TEVA-DOXAZOSIN TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DOXAZOSIN (DOXAZOSIN MESYLATE)

Tersedia dari:

TEVA CANADA LIMITED

Kode ATC:

C02CA04

INN (Nama Internasional):

DOXAZOSIN

Dosis:

4MG

Bentuk farmasi:

TABLET

Komposisi:

DOXAZOSIN (DOXAZOSIN MESYLATE) 4MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

ALPHA-ADRENERGIC BLOCKING AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0131431002; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2014-02-06

Karakteristik produk

PRODUCT MONOGRAPH
PR
TEVA-DOXAZOSIN
Doxazosin Mesylate
Tablets 1 mg, 2 mg and 4 mg
Teva Standard
Antihypertensive Agent
Symptomatic Treatment of Benign Prostatic Hyperplasia (BPH)
Teva Canada Limited
Date of Revision:
30 Novopharm Court
June 15, 2017
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Control # 206318
2
PRODUCT MONOGRAPH
Pr
TEVA-DOXAZOSIN
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
α
1
subtype of
post-synaptic, post-junctional α-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 55-70% 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 statistically significant reductions
in total serum cholesterol
(2.7%