DOXAZOSIN-1 TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

DOXAZOSIN (DOXAZOSIN MESYLATE)

Disponibil de la:

PRO DOC LIMITEE

Codul ATC:

C02CA04

INN (nume internaţional):

DOXAZOSIN

Dozare:

1MG

Forma farmaceutică:

TABLET

Compoziție:

DOXAZOSIN (DOXAZOSIN MESYLATE) 1MG

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ALPHA-ADRENERGIC BLOCKING AGENTS

Rezumat produs:

Active ingredient group (AIG) number: 0131431001; AHFS:

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2016-11-30

Caracteristicilor produsului

_ _
_DOXAZOSIN _Product Monograph_ _
_Page 1 of 43_
PRODUCT MONOGRAPH
PR
DOXAZOSIN – 1
PR
DOXAZOSIN – 2
PR
DOXAZOSIN - 4
Doxazosin Mesylate Tablets
1 mg, 2 mg and 4 mg
ANTIHYPERTENSIVE AGENT
SYMPTOMATIC TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH)
PRO DOC LTÉE
2925, boul. Industriel
Laval, Quebec
H7L 3W9
Date of Preparation:
October 6, 2014
CONTROL NO.: 177733
_ _
_DOXAZOSIN _Product Monograph_ _
_Page 2 of 43_
PRODUCT MONOGRAPH
PR
DOXAZOSIN – 1
PR
DOXAZOSIN – 2
PR
DOXAZOSIN – 4
Doxazosin Mesylate Tablets
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
_ _
_DOXAZOSIN _Product Monograph_ _
_Page 3 of 43_
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 above
and