RATIO-GLYBURIDE TABLET

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

GLYBURIDE

Доступна с:

RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED

код АТС:

A10BB01

ИНН (Международная Имя):

GLIBENCLAMIDE

дозировка:

2.5MG

Фармацевтическая форма:

TABLET

состав:

GLYBURIDE 2.5MG

Администрация маршрут:

ORAL

Штук в упаковке:

300TABS

Тип рецепта:

Prescription

Терапевтические области:

SULFONYLUREAS

Обзор продуктов:

Active ingredient group (AIG) number: 0108708002; AHFS:

Статус Авторизация:

CANCELLED POST MARKET

Дата Авторизация:

2014-09-19

Характеристики продукта

PRODUCT MONOGRAPH
Pr
ratio-GLYBURIDE
(glyburide)
2.5 and 5 mg Tablets
House Standard
Oral Hypoglycaemic
ratiopharm inc.
Date of Preparation:
Canada, J7J 1P3
February 10, 2006
Control No. 103569
Ratiopharm Version 1.0
-2-
PRODUCT MONOGRAPH
Pr
ratio-GLYBURIDE
(glyburide)
2.5 and 5 mg Tablets
House Standard
PHARMACOLOGIC CLASSIFICATION
Oral hypoglycaemic
ACTION AND CLINICAL PHARMACOLOGY
The principal action of glyburide results in an increased insulin
release from the beta cells
of the pancreas. Other mechanisms leading to a reduction of blood
glucose are also
believed to be influenced by glyburide
8
. The insertion of an alkylene chain on the benzene
nucleus results in a product of very high potency.
Schulz and Schmidt
12
indicated that the presence of a sulfonamide (sulphaphenazole)
decreased the distribution volume of
Pr
ratio-GLYBURIDE (glyburide) without influence on
the half-life of the oral hypoglycaemic agent. As a result, insulin
and serum concentrations
of
Pr
ratio-GLYBURIDE were higher and hypoglycaemic attacks could be
expected.
Hirn
and
Konigstein
6
have
observed
hypoglycaemia
when
phenylbutazone
and
oxyphenbutazone were added to
Pr
ratio-GLYBURIDE . Schulz and Schmidt confirmed that
phenylbutazone has an enhancing effect on the blood sugar lowering
effect of
Pr
ratio-
GLYBURIDE and found higher insulin levels. The plasma half-life of
Pr
ratio-GLYBURIDE
did not change with phenylbutazone administration. However, a
significant decrease in the
renal excretion of the main metabolite of
Pr
ratio-GLYBURIDE was observed, suggesting that
the elimination in the bile may compensate for the amount not excreted
in the urine.
Glyburide micronized powder is well absorbed from the intestinal tract
1,2
. Glyburide is
highly bound to plasma proteins after absorption from the
gastrointestinal tract
2,5
. It is
completely metabolized by hydroxylation of the cyclohexyl ring into
3-cis and 4-trans
derivatives in the liver
1,2,9
and the kidneys play only a minor role in their biotransformation
and elimination from plasma
1