TEVA-PRAZOSIN TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

PRAZOSIN (PRAZOSIN HYDROCHLORIDE)

Dostępny od:

TEVA CANADA LIMITED

Kod ATC:

C02CA01

INN (International Nazwa):

PRAZOSIN

Dawkowanie:

2MG

Forma farmaceutyczna:

TABLET

Skład:

PRAZOSIN (PRAZOSIN HYDROCHLORIDE) 2MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100/500

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ALPHA-ADRENERGIC BLOCKING AGENTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0111527002; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2011-09-14

Charakterystyka produktu

PRODUCT MONOGRAPH
PR
TEVA-PRAZOSIN
(Prazosin Hydrochloride)
1.0, 2.0 and 5.0 mg Tablets
Teva Standard
Antihypertensive
Teva Canada Limited
Date of Preparation:
30 Novopharm Court
September 28, 2011
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Submission Control#: 149916
2
PRODUCT MONOGRAPH
PR
TEVA-PRAZOSIN
(Prazosin Hydrochloride).
1.0, 2.0 and 5.0 mg Tablets
Teva Standard
THERAPEUTIC CLASSIFICATION
Antihypertensive
ACTION AND CLINICAL PHARMACOLOGY
TEVA-PRAZOSIN (prazosin hydrochloride) is a sympatholytic
antihypertensive agent. Its
primary mechanism of action is the competitive blockade of the
vascular postsynaptic alpha-
adrenoceptors. Prazosin acts preferentially on post-synaptic alpha
1
-receptors, thereby
blocking the contractile response of vascular smooth muscle to
norepinephrine without
interfering with its activity at alpha
2
-receptors. Abrupt termination of prazosin treatment does
not appear to cause a rebound elevation in blood pressure. Tolerance
to prazosin does not
appear to develop.
Hemodynamic studies have shown that the decrease in blood pressure is
not accompanied by
any significant changes in renal blood flow or glomerular filtration
rate.
A comparative three-way bioavailability study was conducted in order
to compare TEVA-
PRAZOSIN 1 mg and 2 mg Tablets with MINIPRESS
®
2 mg Tablets. The pharmacokinetic
data (mean ± standard deviation) calculated for TEVA-PRAZOSIN and
MINIPRESS
®
are
tabulated below:
3
GEOMETRIC MEAN
ARITHMETIC MEAN (C.V.)
MINIPRESS
1 X 2 MG
TEVA-
PRAZOSIN
2 X 1 MG
% OF
MINIPRESS
®
TEVA-
PRAZOSIN
1 X 2 MG
% OF
MINIPRESS
®
AUC
T
(ng
⋅
h/mL)
67
70
(28)
71
74
(28)
106
69
72
(25)
103
AUC
I
(ng
⋅
h/mL)
72
74
(27)
75
78
(28)
104
74
76
(24)
103
C
max
(ng/mL)
18
19
(30)
21
22
(26)
117
21
22
117
T
max*
(h)
1.15
(0.58)
0.81 (0.44)
-
0.90 (0.49)
-
T
½*
(h)
2.58
(0.79)
2.73 (0.73)
-
2.91 (0.88)
-
*
For the T
max
and T
1/2
parameters these are the arithmetic means (standard deviation).
A comparative, two-way bioavailability study was conducted to compare
TEVA-PRAZOSIN
5 mg