ezetimibe 10 MG Simvastatin 10 MG Oral Tablet
1 INDICATIONS AND USAGE 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, which contain a cholesterol absorption inhibitor and an HMG-CoA reductase inhibitor (statin), are indicated as adjunctive therapy to diet to: • reduce elevated total-C, LDL-C, Apo B, TG, and non-HDL-C, and to increase HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia. ( 1.1 ) • reduce elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia (HoFH), as an adjunct to other lipid-lowering treatments. ( 1.2 ) Limitations of Use ( 1.3 ) • 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. 1.1 Primary hyperlipidemia 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. 1.2 Homozygous Familial hypercholesterolemia (HoFH) 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. 1.3 Limitations of Use 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.
dr.reddys laboratories inc
OVAL WHITE Teva 7584
Related Pills
ezetimibe 10 MG Simvastatin 40 MG Oral Tablet
dr.reddys laboratories inc
ezetimibe 10 MG Simvastatin 80 MG Oral Tablet
dr.reddys laboratories inc
ezetimibe 10 MG Simvastatin 40 MG Oral Tablet
dr.reddys laboratories inc
ezetimibe 10 MG Simvastatin 20 MG Oral Tablet
dr.reddys laboratories inc
DISCLAIMER:
"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."
"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."
"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."
PillSync may earn a commission via links on our site
16 HOW SUPPLIED/STORAGE AND HANDLING
EZETIMIBE AND SIMVASTATIN tablets are available as follows: 10 mg/10 mg- white to off-white, capsule-shaped tablets, debossed with "DRL" on one side of the tablet and with "583" on the other side. They contain 10 mg of ezetimibe and 10 mg of simvastatin. They are available in : Bottles of 30 NDC 43598-742-30 Bottles of 90 NDC 43598-742-90 Bottles of 1000 NDC 43598-742-10 10 mg/20 mg- white to off-white, capsule-shaped tablets, debossed with "DRL" on one side of the tablet and with "584" on the other side. They contain 10 mg of ezetimibe and 20 mg of simvastatin. They are available in : Bottles of 30 NDC 43598-744-30 Bottles of 90 NDC 43598-744-90 Bottles of 1000 NDC 43598-744-10 10 mg/40 mg- white to off-white, capsule-shaped tablets, debossed with "DRL" on one side of the tablet and with "585" on the other side. They contain 10 mg of ezetimibe and 40 mg of simvastatin. They are available in : Bottles of 30 NDC 43598-743-30 Bottles of 90 NDC 43598-743-90 Bottles of 500 NDC 43598-743-05 10 mg/80 mg- white to off-white, capsule-shaped tablets, debossed with "DRL" on one side of the tablet and with "586" on the other side. They contain 10 mg of ezetimibe and 80 mg of simvastatin. They are available in : Bottles of 30 NDC 43598-745-30 Bottles of 90 NDC 43598-745-90 Bottles of 500 NDC 43598-745-05 Storage Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]. Keep container tightly closed. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
More pills like OVAL Teva 7584