NTP-NORFLOXACIN TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

NORFLOXACIN

Commercializzato da:

TEVA CANADA LIMITED

Codice ATC:

J01MA06

INN (Nome Internazionale):

NORFLOXACIN

Dosaggio:

400MG

Forma farmaceutica:

TABLET

Composizione:

NORFLOXACIN 400MG

Via di somministrazione:

ORAL

Confezione:

100/500/1000

Tipo di ricetta:

Prescription

Area terapeutica:

QUINOLONES

Dettagli prodotto:

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

Stato dell'autorizzazione:

CANCELLED PRE MARKET

Data dell'autorizzazione:

2015-08-06

Scheda tecnica

PRODUCT MONOGRAPH
PR
NTP–NORFLOXACIN
(norfloxacin)
Tablets
USP
Antibacterial Agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Submission Control No: 167605
Date of Preparation:
September 23, 2013
2
PRODUCT MONOGRAPH
NTP-NORFLOXACIN
(norfloxacin tablets)
Tablets
USP
THERAPEUTIC CLASSIFICATION
Antibacterial Agent
ACTIONS AND CLINICAL PHARMACOLOGY
NTP-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,
3
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, NTP-NORFLOXACIN (norfloxacin) and Noroxin
®
. The
pharmacokinetic data calculated for norfloxacin in the NTP-NORFLOXACIN
and Noroxin
®
tablet formulations is tabulated below:
Geometric mean
Arithmetic mean (C.V.)
NTP-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)
4
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.,
_Proteus mirabili