Mafenide Acetate

SULFAMYLON Cream is a topical agent indicated for adjunctive therapy of patients with second- and third-degree burns.

SULFAMYLON is contraindicated in patients who are hypersensitive to it. It is not known whether there is cross sensitivity to other sulfonamides.

Fatal hemolytic anemia with disseminated intravascular coagulation, presumably related to a glucose-6-phosphate dehydrogenase deficiency, has been reported following therapy with SULFAMYLON Cream. Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.

SULFAMYLON and its metabolite, ρ-carboxybenzenesulfonamide, inhibit carbonic anhydrase, which may result in metabolic acidosis, usually compensated by hyperventilation. In the presence of impaired renal function, high blood levels of SULFAMYLON and its metabolite may exaggerate the carbonic anhydrase inhibition. Therefore, close monitoring of acid-base balance is necessary, particularly in patients with extensive second-degree or partial-thickness burns and in those with pulmonary or renal dysfunction. Some burn patients treated with SULFAMYLON Cream have also been reported to manifest an unexplained syndrome of marked hyperventilation with resulting respiratory alkalosis (slightly alkaline blood pH, low arterial pCO 2 , and decreased total CO 2 ); change in arterial pO 2 is variable. The etiology and significance of these findings are unknown. Mafenide acetate cream should be used with caution in burn patients with acute renal failure. SULFAMYLON Cream should be administered with caution to patients with history of hypersensitivity to mafenide. It is not known whether there is cross sensitivity to other sulfonamides. Fungal colonization in and below eschar may occur concomitantly with reduction of bacterial growth in the burn wound. However, fungal dissemination through the infected burn wound is rare. Carcinogenesis, Mutagenesis, Impairment of Fertility No long-term animal studies have been performed to evaluate the drug’s potential in these areas. Pregnancy Animal reproduction studies have not been conducted with SULFAMYLON. It is also not known whether SULFAMYLON can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Therefore, the preparation is not recommended for the treatment of a women of childbearing potential, unless the burned area covers more than 20% of the total body surface, or the need for the therapeutic benefit of SULFAMYLON Cream is, in the physician’s judgment, greater than the possible risk to the fetus. Nursing Mothers It is not known whether mafenide acetate is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reaction in nursing infants from SULFAMYLON, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Pediatric Use Same as for adults. (See DOSAGE AND ADMINISTRATION .)

It is frequently difficult to distinguish between an adverse reaction to SULFAMYLON Cream and the effect of a severe burn. A single case of bone marrow depression and a single case of acute attack of porphyria have been reported following therapy with SULFAMYLON Cream. Fatal hemolytic anemia with disseminated intravascular coagulation, presumably related to a glucose-6-phosphate dehydrogenase deficiency, has been reported following therapy with SULFAMYLON Cream. Dermatologic: The most frequently reported reaction was pain on application or a burning sensation. Rare occurrences are excoriation of new skin and bleeding of skin. Allergic: Rash itching, facial edema, swelling, hive, blisters, erythema, and eosinophilia. Respiratory: Tachypnea or hyperventilation, decrease in arterial pCO 2 . Metabolic: Acidosis, increase in serum chloride. Accidental ingestion of SULFAMYLON Cream has been reported to cause diarrhea. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.