ODAN-CHLORAMPHENICOL LIQUID

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CHLORAMPHENICOL

Available from:

ODAN LABORATORIES LTD

ATC code:

S01AA01

INN (International Name):

CHLORAMPHENICOL

Dosage:

0.5MG

Pharmaceutical form:

LIQUID

Composition:

CHLORAMPHENICOL 0.5MG

Administration route:

OPHTHALMIC

Units in package:

15ML/10ML

Prescription type:

Prescription

Therapeutic area:

ANTIBACTERIALS

Product summary:

Active ingredient group (AIG) number: 0151341017; AHFS:

Authorization status:

APPROVED

Authorization date:

2015-09-24

Summary of Product characteristics

PRESCRIBING INFORMATION
PR
ODAN-CHLORAMPHENICOL
CHLORAMPHENICOL OPHTHALMIC SOLUTION, USP
0.5%
AND
CHLORAMPHENICOL OPHTHALMIC OINTMENT, USP
1%
ANTIBIOTIC
ODAN LABORATORIES LTD.
325 Stillview Ave.,
Pointe-Claire, Québec H9R 2Y6
Submission Control No: 215676
Date of Revision :
July 17, 2018
www.odanlab.com
2
PRESCRIBING INFORMATION
ODAN-CHLORAMPHENICOL
CHLORAMPHENICOL OPHTHALMIC SOLUTION USP, 0.5%
AND
CHLORAMPHENICOL OPHTHALMIC OINTMENT USP, 1%
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTION AND CLINICAL PHARMACOLOGY
Chloramphenicol
is
a
broad
spectrum
antibiotic
originally
isolated
from
_Streptomyces _
_venezuelae_.
It
is
primarily bacteriostatic and acts by inhibition of protein synthesis
by
interfering
with
the
transfer of activated amino acids from soluble RNA to ribosomes.
Development of resistance to chloramphenicol can be regarded as
minimal for staphylococci
and many other species of bacteria.
INDICATIONS
This product is indicated for the treatment of superficial ocular
infections involving the
conjunctiva
and/
or
cornea
caused
by
chloramphenicol-susceptible
organisms.
Bacteriological studies should be performed to determine the causative
organisms and their
sensitivity to chloramphenicol.
To
reduce
the
development
of
drug-resistant
bacteria and maintain the effectiveness of
ODAN-CHLORAMPHENICOL
and
other
antibacterial
drugs,
ODAN-
CHLORAMPHENICOL should be used only to treat infections that are
proven or strongly
suspected to be caused by bacteria.
CONTRAINDICATIONS
This product is contraindicated in those persons who have shown
hypersensitivity to any of
its components.
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WARNINGS
Prolonged or frequent intermittent use of topical chloramphenicol
should be avoided because
of possibility of hypersensitivity reactions, including bone-marrow
hypoplasia which may
lead to aplastic anemia. Ophthalmic ointment may retard corneal wound
healing.
PRECAUTIONS
Prolonged
use
of
antibiotics
may
occasionally
result
in
overgrowth
of
non-susceptible
organisms, including fungi. If new infections should appear during
treatment,