Sodium Sulfacetamide
Dosage form: lotion
Drug class:Topical antibiotics
Medically reviewed by Drugs.com. Last updated on Apr 21, 2022.
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Sodium Sulfacetamide Description
Each mL of Sodium Sulfacetamide Lotion, 10% contains 100 mg of Sodium Sulfacetamide in a vehicle consisting of edetic acid, hydroxyethyl cellulose, lauramide DEA, methylparaben, PEG-400 monolaurate, propylene glycol, purified water, silicone emulsion, sodium chloride, sodium metabisulfite, and xanthan gum.
Sodium Sulfacetamide is a sulfonamide with antibacterial activity. Chemically, Sodium Sulfacetamide is N' -[(4-amino phenyl) sulfonyl] - acetamide, monosodium salt, monohydrate. The structural formula is:
Sodium Sulfacetamide - Clinical Pharmacology
The most widely accepted mechanism of action of sulfonamides is the Woods-Fildes theory, based on sulfonamides acting as a competitive inhibitor of para-aminobenzoic acid (PABA) utilization, an essential component for bacterial growth. While absorption through intact skin in humans has not been determined, in vitro studies with human cadaver skin indicated a percutaneous absorption of about 4%. Sodium Sulfacetamide is readily absorbed from the gastrointestinal tract when taken orally and excreted in the urine largely unchanged. The biological half-life has been reported to be between 7 to 13 hours.
The pharmacokinetics of sulfacetamide and its major metabolite sulfaniliamide in Sodium Sulfacetamide Lotion was evaluated in adult subjects (N=14) with acne vulgaris. The subjects applied Sodium Sulfacetamide Lotion to their face, back, chest, and shoulders every 12 hours for 28 days. The percentage of the applied dose of Sodium Sulfacetamide Lotion excreted in the urine as sulfacetamide plus sulfanilamide ranged from 0.08 to 0.33%.
INDICATIONS
Sodium Sulfacetamide Lotion is indicated in the topical treatment of acne vulgaris.
Contraindications
Sodium Sulfacetamide Lotion is contraindicated for use by patients having known hypersensitivity to sulfonamides or any other component of this preparation (see WARNINGS).
Warnings
