SIMVASTATIN tablet, film coated

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

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

Доступна с:

Aphena Pharma Solutions - Tennessee, LLC

ИНН (Международная Имя):

SIMVASTATIN

состав:

SIMVASTATIN 40 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

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

Обзор продуктов:

Simvastatin tablets USP 5 mg are brick red coloured, round shaped, biconvex, film coated tablet debossed “SI” on one side and plain on other side. Bottles of 30 Tablets (NDC 16729-156-10) Bottles of 90 Tablets (NDC 16729-156-15) Bottles of 1000 Tablets (NDC 16729-156-17) Simvastatin tablets USP 10 mg are brick red coloured, oval shaped, biconvex, film-coated tablets, debossed "S 4" on one side and plain on other side. Bottles of 30 Tablets (NDC 16729-004-10) Bottles of 60 Tablets (NDC 16729-004-12) Bottles of 90 Tablets (NDC 16729-004-15) Bottles of 1000 Tablets (NDC 16729-004-17) Simvastatin tablets USP 20 mg are brick red coloured oval shaped, biconvex, film-coated tablets, debossed "S 5" on one side and plain on other side. Bottles of 30 Tablets (NDC 16729-005-10) Bottles of 60 Tablets (NDC 16729-005-12) Bottles of 90 Tablets (NDC 16729-005-15) Bottles of 1000 Tablets (NDC 16729-005-17) 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. Bottles of 30 Tablets (NDC 16729-006-10) Bottles of 60 Tablets (NDC 16729-006-12) Bottles of 90 Tablets (NDC 16729-006-15) Bottles of 1000 Tablets (NDC 16729-006-17) Simvastatin tablets USP 80 mg are brick red coloured,capsule-shaped, biconvex, film-coated tablets, debossed with "SMV" on one side and "80" on the other side. Bottles of 30 Tablets (NDC 16729-007-10) Bottles of 60 Tablets (NDC 16729-007-12) Bottles of 90 Tablets (NDC 16729-007-15) Bottles of 1000 Tablets (NDC 16729-007-17) 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"

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

SIMVASTATIN- SIMVASTATIN TABLET, FILM COATED
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
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 FOR ORAL USE
INITIAL U.S. APPROVAL:1991
RECENT MAJOR CHANGES
Contraindication ( 4) 02/2014
Warnings and Precautions
Myopathy/Rhabdomyolysis ( 5.1) 02/2014
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 who have been taking
simvastatin 80 mg chronically (e.g., for
12 months or more) without evidence of muscle toxicity. (