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simvastatin 5 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. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin tablets can be started simultaneously with diet. Simvastatin tablets are an HMG-CoA reductase inhibitor (statin) indicated as an adjunctive therapy to diet to: Reduce the risk of total mortality by reducing CHD deaths and reduce the risk of non-fatal myocardial infarction, stroke, and the need for revascularization procedures in patients at high risk of coronary events. ( 1.1 ) Reduce elevated total-C, LDL-C, Apo B, TG and increase HDL-C in patients with primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia. ( 1.2 ) Reduce elevated TG in patients with hypertriglyceridemia and reduce TG and VLDL-C in patients with primary dysbeta-lipoproteinemia. ( 1.2 ) Reduce total-C and LDL-C in adult patients with homozygous familial hypercholesterolemia. ( 1.2 ) Reduce elevated total-C, LDL-C, and Apo B in boys and postmenarchal girls, 10 to 17 years of age with heterozygous familial hypercholesterolemia after failing an adequate trial of diet therapy. ( 1.2 , 1.3 ) Limitations of Use Simvastatin tablets have not been studied in Fredrickson Types I and V dyslipidemias. ( 1.4 ) 1.1 Reductions in Risk of CHD Mortality and Cardiovascular Events 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 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. 1.2 hyperlipidemia Simvastatin tablets are indicated to: 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 lV 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 (HoFH) as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable. 1.3 Adolescent Patients with Heterozygous Familial hypercholesterolemia (HeFH) Simvastatin tablets 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: LDL cholesterol remains ≥190 mg/dL; or 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. The minimum goal of treatment in pediatric and adolescent patients is to achieve a mean LDL-C <130 mg/dL. The optimal age at which to initiate lipid-lowering therapy to decrease the risk of symptomatic adulthood CAD has not been determined. 1.4 Limitations of Use Simvastatin tablets have not been studied in conditions where the major abnormality is elevation of chylomicrons (i.e., hyperlipidemia Fredrickson types I and V).

Accord Healthcare, Inc.


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2 hours ago ROUND RED SI simvastatin 5 MG Oral Tablet

ROUND RED SI

2 hours ago ROUND RED SI simvastatin 5 MG Oral Tablet

SI ROUND RED

16. HOW SUPPLIED/STORAGE AND HANDLING

SIMVASTATIN tablets USP 5 mg are brick red coloured, round shaped, biconvex, film coated tablet debossed “SI” on one side and plain on other side. Bottles of 30 Tablets with child-resistant closure (NDC 16729-156-10) Bottles of 90 Tablets with child-resistant closure (NDC 16729-156-15) Bottles of 1000 Tablets (NDC 16729-156-17)

SIMVASTATIN tablets USP 10 mg are brick red coloured, oval shaped, biconvex, film-coated tablets, debossed "S 4" on one side and plain on other side. Bottles of 30 Tablets with child-resistant closure (NDC 16729-004-10) Bottles of 60 Tablets with child-resistant closure (NDC 16729-004-12) Bottles of 90 Tablets with child-resistant closure (NDC 16729-004-15) Bottles of 1000 Tablets with child-resistant closure (NDC 16729-004-17)

SIMVASTATIN tablets USP 20 mg are brick red coloured oval shaped, biconvex, film-coated tablets, debossed "S 5" on one side and plain on other side. Bottles of 30 Tablets with child-resistant closure (NDC 16729-005-10) Bottles of 60 Tablets with child-resistant closure (NDC 16729-005-12) Bottles of 90 Tablets with child-resistant closure (NDC 16729-005-15) Bottles of 1000 Tablets with child-resistant closure (NDC 16729-005-17)

SIMVASTATIN tablets USP 40 mg are brick red coloured, oval shaped, biconvex, film-coated tablets, debossed "S 6" on one side and plain on other side. Bottles of 30 Tablets with child-resistant closure (NDC 16729-006-10) Bottles of 60 Tablets with child-resistant closure (NDC 16729-006-12) Bottles of 90 Tablets with child-resistant closure (NDC 16729-006-15) Bottles of 1000 Tablets with child-resistant closure (NDC 16729-006-17)

SIMVASTATIN tablets USP 80 mg are brick red coloured,capsule-shaped, biconvex, film-coated tablets, debossed with "SMV" on one side and "80" on the other side. Bottles of 30 Tablets with child-resistant closure (NDC 16729-007-10) Bottles of 60 Tablets with child-resistant closure (NDC 16729-007-12) Bottles of 90 Tablets with child-resistant closure (NDC 16729-007-15) Bottles of 1000 Tablets with child-resistant closure (NDC 16729-007-17) Storage Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]. "Dispense in tight containers as defined in the USP"

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