Land: Kanada
Språk: engelska
Källa: Health Canada
PRAZOSIN (PRAZOSIN HYDROCHLORIDE)
TEVA CANADA LIMITED
C02CA01
PRAZOSIN
2MG
TABLET
PRAZOSIN (PRAZOSIN HYDROCHLORIDE) 2MG
ORAL
100/500
Prescription
ALPHA-ADRENERGIC BLOCKING AGENTS
Active ingredient group (AIG) number: 0111527002; AHFS:
APPROVED
2011-09-14
PRODUCT MONOGRAPH PR TEVA-PRAZOSIN (Prazosin Hydrochloride) 1.0, 2.0 and 5.0 mg Tablets Teva Standard Antihypertensive Teva Canada Limited Date of Preparation: 30 Novopharm Court September 28, 2011 Toronto, Ontario Canada M1B 2K9 www.tevacanada.com Submission Control#: 149916 2 PRODUCT MONOGRAPH PR TEVA-PRAZOSIN (Prazosin Hydrochloride). 1.0, 2.0 and 5.0 mg Tablets Teva Standard THERAPEUTIC CLASSIFICATION Antihypertensive ACTION AND CLINICAL PHARMACOLOGY TEVA-PRAZOSIN (prazosin hydrochloride) is a sympatholytic antihypertensive agent. Its primary mechanism of action is the competitive blockade of the vascular postsynaptic alpha- adrenoceptors. Prazosin acts preferentially on post-synaptic alpha 1 -receptors, thereby blocking the contractile response of vascular smooth muscle to norepinephrine without interfering with its activity at alpha 2 -receptors. Abrupt termination of prazosin treatment does not appear to cause a rebound elevation in blood pressure. Tolerance to prazosin does not appear to develop. Hemodynamic studies have shown that the decrease in blood pressure is not accompanied by any significant changes in renal blood flow or glomerular filtration rate. A comparative three-way bioavailability study was conducted in order to compare TEVA- PRAZOSIN 1 mg and 2 mg Tablets with MINIPRESS ® 2 mg Tablets. The pharmacokinetic data (mean ± standard deviation) calculated for TEVA-PRAZOSIN and MINIPRESS ® are tabulated below: 3 GEOMETRIC MEAN ARITHMETIC MEAN (C.V.) MINIPRESS 1 X 2 MG TEVA- PRAZOSIN 2 X 1 MG % OF MINIPRESS ® TEVA- PRAZOSIN 1 X 2 MG % OF MINIPRESS ® AUC T (ng ⋅ h/mL) 67 70 (28) 71 74 (28) 106 69 72 (25) 103 AUC I (ng ⋅ h/mL) 72 74 (27) 75 78 (28) 104 74 76 (24) 103 C max (ng/mL) 18 19 (30) 21 22 (26) 117 21 22 117 T max* (h) 1.15 (0.58) 0.81 (0.44) - 0.90 (0.49) - T ½* (h) 2.58 (0.79) 2.73 (0.73) - 2.91 (0.88) - * For the T max and T 1/2 parameters these are the arithmetic means (standard deviation). A comparative, two-way bioavailability study was conducted to compare TEVA-PRAZOSIN 5 mg Läs hela dokumentet