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Pharmacokinetics of ibuprofen in febrile children
M C Nahata1, D E Durrell, D A Powell
1College of Pharmacy, Ohio State University, Columbus.
Insights
Ibuprofen is a potential fever reducer for children. This study found that ibuprofen pharmacokinetics were consistent across different doses and ages in pediatric patients, with no adverse effects observed.
Area of Science:
- Pediatric Pharmacology
- Pharmacokinetics
- Drug Safety
Background:
- Acetaminophen is commonly used for pediatric fever, but ibuprofen's pharmacokinetic profile in children is not well-established.
- Limited data exists on ibuprofen's use as an alternative antipyretic in pediatric populations.
Purpose of the Study:
- To investigate the pharmacokinetics of ibuprofen in children aged 3-10 years.
- To evaluate the impact of different ibuprofen dosages (5 mg/kg and 10 mg/kg) on its absorption and elimination in pediatric patients.
- To assess the safety and tolerability of ibuprofen in this age group.
Main Methods:
- A pharmacokinetic study involving 17 pediatric patients (3-10 years) with fever.
- Administration of single oral doses of ibuprofen (5 mg/kg or 10 mg/kg).
- Serial blood sampling over 8 hours, with serum concentrations analyzed using High-Performance Liquid Chromatography (HPLC).
Main Results:
- Ibuprofen serum concentrations varied between 17-42 µg/mL (5 mg/kg) and 25-53 µg/mL (10 mg/kg).
- Pharmacokinetic parameters (tmax, oral clearance, elimination half-life) were similar across both dosage groups and showed no correlation with patient age.
- No adverse events were reported during the study.
Conclusions:
- Ibuprofen pharmacokinetics in children aged 3-10 years appear unaffected by doses ranging from 5 to 10 mg/kg.
- Age does not significantly influence ibuprofen's pharmacokinetic behavior in this pediatric cohort.
- Ibuprofen demonstrates a favorable safety profile for fever management in children within the studied dose range.
Abstract:
Ibuprofen may be an alternative to acetaminophen to control fever in children but little is known about its pharmacokinetics in pediatric patients. We studied 17 patients (age 3-10 yr) with fever; the most prevalent diagnoses were streptococcal pharyngitis and otitis media. Ibuprofen liquid was given as a single dose, 5 mg/kg (9 patients) or 10 mg/kg (8 patients). Multiple blood samples were collected over 8 hours and analyzed by HPLC. The maximum observed serum concentrations of ibuprofen ranged from 17-42 micrograms.ml-1 at 5 mg.kg-1 and 25-53 micrograms.ml-1 at 10 mg.kg-1 doses. Pharmacokinetics did not appear to be affected by ibuprofen dose. Mean tmax, oral clearance and elimination half life were 1.1 h, 1.2 ml.min-1.kg-1, and 1.6 h, respectively in patients at 5 mg.kg-1 doses; the corresponding values were 1.2 h, 1.4 ml.min-1.kg-1, and 1.6 h in those receiving 10 mg.kg-1 doses. There was no relationship between age and ibuprofen kinetics. No adverse effects occurred in any patients. These data suggest that ibuprofen pharmacokinetics may not be affected by dose between 5 and 10 mg/kg or age between 3 and 10 years.
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