SIMVASTATIN tablet, film coated

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

PD-Rx Pharmaceuticals, Inc.

INN (Rahvusvaheline Nimetus):

SIMVASTATIN

Koostis:

SIMVASTATIN 80 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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

Toote kokkuvõte:

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: Bottles of 30        NDC 43063-080-30 Bottles of 90       NDC 43063-080-90 Storage Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

SIMVASTATIN- SIMVASTATIN TABLET, FILM COATED
PD-RX 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
Contraindications (4) 02/2014
Warnings and Precautions Myopathy/Rhabdomyolysis (5.1) 02/2014
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 evidence of muscle toxicity. ( 2.2)
Patients who are currently tolerating t