SODIUM SULFACETAMIDE
Generic: SODIUM SULFACETAMIDE
Basic Information
Manufacturer
Akron Pharma Inc
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
732dc306-069f-4cbf-9398-8a057829b83e
Indications & Usage
INDICATIONS: This product is intended for topical application in the following scaling dermatoses: seborrheic dermatitis and seborrhea sicca (dandruff).
Warnings
WARNINGS: Sulfonamides are known to cause Stevens-Johnson syndrome in hypersensitive individuals.
Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically.
Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported.
In one of these cases, there was a fatal outcome.
KEEP OUT OF THE REACH OF CHILDREN.
Stevens-Johnson syndrome also has been reported following the use of sodium sulfacetamide topically.
Cases of drug-induced systemic lupus erythematosus from topical sulfacetamide also have been reported.
In one of these cases, there was a fatal outcome.
KEEP OUT OF THE REACH OF CHILDREN.
Adverse Reactions
ADVERSE REACTIONS: Reports of irritation and hypersensitivity to sodium sulfacetamide are uncommon.
The following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome was reported (see WARNINGS).
The following adverse reactions, reported after administration of sterile ophthalmic sodium sulfacetamide, are noteworthy: instances of Stevens-Johnson syndrome and instances of local hypersensitivity which progressed to a syndrome resembling systemic lupus erythematosus; in one case a fatal outcome was reported (see WARNINGS).