Although rare, sensitivity to 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. Particular caution should be employed if areas of denuded or abraded skin are involved.
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. In one of these cases, there was a fatal outcome.
KEEP OUT OF REACH OF CHILDREN.
There is currently no manufacturer warning information available for this drug.
AVAR™-e LS Emollient Cream is indicated for use in the topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.
DESCRIPTION:
Each gram of AVAR™-e LS Emollient Cream (sodium sulfacetamide 10% w/w and sulfur 2% w/w) contains 100 mg of sodium sulfacetamide and 20 mg of colloidal sulfur in an emollient cream vehicle containing: arabica gum, benzyl alcohol, cetyl alcohol, dimethicone, disodium EDTA, emulsifying wax, fragrance, glycerine, glyceryl stearate (and) PEG-100 stearate, isostearyl palmitate, nicotinamide, phenoxyethanol, purified water, sodium lactate, sodium thiosulfate and zinc oxide.
Sodium sulfacetamide is a sulfonamide with antibacterial activity while sulfur acts as a keratolytic agent. Sodium sulfacetamide is C
8H
9N
2NaO
3S·H
2O with molecular weight of 254.24. Chemically, it is N-[(4-aminophenyl)sulfonyl]-acetamide, monosodium salt, monohydrate. The structural formula is:
