"The U.S. Food and Drug Administration today approved Differin Gel 0.1% (adapalene), a once-daily topical gel for the over-the-counter (OTC) treatment of acne. Differin Gel 0.1% is approved for use in people 12 years of age and older.
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 hemolyt-ic anemia, purpura hemorrhagica, drug fever, jaundice, and contact dermatitis indicate hypersensitivity to sulfon-amides. Particular caution should be employed if areas of denuded or abraded skin are involved.
FOR EXTERNAL USE ONLY. Keep away from eyes. Keep out of reach of children. Keep container tightly closed.
If irritation develops, use of the product should be discontinued and appropriate therapy instituted. Patients should be carefully observed for possible local irritation or sensitization during long-term therapy. The object of this therapy is to achieve desquamation without irritation, but sodium sulfacetamide and sulfur can cause reddening and scaling of the epidermis. These side effects are not unusual in the treatment of acne vulgaris, but patients should be cautioned about the possibility.
Carcinogenesis, Mutagenesis and Impairment of Fertility
Long-term studies in animals have not been performed to evaluate carcinogenic potential. Pregnancy: Category C. Animal reproduction studies have not been conducted with ROSANIL® (sodium sulfacetamide 10% and sulfur 5%) Cleanser. It is also not known whether ROSANIL® Cleanser (sodium sulfacetamide and sulfur) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. ROSANIL (sodium sulfacetamide and sulfur) ® Cleanser should be given to a pregnant woman only if clearly needed. Nursing Mothers: It is not known whether sodium sulfacetamide is excreted in the human milk following topical use of ROSANIL® Cleanser (sodium sulfacetamide and sulfur) . However, small amounts of orally administered sulfonamides have been reported to be eliminated in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when ROSANIL® Cleanser (sodium sulfacetamide and sulfur) is administered to a nursing woman. Pediatric Use: Safety and effectiveness in children under the age of 12 have not been established.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/8/2009
Additional Rosanil Information
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