SIMVASTATIN tablet film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

simvastatin (UNII: AGG2FN16EV) (simvastatin - UNII:AGG2FN16EV)

Tilgjengelig fra:

Ingenus Pharmaceuticals, LLC

INN (International Name):

simvastatin

Sammensetning:

simvastatin 10 mg

Resept typen:

PRESCRIPTION DRUG

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

SIMVASTATIN- SIMVASTATIN TABLET, FILM COATED
INGENUS PHARMACEUTICALS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
SIMVASTATIN TABLETS SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR SIMVASTATIN TABLETS.
SIMVASTATIN TABLETS, USP
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Dosage and Administration
Contraindications (4) 02/2012
Warnings and Precautions
INDICATIONS AND USAGE
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)
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 80 mg
chronically (e.g., for 12 months or more) without
evidence of muscle toxicity. (2.2)
Patients who are currently tolerating th