there is an increased risk for cardiovascular disease (e.g., positive family history of premature cardiovascular disease or >= 2 other risk factors are present). In one pediatric study, sixteen children aged < 17 years received a mean simvastatin dose of 16 mg daily for two years. LDL-cholesterol was decreased by 37% and HDL-cholesterol increased by 22.5%. No adverse effects or effects on growth were reported.
Children < 10 years: Safe and effective use has not been established.
- for the treatment of patients with homozygous familial hypercholesterolemia:
Oral dosage:
Adults: Based on the results of a controlled clinical trial, the FDA-approved dosage is 40 mg PO once daily in the evening or 80 mg/day PO, given in 3 divided doses of 20 mg, 20 mg, and an evening dose of 40 mg. Dosage adjustments should be made at 4 week intervals to achieve NCEP target goals for LDL-cholesterol. Simvastatin may be used as an adjunct to other lipid-lowering therapy (e.g., LDL apheresis) when available.
Adult patients taking gemfibrozil, danazol, or cyclosporine: Initially, 5 mg PO once daily in the evening. Do not exceed 10 mg/day.
Adult patients taking amiodarone or verapamil: The dosage range is 5 - 20 mg PO once daily in the evening. Do not exceed 20 mg/day. When given with amiodarone or verapamil, simvastatin is associated with a dose-related risk of developing myopathy and/or rhabdomyolysis.
Elderly: See adult dosage. Elderly patients may be more sensitive to the effects of the usual adult dosage of simvastatin; dosage should be individualized to achieve serum lipoprotein goals. Long-term therapy with 20 - 80 mg/day PO has been used safely in elderly patients, with no differences in safety relative to younger patients.
Adolescents and Children: Safe and effective use has not been established for pediatric patients with homozygous hypercholesterolemia.
For myocardial infarction prophylaxis or stroke prophylaxis in patients at high risk of coronary events due to existing coronary heart disease, diabetes, peripheral vessel disease, or history of stroke or other cerebrovascular disease:
- to reduce non-fatal myocardial infarction and stroke, to decrease total mortality by reducing coronary death, and to reduce the risk of undergoing coronary or non-coronary revascularization procedures:
Oral dosage:
Adults: Initially, 40 mg PO once daily in the evening. Adjust dosage at intervals >= 4 weeks to achieve target NCEP lipid goals. The usual dosage range is 20 - 80 mg PO once daily. The FDA-approved the 40 mg starting dosage and revised indications for high-risk patients based on the favorable findings of the Heart Protection Study. In the previously published Scandinavian Simvastatin Survival Study, the initial dose was 20 mg/day PO given as a single dose in the evening; the dose was increased to a maximum of 40 mg/day or reduced to 10 mg/day depending on total serum cholesterol response.
Adult patients taking gemfibrozil, danazol, or cyclosporine: Initially, 5 mg PO once daily in the evening. Do not exceed 10 mg/day.
Adult patients taking amiodarone or verapamil: The dosage range is 5 - 20 mg PO once daily in the evening. Do not exceed 20 mg/day. When given with amiodarone or verapamil, simvastatin is associated with a dose-related risk of developing myopathy and/or rhabdomyolysis.
Elderly: See adult dosage. Elderly patients may be more sensitive to the effects of the usual adult dosage of simvastatin; dosage should be individualized to achieve serum lipoprotein goals. In the 4S study and other large clinical studies, about 22% of patients were elderly; simvastatin significantly reduced total mortality and coronary mortality in elderly patients with coronary artery disease. Long-term therapy with 20 - 80 mg/day PO has been used safely in elderly patients, with no differences in safety relative to younger patients.
For slowing the progression of coronary atherosclerosis†:
Oral dosage:
Adults: Initially, 20 - 40 mg PO once daily in the evening. Individualize dosage at >= 4 week intervals to achieve target NCEP lipid goals. The usual dosage range is 20 - 80 mg PO once daily. In the Multicenter Anti-Atheroma Study (MAAS), 381 patients were treated with diet and either simvastatin 20 mg/day PO or placebo for a period of 4 years. Treatment with simvastatin reduced hyperlipidemia and slowed the progression of coronary atherosclerosis based on quantitative coronary angiography.
Adult patients taking gemfibrozil, danazol, or cyclosporine: Initially, 5 mg PO once daily in the evening. Do not exceed 10 mg/day.
Adult patients taking amiodarone or verapamil: The dosage range is 5 - 20 mg PO once daily in the evening. Do not exceed 20 mg/day. When given with amiodarone or verapamil, simvastatin is associated with a dose-related risk of developing myopathy and/or rhabdomyolysis.
Elderly: See adult dosage. Elderly patients may be more sensitive to the effects of the usual adult dosage of simvastatin; dosage should be individualized to achieve serum lipoprotein goals. In the 4S study and other large clinical studies, about 22% of patients were elderly; simvastatin significantly reduced total mortality and coronary mortality in elderly patients with coronary artery disease. Long-term therapy with 20 - 80 mg/day PO has been used safely in elderly patients, with no differences in safety relative to younger patients.
Maximum Dosage Limits:
- Adults: 80 mg/day PO for most patients; max 10 mg/day PO if taking gemfibrozil, danazol, or cyclosporine; max 20 mg/day PO if taking amiodarone or verapamil.
- Elderly: 80 mg/day PO for most patients; max 10 mg/day PO if taking gemfibrozil, danazol, or cyclosporine; max 20 mg/day PO if taking amiodarone or verapamil.
- Adolescents: 40 mg/day PO.
- Children >= 10 years: 40 mg/day PO.
- Children < 10 years: Not recommended.
Patients with hepatic impairment:
Not recommended in patients with hepatic disease (see Contraindications).
Patients with renal impairment:
CrCl > 20 ml/min: No dosage adjustment is required.
CrCl <= 20 ml/min: 5 mg PO once daily in the evening initially; close monitoring is advised.
Intermittent hemodialysis:
The hemodialyzability of simvastatin and its metabolites is unknown.
†non-FDA-approved indication
[ Last revised: 9/6/2005 6:05:00 PM ]
Related entries
Syndicate
|
