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:

State of Florida DOH Central Pharmacy

ИНН (Международная Имя):

SIMVASTATIN

состав:

SIMVASTATIN 20 mg

Администрация маршрут:

ORAL

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below). In patients with 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 tablets are indicated to: - Reduce elevated total-C, LDL-C, Apo B, and TG, and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson types IIa and IIb). - Treat patients with hypertriglyceridemia (Fredrickson type lV hyperlipidemia).

Обзор продуктов:

Simvastatin Tablets 5 mg are peach colored, round, film-coated tablets, debossed RX6 on one side and plain on the other side. Simvastatin Tablets 10 mg are peach colored, round, film-coated tablets, debossed RX790 on one side and plain on the other side. Simvastatin Tablets 20 mg are tan colored, round, film-coated tablets, debossed RX791 on one side and plain on the other side. Simvastatin Tablets 40 mg are brick red colored, round, film-coated tablets, debossed RX792 on one side and plain on the other side. Simvastatin Tablets 80 mg are brick red colored, round, film-coated tablets, debossed RX793 on one side and plain on the other side. They are supplied by State of Florida DOH Central Pharmacy as follows: Storage Store at 20 - 25° C (68 - 77° F). (See USP Controlled Room Temperature). Manufactured for: Ranbaxy Pharmaceuticals Inc. Jacksonville, FL 32257 USA This Product was Repackaged By: State of Florida DOH Central Pharmacy 104-2 Hamilton Park Drive Tallahassee, FL 32304 United States

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

SIMVASTATIN - SIMVASTATIN TABLET, FILM COATED
STATE OF FLORIDA DOH CENTRAL PHARMACY
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SIMVASTATIN
TABLETS
DESCRIPTION
Simvastatin is a lipid-lowering agent that is derived synthetically
from a fermentation product of
_Aspergillus terreus_. After oral ingestion, simvastatin, which is an
inactive lactone, is hydrolyzed to the
corresponding β-hydroxyacid form. This is an inhibitor of
3-hydroxy-3-methylglutaryl-coenzyme A
(HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA
to mevalonate, which is an
early and rate-limiting step in the biosynthesis of cholesterol.
Simvastatin is butanoic acid,
2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahy-dro-4-
hydroxy-6-oxo-2_H_-pyran-2-yl)-ethyl]-1-naphthalenyl ester,
[1_S_-[1α,3α,7β,8β(2_S_*,4_S_*),-8aβ]]. The
molecular formula of simvastatin is C
H O and its molecular weight is 418.57. Its structural formula
is:
Simvastatin is a white to off-white, nonhygroscopic, crystalline
powder that is practically insoluble in
water, and freely soluble in chloroform, methanol and ethanol.
Simvastatin tablets for oral administration contain either 5 mg, 10
mg, 20 mg, 40 mg and 80 mg of
simvastatin and the following inactive ingredients: ascorbic acid,
butylated hydroxyanisole, citric acid,
croscarmellose sodium, hydroxypropyl cellulose, hypromellose, iron
oxides, isopropyl alcohol,
lactose monohydrate, magnesium stearate, microcrystalline cellulose,
pregelatinized starch, talc and
titanium dioxide.
CLINICAL PHARMACOLOGY
Epidemiological studies have demonstrated that elevated levels of
total cholesterol (total-C), low-
density lipoprotein cholesterol (LDL-C), as well as decreased levels
of high-density lipoprotein
cholesterol (HDL-C) are associated with the development of
atherosclerosis and increased
cardiovascular risk. Lowering LDL-C decreases this risk. However, the
independent effect of raising
HDL-C or lowering TG on the risk of coronary and cardiovascular
morbidity and mortality has not been
determined.
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38
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PHARMACOKINETICS
Simvastat