Sulfacetamide Sodium
Generic: SULFACETAMIDE SODIUM
Basic Information
Manufacturer
Asclemed USA, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
c4c29e13-8303-4a9a-bb47-d7413eaf2f26
Indications & Usage
INDICATIONS AND USAGE: Sulfacetamide Sodium Ophthalmic Solution USP, 10% 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.
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.
Warnings
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.
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
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 ).
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 ).