SANDOZ OFLOXACIN SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

OFLOXACIN

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

S01AE01

INN (International Name):

OFLOXACIN

Dosage:

0.3%

Pharmaceutical form:

SOLUTION

Composition:

OFLOXACIN 0.3%

Administration route:

OPHTHALMIC

Units in package:

5ML

Prescription type:

Prescription

Therapeutic area:

ANTIBACTERIALS

Product summary:

Active ingredient group (AIG) number: 0122759007; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2019-08-01

Summary of Product characteristics

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_Sandoz Ofloxacin _
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PRODUCT MONOGRAPH
PR
SANDOZ OFLOXACIN
(Ofloxacin Ophthalmic Solution USP, 0.3%)
Antibacterial Agent
Sandoz Canada Inc.
145, Jules-Léger
Boucherville, QC
J4B 7K8
Date of Revision:
May 9, 2018
Submission Control No: 215604
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_Sandoz Ofloxacin _
_Page 2 of 26_
PR
SANDOZ OFLOXACIN
(Ofloxacin Ophthalmic Solution USP, 0.3%)
THERAPEUTIC CLASSIFICATION
Antibacterial Agent
ACTION AND CLINICAL PHARMACOLOGY
The primary mechanism of action of ofloxacin appears to be the
specific inhibition of DNA
gyrase (topoisomerase II). This enzyme is responsible for the negative
supercoiling of bacterial
DNA and consequently for its topological configuration, governing
functions such as RNA
transcription, protein synthesis, DNA replication and repair
functions.
INDICATIONS AND CLINICAL USE
Sandoz Ofloxacin (Ofloxacin Ophthalmic Solution USP, 0.3%) is
indicated for the treatment of
conjunctivitis when caused by susceptible strains of the following
bacteria:
GRAM POSITIVE BACTERIA
_Staphylococcus aureus _
_Staphylococcus epidermidis _
_Streptococcus pneumoniae _
_ _
GRAM NEGATIVE BACTERIA
_Haemophilus influenza _
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Ofloxacin
Ophthalmic Solution 0.3%
and other antibacterial drugs, Ofloxacin Ophthalmic Solution 0.3%
should be used only to treat infections that are proven or strongly
suspected to be caused by
bacteria.
CONTRAINDICATIONS
Ofloxacin Ophthalmic Solution 0.3% is contraindicated in patients with
a history of
hypersensitivity to ofloxacin or to any of the components of this
medication. A history of
hypersensitivity to other quinolones also contraindicates use of
ofloxacin.
WARNING
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_Sandoz Ofloxacin _
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Ofloxacin Ophthalmic Solution 0.3% is not for injection into the eye.
In patients receiving systemic quinolone therapy, serious and
occasionally fatal hypersensitivity
(anaphylactic) reactions, some following the first dose, have been
reported. Some reactions were
accompanied by cardiovascular