Negara: Kanada
Bahasa: Inggris
Sumber: Health Canada
DOXAZOSIN (DOXAZOSIN MESYLATE)
PHARMASCIENCE INC
C02CA04
DOXAZOSIN
4MG
TABLET
DOXAZOSIN (DOXAZOSIN MESYLATE) 4MG
ORAL
100
Prescription
ALPHA-ADRENERGIC BLOCKING AGENTS
Active ingredient group (AIG) number: 0131431002; AHFS:
APPROVED
2001-09-21
PRODUCT MONOGRAPH PR PMS-DOXAZOSIN Doxazosin Mesylate Tablets, House Standard 1 mg, 2 mg and 4 mg ANTIHYPERTENSIVE AGENT SYMPTOMATIC TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH) PHARMASCIENCE INC. 6111 Royalmount Ave., Suite 100 Montréal, Canada H4P 2T4 Date of Revision: June 9, 2017 www.pharmascience.com SUBMISSION CONTROL NO. 206343 _ _ _pms-DOXAZOSIN Product Monograph _ _Page 2 of 38_ PRODUCT MONOGRAPH PR PMS-DOXAZOSIN Doxazosin Mesylate Tablets, House Standard 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 2-6 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 hours), with the usual supine response 6-11 mm Hg systolic and 5-9 mm Hg diastolic. The response in the standing position tended to be larger by 3- 5 mm Hg. Peak blood pressure effects (1-6 hours) were larger by about 50-75% (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 ≥ 65 years old and <65 years old. During controlled clinical studies, predominantly normocholesterolemic patients receiving doxa Baca dokumen lengkapnya