NOROXIN TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

NORFLOXACIN

Disponible desde:

MERCK CANADA INC

Código ATC:

J01MA06

Designación común internacional (DCI):

NORFLOXACIN

Dosis:

400MG

formulario farmacéutico:

TABLET

Composición:

NORFLOXACIN 400MG

Vía de administración:

ORAL

Unidades en paquete:

30

tipo de receta:

Prescription

Área terapéutica:

QUINOLONES

Resumen del producto:

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

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2005-06-18

Ficha técnica

PRODUCT MONOGRAPH
NOROXIN
®
(norfloxacin tablets, USP)
400 mg
THERAPEUTIC CLASSIFICATION
ANTIBACTERIAL AGENT
MERCK FROSST CANADA LTD.
Date of Preparation:
KIRKLAND, QUEBEC, CANADA
June 15, 2005
Date of Revision:
Control No. 099220
NOROXIN
®
is a Registered Trademark of Merck & Co., Inc.
Used under license
1
PRODUCT MONOGRAPH
NAME OF DRUG
NOROXIN
®
(norfloxacin tablets, USP)
400 mg
THERAPEUTIC CLASSIFICATION
Antibacterial Agent
ACTION AND CLINICAL PHARMACOLOGY
NOROXIN
®
(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)
inhibition of the relaxation of supercoiled DNA,
3)
promotion of double-stranded DNA breakage.
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:
2
_Escherichia coli,_
_Klebsiella pneumoniae,_
unspecified _Klebsiella_ spp.,
unspecified _Enterobacter_ spp.,
unspecified _Citrobacter _spp.,
_Proteus mirabilis,_
_Staphylococcus aureus,_
_Streptococcus faecalis,_
_Pseudomonas aeruginosa,_
The
treatment
of
adults
with
gonococcal
urethritis,
or
cervicitis
due
to
penicillinase-producing and non-penicillinase-producing _Neisseria
gonorrhoeae._
Appropriate culture and susceptibility studies should be carried out
prior to
initiation of therapy with NOROXIN
®
(norfloxacin) and if clinically indicated during
treatment. Therapy may be initiated before obtaining results of these
tests (see
MICROBIOLOGY), however, modification of such treatment may be required
once the results become available.
CONTRAINDICATIONS
NOROXIN
®
(norfloxacin)
is
contraindicated
in
patients
with
known
hypersensitivity to norfloxa