PREGNANCY RECOMMENDATION: No Human Data—Probably Compatible
BREASTFEEDING RECOMMENDATION: No Human Data—Potential Toxicity
No reports describing the use of mafenide during human pregnancy have been located. The cream formulation is absorbed into the systemic circulation and exposure of the embryo–fetus probably occurs. The anti-infective did not cause fetal toxicity in the only animal species tested. Although the mechanism of action is different from the sulfonamides, it is closely related to that class of agents (see also Sulfonamides). Because of its indication for severe burns, it should not be withheld because of pregnancy.
FETAL RISK SUMMARY
Mafenide is an anti-infective available as a topical 11.2% cream or 5% solution. The cream is indicated for adjunctive therapy of patients with second- and third-degree burns. The solution is indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds. The mechanism of action of mafenide is not known but is different from the sulfonamides. In addition, it is not known if there is cross-sensitivity to other sulfonamides. (See also Sulfonamides.) The cream formulation is absorbed into the systemic circulation where the agent is converted to an inactive metabolite. Peak blood concentrations ranged from 26 to 197 mcg/mL 2 hours after application (1,2).
A reproduction study has been conducted in rats. In pregnant rats given oral doses of mafenide up to 600 mg/kg/day, no evidence of fetal harm was observed. No animal studies evaluating the potential for carcinogenicity or for effects on fertility have been conducted. However, the drug was not mutagenic in one assay (1).
It is not known if mafenide crosses the human placenta. The molecular weight of the free base (about 186) is low enough that passage to the embryo–fetus should be expected.
No reports describing the use of mafenide during human lactation have been located. The molecular weight of the free base (about 186) is low enough that excretion into breast milk should be expected. Although the mechanism of action is different from the sulfonamides, it is closely related to that class of agents (see also Sulfonamides). Mafenide and its metabolite inhibit carbonic anhydrase, which has caused metabolic acidosis in patients treated with the drug. Hemolytic anemia, presumably related to glucose-6-phosphate dehydrogenase deficiency, has also been reported during treatment. Because the indications for this agent suggest long-term exposure from milk that could increase the possibility of toxicity, nursing is best avoided if the mother requires treatment.
1.Product information. Sulfamylon. Mylan Pharmaceuticals, 2008.
2.Product information. Sulfamylon Cream. Mylan Pharmaceuticals, 2007.