Land: Canada
Taal: Engels
Bron: Health Canada
PRAZOSIN (PRAZOSIN HYDROCHLORIDE)
APOTEX INC
C02CA01
PRAZOSIN
5MG
TABLET
PRAZOSIN (PRAZOSIN HYDROCHLORIDE) 5MG
ORAL
100
Prescription
ALPHA-ADRENERGIC BLOCKING AGENTS
Active ingredient group (AIG) number: 0111527003; AHFS:
MARKETED
1990-12-31
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 Lees het volledige document