Țară: Canada
Limbă: engleză
Sursă: Health Canada
DOXAZOSIN (DOXAZOSIN MESYLATE)
PRO DOC LIMITEE
C02CA04
DOXAZOSIN
4MG
TABLET
DOXAZOSIN (DOXAZOSIN MESYLATE) 4MG
ORAL
100
Prescription
ALPHA-ADRENERGIC BLOCKING AGENTS
Active ingredient group (AIG) number: 0131431002; AHFS:
CANCELLED POST MARKET
2016-11-30
_ _ _DOXAZOSIN _Product Monograph_ _ _Page 1 of 43_ PRODUCT MONOGRAPH PR DOXAZOSIN – 1 PR DOXAZOSIN – 2 PR DOXAZOSIN - 4 Doxazosin Mesylate Tablets 1 mg, 2 mg and 4 mg ANTIHYPERTENSIVE AGENT SYMPTOMATIC TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH) PRO DOC LTÉE 2925, boul. Industriel Laval, Quebec H7L 3W9 Date of Preparation: October 6, 2014 CONTROL NO.: 177733 _ _ _DOXAZOSIN _Product Monograph_ _ _Page 2 of 43_ PRODUCT MONOGRAPH PR DOXAZOSIN – 1 PR DOXAZOSIN – 2 PR DOXAZOSIN – 4 Doxazosin Mesylate Tablets 1 mg, 2 mg and 4 mg THERAPEUTIC CLASSIFICATION Antihypertensive Agent Symptomatic Treatment of Benign Prostatic Hyperplasia (BPH) ACTIONS AND CLINICAL PHARMACOLOGY The mechanism of action of doxazosin mesylate is selective blockade of alpha 1 subtype of post-synaptic, post-junctional alpha-adrenergic receptors. PHARMACODYNAMICS Hypertension Administration of doxazosin mesylate results in a reduction in systemic vascular resistance. In patients with hypertension there is little change in cardiac output. Maximum reductions in blood pressure usually occur 2 to 6 hours after dosing and are associated with a small increase in standing heart rate. Doxazosin mesylate has a greater effect on blood pressure and heart rate in the standing position. Tolerance has not been observed in long-term therapy. Systolic and diastolic blood pressure is lowered in both the supine and standing positions. In clinical trials, blood pressure responses were measured at the end of the dosing interval (24 _ _ _DOXAZOSIN _Product Monograph_ _ _Page 3 of 43_ hours), with the usual supine response 6 to 11 mm Hg systolic and 5 to 9 mm Hg diastolic. The response in the standing position tended to be larger by 3 to 5 mm Hg. Peak blood pressure effects (1 to 6 hours) were larger by about 50 to 75% (i.e., trough values were about 55 to 70% of peak effect), with the larger peak-trough differences seen in systolic pressures. There was no apparent difference in the blood pressure response of Caucasians and Blacks or of patients above and Citiți documentul complet