Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
SIMVASTATIN (UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV)
DOH CENTRAL PHARMACY
SIMVASTATIN
SIMVASTATIN 10 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, simvastatin1 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 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 are is indicated to: ● Reduce elevated total cholesterol (t
Simvastatin tablets 10 mg are peach colored, oval shaped, biconvex, film-coated tablets debossed with ‘LL’ on one side and ‘C02’plain on the other side. Simvastatin tablets 20 mg are tan colored, oval shaped, biconvex, film-coated tablets debossed with ‘LL’ on one side and ‘C03’ on the other side. Simvastatin tablets 40 mg are brick red colored, oval shaped, biconvex, film-coated tablets debossed with ‘LL’ on one side and ‘C04’ on the other side. Simvastatin tablets 80 mg are brick red colored, capsule shaped, biconvex, film-coated tablets debossed with ‘LL’ on one side and ‘C05’ on the other side. They are supplied by State of Florida DOH Central Pharmacy as follows: Store between 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Preserve in tight container as defined in USP.
Abbreviated New Drug Application
SIMVASTATIN - SIMVASTATIN TABLET, FILM COATED DOH CENTRAL PHARMACY ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION SIMVASTATIN TABLETS USP. THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SIMVASTATIN . SEE FULL PRESCRIBING INFORMATION FOR SIMVASTATIN. INITIAL U.S. APPROVAL 2007 INDICATIONS AND USAGE Simvastatin is 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 has not been studied in Fredrickson Types I and V dyslipidemias. ( 1.4 ) DOSAGE AND ADMINISTRATION Dose range is 5-80 mg/day. ( 2.1 ) Recommended usual starting dose is 20-40 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 ) Adolescents (10-17 years of age) with HeFH: starting dose is 10 mg/day; maximum recommended dose is 40 mg/day. ( 2.3 ) DOSAGE FORMS AND STRENGTHS Tablets: 10 mg; 20 mg; 40 mg; 80 mg ( 3 ) CONTRAINDICATIONS Hypersensitivity to any component of this medication. ( 4 , 6.2 ) Active liver disease, which may include unexplained persistent elevations in hepatic transaminase levels. ( 4 , 5.2 ) Women who are pregnant or may become pregnant. ( 4 , 8.1 ) Nursing mothe Přečtěte si celý dokument