PMS-DOXAZOSIN TABLET

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

DOXAZOSIN (DOXAZOSIN MESYLATE)

Prieinama:

PHARMASCIENCE INC

ATC kodas:

C02CA04

INN (Tarptautinis Pavadinimas):

DOXAZOSIN

Dozė:

2MG

Vaisto forma:

TABLET

Sudėtis:

DOXAZOSIN (DOXAZOSIN MESYLATE) 2MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

100

Recepto tipas:

Prescription

Gydymo sritis:

ALPHA-ADRENERGIC BLOCKING AGENTS

Produkto santrauka:

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

Autorizacija statusas:

APPROVED

Leidimo data:

2001-09-21

Prekės savybės

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