PMS-OFLOXACIN SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

OFLOXACIN

Available from:

PHARMASCIENCE INC

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:

2016-10-28

Summary of Product characteristics

PRODUCT MONOGRAPH
Pr
pms-OFLOXACIN
Ofloxacin Ophthalmic Solution USP
0.3%
Antibacterial Agent
PHARMASCIENCE INC.
Date of Preparation:
6111 Royalmount Avenue, Suite #100
April 14, 2004
Montreal (Quebec), CANADA
H4P 2T4
Control No.
090906
2
PRODUCT MONOGRAPH
Pr
pms-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 USES
pms-OFLOXACIN (Ofloxacin) 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 influenzae
3
CONTRAINDICATIONS
pms-OFLOXACIN (Ofloxacin) 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
Ofloxacin is not for injection into the eye.
PRECAUTIONS
General
Prolonged use of Ofloxacin may result in overgrowth of nonsusceptible
organisms, including fungi.
Whenever clinical judgement dictates, the patient should be examined
with the aid of magnification,
such as slit lamp biomicroscopy and, where appropriate, fluorescein
staining.
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 collapse, loss of consciousness,
tingling, angioedema (including
laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea,
urticaria, and itching. Onl