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Pharmacokinetics of ketoprofen syrup in small children
H Kokki1, A Le Liboux, A Jekunen
1Department of Anesthesiology and Intensive Care, Kuopio University Hospital, Finland.
Insights
This study determined ketoprofen pharmacokinetics in children aged 6 months to 7 years. Ketoprofen syrup demonstrated rapid absorption and a half-life similar to adults, suggesting predictable dosing in pediatric populations.
Area of Science:
- Pharmacology
- Pediatric Medicine
- Drug Metabolism
Background:
- Ketoprofen, a nonsteroidal anti-inflammatory drug (NSAID), possesses analgesic, anti-inflammatory, and antipyretic properties.
- Limited pharmacokinetic data exists for ketoprofen in young children.
- Understanding pediatric pharmacokinetics is crucial for safe and effective drug administration.
Purpose of the Study:
- To determine the pharmacokinetic profile of ketoprofen syrup in pediatric patients.
- To assess ketoprofen absorption, distribution, metabolism, and excretion in children aged 6 months to 7 years.
- To compare ketoprofen pharmacokinetics between two pediatric age groups.
Main Methods:
- A prospective study involving two groups of 10 children (Group 1: 6 months to 2 years; Group 2: 2 to 7 years).
- Administration of ketoprofen syrup at a dose of 0.5 mg/kg.
- Serial venous blood sampling at predefined intervals (0.5 to 12 hours post-dose).
- Quantification of plasma ketoprofen levels using a validated High-Performance Liquid Chromatography (HPLC) method.
Main Results:
- Ketoprofen syrup was rapidly absorbed, with peak plasma concentrations (Cmax) achieved at 0.5 hours post-administration.
- The mean Cmax was 3 micrograms/ml.
- Pharmacokinetic parameters, including elimination half-life (approximately 2.0 hours in Group 1 and 1.9 hours in Group 2), were similar between the two pediatric groups.
- The observed half-life in children was comparable to that reported in adult populations.
Conclusions:
- Ketoprofen exhibits rapid absorption and a predictable pharmacokinetic profile in children aged 6 months to 7 years.
- The elimination half-life of ketoprofen in pediatric patients is similar to adults, supporting its established dosing guidelines.
- These findings provide valuable pharmacokinetic data for the safe and effective use of ketoprofen in pediatric populations.
Abstract:
Ketoprofen is a nonsteroidal anti-inflammatory drug with analgesic, anti-inflammatory, and antipyretic properties. Its pharmacokinetics has not been determined in small children. The objective here was to determine the pharmacokinetics of ketoprofen syrup, 0.5 mg/kg, in two groups of 10 children. Group 1 was from ages 6 months up to 2 years (7/10 younger than 1 year), and Group 2 was from ages 2 to 7 years. Venous blood samples were collected before drug administration and 0.5, 1, 2, 4, 6, 8, and 12 hours after. A validated HPLC method was used to determine plasma levels of ketoprofen. The lower limit of quantification was 0.02 microgram/ml of plasma. Ketoprofen syrup was absorbed rapidly, the plasma level reaching its maximum at 0.5 hours, with C0.5 hours = 3 micrograms/ml. The pharmacokinetics was similar between the two groups of children. The elimination half-life, 2.0 hours in Group 1 or 1.9 hours in Group 2, was similar to that reported in adults.