SODIUM SULAMYD 10% DROPS

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SULFACETAMIDE SODIUM

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

S01AB04

INN (International Name):

SULFACETAMIDE

Dosage:

100MG

Pharmaceutical form:

DROPS

Composition:

SULFACETAMIDE SODIUM 100MG

Administration route:

OPHTHALMIC

Units in package:

15ML

Prescription type:

Prescription

Therapeutic area:

ANTIBACTERIALS

Product summary:

Active ingredient group (AIG) number: 0106092001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2018-08-01

Summary of Product characteristics

PRESCRIBING INFORMATION
PR
SODIUM SULAMYD 10%
®
SULFACETAMIDE SODIUM
OPHTHALMIC SOLUTION
ANTIBACTERIAL
Sandoz Canada Inc.
Date of preparation: 18 June 2018
145, rue Jules-Léger
Boucherville, QC, Canada
J4B 7K8
Control No. : 214225
PR
SODIUM SULAMYD 10% ®
sulfacetamide sodium
Ophthalmic Solution
Antibacterial
PHARMACOLOGY
Sodium sulfacetamide, a bacteriostatic sulfonamide, is effective
against a wide range of
microorganisms, commonly associated with external ocular infections.
Sodium
sulfacetamide inhibits the growth of susceptible strains of
_Pseudomonas æruginosa, _
_Staphylococcus aureus_
and
_ albus, Klebsiella pneumoniae, Escherichia coli _
and
_ _
_Enterobacter ærogenes._
Sodium sulfacetamide penetrates into ocular fluids and tissues in
high concentration.
INDICATIONS
The treatment of conjunctivitis, corneal ulcer, and other superficial
ocular infections due
to susceptible microorganisms, and as adjunctive treatment in systemic
therapy of
trachoma.
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS
OF SODIUM SULAMYD 10% AND OTHER ANTIBACTERIAL DRUGS, SODIUM SULAMYD
10% SHOULD BE USED ONLY TO TREAT INFECTIONS THAT ARE PROVEN OR
STRONGLY SUSPECTED TO
BE CAUSED BY BACTERIA.
CONTRAINDICATIONS
Hypersensitivity to sulfonamide preparations.
PRECAUTIONS
The solutions are incompatible with silver preparations. Do not use
solutions if coloured.
Sulfonamides may be inactivated by the para-aminobenzoic acid present
in purulent
exudates. If sensitivity reactions occur, discontinue treatment.
Topical anesthetics derived from aminobenzoic acid may antagonize the
antibacterial
effect of topical sulfonamides if applied concurrently.
If prompt clinical response is not obtained with Ophthalmic Solution
10%, further
evaluation is advised.
SUSCEPTIBILITY/RESISTANCE
DEVELOPMENT OF DRUG RESISTANT BACTERIA
Prescribing SODIUM SULAMYD 10% in the absence of a proven or strongly
suspected
bacterial infection is unlikely to provide benefit to the patient and
risks the development
of resistant organi