SIMVASTATIN tablet, film coated

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Biocon Limited

INN (Rahvusvaheline Nimetus):

SIMVASTATIN

Koostis:

SIMVASTATIN 5 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-de

Toote kokkuvõte:

Simvastatin Tablets, USP 5 mg are white to off white, oval, biconvex, film-coated tablets with the logo “B300” debossed on one side and “5” on the other side. They are supplied as follows: NDC 65727-065-12 bottles of 30 NDC 65727-065-13 bottles of 45 NDC 65727-065-14 bottles of 90 NDC 65727-065-15 bottles of 1000 Simvastatin Tablets, USP 10 mg are peach to dark peach, oval, biconvex, film-coated tablets with the logo “B301”debossed on one side and “10” on the other side. They are supplied as follows: NDC 65727-066-12 bottles of 30 NDC 65727-066-13 bottles of 45 NDC 65727-066-14 bottles of 90 NDC 65727-066-15 bottles of 1000. Simvastatin Tablets, USP 20 mg are orange to dark orange, oval, biconvex, film-coated tablets with the logo “B302” debossed on one side and “20” on the other side. They are supplied as follows: NDC 65727-067-12 bottles of 30 NDC 65727-067-13 bottles of 45 NDC 65727-067-14 bottles of 90. NDC 65727-067-15 bottles of 1000 Simvastatin Tablets, USP 40 mg are light pink to pink, oval, biconvex, film-coated tablets with the logo “B303” debossed on one side and “40” on the other side. They are supplied as follows: NDC 65727-068-12 bottles of 30 NDC 65727-068-13 bottles of 45 NDC 65727-068-14 bottles of 90. NDC 65727-068-15 bottles of 1000 Simvastatin Tablets, USP 80 mg are pink to dark pink, capsule-shaped, film-coated tablets with the logo “B304” debossed on one side and “80” on the other side.  They are supplied as follows: NDC 65727-069-12 bottles of 30 NDC 65727-069-13 bottles of 45 NDC 65727-069-14 bottles of 90 NDC 65727-069-15 bottles of 1000. Storage Store between 20 to 25°C (68 to 77°F). Dispense in a tightly-closed container as defined in the USP.

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

SIMVASTATIN- SIMVASTATIN TABLET, FILM COATED
BIOCON LIMITED
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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.
SIMVASTATIN TABLETS, USP 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 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 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 tole