Fatal hemolytic anemia with disseminated intravascular coagulation, presumably related to a glucose-6-phosphate dehydrogenase deficiency, has been reported following therapy with mafenide acetate.

General: Mafenide acetate and its metabolite, p-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 mafenide acetate 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 bums and in those with pulmonary or renal dysfunction. Some bum patients treated with mafenide acetate have also been reported to manifest an unexplained syndrome of masked hyperventilation with resulting respiratory alkalosis (slightly alkaline blood pH, low arterial pC02, and decreased total C02); change in arterial p02 is variable. The etiology and significance of these findings are unknown.

Mafenide acetate should be used with caution in bum patients with acute renal failure.

Fungal colonization may occur concomitantly with reduction of bacterial growth in the bum wound. However, systemic fungal infection through the infected bum wound is rare.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

No long-term animal studies have been performed to evaluate the carcinogenic potential of mafenide acetate; however, the drug did not induce mutations in L5178Y mouse lymphoma cells at the TK locus.

Animal studies have not been performed to evaluate the potential effects of mafenide acetate on fertility.

Pregnancy: Teratogenic Effects. Pregnancy Category C: A teratology study performed in rats using oral doses of up to 600 mg/kg/day revealed no evidence of harm to the fetus due to mafenide acetate. There are no adequate data regarding the potential reproductive toxicity of mafenide acetate in a non-rodent species, nor are there adequate and well-controlled studies in pregnant women. Mafenide acetate should be used during pregnancy only if the potential benefit justifies the potential 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 reactions in nursing infants from mafenide acetate, 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: The safety and effectiveness of SULFAMYLON® For 5% Topical Solution have been established in the age groups 3 months to 16 years. Geriatric Use: No studies have been conducted to specifically examine the effects of mafenide acetate on bum wounds in geriatric patients.

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