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Pharmacokinetics of tacrolimus ointment after single and repeated treatment in pediatric atopic dermatitis

Pharmacokinetics of tacrolimus ointment after single and repeated treatment in pediatric atopic dermatitis

 
 

The pharmacokinetic profile of tacrolimus ointment 0.03% after 1 and 14 days of topical application in 53 infants (aged 3-24 months) with atopic dermatitis (AD) was determined. Patients were stratified according to the body surface area (BSA) affected (5-20%; 20-40% and >40%) and randomized to once- or twice-daily applications. The majority of blood samples (97%) contained < 1 ng/ml tacrolimus and 20% were below the lower limit of detection (0.025 ng/ml). The area under the curve (AUC) increased with increasing BSA. The mean half-life was 80 h (range 25-175 h). There were no clinically significant changes in laboratory values, and adverse events mainly comprised minor infections and local skin irritation. Thus ...

 
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