APO-HYDRALAZINE TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

HYDRALAZINE HYDROCHLORIDE

Доступно од:

APOTEX INC

АТЦ код:

C02DB02

INN (Међународно име):

HYDRALAZINE

Дозирање:

50MG

Фармацеутски облик:

TABLET

Састав:

HYDRALAZINE HYDROCHLORIDE 50MG

Пут администрације:

ORAL

Јединице у пакету:

100

Тип рецептора:

Prescription

Терапеутска област:

DIRECT VASODILATORS

Резиме производа:

Active ingredient group (AIG) number: 0107444001; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2012-09-06

Карактеристике производа

PRODUCT MONOGRAPH
APO-HYDRALAZINE
HYDRALAZINE HYDROCHLORIDE TABLETS USP
10, 25 AND 50 MG
ANTIHYPERTENSIVE AGENT
APOTEX INC.
DATE OF PREPARATION:
150 SIGNET DRIVE
DECEMBER 14, 2016
TORONTO, ONTARIO
M9L 1T9
Control #: 199983
1
PRODUCT MONOGRAPH
APO-HYDRALAZINE
Hydralazine Hydrochloride Tablets USP
10, 25 and 50 mg
THERAPEUTIC CLASSIFICATION
Antihypertensive Agent
ACTIONS AND CLINICAL PHARMACOLOGY
Although the precise mechanism of action of hydralazine hydrochloride
is not fully understood, the major
effects are on the cardiovascular system. Hydralazine apparently
lowers blood pressure by exerting a
peripheral vasodilating effect through a direct relaxation of vascular
smooth muscle. Hydralazine, by
altering cellular calcium metabolism, interferes with the calcium
movements within the vascular smooth
muscle that are responsible for initiating or maintaining the
contractile state.
The peripheral vasodilating effect of hydralazine results in decreased
arterial blood pressure (diastolic
more than systolic); decreased peripheral vascular resistance; and an
increased heart rate, stroke volume,
and cardiac output. The vasodilating effect is much greater on
arterioles than on veins, and vascular
resistance decreases more in the coronary, cerebral, splanchnic and
renal circulations than in skin and
muscle.
Hydralazine usually increases renin activity in plasma, presumably as
a result of increased secretion of
renin by the renal juxtaglomerular cells in response to reflex
sympathetic discharge. This increase in
renin activity leads to the production of angiotensin II, which then
causes stimulation of aldosterone and
consequent sodium reabsorption and fluid retention.
2
Sodium retention and excessive sympathetic stimulation of the heart
caused by hydralazine may be
precluded by co-administration of a thiazide diuretic and a
beta-blocker. Beta-adrenergic blocking drugs
and hydralazine are complementary in their pharmacologic effects, a
beta-adrenergic blocking agent
minimizes hydralazine-induced increases in cardiac rate and o