Are Dosing Adjustments Required for Colchicine in

Authors: Suman Wason Robert D Faulkner Matthew W Davis

Publish Date: 2012/06/29

Volume: 29, Issue: 6, Pages: 551-561

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Abstract

The objective of this study was to compare the relative bioavailability of the US Food and Drug Administrationapproved formulation of colchicine after a single 06 mg dose in young 18–30 years of age and elderly ≥60 years of age healthy subjects to determine whether dosing adjustments are required in elderly patientsA singledose singledrug parallelgroup study was performed in 20 young subjects with normal renal function defined as creatinine clearance CrCl ≥80 mL/min and 18 elderly subjects with normal or mild renal impairment CrCl ≥50 mL/min in otherwise good health Blood samples were collected for up to 72 hours postdose and analyzed for colchicine using a validated liquid chromatography/tandem mass spectrometry method Noncompartmental pharmacokinetic parameters were compared using analysis of variance methodsThere were no statistically significant P 005 differences in mean colchicine pharmacokinetic parameters between young and elderly subjects including peak plasma concentration C max 253 vs 256 ng/mL time to C max 125 vs 125 hours area under the plasma concentrationtime curve to infinity 2229 vs 2501 ng/h/mL elimination halflife 254 vs 301 hours oral clearance 040 vs 035 L/h/kg and apparent volume of distribution 143 vs 148 L/kg respectivelyThe lack of any significant differences in colchicine pharmacokinetic parameters between young and elderly healthy subjects with some of the latter including mild renal impairment suggests that dose modification of colchicine may not be necessary in healthy elderly patients However when evaluating the use of colchicine dosing in an elderly patient the confounding effect on overall exposure and safety from comorbid conditions the use of concomitant medications and the administration of multiple doses should be consideredThis article is published under an open access license Please check the Copyright Information section for details of this license and what reuse is permitted If your intended use exceeds what is permitted by the license or if you are unable to locate the licence and reuse information please contact the Rights and Permissions team

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