![]() Respiratory: Tachypnea or hyperventilation, decrease in arterial pCO 2. Rare occurrences are excoriation of new skin and bleeding of skin.Īllergic: Rash itching, facial edema, swelling, hive, blisters, erythema, and eosinophilia. Fatal hemolytic anemia with disseminated intravascular coagulation, presumably related to a glucose-6-phosphate dehydrogenase deficiency, has been reported following therapy with SULFAMYLON Cream.ĭermatologic: The most frequently reported reaction was pain on application or a burning sensation. A single case of bone marrow depression and a single case of acute attack of porphyria have been reported following therapy with SULFAMYLON Cream. It is frequently difficult to distinguish between an adverse reaction to SULFAMYLON Cream and the effect of a severe burn. 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. It is not known whether mafenide acetate is excreted in human milk. 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. It is also not known whether SULFAMYLON can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. No long-term animal studies have been performed to evaluate the drug’s potential in these areas.Īnimal reproduction studies have not been conducted with SULFAMYLON. However, fungal dissemination through the infected burn wound is rare.Ĭarcinogenesis, Mutagenesis, Impairment of Fertility It is not known whether there is cross sensitivity to other sulfonamides.įungal colonization in and below eschar may occur concomitantly with reduction of bacterial growth in the burn wound. SULFAMYLON Cream should be administered with caution to patients with history of hypersensitivity to mafenide. Mafenide acetate cream should be used with caution in burn patients with acute renal failure. ![]() The etiology and significance of these findings are unknown. 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. 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. In the presence of impaired renal function, high blood levels of SULFAMYLON and its metabolite may exaggerate the carbonic anhydrase inhibition. SULFAMYLON and its metabolite, ρ-carboxybenzenesulfonamide, inhibit carbonic anhydrase, which may result in metabolic acidosis, usually compensated by hyperventilation. SULFAMYLON exerts bacteriostatic action against many gram-negative and gram-positive organisms, including Pseudomonas aeruginosa and certain strains of anaerobes. SULFAMYLON is active in the presence of pus and serum, and its activity is not altered by changes in the acidity of the environment. It should be noted, however, that delayed eschar separation has occurred in some cases.Īpplied topically, SULFAMYLON Cream diffuses through devascularized areas, is absorbed, and rapidly converted to a metabolite (ρ-carboxybenzenesulfonamide) which is cleared through the kidneys. Reduction in bacterial growth after application of SULFAMYLON Cream has also been reported to permit spontaneous healing of deep partial-thickness burns, and thus prevent conversion of burn wounds from partial-thickness to full-thickness. SULFAMYLON Cream, applied topically produces a marked reduction in the bacterial population present in the avascular tissues of second- and third-degree burns.
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