Single-dose and steady-state pharmacokinetics of celecoxib in children
Abstract
BACKGROUND AND OBJECTIVE: Celecoxib is a member of a novel group of agents that selectively inhibit cyclooxygenase 2 (COX-2). COX-2 inhibitors have emerged as an important class of drugs because of the lower incidence of side effects when compared with traditional nonsteroidal anti-inflammatory drugs, which inhibit both cyclooxygenase 1 and COX-2. Because children often differ from adults with respect to drug disposition, the objective of this study was to determine the single-dose and steady-state pharmacokinetics of celecoxib in pediatric patients.
METHODS: Celecoxib plasma concentrations were determined at intervals over 12 hours after a 250-mg/m(2) dose and again 1 week later after twice-daily dosing (steady state).
RESULTS: Peak plasma concentrations (1234 +/- 528 microg/L) were achieved 3 hours after drug administration. The area under the celecoxib plasma concentration-time curve was 7709 +/- 3176 microg/L x h, the elimination half-life (t(1/2)) was 3.7 +/- 1.1 hours, the apparent volume of distribution was 7.9 +/- 7.8 L/kg, and the lower oral clearance of the drug was 1.4 +/- 1.0 L x h(-1) x kg(-1). Statistical analysis revealed a significantly lower [corrected] apparent oral clearance and longer t(1/2) (P <.05) at steady state compared with pharmacokinetics after a single dose. In addition, when the results were compared in children and adults, the drug was cleared approximately twice as fast in children and had a t(1/2) that was approximately half as long.…
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Evidence Hub reads this as a clinical trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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