title: Pharmacokinetics of tacrolimus following topical application of tacrolimus ointment in adult and pediatric patients with moderate to severe atopic dermatitis.
abstract: OBJECTIVE
  To characterize the pharmacokinetics of tacrolimus after topical application in adult and pediatric patients with moderate to severe atopic dermatitis from all clinical trials in which tacrolimus blood levels were obtained.
  
  
  METHODS
  Tacrolimus ointment 0.03% or 0.1% was applied twice daily. In the adult and pediatric pharmacokinetic studies, serial blood samples were obtained after single and repeated topical application. During the 12 clinical efficacy trials of tacrolimus ointment, single blood samples were obtained at various times relative to tacrolimus ointment application.
  
  
  RESULTS
  In the pharmacokinetic studies, 89% to 95% of tacrolimus whole blood concentration samples were less than 1 ng/mL; mean maximum concentrations ranged from 0.2 to 1.6 ng/mL and mean area under the blood concentration-time curves (0-12 hours) ranged from 1.4 to 13.1 ng x hr/mL. Likewise, in the clinical efficacy trials, the majority (85%-99%) of tacrolimus concentration samples were less than 1 ng/mL.
  
  
  CONCLUSIONS
  Tacrolimus ointment is associated with minimal systemic absorption and no evidence of systemic accumulation in patients with moderate to severe atopic dermatitis and extensive disease.
authors: University of Utah Health Sciences Center, Salt Lake City, UT 84132, USA. Krueger@derm.med.utah.edu
authors: Gerald G
authors: GG
authors: Krueger
authors: Lawrence
authors: L
authors: Eichenfield
authors: J John
authors: JJ
authors: Goodman
authors: Bernice R
authors: BR
authors: Krafchik
authors: Christopher S
authors: CS
authors: Carlin
authors: Mei-Lin
authors: ML
authors: Pang
authors: Richard
authors: R
authors: Croy
authors: Mary Elizabeth
authors: ME
authors: Holum
authors: Eileen
authors: E
authors: Jaracz
authors: Taiji
authors: T
authors: Sawamoto
authors: James
authors: J
authors: Keirns
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000368:Aged; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D003876:Dermatitis, Atopic / Q000188:drug therapy*; D016903:Drug Monitoring; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009823:Ointment Bases; D009824:Ointments; D010599:Pharmacokinetics; D016559:Tacrolimus / Q000008:administration & dosage / Q000097:blood / Q000493:pharmacokinetics*
chemical_list: D009823:Ointment Bases; D009824:Ointments; D016559:Tacrolimus