SIMVASTATIN tablet film coated

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

McKesson Contract Packaging

INN (mednarodno ime):

SIMVASTATIN

Sestava:

SIMVASTATIN 40 mg

Tip zastaranja:

PRESCRIPTION DRUG

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

SIMVASTATIN- SIMVASTATIN TABLET, FILM COATED
MCKESSON CONTRACT PACKAGING
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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 TABLETS, USP.
SIMVASTATIN TABLETS, USP
INITIAL U.S. APPROVAL: 1991
RECENT MAJOR CHANGES
Dosage and Administration
Coadministration with Other Drugs (2.3) 10/2012
Contraindications (4) 10/2012
Warnings and Precautions
Myopathy/Rhabdomyolysis (5.1) 10/2012
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 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 Us 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 80 mg
chronically (e.g., for 12 months o