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[Pharmacokinetic and clinical studies with sisomicin in paediatrics (author's transl)]
Insights
Sisomicin, a novel aminoglycoside antibiotic, demonstrated effective pharmacokinetic and clinical outcomes in pediatric patients. Age-adjusted dosing ensured adequate serum concentrations and successful infection treatment with good tolerance.
Area of Science:
- Pharmacology
- Pediatrics
- Infectious Diseases
Context:
- Aminoglycoside antibiotics are crucial for treating serious bacterial infections.
- Sisomicin represents a newer option within this class.
- Pediatric pharmacokinetics often differ significantly from adults, necessitating specific investigations.
Purpose:
- To investigate the pharmacokinetics and clinical efficacy of sisomicin in children.
- To determine appropriate dosing regimens based on age and weight.
- To evaluate the safety and tolerance of sisomicin in pediatric populations.
Summary:
- Pharmakokinetic and clinical studies were conducted on 40 children (seven days to ten years) receiving sisomicin (1.0 mg/kg i.m.).
- Serum concentrations varied by age, with newborns showing delayed renal elimination and smaller distribution volumes.
- Age-adjusted dosing achieved therapeutic serum levels (3.1–6.2 mg/l at 1 hour) over ten days.
- Clinical efficacy was high, with 18/20 children cured and 20/21 pathogens eradicated.
- Sisomicin exhibited good local and systemic tolerance.
Impact:
- Establishes sisomicin as a viable treatment option for pediatric infections.
- Provides evidence for age-specific dosing strategies in children.
- Contributes to the understanding of aminoglycoside pharmacokinetics in pediatric populations.
- Highlights the importance of pharmacokinetic variability in pediatric drug therapy.
Abstract:
Pharmakokinetic and clinical investigations were carried out with sisomicin, one of the newer aminoglycoside antibiotics, in 40 children aged from seven days to ten years. Serum concentrations were determined in 35 children 1/2, 1, 2, 4 and 6 hours after i. m. injection of 1.0 mg sisomicin/kg body weight. The average peak serum levels were 2.48 mg/l in children under three months and 3.58 mg/l in children between seven months and ten years. Renal elimination in newborns is delayed in comparison to older infants and children; the distribution volume of the central compartment diminishes with increasing age. The effect of these two counteracting tendencies is that renal clearance remains constant in the age groups investigated, however the frequency of drug administration must be adjusted according to age. During an average treatment period of ten days adequate serum concentrations between 3.1 mg/l and 6.2 mg/l one hour after injection could be achieved with dosages adjusted to age and body weight. Clinical results were good: 18 out of 20 children could be cured clinically, and 20 out of 21 isolated infectious agents were eliminated. There were no problems in local and systemic tolerance.