DOM-DOXAZOSIN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DOXAZOSIN (DOXAZOSIN MESYLATE)

Available from:

DOMINION PHARMACAL

ATC code:

C02CA04

INN (International Name):

DOXAZOSIN

Dosage:

2MG

Pharmaceutical form:

TABLET

Composition:

DOXAZOSIN (DOXAZOSIN MESYLATE) 2MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

ALPHA-ADRENERGIC BLOCKING AGENTS

Product summary:

Active ingredient group (AIG) number: 0131431003; AHFS:

Authorization status:

APPROVED

Authorization date:

2002-07-30

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
DOM-DOXAZOSIN
Doxazosin Mesylate Tablets, House Standard
1 mg, 2 mg and 4 mg
ANTIHYPERTENSIVE AGENT
SYMPTOMATIC TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH)
DOMINION PHARMACAL
6111 Royalmount Ave., Suite 100
Montréal, Quebec
H4P 2T4
Date of Revision:
March 3, 2017
SUBMISSION CONTROL NO.: 202195
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_Dom-DOXAZOSIN Product Monograph _
_Page 2 of 48_
PRODUCT MONOGRAPH
PR
DOM-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 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
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%
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_Dom-DOXAZOSIN Product Monograph _
_Page 3 of 48_
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,
predomi