simvastatin- Simvastatin tablet, orally disintegrating

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

Simvastatin (UNII: AGG2FN16EV) (Simvastatin - UNII:AGG2FN16EV)

Boleh didapati daripada:

Synthon Pharmaceuticals, Inc.

INN (Nama Antarabangsa):

Simvastatin

Borang farmaseutikal:

TABLET, ORALLY DISINTEGRATING

Komposisi:

20 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

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

Ringkasan produk:

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.

Ciri produk

SIMVASTATIN- SIMVASTATIN TABLET, ORALLY DISINTEGRATING
SYNTHON PHARMACEUTICALS, INC.
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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