FOR TOPICAL EYE USE ONLY - NOT FOR INJECTION.
FATALITIES HAVE OCCURRED, ALTHOUGH RARELY, DUE TO SEVERE REACTIONS TO SULFONAMIDES
INCLUDING STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS, FULMINANT HEPATIC ECROSIS, AGRANULOCYTOSIS, APLASTIC ANEMIA AND OTHER BLOOD DYSCRASIAS. Sensitizations
may recur when a sulfonamide is readministered, irrespective of the route of
administration. Sensitivity reactions have been reported in individuals with
no prior history of sulfonamide hypersensitivity. At the first sign of hypersensitivity,
skin rash or other serious reaction, discontinue use of this preparation.
Prolonged use of topical anti-bacterial agents may give rise to overgrowth of nonsusceptible organisms including fungi. Bacterial resistance to sulfonamides may also develop.
The effectiveness of sulfonamides may be reduced by the para-aminobenzoic acid present in purulent exudates.
Sensitization may recur when a sulfonamide is readministered irrespective of the route of administration, and cross-sensitivity between different sulfonamides may occur.
At the first sign of hypersensitivity, increase in purulent discharge, or aggravation
of inflammation or pain, the patient should discontinue use of the medication
and consult a physician (see WARNINGS).
Carcinogenesis, mutagenesis, impairment of fertility
No studies have been conducted in animals or in humans to evaluate the possibility of these effects with ocularly administered sulfacetamide. Rats appear to be especially susceptible to the goitrogenic effects of sulfonamides, and long-term oral administration of sulfonamides has resulted in thyroid malignancies in these animals.
Pregnancy Category C. Animal reproduction studies have not been conducted with sulfonamide ophthalmic preparations. Kernicterus may occur in the newborn as a result of treatment of a pregnant woman at term with orally administered sulfonamides. There are no adequate and well controlled studies of sulfonamide ophthalmic preparations in pregnant women and it is not known whether topically applied sulfonamides can cause fetal harm when administered to a pregnant woman. This product should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
Systemically administered sulfonamides are capable of producing kernicterus in infants of lactating women. Because of the potential for the development of kernicterus in neonates, a decision should be made whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother.
Safety and effectiveness in infants below the age of two months have not been established.