Rosula
Generic name:sodium sulfacetamide and sulfur
Dosage form: aerosol, foam
Drug class:Topical antibiotics
Medically reviewed by Drugs.com. Last updated on Jul 22, 2021.
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
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FOR EXTERNAL USE ONLY
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The Rosula brand name has been discontinued in the U.S. If generic versions of this product have been approved by the FDA, there may be generic equivalents available.
DESCRIPTION
Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Chemically, sodium sulfacetamide is N-[(4-aminophenyl) sulfonyl]-acetamide, monosodium salt, monohydrate.
The structural formula is:
Each gram of Rosula (sodium sulfacetamide 10% and sulfur 4%) Foam contains 100 mg of sodium sulfacetamide and 40 mg of sulfur in an aqueous based foam vehicle containing cetyl alcohol NF, stearyl alcohol NF, polysorbate 60, methylparaben NF, propylparaben NF, propylene glycol NF, lactic acid USR purified water USR Also contains: Propellant HFA-134A (1,1,1,2- tetrafluoroethane).
CLINICAL PHARMACOLOGY
Sodium sulfacetamide exhibits antibacterial activity. The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory which is based on the fact that sulfonamides act as competitive antagonists to para-aminobenzoic acid (PABA), an essential component for bacterial growth. While absorption through intact skin has not been determined, sodium sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine, largely unchanged. The biological half-life has variously been reported as 7 to 12.8 hours.
The exact mechanism of the keratolytic activity of sulfur is unknown, but it is reported to result from the interaction of sulfur with the cysteine content of keratinocytes. Furthermore, in comb...
