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These highlights do not include all the information needed to use simvastatin safely and effectively. See full prescribing information for simvastatin tablets. Simvastatin Tablets, USP Initial U.S. Approval: 1991
Medication labelWhy this: Advisory · dailymed-prescription
In patients at high risk of coronary events because of existing coronary heart disease, diabetes, peripheral vessel disease, history of stroke or other cerebrovascular disease, simvastatin tablets, USP are indicated to: Reduce the risk of total mortality by reducing CHD deaths. Reduce the risk of non-fatal myocardial infarction and stroke. Reduce the need for coronary and non-coronary revascularization procedures. Reduce elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and triglycerides (TG), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hyperlipidemia (Fredrickson type IIa, heterozygous familial and nonfamilial) or mixed dyslipidemia (Fredrickson type IIb). Reduce elevated TG in patients with hypertriglyceridemia (Fredrickson type IV hyperlipidemia). Reduce elevated TG and VLDL-C in patients with primary dysbetalipoproteinemia (Fredrickson type III hyperlipidemia). Reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable. Simvastatin tablets, USP are indicated as an adjunct to diet to reduce total-C, LDL-C, and Apo B levels in adolescent boys and girls who are at least one year post-menarche, 10 to 17 years of age, with HeFH, if after an adequate trial of diet therapy the following findings are present: 1. LDL cholesterol remains ≥190 mg/dL; or 2. LDL cholesterol remains ≥160 mg/dL and There is a positive family history of premature cardiovascular disease (CVD) or Two or more other CVD risk factors are present in the adolescent patient.
- generic_name
- simvastatin
- product_names
- Simvastatin
- ndc
- 13107-050, 13107-051, 13107-052, 13107-053, 13107-054, 13107-050-30, 13107-050-90, 13107-050-01, 13107-050-00, 13107-050-99, 13107-050-26, 13107-051-30, 13107-051-90, 13107-051-01, 13107-051-00, 13107-051-99, 13107-051-26, 13107-052-30, 13107-052-90, 13107-052-01, 13107-052-00, 13107-052-99, 13107-052-26, 13107-053-30, 13107-053-90, 13107-053-01, 13107-053-00, 13107-053-99, 13107-053-22, 13107-054-30, 13107-054-90, 13107-054-00, 13107-054-99
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en