NOROXIN SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

NORFLOXACIN

Available from:

MERCK CANADA INC

ATC code:

S01AX12

INN (International Name):

NORFLOXACIN

Dosage:

3MG

Pharmaceutical form:

SOLUTION

Composition:

NORFLOXACIN 3MG

Administration route:

OPHTHALMIC

Units in package:

5ML

Prescription type:

Prescription

Therapeutic area:

ANTIBACTERIALS

Product summary:

Active ingredient group (AIG) number: 0116961002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2005-06-18

Summary of Product characteristics

PRODUCT MONOGRAPH
NOROXIN
®
Ophthalmic Solution
(norfloxacin ophthalmic solution)
0.3%
THERAPEUTIC CLASSIFICATION
Antibacterial Agent
Date of Preparation:
MERCK FROSST CANADA LTD.
June 15,2005
KIRKLAND, QUEBEC, CANADA
Date of Revision:
Control#: 099220
NOROXIN
®
is a Registered Trademark of Merck & Co., Inc.
Used under license.
1
PRODUCT MONOGRAPH
NAME OF DRUG
NOROXIN
®
Ophthalmic Solution
(norfloxacin ophthalmic solution)
0.3%
THERAPEUTIC CLASSIFICATION
Antibacterial Agent
ACTION AND CLINICAL PHARMACOLOGY
NOROXIN
®
Ophthalmic
Solution
(norfloxacin
ophthalmic
solution)
is
a
fluoroquinolone
carboxylic
acid
antibacterial
agent
for
ocular
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
NOROXIN
®
Ophthalmic Solution (norfloxacin ophthalmic solution) is indicated in
adults and children for the treatment of acute superficial infections
of the eye and
its adnexae (conjunctivitis, blepharoconjunctivitis and blepharitis)
when caused
by susceptible bacteria.
CONTRAINDICATIONS
2
NOROXIN
®
Ophthalmic
Solution
(norfloxacin
ophthalmic
solution)
is
contraindicated in patients with known hypersensitivity to any
component of this
product or any chemically related quinolone antibacterial agent.
PRECAUTIONS
General
As with other antibacterial preparations, prolonged use may result in
overgrowth
of non susceptible bacteria including fungi. If superinfection or
resistance should
develop, treatment with NOROXIN
®
Ophthalmic Solution (norfloxacin ophthalmic
solution) should be discontinued and appropriate therapy instituted.
Information for the patient
Patients should be instructed of the following:
1.
How to properly use this ophthalmic solution as t