Country: United States
Language: English
Source: NLM (National Library of Medicine)
SIMVASTATIN (UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV)
NuCare Pharmaceuticals, Inc.
SIMVASTATIN
SIMVASTATIN 5 mg
ORAL
PRESCRIPTION DRUG
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 USP can be started simultaneously with diet. 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. Simvastatin tablets USP are indicated to: - Reduce elevated total cho
Simvastatin tablets USP are supplied as follows: 5 mg: Light-yellow, round, convex, film-coated tablets, debossed 7152 on one side and TV on the other side. They are supplied as follows: NDC 68071-3157-3 bottles of 30 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Abbreviated New Drug Application
SIMVASTATIN- SIMVASTATIN TABLET, FILM COATED NUCARE PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SIMVASTATIN TABLETS USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR SIMVASTATIN TABLETS USP. SIMVASTATIN TABLETS USP FOR ORAL USE INITIAL U.S. APPROVAL: 1991 RECENT MAJOR CHANGES Contraindications ( 4) 02/2014 Warnings and Precautions Myopathy/Rhabdomyolysis ( 5.1) 02/2014 INDICATIONS AND USAGE Simvastatin tablets USP 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 dysbetalipoproteinemia. ( 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 USP have not been studied in Fredrickson Types I and V dyslipidemias. ( 1.4) DOSAGE AND ADMINISTRATION Dose range is 5 to 40 mg/day. ( 2.1) Recommended usual starting dose is 10 or 20 mg once a day in the evening. ( 2.1) Recommended starting dose for patients at high risk of CHD is 40 mg/day. ( 2.1) Due to the increased risk of myopathy, including rhabdomyolysis, use of the 80 mg dose of simvastatin tablets should be restricted to patients who have been taking simvastatin, USP 80 mg chronically (e.g., for 12 months or more) without evidence of muscle to Read the complete document