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Once-a-day individualized amikacin dosing for suspected infection at birth based on population pharmacokinetic models
J M Labaune1, N Bleyzac, P Maire
1Department of Neonatology, Debrousse Hospital, Cl. Bernard University, Lyon, France.
Insights
Individualized amikacin dosing for neonates is crucial due to pharmacokinetic variability. A new dosing chart, based on gestational age and weight, helps achieve target serum levels for treating neonatal infections effectively.
Area of Science:
- Neonatal pharmacology
- Pediatric infectious diseases
- Clinical pharmacokinetics
Background:
- Amikacin is essential for neonatal infections, but dosage is challenging due to high inter-individual pharmacokinetic variability.
- Current dosing regimens lack precise definition for neonates, impacting treatment efficacy and safety.
Purpose of the Study:
- To develop and validate an individualized, goal-oriented amikacin dosage regimen for neonates within the first 48 hours of life.
- To improve achievement of target amikacin serum concentrations in this vulnerable population.
Main Methods:
- Population pharmacokinetic data and USCPACK software were utilized to design a once-daily dosing chart.
- The chart stratifies dosage by gestational age and body weight for neonates under 2 days old.
- Prospective validation was conducted in 57 neonates across three gestational age groups.
Main Results:
- Target peak amikacin serum levels were achieved in 62-80% of neonates after the first dose and 80-100% after the second dose.
- 100% of neonates achieved target trough amikacin concentrations.
- The dosing chart demonstrated effectiveness in guiding appropriate amikacin administration.
Conclusions:
- Individualization of amikacin dosage regimens is necessary for neonates.
- The developed dosing chart provides a practical tool for optimizing amikacin therapy in early neonatal life.
- This approach enhances the likelihood of achieving therapeutic drug concentrations and improving treatment outcomes.
Abstract:
Amikacin is widely used in the treatment of suspected or confirmed neonatal infections. However, dosage regimens are not well defined in this group of patients because of a wide inter-individual pharmacokinetic variability. An individualized goal-oriented amikacin dosage design was applied using population pharmacokinetic data. A dosing chart was developed for neonates during the first 2 days of life, by using population pharmacokinetic parameter values and USCPACK software. This dosing chart based on gestational age (GA) and body weight gives a once-a-day amikacin dosage regimen involving an injection every 24 h. Validation was performed in 57 neonates less than 2 days old, divided into three GA groups and prospectively treated using the dosing chart. Target peak serum levels of amikacin were obtained in 62-80% of patients after the first dose and in 80-100% after the second dose, and trough concentrations were obtained in 100%. This study has confirmed the need for individualization of amikacin dosage regimens in neonates.