SIMVASTATIN- simvastatin tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Simvastatin (UNII: AGG2FN16EV) (Simvastatin - UNII:AGG2FN16EV)

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

Simvastatin

Composition:

Simvastatin 10 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 summary:

Simvastatin Tablets, USP 5 mg are brown colored, round, biconvex, film-coated tablets, debossed 'RDY' on one side and '197' on other side. They are supplied as follows: Simvastatin Tablets USP, 10 mg are brown colored, round, biconvex, film-coated tablets, debossed 'RDY' on one side and '198' on other side. They are supplied as follows: 55700-223-30 Simvastatin Tablets USP, 20 mg are brown colored, round, biconvex, film-coated tablets, debossed 'RDY' on one side and '199' on other side. They are supplied as follows: Simvastatin Tablets USP, 40 mg are brown colored, round, biconvex, film-coated tablets, debossed 'RDY' on one side and '200' on other side. They are supplied as follows: Simvastatin Tablets USP, 80 mg are brown colored, oval shaped, biconvex, film-coated tablets, debossed 'RDY' on one side and '268' on other side. They are supplied as follows: Storage Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SIMVASTATIN- SIMVASTATIN TABLET, FILM COATED
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS 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
Coadministration with Other Drugs (2.3) XX/XXXX
Contraindications (4) XX/XXXX
Warnings and Precautions Myopathy/Rhabdomyolysis (5.1) XX/XXXX
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 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 should be
restricted to patients who have been taking simvastatin 80 mg
chronically (e.g., for 12 months or more) without