SIMVASTATIN tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Aphena Pharma Solutions - Tennessee, LLC

INN (International Name):

SIMVASTATIN

Sammensetning:

SIMVASTATIN 5 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

Repackaged by Aphena Pharma Solutions - TN. See Repackaging Information for available configurations. Simvastatin Tablets USP, 5 mg are yellow colored, round shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘15’ on the other side. They are supplied as follows:                 Bottles of 30                       NDC 52343-021-30                 Bottles of 90                       NDC 52343-021-90                 Bottles of 1000                   NDC 52343-021-99 Simvastatin Tablets USP, 10 mg are light pink colored, round shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘01’ on the other side. They are supplied as follows:                 Bottles of 30                       NDC 52343-022-30                 Bottles of 45                       NDC 52343-022-45                 Bottles of 90                       NDC 52343-022-90                 Bottles of 1000                   NDC 52343-022-99 Simvastatin Tablets USP, 20 mg are light pink colored, round shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘02’ on the other side. They are supplied as follows:                 Bottles of 30                       NDC 52343-023-30                 Bottles of 45                       NDC 52343-023-45                 Bottles of 90                       NDC 52343-023-90                 Bottles of 1000                   NDC 52343-023-99 Simvastatin Tablets USP, 40 mg are pink colored, round shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘03’ on the other side. They are supplied as follows:                 Bottles of 30                       NDC 52343-024-30                 Bottles of 45                       NDC 52343-024-45                 Bottles of 90                       NDC 52343-024-90                 Bottles of 1000                   NDC 52343-024-99 Simvastatin Tablets USP, 80 mg are pink colored, capsule shaped, biconvex, film coated tablets, debossed with ‘A’ on one side and ‘04’ on the other side. They are supplied as follows:                 Bottles of 30                       NDC 52343-025-30                 Bottles of 45                       NDC 52343-025-45                 Bottles of 90                       NDC 52343-025-90                 Bottles of 1000                   NDC 52343-025-99 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

SIMVASTATIN - SIMVASTATIN TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
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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 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 80 mg
chronically (e.g.,