Premium
Pharmacokinetics of rofecoxib in children
Author(s) -
Edwards D. J.,
Prescilla R. P.,
Fratarelli D. A.,
Haritos D.,
Aranda J. V.
Publication year - 2004
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1016/j.clpt.2003.11.276
Subject(s) - rofecoxib , medicine , pharmacokinetics , half life , anesthesia , clinical pharmacology , renal function , oral administration , pharmacology , cyclooxygenase , biochemistry , chemistry , enzyme
Rofecoxib is a selective COX‐2 inhibitor approved for pain control and the treatment of arthritis in adults. There are no published pharmacokinetic data in children. We investigated the disposition of rofecoxib in children with sickle cell hemoglobinopathy admitted for pain episodes. Subjects (5 males, 3 females) aged 3 to 14 years (mean 8.9 years) with normal liver and kidney function received a single oral dose of rofecoxib (1 mg/kg, maximum 50 mg) as a suspension. The mean dose was 35.6 mg (range 15–50 mg). Blood samples were collected for up to 72 hours following drug administration and plasma assayed for rofecoxib using HPLC. Peak concentrations of rofecoxib averaged 582±129 ng/mL with a median t max of 4.0 hours. Two subjects were discharged at 12 hours and subsequent blood samples were not obtained preventing characterization of elimination. In the remaining 6 subjects, oral clearance (Cl/F) averaged 1.32±0.35 mL/min/kg with an elimination half‐life of 14.8±4.5 hours. The results are consistent with studies in adults reporting clearance to be ~120 mL/min with a half‐life of 17 hours and suggest that rofecoxib disposition is similar in children and adults. Clinical Pharmacology & Therapeutics (2004) 75 , P73–P73; doi: 10.1016/j.clpt.2003.11.276