BCI SIMVASTATIN TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

SIMVASTATIN

Доступно од:

BAKER CUMMINS INC

АТЦ код:

C10AA01

INN (Међународно име):

SIMVASTATIN

Дозирање:

20MG

Фармацеутски облик:

TABLET

Састав:

SIMVASTATIN 20MG

Пут администрације:

ORAL

Јединице у пакету:

100

Тип рецептора:

Prescription

Терапеутска област:

HMG-COA REDUCTASE INHIBITORS

Резиме производа:

Active ingredient group (AIG) number: 0122415003; AHFS:

Статус ауторизације:

CANCELLED PRE MARKET

Датум одобрења:

2017-08-30

Карактеристике производа

PRODUCT MONOGRAPH
BCI SIMVASTATIN
(Simvastatin Tablets USP)
5, 10, 20, 40 & 80 mg
THERAPEUTIC CLASSIFICATION
Lipid Metabolism Regulator
Baker Cummins Inc.
Date of Preparation: February 25, 2005
1 Place Ville-Marie, Suite 3900
Montreal, Quebec
H3B 4M7
Control#: 097152
1
PRODUCT MONOGRAPH
NAME OF DRUG
BCI SIMVASTATIN
(Simvastatin Tablets USP)
5, 10, 20, 40 & 80 mg
THERAPEUTIC CLASSIFICATION
Lipid Metabolism Regulator
ACTION AND CLINICAL PHARMACOLOGY
BCI SIMVASTATIN (simvastatin) is a lipid-lowering agent derived
synthetically from a fermentation
product of _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
2
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 P450 isoform 3A4).
The major active metabolites present in human plasma are the
ß-hydroxyacid of simvastatin and four
other active metabolites (see PHARMACOLOGY, Pharmacokinetics).
A randomized, single-dose, cross-over comparative bioavailability
study of _CO_ SIMVASTATIN tablets
80 mg and Zocor® 80 mg tablets has been performed in the fasting
state. A summary of the
bioavailability data is tabulated below.
3
Summary Table of the Comparative Bioavailability Study in the
Fasted State (1 x 80 mg) from Measured Data on Simvastatin
Parameter
Geometric Mean
Arithmetic Me