RATIO FOSINOPRIL TABLET

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

FOSINOPRIL SODIUM

Доступна с:

RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED

код АТС:

C09AA09

ИНН (Международная Имя):

FOSINOPRIL

дозировка:

10MG

Фармацевтическая форма:

TABLET

состав:

FOSINOPRIL SODIUM 10MG

Администрация маршрут:

ORAL

Штук в упаковке:

100

Тип рецепта:

Prescription

Терапевтические области:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Обзор продуктов:

Active ingredient group (AIG) number: 0122777001; AHFS:

Статус Авторизация:

CANCELLED POST MARKET

Дата Авторизация:

2008-08-01

Характеристики продукта

PRODUCT MONOGRAPH
ratio-FOSINOPRIL
(Fosinopril Sodium Tablets)10 and 20 mg
Angiotensin Converting Enzyme Inhibitor
Ratiopharm Inc.
Date of Preparation:
17800 Lapointe
January 18, 2006
Mirabel PQ
Canada, J7J 1P3
Control #103439
PRODUCT MONOGRAPH
ratio-FOSINOPRIL
(Fosinopril Sodium Tablets)
10 and 20 mg
THERAPEUTIC CLASSIFICATION
Angiotensin Converting Enzyme Inhibitor
ACTION AND CLINICAL PHARMACOLOGY
ratio-FOSINOPRIL (fosinopril sodium) is an angiotensin converting
enzyme (ACE) inhibitor which is
used in the treatment of mild to moderate essential hypertension and
in the management of symptomatic
congestive heart failure.
Following oral administration, fosinopril sodium, an ester prodrug, is
rapidly hydrolyzed to fosinoprilat,
its principal active metabolite.
ACE is a peptidyl dipeptidase that catalyzes the conversion of
angiotensin I to the vasoconstrictor
substance, angiotensin II. Angiotensin II also stimulates aldosterone
secretion by the adrenal cortex.
Inhibition of ACE activity leads to decreased levels of angiotensin II
thereby resulting in decreased
vasoconstriction and decreased aldosterone secretion. The latter
decrease may result in a small increase in
serum potassium. Decreased levels of angiotensin II and the
accompanying lack of negative feedback on
renal renin secretion results in increases in plasma renin activity.
ACE is identical to kininase II. Thus, fosinopril sodium may interfere
with the degradation of bradykinin,
a potent peptide vasodilator. However, it is not known whether this
contributes to the therapeutic effects
of fosinopril sodium.
While the mechanism through which fosinopril sodium lowers blood
pressure appears to result primarily
from suppression of the renin-angiotensin-aldosterone system,
fosinopril sodium has an antihypertensive
3
effect in patients with low-renin hypertension. The antihypertensive
effect of angiotensin converting
enzyme inhibitors is generally lower in black patients than in
non-blacks.
Pharmacokinetics and Metabolism
Following
oral
administration,
fosinopril