SIMVASTATIN tablet

Страна: США

мова: англійська

Джерело: NLM (National Library of Medicine)

Активний інгредієнт:

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

Доступна з:

Physicians Total Care, Inc.

ІПН (Міжнародна Ім'я):

SIMVASTATIN

Склад:

SIMVASTATIN 5 mg

Адміністрація маршрут:

ORAL

Тип рецепту:

PRESCRIPTION DRUG

Терапевтичні свідчення:

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 tablets, USP 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, USP are indicated to: - Reduce elevated total cholesterol (

Огляд продуктів:

Simvastatin tablets, USP 5 mg are cream, round tablets, with “SV” over "5" on one side and “>” on the other side. They are supplied as follows: Simvastatin tablets, USP 10 mg are pink, round tablets, with “SV” over "10" on one side and “>” on the other side. They are supplied as follows: Simvastatin tablets, USP 20 mg are tan, round tablets, with “SV” over "20" on one side and “>” on the other side. They are supplied as follows:                                                                                                  Simvastatin tablets, USP 40 mg are pink, round tablets, with “SV” over "40" on one side and “>” on the other side. They are supplied as follows: Simvastatin tablets, USP 80 mg are pink, capsule-shaped tablets, with “SV80” on one side and “>” on the other side.They are supplied as follows: Storage Store between 15-30°C (59-86°F).

Статус Авторизація:

Abbreviated New Drug Application

Характеристики продукта

SIMVASTATIN - SIMVASTATIN TABLET
PHYSICIANS TOTAL CARE, INC.
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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
INITIAL U.S. APPROVAL: 1991
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 5-80 mg/day. (2.1)
Recommended usual starting dose is 20-40 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)
Adolescents (10-17 years of age) with HeFH: starting dose is 10
mg/day; maximum recommended dose is 40 mg/day.
(2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 5 mg; 10 mg; 20 mg; 40 mg; 80 mg (3)
CONTRAINDICATIONS
Hypersensitivity to any component of this medication. (4, 6.2)
Active liver disease, which may include unexplained persistent
elevations in hepatic transaminase levels. (4, 5.2)
Women who are pregnant or may become pregnant. (4, 8.1)
Nursing mothers. (4,