Absorption and efficacy of miconazole nitrate 0.25% ointment in infants with diaper dermatitis
Eichenfield, L.F.; Bogen, M.L.
Journal of Drugs in Dermatology Jdd 6(5): 522-526
2007
ISSN/ISBN: 1545-9616 PMID: 17679187 Document Number: 10691
The potential for toxicity from systemic absorption of topical miconazole in infants is a concern. To assess the relative safety of 0.25% miconazole based on the amount absorbed through the skin of infants with diaper dermatitis after multiple applications. Of 24 infants with moderate to severe diaper dermatitis, 19 received 0.25% miconazole nitrate ointment and 5 received 2% miconazole nitrate cream for 7 days at each diaper change and after bathing. Blood samples were collected prior to treatment and after 7 days. In the 0.25% treatment group, blood concentrations of miconazole were nondetectable (< 1 ng/mL) in 83% (15/18) and minimal (3.0 to 3.8 ng/mL) in 17% (3/18). Samples were missing for one patient. For the 5 infants in the 2% treatment group, miconazole concentration was nondetectable in 20% (1/5) and less than 7.4 ng/mL in 4 infants. No adverse events were noted. Systemic absorption of 0.25% miconazole nitrate ointment was minimal, demonstrating its safety in the treatment of moderate to severe diaper dermatitis.
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