GLICLAZIDE TABLET

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

GLICLAZIDE

Доступна с:

SANIS HEALTH INC

код АТС:

A10BB09

ИНН (Международная Имя):

GLICLAZIDE

дозировка:

80MG

Фармацевтическая форма:

TABLET

состав:

GLICLAZIDE 80MG

Администрация маршрут:

ORAL

Штук в упаковке:

100

Тип рецепта:

Prescription

Терапевтические области:

SULFONYLUREAS

Обзор продуктов:

Active ingredient group (AIG) number: 0119934001; AHFS:

Статус Авторизация:

APPROVED

Дата Авторизация:

2010-02-04

Характеристики продукта

PRODUCT MONOGRAPH
PR
GLICLAZIDE
Gliclazide 80 mg Tablets
Manufacturer’s Standard
Hypoglycemic sulfonylurea
ORAL HYPOGLYCEMIC AGENT
Sanis Health Inc.
Date of Revision:
1 President’s Choice Circle
March 19, 2020
Brampton, Ontario
L6Y 5S5
www.sanis.com
Control No. 237133
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_GLICLAZIDE Page 2 of 30_
PRODUCT MONOGRAPH
Pr
GLICLAZIDE
Gliclazide 80 mg tablets
Manufacturer’s Standard
Oral Hypoglycemic Agent
ACTION AND CLINICAL PHARMACOLOGY
GLICLAZIDE (gliclazide) is a hypoglycemic agent of the sulfonylurea
group.
The hypoglycemic action of gliclazide is related to an improvement in
insulin secretion from
the functioning beta cells of the pancreas. It potentiates the insulin
release, improves the
dynamics of insulin.
Hemobiological properties of gliclazide have been observed in
pharmacology studies. These
are attributed to gliclazide action on the platelet behaviour,
prostaglandin equilibrium and
fibrinolysis.
Gliclazide is rapidly absorbed from the gastro-intestinal tract and
the plasma peak of
gliclazide occurs between 4 and 6 hours. In man it is highly bound to
plasma proteins, about
94%. The mean elimination half-life in man approximates 10.4 hours.
Following oral administration the unchanged gliclazide in plasma is
extensively metabolized
with little of the unchanged compound (<1%) appearing in the urine.
Gliclazide metabolites and conjugates are primarily eliminated via
kidneys: 60 to 70% and
about 10 to 20% via faeces.
Some five principal metabolites have been identified in urine,
essentially oxidized and
hydroxylated derivatives, some as glucuronic acid conjugates.
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_GLICLAZIDE Page 3 of 30_
A comparative, two-way, single-dose non-fasting bioavailability study
was performed with
GLICLAZIDE 80 mg Tablets and DIAMICRON
®
80
mg Tablets in 18 healthy male
volunteers.
The pharmacokinetic data calculated for gliclazide in the GLICLAZI