Product Description.:
BLEPH?-10 (sulfacetamide sodium ophthalmic solution, USP) 10% is a sterile, topical anti-bacterial agent for ophthalmic use.
Contains: Active: sulfacetamide sodium 10% (100 mg/mL). Preservative: benzalkonium chloride 0.005%. lnactives: edetate disodium polysorbate 80 polyvinyl alcohol 1.4% purified water sodium phosphate dibasic sodium phosphate monobasic sodium thiosulfate hydrochloric acid and/or sodium hydroxide to adjust the pH (6.8 to 7.5).
INDICATIONS AND USAGE
BLEPH?-10 solution is indicated 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 sulfa drugs.
CONTRAINDICATIONS
BLEPH?-10 solution is contraindicated in individuals who have a hypersensitivity to sulfonamides or to any ingredient of the preparation.
WARNINGS
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 NECROSIS, 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.
ADVERSE REACTIONS
Bacterial and fungal corneal ulcers have developed during treatment with sulfonamide ophthalmic preparations.
The most frequently reported reactions are local irritation, stinging and burning. Less commonly reported reactions include non-specific conjunctivitis, conjunctival hyperemia, secondary infections and allergic reactions.
Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including Stevens-Johnson syndrome, toxic epidermal necrolysis, fulminant hepatic necrosis, agranulocytosis, aplastic anemia, and other blood dyscrasias (see WARNINGS).
