Sulfacetamide sodium ophthalmic solution is indicated for the treatment of conjunctivitis and other superficial ocular infections caused by susceptible microorganisms. It is also used as an adjunct in systemic sulfonamide therapy for trachoma. It is effective against organisms such as Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species.

Topical sulfonamides are not adequately effective against Neisseria species, Serratia marcescens, and Pseudomonas aeruginosa. A significant proportion of staphylococcal strains are fully resistant to sulfonamides.

Sulfonamides are bacteriostatic agents with a similar spectrum of activity across the class. They inhibit bacterial synthesis of dihydrofolic acid by competitively blocking the enzyme dihydropteroate synthetase, preventing condensation of pteridine with aminobenzoic acid. Resistant bacterial strains may have altered dihydropteroate synthetase with reduced affinity for sulfonamides or may produce increased amounts of aminobenzoic acid.

Topically applied sulfonamides are active against susceptible strains of common ocular pathogens, including Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group), Haemophilus influenzae, Klebsiella species, and Enterobacter species.

However, they are not adequately effective against Neisseria species, Serratia marcescens, and Pseudomonas aeruginosa. A significant proportion of staphylococcal isolates are resistant to sulfonamides.

For conjunctivitis and other superficial ocular infections: Instill one or two drops into the conjunctival sac(s) of the affected eye(s) every two to three hours initially. Dosages may be tapered by increasing the time interval between doses as the condition responds. The usual duration of treatment is seven to ten days.

For trachoma: Instill two drops into the conjunctival sac(s) of the affected eye(s) every two hours. Topical administration must be accompanied by systemic administration.

Sulfacetamide preparations are incompatible with silver-containing preparations.

Sulfacetamide sodium ophthalmic solution is contraindicated in patients with known hypersensitivity to sulfonamides or any component of the formulation.

During treatment with sulfonamide ophthalmic preparations, bacterial and fungal corneal ulcers have been reported. The most common adverse effects include local irritation, stinging, and burning sensation. Less frequently reported effects include non-specific conjunctivitis, conjunctival redness (hyperemia), secondary infections, and allergic reactions.

Rare but serious and sometimes fatal reactions have occurred, including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood disorders.

Pregnancy Category C. Animal reproduction studies have not been performed with ophthalmic sulfonamides. Oral sulfonamides taken at term in pregnancy may cause kernicterus in newborns. Adequate controlled studies in pregnant women are lacking, and it is unknown whether topical use causes fetal harm. The drug should be used during pregnancy only if clearly needed.

Systemically administered sulfonamides may cause kernicterus in nursing infants. Therefore, a decision should be made whether to discontinue breastfeeding or discontinue the drug, considering its importance to the mother.

Prolonged use of topical antibacterial agents may lead to overgrowth of non-susceptible organisms, including fungi. Bacterial resistance may also develop. The presence of para-aminobenzoic acid in purulent exudates may reduce the effectiveness of sulfonamides.

Sensitization may recur upon re-exposure, regardless of route, and cross-sensitivity among sulfonamides may occur. At the first sign of hypersensitivity, increased discharge, or worsening inflammation or pain, the drug should be discontinued and medical advice sought.

Pediatric use: Safety and effectiveness in infants below 2 months of age have not been established.

Ophthalmic antibacterial drugs

Store below 25°C.