GARAMYCIN OTIC DROPS 0.3%

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

GENTAMICIN (GENTAMICIN SULFATE)

Available from:

MERCK CANADA INC

ATC code:

S02AA14

INN (International Name):

GENTAMICIN

Dosage:

3MG

Pharmaceutical form:

DROPS

Composition:

GENTAMICIN (GENTAMICIN SULFATE) 3MG

Administration route:

OTIC

Units in package:

7.5ML

Prescription type:

Prescription

Therapeutic area:

ANTIBACTERIALS

Product summary:

Active ingredient group (AIG) number: 0105695002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2014-03-03

Summary of Product characteristics

PRESCRIBING INFORMATION
GARAMYCIN
®
OPHTHALMIC DROPS 0.3%
GARAMYCIN
® OTIC DROPS 0.3%
GARAMYCIN
®
OPHTHALMIC OINTMENT 0.3%
(Gentamicin sulfate)
Topical antibiotic
Merck Canada Inc.
Date of Preparation:
16750 route Transcanadienne
March 7, 2011
Kirkland, Quebec H9H 4M7
Control # 145172
PRESCRIBING INFORMATION
GARAMYCIN
®
OPHTHALMIC DROPS 0.3%
GARAMYCIN
® OTIC DROPS 0.3%
GARAMYCIN
®
OPHTHALMIC OINTMENT 0.3%
(Gentamicin sulfate)
Topical antibiotic
ACTION AND PHARMACOLOGY
GARAMYCIN, an aminoglycoside antibiotic, is active against the
gram-positive bacteria
commonly
found
in
eye-ear
infections:
coagulase-positive
and
coagulase-negative
Staphylococci,
Group
A
beta-hemolytic
and
non-hemolytic
Streptococci;
and
Diplococcus pneumoniae. GARAMYCIN is also active against gram-negative
bacteria
including P. aeruginosa, indole-positive and indole-negative Proteus
species, E. coli,
species of the Klebsiella-Enterobacter-Serratia group, Citrobacter
species, Salmonella
and Shigella, Moraxella species, Providencia species, H. vaginicola
and Neisseria
species, especially the gonococcus.
INDICATIONS
Ophthalmic: The treatment of superficial bacterial infections of the
conjunctiva, cornea,
eyelids, tear ducts and skin adjacent to the eye. Such infections
include conjunctivitis,
blepharitis,
blepharoconjunctivitis,
keratitis,
keratoconjunctivitis,
episcleritis,
dacryocystitis, corneal ulcers and infected eye sockets. Also for the
prevention of ocular
infection if injury makes the eye or adjacent area vulnerable to
infections: after removal
of foreign bodies, after burns or laceration to the lids or
conjunctivae or after damage
from chemical or physical agents and before and after eye surgery.
Otic: May be used for the topical treatment of otitis externa caused
by susceptible
bacteria.
CONTRAINDICATIONS
Sensitivity to any of the components in GARAMYCIN.
Ophthalmic Use
As with all GARAMYCIN preparations containing benzalkonium chloride,
patients are
advised not to wear soft contact lenses during treatment.
Otic Use
GARAMYCIN Otic p