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Pharmacokinetics of amikacin in infants and pre-school children
Insights
This study on amikacin sulfate in young patients found that a 7.5 mg/kg dose every 12 hours is safe and effective. Pharmacokinetic analysis confirmed predictable levels and no accumulation in infants and children.
Area of Science:
- Pharmacology
- Pediatric Medicine
- Clinical Pharmacy
Background:
- Amikacin sulfate is a crucial antibiotic for treating bacterial infections in pediatric populations.
- Understanding amikacin sulfate pharmacokinetics is essential for optimizing pediatric dosing and ensuring therapeutic efficacy.
- Limited pharmacokinetic data exists for amikacin sulfate in infants and young children.
Purpose of the Study:
- To investigate the pharmacokinetic properties of amikacin sulfate in infants and children.
- To evaluate the safety and efficacy of a specific amikacin sulfate dosage regimen in pediatric patients.
- To analyze amikacin sulfate serum concentrations, half-life, and urinary excretion in the studied age groups.
Main Methods:
- Studied pharmacokinetic properties of amikacin sulfate in infants and children (3 weeks to 6 years).
- Administered 7.5 mg/kg doses every 12 hours via intramuscular and intravenous routes.
- Utilized standard assay methods and two-compartment open model kinetic analysis for serum concentration and half-life determination.
Main Results:
- Peak serum concentrations of amikacin sulfate varied by administration route and age group.
- Mean serum half-lives were approximately 2.0-2.2 hours, indicating efficient drug clearance.
- Urinary recovery ranged from 34.5-65% (IM) and 45.8-63.3% (IV) within 12 hours, with no observed accumulation after four days.
Conclusions:
- The dosage regimen of 7.5 mg/kg every 12 hours for amikacin sulfate is deemed safe and effective for infants and children.
- Pharmacokinetic parameters suggest predictable drug behavior and minimal risk of accumulation in pediatric patients.
- This study provides valuable pharmacokinetic insights supporting the use of amikacin sulfate in pediatric infectious disease management.
Abstract:
The pharmacokinetic properties of amikacin sulfate in infants and children aged from three weeks to 6 years were studied during treatment with doses of 7.5 mg/kg every 12 hours using standard assay methods and technique of two compartment open model kinetic analysis. Peak serum concentrations of amikacin were measured 30 or 60 min after the first intramuscular injection. These ranged from 11.8 microgram/ml to 23 microgram/ml in infants and from 9.0 microgram/ml to 29 microgram/ml in children. Five minutes after the first intravenous bolous injection they varied from 16 microgram/ml to 29.8 microgram/ml in infants and from 34 microgram/ml to 42 microgram/ml in children. Twelve hours after injection serum concentrations were less than 0.8 microgram/ml in all patients. Mean serum half-lives of amikacin in infants and children were 2.1 hours and 2.0 hours after intramuscular, and 2.2 and 2.0 hours after intravenous administration respectively. No evidence of accumulation was observed after four days treatment. The amount of antibiotic recovered within 12 hours from the urine in all patients ranged from 34.5 to 65% of an intramuscular dose, and from 45.8 to 63.3% of an intravenous dose. The dosage regime of 7.5 mg/kg body weight given every 12 hours should be safe and effective for the treatment of infections in the age groups studied.