ALTACE PLUS FELODIPINE 5MG + 5MG TABLET

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

FELODIPINE; RAMIPRIL

Доступна с:

SANOFI-AVENTIS CANADA INC

код АТС:

C09BB05

ИНН (Международная Имя):

RAMIPRIL AND FELODIPINE

дозировка:

5MG; 5MG

Фармацевтическая форма:

TABLET

состав:

FELODIPINE 5MG; RAMIPRIL 5MG

Администрация маршрут:

ORAL

Штук в упаковке:

100

Тип рецепта:

Prescription

Терапевтические области:

DIHYDROPYRIDINES

Обзор продуктов:

Active ingredient group (AIG) number: 0237542001; AHFS:

Статус Авторизация:

CANCELLED POST MARKET

Дата Авторизация:

2012-10-15

Характеристики продукта

PRODUCT MONOGRAPH
PR
ALTACE
®
PLUS FELODIPINE
(Felodipine Extended Release + Ramipril)
FILM-COATED TABLETS: 2.5 + 2.5 MG, AND 5 + 5 MG
Antihypertensive Agent
sanofi-aventis Canada Inc.
2150 St. Elzear Blvd. West
Laval, Quebec H7L 4A8
Date of Revision:
April 29, 2011
Submission Control No. 143667
2
PRODUCT MONOGRAPH
PR
ALTACE
® PLUS FELODIPINE
(Felodipine Extended Release + Ramipril)
FILM-COATED TABLETS: 2.5 + 2.5 MG, AND 5 + 5 MG
THERAPEUTIC CLASSIFICATION
Antihypertensive Agent
ACTION AND CLINICAL PHARMACOLOGY
Altace Plus Felodipine (felodipine ER/ramipril) is a formulation
containing extended-release
felodipine, a dihydropyridine calcium channel blocker, along with
immediate-release ramipril,
an angiotensin converting enzyme (ACE) inhibitor.
RAMIPRIL:
Ramipril is an ACE inhibitor. Following oral administration, ramipril
is rapidly hydrolyzed to
ramiprilat, its principal active metabolite. ACE 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 (see PRECAUTIONS).
Decreased levels of
angiotensin II and the accompanying lack of negative feedback on renal
renin secretion result in
increases in plasma renin activity.
ACE is identical to kininase II. Thus, ramipril may also block the
degradation of the
vasodepressor peptide bradykinin, which may contribute to its
therapeutic effect.
FELODIPINE:
The therapeutic effect of the dihydropyridine class of calcium channel
blockers is believed to be
related to their specific cellular action of selectively inhibiting
transmembrane influx of calcium
ions into cardiac muscle and vascular smooth muscle. The contractile
processes of these tissues
are dependent upon the movement of extracellular calcium into the
cells through specific ion
chann