FDA records indicate that there are no current recalls for this drug.
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Sodium Sulfacetamide Solution Recall
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Questions & Answers
Side Effects & Adverse Reactions
Although rare, sensitivity t o sodium sulfacetamide may occur. Therefore, caution and careful supervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity to topical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpura hemorrhagica, drug fever, jaundice, and contact dermatitis indicate hypersensitivity to sulfonamides. 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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Sodium Sulfacetamide Medicated Pads are indicated in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
History
There is currently no drug history available for this drug.
Other Information
Sodium Sulfacetamide Medicated Pads 10% contain a 10% solution of sodium sulfacetamide on a textured pad. Each gram of medicated solution contains 100 mg sodium sulfacetamide, purified water, sodium EDTA, sodium thiosulfate and urea ( 1 0%). Sodium Sulfacetamide Medicated Pads are greaseless and leave no residue when applied to the skin.
Sodium sulfacetamide is a sulfonamide with antibacterial activity. Chemically, sodium sulfacetamide is C8H9N2Na03S•H2O, with a molecular weight of 254.24. Chemically it is acetamide, N- [(4 aminophenyl) sulfonyl]-, monosodium salt and monohydrate, with the following structural formula:
Sources
Sodium Sulfacetamide Solution Manufacturers
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E. Fougera & Co., A Division Of Nycomed Us Inc.
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