SIMVASTATIN tablet, film coated

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

SIMVASTATIN (UNII: AGG2FN16EV) (SIMVASTATIN - UNII:AGG2FN16EV)

Beschikbaar vanaf:

Contract Pharmacy Services-PA

INN (Algemene Internationale Benaming):

SIMVASTATIN

Samenstelling:

SIMVASTATIN 5 mg

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 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 is 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 is indicated to: - Reduce elevated total cholesterol (total-C), low-density lipopr

Product samenvatting:

Simvastatin Tablets USP, 20 mg are brown, oval shaped, biconvex, beveled edge, film-coated tablets debossed with "ZA21" on one side and plain on other side and are supplied as follows. NDC 67046-672-30 in blister of 30 Simvastatin Tablets USP, 40 mg are pink, oval shaped, biconvex, beveled edge, film-coated tablets debossed with "ZA22" on one side and plain on other side and are supplied as follows. NDC 67046-675-30 in blister of 30 Storage Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

SIMVASTATIN- SIMVASTATIN TABLET, FILM COATED
CONTRACT PHARMACY SERVICES-PA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SIMVASTATIN SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR SIMVASTATIN.
INITIAL U.S. APPROVAL: 1991
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 to 80 mg/day. ( 2.1 )
Recommended usual starting dose is 20 to 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 to 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: 5 mg; 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