title: Pharmacokinetics of colchicine in pediatric and adult patients with familial Mediterranean fever.
abstract: This study sought to determine the appropriate starting dose of colchicine in children aged 2 to 4 years with familial Mediterranean fever (FMF) based on steady-state pharmacokinetics in pediatric patients with FMF from 2 to less than 16 years and adult patients with FMF from 16 to 65 years. Outpatients received colchicine for 90 days starting with a fixed dose for 14 days (blood sampling days 14 and 15). After starting doses of colchicine (0.6 mg/day [2 to less than 4 years], 0.9 mg/day [from 4 to less than 6 years], 0.9 mg/day [from 6 to less than 12 years], 1.2 mg/day [from 12 to less than 16 years], and 1.2 mg/day [from 16 to less than 65 years]), the observed steady-state pharmacokinetic parameters were comparable across age groups, despite the higher doses of colchicine on a mg/kg/day basis in the younger age groups. An exception occurred with once-daily colchicine, whereby mean Cmax for colchicine was higher in patients 4 to less than 6 years (9.4 ng/mL) compared with the younger and older age groups (6.1-6.7 ng/mL). Mean AUC0?24h values in children 2 to less than 4, 6 to less than 12, and 12 to less than 16 years were similar to those in adults. However, mean AUC0?24h values in children 4 to less than 6 years were 25 percent higher than those observed in adults. The results show that the recommended starting dose for children 2-4 years and 4-6 years should be 0.6 mg/day (half the US adult dose). Children aged 6 to less than 12 years should receive 0.9 mg/day (i.e. three-quarters of the US adult dose). The safety of colchicine in children 2 to less than 4 years was comparable to that in older children and adults.
authors.forename: Y
authors.initials: Y
authors.lastname: Berkun
authors.forename: S
authors.initials: S
authors.lastname: Wason
authors.forename: R
authors.initials: R
authors.lastname: Brik
authors.forename: Y
authors.initials: Y
authors.lastname: Butbul
authors.forename: E
authors.initials: E
authors.lastname: Ben-Chetrit
authors.forename: P J
authors.initials: PJ
authors.lastname: Hashkes
authors.forename: A
authors.initials: A
authors.lastname: Livneh
authors.forename: S
authors.initials: S
authors.lastname: Ozen
authors.forename: H
authors.initials: H
authors.lastname: Ozdogan
authors.forename: R
authors.initials: R
authors.lastname: Faulkner
authors.forename: M W
authors.initials: MW
authors.lastname: Davis
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002675:Child, Preschool; D003078:Colchicine / Q000008:administration & dosage / Q000009:adverse effects / Q000493:pharmacokinetics*; D010505:Familial Mediterranean Fever / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged
chemical_list: D003078:Colchicine