Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
DOXAZOSIN (DOXAZOSIN MESYLATE)
JAMP PHARMA CORPORATION
C02CA04
DOXAZOSIN
1MG
TABLET
DOXAZOSIN (DOXAZOSIN MESYLATE) 1MG
ORAL
100
Prescription
ALPHA-ADRENERGIC BLOCKING AGENTS
Active ingredient group (AIG) number: 0131431001; AHFS:
APPROVED
2019-07-10
_JAMP-DOXAZOSIN (doxazosin mesylate) Product Monograph_ _Page 1 of 40_ PRODUCT MONOGRAPH PR JAMP-DOXAZOSIN Doxazosin Tablets USP 1 mg, 2 mg and 4 mg Doxazosin ( as Doxazosin Mesylate) Antihypertensive Agent Antihypertensive Agent Symptomatic Treatment of Benign Prostatic Hyperplasia (BPH) Jamp Pharma Corporation. 1310 rue Nobel Boucherville, Québec J4B 5H3 Date of Preparation: June 28, 2019 CONTROL NUMBER: 212001 _JAMP-DOXAZOSIN (doxazosin mesylate) Product Monograph_ _Page 2 of 40_ PRODUCT MONOGRAPH NAME OF DRUG Pr JAMP-DOXAZOSIN Doxazosin Tablets USP 1 mg, 2 mg and 4 mg Doxazosin (as Doxazosin Mesylate) THERAPEUTIC CLASSIFICATION Antihypertensive Agent Symptomatic Treatment of Benign Prostatic Hyperplasia (BPH) ACTIONS AND CLINICAL PHARMACOLOGY The mechanism of action of JAMP-DOXAZOSIN (doxazosin mesylate) is selective blockade of alpha 1 subtype of post-synaptic, post-junctional alpha-adrenergic receptors. PHARMACODYNAMICS Hypertension Administration of JAMP-DOXAZOSIN 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. JAMP-DOXAZOSIN 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 55-70% 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 ≥6 Izlasiet visu dokumentu