Sulfacetamide Sodium and Sulfur Sodium Sulfacetamide - Sulfur

• Sodium Sulfacetamide 9% - Sulfer 4.25% Supesnion is contraindicated for use by patients having known hypersensitivity to sulfonamides, sulfur or any other component of this preparation.
• Sodium Sulfacetamide 9% - Sulder 4.25% Supension is not to be used by patients with kidney disease.

• 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.
• FOR EXTERNAL USE ONLY.
• NOT FOR OPHTHALMIC USE.
• KEEP OUT OF REACH OF CHILDREN.
• Keep container tightly closed.
• General Nonsusceptible organisms, including fungi, may proliferate with the use of this preparation.
• 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.
• Systemic absorption of topical sulfonamides is greater following application to large, infected, abraded, denuded or severely burned areas.
• Under these circumstances, any of the adverse effects produced by the systemic administration of these agents could potentially occur, and appropriate observations and laboratory determinations should be performed.
• 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.
• Information for patients Avoid contact with eyes, lips and mucous membranes.
• Drug Interactions This product is incompatible with silver preparations.
• Carcinogenesis, Mutagenesis and Impairment of Fertility Long-term studies in animals have not been performed to evaluate carcinogenic potential.
• Studies on reproduction and fertility also have not been performed.
• Chromosomal nondisjunction has been reported in the yeast, Saccharomyces cerevisiae, following application of sodium sulfacetamide.
• The significance of this finding to the topical use of sodium sulfacetamide in the human is unknown.
• PREGNANCY Category C Animal reproduction studies have not been conducted with Sodium Sulfacetamide 9% - Sulfer 4.25% Suspension.
• NURSING MOTHERS It is not known whether this drug is excreted in the human milk.
• PEDIATRIC USE Safety and effectiveness in
• General Nonsusceptible organisms, including fungi, may proliferate with the use of this preparation.
• 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.
• Systemic absorption of topical sulfonamides is greater following application to large, infected, abraded, denuded or severely burned areas.
• Under these circumstances, any of the adverse effects produced by the systemic administration of these agents could potentially occur, and appropriate observations and laboratory determinations should be performed.
• 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.

• Category C Animal reproduction studies have not been conducted with Sodium Sulfacetamide 9% - Sulfer 4.25% Suspension.
• It is not known whether Sodium Sulfacetamide 9% - Sulfer 4.25% Suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.
• Sodium Silfacetamide 9% - Sulfer 4.25% should be given to a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.
• It is not known whether this drug is excreted in the human milk.
• 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 Sodium Sulfacetamide 9% - Sulfur 4.25% Supesnion is administered to a nursing woman.

This product is incompatible with silver preparations.

• The oral LD 50 of sulfacetamide in mice is 16.5 g/kg.
• In the event of overdosage, emergency treatment should be started immediately.
• Manifestations Overdosage may cause nausea and vomiting.
• Large oral overdosage may cause hematuria, crystalluria and renal shutdown due to the precipitation of sulfa crystals in the renal tubules and the urinary tract.
• For treatment, contact your local Poison Control Center (1-800-222-1222), or your doctor.