PENTAMYCETIN LIQ 2.5MG/ML SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CHLORAMPHENICOL

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

S01AA01

INN (International Name):

CHLORAMPHENICOL

Dosage:

2.5MG

Pharmaceutical form:

SOLUTION

Composition:

CHLORAMPHENICOL 2.5MG

Administration route:

OPHTHALMIC

Units in package:

10ML

Prescription type:

Prescription

Therapeutic area:

ANTIBACTERIALS

Product summary:

Active ingredient group (AIG) number: 0151341012; AHFS:

Authorization status:

DORMANT

Authorization date:

2017-08-03

Summary of Product characteristics

PRESCRIBING INFORMATION
PR
PENTAMYCETIN
®
Chloramphenicol Ophthalmic Solution USP
0.25%, 0.5%
Chloramphenicol Ophthalmic Ointment USP
1%
Antibiotic
PR
PENTAMYCETIN/HC
®
Chloramphenicol and Hydrocortisone Eye and Ear Suspension
(chloramphenicol 0.2% and hydrocortisone acetate 1%)
Chloramphenicol and Hydrocortisone Eye and Ear Ointment
(chloramphenicol 1% and hydrocortisone acetate 1%)
Antibiotic/Corticosteroid
Sandoz Canada Inc.
145 Jules-Léger
Date of Revision: June 14, 2018
Boucherville, QC, Canada
J4B 7K8
Submission control number: 214703
_ _
_Pentamycetin and Pentamycetin/HC_
_Page 2 of 13 _
PR
PENTAMYCETIN
®
Chloramphenicol Ophthalmic Solution USP
0.25%, 0.5%
Chloramphenicol Ophthalmic Ointment USP
1%
Antibiotic
PR
PENTAMYCETIN/HC
®
Chloramphenicol and Hydrocortisone Eye and Ear Suspension
(chloramphenicol 0.2% and hydrocortisone acetate 1%)
Chloramphenicol and Hydrocortisone Eye and Ear Ointment
(chloramphenicol 1% and hydrocortisone acetate 1%)
Antibiotic/Corticosteroid
INDICATIONS AND CLINICAL USE
PENTAMYCETIN, OPHTHALMIC SOLUTION AND OINTMENT
Treatment of superficial ocular infections involving the conjunctiva
and/or the cornea, caused by
microorganisms shown by bacteriological studies to be susceptible to
chloramphenicol.
PENTAMYCETIN/HC, EYE AND EAR SUSPENSION AND OINTMENT
For topical use in superficial ocular and auditory infections, such as
non-purulent conjunctivitis
and otitis externa, caused by microorganisms shown by bacteriological
studies to be susceptible
to chloramphenicol. Hydrocortisone acetate has anti-inflammatory
effects.
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF
PENTAMYCETIN &
PENTAMYCETIN/HC AND OTHER ANTIBACTERIAL DRUGS,
PENTAMYCETIN & PENTAMYCETIN/HC SHOULD BE USED ONLY TO TREAT INFECTIONS
THAT
ARE PROVEN OR STRONGLY SUSPECTED TO BE CAUSED BY BACTERIA.
WARNINGS
Bone marrow hypoplasia, including aplastic anemia and death, has been
reported following local
application of chloramphenicol.
Chloramphenicol should not be used when less poten