Sulfamylon Cream

WARNINGS

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

PRECAUTIONS

SULFAMYLON and Its metabolite, p-carboxybenzenesulfonamlde, 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 (mafenide acetate cream) have also been reported to manifest an unexplained syndrome of marked hyperventilation with resulting respiratory alkalosis (slightly alkaline blood pH, low arterial pC02 and decreased total CO2); change in arterial p02 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 (mafenide acetate 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 Category C

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 (mafenide acetate 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.)

Last reviewed on RxList: 7/17/2008
This monograph has been modified to include the generic and brand name in many instances.

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