ODAN-SULFACETAMIDE SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SULFACETAMIDE SODIUM

Available from:

ODAN LABORATORIES LTD

ATC code:

S01AB04

INN (International Name):

SULFACETAMIDE

Dosage:

10%

Pharmaceutical form:

SOLUTION

Composition:

SULFACETAMIDE SODIUM 10%

Administration route:

OPHTHALMIC

Units in package:

15ML

Prescription type:

Prescription

Therapeutic area:

ANTIBACTERIALS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2015-10-14

Summary of Product characteristics

PRESCRIBINGINFORMATION
PR
ODAN-SULFACETAMIDE
SULFACETAMIDE SODIUM OPHTHALMIC SOLUTION, USP
10 %
ANTIBACTERIAL
ODAN LABORATORIES LTD.
325 Stillview Ave.,
Pointe-Claire, Québec H9R 2Y6
Control No: 220032
Date of Revision:
October 18, 2018
www.odanlab.com
2
PRESCRIBING INFORMATION
PR
ODAN-SULFACETAMIDE
SULFACETAMIDE SODIUM OPHTHALMIC SOLUTION, USP
10 %
THERAPEUTIC CLASSIFICATION
Antibacterial
ACTION AND CLINICAL PHARMACOLOGY
The sulfonamides are bacteriostatic agents and the spectrum of
activity is similar for all.
Sulfonamides inhibit
bacterial synthesis of dihydrofolic acid by preventing the
condensation of the
pteridine with aminobenzoic
acid through competitive inhibition of the enzyme dihydropteroate
synthetase. Resistant strains have altered
dihydropteroate synthetase with reduced affinity for
sulfonamides or produce increased quantities of
aminobenzoic acid.
Topically applied sulfonamides are considered active against
susceptible strains of the following
common
bacterial eye pathogens: Escherichia coli, Staphylococcus aureus,
Streptococcus
pneumoniae, Streptococcus
(viridans group), Haemophilus influenzae, Klebsiella species, and
Enterobacter species.
Topically applied sulfonamides do not provide adequate coverage
against Neisseria species, Serratia
marcescens and Pseudomonas aeruginosa. A significant percentage of
staphylococcal isolates are
completely
resistant to sulfadrugs.
INDICATIONS
For the treatment of conjunctivitis and other superficial ocular
infections due to susceptible
microorganisms
and as an adjunctive in systemic sulfonamide therapy of trachoma:
Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae,
Streptococcus (viridans group),
Haemophilus influenzae, Klebsiella species, and Enterobacter species.
Topically applied sulfonamides do not provide adequate coverage
against Neisseria species, Serratia
marcescens and Pseudomonas aeruginosa. A significant percentage of
staphylococcal isolates are
completely
resistant to sulfadrugs.
To reduce the development of drug-resistant bacteria a