SIMVASTATIN tablet, film coated

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

NuCare Pharmaceuticals,Inc.

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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 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 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 are indicated to: - Reduce elevated total cholesterol (to

उत्पाद समीक्षा:

Simvastatin tablets USP 40 mg are brick red coloured, oval shaped, biconvex, film-coated tablets, debossed S 6 on one side and plain on other side. NDC 68071-4998-3 BOTTLES OF 30 Storage Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]. "Dispense in tight containers as defined in the USP"

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

SIMVASTATIN- SIMVASTATIN TABLET, FILM COATED
NUCARE PHARMACEUTICALS,INC.
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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, FOR ORAL USE
INITIAL U.S. APPROVAL:1991
RECENT MAJOR CHANGES
Dosage and Administration
Chinese Patients Taking Lipid-Modifying Doses (greater than or equal
to 1 g/day
Niacin) of Niacin-Containing Products-removal (2.7)
03/2019
Warnings and Precautions
Myopathy/Rhabdomyolisis ( 5.1)
03/2019
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