DOM-SIMVASTATIN TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

SIMVASTATIN

Доступно од:

DOMINION PHARMACAL

АТЦ код:

C10AA01

INN (Међународно име):

SIMVASTATIN

Дозирање:

40MG

Фармацеутски облик:

TABLET

Састав:

SIMVASTATIN 40MG

Пут администрације:

ORAL

Јединице у пакету:

100

Тип рецептора:

Prescription

Терапеутска област:

HMG-COA REDUCTASE INHIBITORS

Резиме производа:

Active ingredient group (AIG) number: 0122415002; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2004-05-18

Карактеристике производа

PRODUCT MONOGRAPH
Pr
DOM-SIMVASTATIN
(Simvastatin tablets USP)
5 mg, 10 mg, 20 mg, 40 mg and 80 mg Tablets
Lipid Metabolism Regulator
DOMINION PHARMACAL
Date of Preparation:
6111 Royalmount Ave., Suite #100
May 18, 2004
Montreal, Quebec H4P 2T4
Control #: 091575
-2-
PRODUCT MONOGRAPH
Pr
DOM-SIMVASTATIN
(Simvastatin tablets USP)
5, 10, 20, 40 and 80 mg Tablets
THERAPEUTIC CLASSIFICATION
Lipid Metabolism Regulator
ACTIONS AND CLINICAL PHARMACOLOGY
Simvastatin is a lipid-lowering agent derived synthetically from a
fermentation product
_Aspergillus_
_terreus_
.
After oral ingestion, simvastatin, which is an inactive lactone, is
hydrolyzed to the corresponding
$
-hydroxyacid
form.
This
principal
metabolite
is
a
specific
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 reduces cholesterol production by the liver and induces
some changes in cholesterol
transport and disposition in the blood and tissues. The mechanism(s)
of this effect is believed to
involve both reduction of the synthesis of Low Density Lipoprotein
(LDL), and an increase in LDL
catabolism as a result of induction of the hepatic LDL receptors.
Simvastatin has complex pharmacokinetic characteristics (see
PHARMACOLOGY).
Simvastatin is metabolized by the microsomal hepatic enzyme system
(cytochrome P-450 isoform
3A4). The major active metabolites present in human plasma are the
$
-hydroxyacid of simvastatin
and four other active metabolites (see PHARMACOLOGY,
Pharmacokinetics).
BIOAVAILABILITY:
-3-
A comparative, single-dose, two-way crossover bioavailability study
was performed under fasting
conditions on two Simvastatin tablet products, DOM-SIMVASTATIN 80 mg
Tablets and ZOCOR
®
80 mg Tablets, by Merck Frosst Canada & Co., Canada. The
pharmacokinetic data calculated for
the DOM-SIMVASTATIN 80 mg Tablets and Zocor
®
80 mg tablet formulation are tabulated below:
SIMVASTATIN
FROM MEASU