APO-PRAZO TAB 5MG TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

PRAZOSIN (PRAZOSIN HYDROCHLORIDE)

Beschikbaar vanaf:

APOTEX INC

ATC-code:

C02CA01

INN (Algemene Internationale Benaming):

PRAZOSIN

Dosering:

5MG

farmaceutische vorm:

TABLET

Samenstelling:

PRAZOSIN (PRAZOSIN HYDROCHLORIDE) 5MG

Toedieningsweg:

ORAL

Eenheden in pakket:

100

Prescription-type:

Prescription

Therapeutisch gebied:

ALPHA-ADRENERGIC BLOCKING AGENTS

Product samenvatting:

Active ingredient group (AIG) number: 0111527003; AHFS:

Autorisatie-status:

MARKETED

Autorisatie datum:

1990-12-31

Productkenmerken

Page 1 of 17
PRODUCT MONOGRAPH
APO-PRAZO
PRAZOSIN
H
YDROCHLORIDE TABLETS
1.0, 2.0, AND 5.0 MG
ANTIHYPERTENSIVE
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
CANADA M9L 1T9
SUBMISSION CONTROL NO.: 217479
DATE OF REVISION:
AUGUST 01, 2018
Page 2 of 17
APO-PRAZO
PRAZOSIN HYDROCHLORIDE TABLETS
1.0, 2.0 AND 5.0 MG
THERAPEUTIC CLASSIFICATION
Antihypertensive
ACTIONS AND CLINICAL PHARMACOLOGY
APO-PRAZO is a formulation of prazosin hydrochloride and is a
conventional release
formulation. Prazosin causes a decrease in total peripheral
resistance. Animal studies suggest
that the vasodilator effect of prazosin is related to selective
blockade of post-synaptic alpha
1
-
adrenoceptors. The results of dog forelimb experiments demonstrate
that the peripheral
vasodilator effect is confined mainly to the level of the resistance
vessels (arterioles).
Hemodynamic studies have been carried out in man following acute
single dose administration
and during the course of long term maintenance therapy. The results
confirm that the therapeutic
effect is a fall in blood pressure unaccompanied by a clinically
significant change in heart rate,
renal blood flow and glomerular filtration rate. In patients with
hypertension there is little change
in cardiac output. In addition, clinical pharmacology studies have
shown that both prazosin and
prazosin GITS antagonize the vasopressor effect of intravenous
phenylephrine, an alpha
1
-
agonist.
In man blood pressure is lowered in both the supine and standing
positions. The hypotensive
effect of prazosin hydrochloride is greater when the patient is
standing, and a mild reflex
tachycardia can result. Tolerance has not been observed to develop in
long term hypertensive
therapy. Rebound elevation of blood pressure does not seem to occur
following abrupt cessation
of therapy with prazosin.
Following oral administration of prazosin in normal volunteers and
hypertensive patients, plasma
Page 3 of 17
concentrations reach a peak at about 3 hours with a plasma half-life
of 2-3 hours. The drug is
highly bound t