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Pharmacokinetics of isepamicin in paediatric patients
F Scaglione1, A Viganò, R Colucci
1Department of Pharmacology, University of Milan, Italy.
Insights
Isepamicin dosing is pharmacokinetically appropriate for pediatric patients. Neonates under 16 days require once-daily dosing, while older children benefit from twice-daily administration.
Area of Science:
- Pharmacology
- Pediatric Medicine
- Clinical Pharmacy
Background:
- Isepamicin is an aminoglycoside antibiotic used in treating bacterial infections.
- Understanding its pharmacokinetic profile in pediatric populations is crucial for safe and effective dosing.
Purpose of the Study:
- To evaluate the pharmacokinetics of isepamicin in pediatric patients across different age groups.
- To determine appropriate dosing regimens for neonates and older children.
Main Methods:
- Pharmacokinetic analysis of isepamicin in 50 pediatric patients (newborn to 13 years).
- Patients were divided into four age groups with varying dosing frequencies.
- Plasma samples were collected at multiple time points post-administration.
Main Results:
- Isepamicin exhibited similar pharmacokinetic profiles in children aged 16 days to 13 years compared to adults.
- Neonates (up to 16 days) showed a distinct profile with a larger AUC, longer half-life, lower Cmax, and reduced clearance.
- The drug was well-tolerated across all pediatric age groups.
Conclusions:
- A once-daily 7.5 mg/kg dose of isepamicin is suitable for neonates (<16 days).
- A twice-daily 7.5 mg/kg dose is pharmacokinetically appropriate for children aged 16 days to 13 years.
- Isepamicin demonstrates good tolerability in pediatric patients.
Abstract:
The pharmacokinetics of isepamicin were evaluated in 50 paediatric patients ranging from newborn to 13 years old. Children with subdivided according to age: Group I (6-13 years); Group II (4 months to 6 years); Group III (16 days to 4 months); and Group IV (newborn to 16 days). All patients received isepamicin 7.5 mg/kg every 12 hours except those in Group IV who received 7.5 mg/kg once daily. Isepamicin was administered initially as an intravenous 30-minute infusion and then either intravenously or intramuscularly for between 4 and 12 days. Plasma samples were obtained after the first or second dose on day 1 at 0, 0.5, 1, 4, 6, 8 and 12 hours after the initiation of dosing and at 0.5 and 12 hours on other dosing days. Additional samples were collected in the Group IV patients at 18, 20 and 24 hours. Isepamicin showed a similar plasma concentration-time profile in Groups I, II and III (children from 16 days to 13 years), and in these groups the profile was generally similar to that observed in adults. Neonates up to the age of 16 days (Group IV) showed a distinctly different pharmacokinetic profile: a significantly larger AUC, longer half-life, lower Cmax and lower total body clearance. Isepamicin 7.5 mg/kg administered once daily to children less than 16 days old and twice daily to children aged 16 days to 13 years appears to be pharmacokinetically appropriate. The drug was very well tolerated by children of all age groups.