APO-DOXAZOSIN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DOXAZOSIN (DOXAZOSIN MESYLATE)

Available from:

APOTEX INC

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:

1999-07-22

Summary of Product characteristics

Page 1 of 32
PRODUCT MONOGRAPH
PR
APO-DOXAZOSIN
Doxazosin Mesylate Tablets
Apotex Standard
1 mg, 2 mg and 4 mg doxazosin
/ tablet
Antihypertensive Agent
Symptomatic Treatment of Benign Prostatic Hyperplasia (BPH)
APOTEX INC.
150
Signet Drive
Toronto,
Ontario
M9L 1T9
Control Number: 216873
DATE OF REVISION:
October 29, 2018
Page 2 of 32
PRODUCT MONOGRAPH
PR
APO-DOXAZOSIN
Doxazosin Mesylate Tablets
Apotex Standard
1 mg, 2 mg and 4 mg
doxazosin/tablet
THERAPEUTIC CLASSIFICATION
Antihypertensive Agent
Symptomatic Treatment of Benign Prostatic Hyperplasia (BPH)
ACTIONS AND CLINICAL PHARMACOLOGY
The mechanism of action of APO-DOXAZOSIN. is selective blockade of
alpha
1
subtype of
post-synaptic, post-junctional alpha-adrenergic receptors.
Pharmacodynamics
Hypertension
Administration of APO-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 to 6 hours after dosing and are associated
with a small increase in
standing heart rate. APO-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 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 ≥ 65 years old and < 65 years old.
During controlled clinical studies, predominantly normocholesterolemic
patients receiving
Doxazosin Mesylate had small but statist