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Ovace Foam
  • Professionals
  • FDA PI

Ovace Foam

Generic name:sulfacetamide sodium
Dosage form: aerosol, foam
Drug class:Topical antibiotics

Medically reviewed by Drugs.com. Last updated on Feb 21, 2022.

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.

DESCRIPTION:

Each gram of Ovace® (Sodium Sulfacetamide 10%) Foam contains 100 mg of Sodium Sulfacetamide USP in an aqueous base consisting of: Cocamidopropyl betaine, Edetate disodium, Emulsifying wax, Lactic acid, Laureth-7, Lauryl/Myristyl alcohol, Methylparaben, Polyethylene glycol, Polyoxyl 40 stearate, Povidone, Propylparaben, Purified Water, PVP/DMAPA acrylates co-polymer, and Sorbitan monolaurate, and is dispensed from an aluminum can pressurized with Heptafluoropropane.

Sodium sulfacetamide is C8H9N2NaO3S·H2O with a molecular weight of 254.24. Chemically, it is acetamide N-[(4-aminophenyl)sulfonyl]-, monosodium salt, monohydrate, with the following structural formula:


Sodium sulfacetamide is an odorless, white, crystalline powder with a bitter taste. It is freely soluble in water, sparingly soluble in alcohol, while practically insoluble in benzene, in chloroform, and in ether.

CLINICAL PHARMACOLOGY:

Sodium sulfacetamide exerts a bacteriostatic effect against sulfonamide sensitive gram-positive and gram-negative microorganisms commonly isolated from secondary cutaneous pyogenic infections. It acts by restricting the synthesis of folic acid required by bacteria for growth, by its competition with para-aminobenzoic acid. There are no clinical data available on the degree and rate of systemic absorption of Ovace® Foam when applied to the skin or scalp. However, significant absorption of sodium sulfacetamide through the skin has been reported.

The following in vitro data are available but their clinical significance is unknown. Organisms which show susceptibility to sodium sulfacetamide are: Streptococci, Staphylococci, E. coli, Klebsiella pneumoniae, Pseudomonas pyocyanea, Salmonella species, Proteus vulgaris, Nocardia and Actinomyces.

INDICATIONS AND USAGE:

Ovace® Foam<