FDA label c4a0aa6d-4c2a-464f-9822-57ebc8aeae5c

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

ADVERSE REACTIONS In the clinical setting of severe burns, it is often difficult to distinguish between an adverse reaction to mafenide acetate and burn sequelae. In a clinical study of pediatric patients with acute burns requiring autografts who received SULFAMYLON ® for 5% Topical Solution in addition to double antibiotic solution (DAB) wound therapy (neomycin sulfate 40 mg and polymyxin B 200,000 units/liter), the incidence of rash (4.6%) and itching (2.8%) in the group which received SULFAMYLON ® for 5% Topical Solution was not different from that experienced with (DAB) dressings alone (5.7% and 1.3%, respectively). From other clinical settings, a single case of bone marrow depression and a single case of an acute attack of porphyria have been reported following therapy with mafenide acetate. Fatal hemolytic anemia with disseminated intravascular coagulation, presumably related to a glucose-6-phosphate dehydrogenase deficiency, has been reported following therapy with mafenide acetate. The following adverse reactions have been reported with topical mafenide acetate therapy: Dermatologic and Allergic: Pain or burning sensation, rash and pruritus (often localized to the area covered by the wound dressing), erythema, skin maceration from prolonged wet dressings, facial edema, swelling, hives, blisters, eosinophilia. Respiratory or Metabolic: Tachypnea, hyperventilation, decrease in pCO 2 , metabolic acidosis, increase in serum chloride.