Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
Simvastatin (UNII: AGG2FN16EV) (Simvastatin - UNII:AGG2FN16EV)
Synthon Pharmaceuticals, Inc.
Simvastatin
TABLET, ORALLY DISINTEGRATING
20 mg
ORAL
PRESCRIPTION DRUG
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 Orally Disintegrating 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 Orally Disintegrating 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 Orally Disintegrating 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 IIb3
Simvastatin Orally Disintegrating Tablets 10 mg are yellow, round, biconvex tablets with S10 debossed on one side and ODT on the other side. They are supplied as follows: NDC 63672-0001-1 , Bottles of 30 NDC 63672-0001-3 , Bottles of 90 Simvastatin Orally Disintegrating Tablets 20 mg are peach, round, biconvex tablets with S20 debossed on one side and ODT on the other side. They are supplied as follows: NDC 63672-0002-1 , Bottles of 30 NDC 63672-0002-3 , Bottles of 90 Simvastatin Orally Disintegrating Tablets 40 mg are pink, round, biconvex tablets with S40 debossed on one side and ODT on the other side. They are supplied as follows: NDC 63672-0003-1 , Bottles of 30 NDC 63672-0003-3 , Bottles of 90 Simvastatin Orally Disintegrating Tablets 80 mg are white, round, biconvex tablets with S80 debossed on one side and ODT on the other side. They are supplied as follows: NDC 63672-0004-1 , Bottles of 30 NDC 63672-0004-3 , Bottles of 90 Store bottles at controlled room temperature, 20° to 25°C (68° to 77°F). Excursions permitted to 15° to 30°C (59° to 86°F). See USP Controlled Room Temperature.
SIMVASTATIN- SIMVASTATIN TABLET, ORALLY DISINTEGRATING SYNTHON PHARMACEUTICALS, INC. ---------- SIMVASTATIN ORALLY DISINTEGRATING TABLETS (SIMVASTATIN) PRESCRIBING INFORMATION 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-(tetrahydro-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 empirical 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 Orally Disintegrating Tablets for oral administration contain either 10 mg, 20 mg, 40 mg or 80 mg of simvastatin. The tablets begin disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed. Simvastatin Orally Disintegrating Tablets also contain the following inactive ingredients: crospovidone, glyceryl behenate, hydroxypropyl cellulose, iron oxide yellow (10 mg and 20 mg tablets only), iron oxide red (20 mg and 40 mg tablets only), mint menthol, povidone, silicified microcrystalline cellulose, and sucralose. Butylated hydroxyanisole is added as an preservative. 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 Citiți documentul complet