Pharmacokinetics Of Colchicine In Pediatric And Adult Patients With Familial Mediterranean Fever
Hashkes, P. J.
Davis, M. W.
xmlui.mirage2.itemSummaryView.MetaDataShow full item record
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 >= 2 to <16 years and adult patients with FMF >= 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 <4 years], 0.9 mg/day [>= 4 to <6 years], 0.9 mg/day [>= 6 to <12 years], 1.2 mg/day [>= 12 to <16 years], and 1.2 mg/day [>= 16 to <= 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 C-max for colchicine was higher in patients 4 to <6 years (9.4 ng/mL) compared with the younger and older age groups (6.1-6.7 ng/mL). Mean AUC(0_24h) values in children 2 to <4, 6 to <12, and 12 to <16 years were similar to those in adults. However, mean AUC(0_24h) values in children 4 to <6 years were 25% 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 <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 <4 years was comparable to that in older children and adults.