Absorption and efficacy of miconazole nitrate 0.25% ointment in infants with diaper dermatitis.
BACKGROUND
The potential for toxicity from systemic absorption of topical miconazole in infants is a concern.


OBJECTIVE
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
Systemic absorption of 0.25% miconazole nitrate ointment was minimal, demonstrating its safety in the treatment of moderate to severe diaper dermatitis.
Eichenfield
Lawrence F
LF
Rady Children's Hospital-San Diego, CA 92123-4204, USA. TVBECK@CHSD.org
Bogen
Melissa L
ML
D000935:Antifungal Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D003963:Diaper Rash / Q000188:drug therapy* / Q000209:etiology / Q000378:metabolism; D005260:Female; D005767:Gastrointestinal Diseases / Q000150:complications; D006801:Humans; D007223:Infant; D008297:Male; D008825:Miconazole / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D009824:Ointments; D012720:Severity of Illness Index; D012869:Skin Absorption; D016896:Treatment Outcome
D000935:Antifungal Agents; D009824:Ointments; D008825:Miconazole