AVA-NORFLOXACIN TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

NORFLOXACIN

Доступно од:

AVANSTRA INC

АТЦ код:

J01MA06

INN (Међународно име):

NORFLOXACIN

Дозирање:

400MG

Фармацеутски облик:

TABLET

Састав:

NORFLOXACIN 400MG

Пут администрације:

ORAL

Јединице у пакету:

100/500/1000

Тип рецептора:

Prescription

Терапеутска област:

QUINOLONES

Резиме производа:

Active ingredient group (AIG) number: 0116961001; AHFS:

Статус ауторизације:

CANCELLED POST MARKET

Датум одобрења:

2014-08-21

Карактеристике производа

PRODUCT MONOGRAPH
PR
AVA–NORFLOXACIN
(norfloxacin)
Tablets
USP
Antibacterial Agent
Avanstra Inc.
10761 – 25th NE
Suite 110, Building “B”
Calgary, Alberta
T2C 3C2
Canada
Submission Control No: 146071
Date of Preparation:
April 14, 2011
1
PRODUCT MONOGRAPH
AVA-NORFLOXACIN
(norfloxacin tablets)
Tablets
USP
THERAPEUTIC CLASSIFICATION
Antibacterial Agent
ACTIONS AND CLINICAL PHARMACOLOGY
AVA-NORFLOXACIN (norfloxacin) is a quinolone carboxylic acid
antibacterial agent for oral
administration. Norfloxacin inhibits bacterial deoxyribonucleic acid
synthesis and is
bactericidal.
At the molecular level, three specific actions have been attributed to
norfloxacin in the inhibition
of _E. coli_ cells:
1)
inhibition of the ATP-dependent DNA supercoiling reaction catalyzed by
DNA gyrase,
2
2)
inhibition of the relaxation of supercoiled DNA,
3)
promotion of double-stranded DNA breakage.
A comparative, two-way single dose bioavailability study was performed
on two norfloxacin 400
mg tablet formulations, AVA-NORFLOXACIN (norfloxacin) and Noroxin
®
. The
pharmacokinetic data calculated for norfloxacin in the AVA-NORFLOXACIN
and Noroxin
®
tablet formulations is tabulated below:
Geometric mean
Arithmetic mean (C.V.)
AVA-NORFLOXACIN
1 x 400 mg
Noroxin
®**
1 x 400 mg
Ratio of Geometric
Means (%)
AUC
T
5669
5467
103
(ng
!
h/mL)
5787 (21)
5753 (29)
AUC
I
5986
5789
103
(ng
!
h/mL)
6113 (21)
6082 (29)
C
max
1048
958
109
(ng/mL)
1069 (21)
1018 (31)
T
max
*
1.35 (0.72)
1.42 (0.48)
-
(h)
T
1/2
*
5.10 (0.41)
5.17 (0.47)
-
(h)
*For the T
max
and T
1/2
parameters these are the arithmetic means (standard deviation).
**Noroxin
®
(Merck, Sharp and Dohme Canada, Canada)
3
INDICATIONS AND CLINICAL USE
The treatment of upper and lower urinary tract infections,
specifically complicated and
uncomplicated cystitis, pyelitis and pyelonephritis caused by
susceptible strains of the following
microorganisms:
_Escherichia coli_
_Klebsiella pneumoniae_,
unspecified _Klebsiella_ spp.,
unspecified _Enterobacter_ spp.,
unspecified _Citrobacter_ spp.,
_