Avar
(sulfacetamide sodium)Avar Prescribing Information
Sodium Sulfacetamide 10% Sulfur 2% Cream is indicated in the topical control of acne vulgaris, acnerosacea and seborrheic dermatitis.
Cleanse skin thoroughly before application. Apply a thin layer to affected areas 1-3 times daily or as directed by a physician. To minimize potential dryness, start with one application daily, then gradually increase to 2-3 times daily as needed or as directed by a physician.
Sodium Sulfacetamide 10% Sulfur 2% Cream is contraindicated foruse by patients having knownhypersensitivity to sulfonamides, sulfur or any other component of this preparation. Sodium Sulfacetamide 10% Sulfur 2%Cream is not to be used by patients with kidney disease.
Although rare, sodium sulfacetamide may cause local irritation.
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 Sodium Sulfacetamide 10% Sulfur 2% Cream contains 100 mg of Sodium Sulfacetamide and 20 mg of Sulfurin a base containing BHT, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol,Disodium EDTA, Ethylhexyl Palmitate, Ethylparaben, Fragrance, Glyceryl Monostearate SE, Methylparaben, Phenoxyethanol, Propylene Glycol, Propylparaben, Purified Water, Sodium Thiosulfate and Xanthan Gum.
Sodium Sulfacetamide exhibits antibacterial activity. It is believed to blockbacterial growth by acting as a competitive antagonist of para-aminobenzoic acid (PABA). While absorptionthrough intact skin has not been determined for sodium sulfacetamide, it is estimated that 1% of topically appliedsulfur is absorbed. Although the exact mode of the keralytic activity of sulfur is unknown, it is reported to resultfrom the interaction of sulfur with the cysteine content of keratinocytes. In combination with sulfacetamide, sulfurhas been reported to inhibit P. acnes, thereby reducing the associated inflammation.
Sodium Sulfacetamide 10% Sulfur 2% Cream is available in 2 oz (57 g) tubes, NDC 42192-150-02.
Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature]
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
All prescription substitutions using this product shall be made subject to state and federal statutes as applicable. NOTE: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency orother equivalency testing. No representation is made as to generic status or bioequivalency. Each personrecommending a prescription substitution using this product shall make such recommendations based on each suchperson’s professional opinion and knowledge, upon evaluating the active ingredients, excipients, inactive ingredients andchemical formulation information provided herein.
Although rare, sensitivity to sodium sulfacetaminde may occur. Therefore, caution and carefulsupervision should be observed when prescribing this drug for patients who may be prone to hypersensitivity totopical sulfonamides. Systemic toxic reactions such as agranulocytosis, acute hemolytic anemia, purpurahemorrhagica, drug fever, jaundice and contact dermatitis indicate hypersensitivity to sulfonamides. Particularcaution should be employed if areas of denuded or abraded skin are involved.