JAMP-DOXAZOSIN TABLET

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

DOXAZOSIN (DOXAZOSIN MESYLATE)

Fáanlegur frá:

JAMP PHARMA CORPORATION

ATC númer:

C02CA04

INN (Alþjóðlegt nafn):

DOXAZOSIN

Skammtar:

1MG

Lyfjaform:

TABLET

Samsetning:

DOXAZOSIN (DOXAZOSIN MESYLATE) 1MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

100

Gerð lyfseðils:

Prescription

Lækningarsvæði:

ALPHA-ADRENERGIC BLOCKING AGENTS

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2019-07-10

Vara einkenni

_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