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EZETIMIBE AND SIMVASTATIN TABLETS. These highlights do not include all the information needed to use EZETIMIBE AND SIMVASTATIN TABLETS safely and effectively. See full prescribing information for EZETIMIBE AND SIMVASTATIN TABLETS . EZETIMIBE AND SIMVASTATIN tablets for oral use Initial U.S. Approval: 2004
Medication labelWhy this: Advisory · dailymed-prescription
Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. Ezetimibe and simvastatin tablets are indicated for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. Ezetimibe and simvastatin tablets are indicated for the reduction of elevated 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. No incremental benefit of ezetimibe and simvastatin tablets on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been established. Ezetimibe and simvastatin tablets have not been studied in Fredrickson type I, III, IV, and V dyslipidemias.
- generic_name
- ezetimibe and simvastatin
- product_names
- Ezetimibe and Simvastatin
- ndc
- 51407-190, 51407-191, 51407-192, 51407-193, 43598-742, 51407-190-30, 51407-190-90, 51407-190-10, 43598-744, 51407-191-30, 51407-191-90, 51407-191-10, 43598-743, 51407-192-30, 51407-192-90, 51407-192-05, 51407-192-10, 43598-745, 51407-193-30, 51407-193-90, 51407-193-05
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en