Document Detail

The pharmacokinetics of tacrolimus after first and repeated dosing with 0.03% ointment in infants with atopic dermatitis.
MedLine Citation:
PMID:  19335418     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: In adults and children aged > 2 years, systemic absorption of tacrolimus from tacrolimus ointment is very low. In this study, the pharmacokinetics of tacrolimus 0.03% ointment were investigated in infants aged 3-24 months. METHODS: The pharmacokinetics of tacrolimus after first and repeated topical application of tacrolimus 0.03% ointment were evaluated in 53 infants (age, 3-24 month) with atopic dermatitis requiring treatment with mid-potency topical corticosteroids. Patients were grouped according to percentage of body surface area affected (Group 1: 5-20%; Group 2: > 20-40%; Group 3: > 40%). After stratification, patients were randomized (double-blind) to receive once-daily or twice-daily tacrolimus 0.03% ointment. RESULTS: Blood samples taken on days 1 and 14 (first and last application) showed minimal systemic tacrolimus exposure. Overall, 97% of blood samples assayed contained tacrolimus concentrations < 1 ng/ml, and 20% were below the lower limit of quantification (0.025 ng/ml). Systemic tacrolimus exposure was variable, but tended to increase as the treated body surface area increased. Mean apparent half-life of tacrolimus was 80 +/- 35 h (range: 25-175 h). Most patients experienced substantial clinical improvement in their atopic dermatitis. There were no clinically significant changes in laboratory values, and the most frequently reported adverse events were minor infections and local skin irritations. CONCLUSIONS: Tacrolimus 0.03% ointment in infants is associated with very low systemic exposure to tacrolimus. Treatment was well tolerated and led to considerable clinical improvement.
Sakari Reitamo; Johanna Mandelin; Andris Rubins; Anita Remitz; Mika Mäkelä; Kristine Cirule; Silvestrs Rubins; Sanita Zigure; Vincent Ho; James Dickinson; Nasrullah Undre
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  International journal of dermatology     Volume:  48     ISSN:  1365-4632     ISO Abbreviation:  Int. J. Dermatol.     Publication Date:  2009 Apr 
Date Detail:
Created Date:  2009-04-01     Completed Date:  2009-07-13     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0243704     Medline TA:  Int J Dermatol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  348-55     Citation Subset:  IM    
Department of Dermatology, Helsinki University Hospital, Helsinki, Finland.
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MeSH Terms
Administration, Topical
Dermatitis, Atopic / drug therapy*
Follow-Up Studies
Immunosuppressive Agents / administration & dosage*,  adverse effects,  pharmacokinetics*
Tacrolimus / administration & dosage*,  adverse effects,  pharmacokinetics*
Treatment Outcome
Reg. No./Substance:
0/Immunosuppressive Agents; 0/Ointments; 109581-93-3/Tacrolimus

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