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Population Pharmacokinetics of Moxifloxacin in Children
Rachel G Greenberg1,2, Cornelia B Landersdorfer3, Nazario Rivera-Chaparro4
1Duke Clinical Research Institute, Duke University School of Medicine, 300 W. Morgan St, Durham, NC, 27701, USA. rachel.greenberg@duke.edu.
Background/Objective:
Moxifloxacin is a fluoroquinolone that is commonly used in adults, but not children. Certain clinical situations compel pediatric clinicians to use moxifloxacin, despite its potential for toxicity and limited pharmacokinetics (PK) data. Our objective was to further characterize the pharmacokinetics of moxifloxacin in children.
Methods:
We performed an opportunistic, open-label population PK study of moxifloxacin in children < 18 years of age who received moxifloxacin as part of standard care. A set of structural PK models and residual error models were explored using nonlinear mixed-effects modeling. Covariates with known biological relationships were investigated for their influence on PK parameters.
Results:
We obtained 43 moxifloxacin concentrations from 14 participants who received moxifloxacin intravenously (n = 8) or orally (n = 6). The dose of moxifloxacin was 10 mg/kg daily in participants ≤ 40 kg and 400 mg daily in participants > 40 kg. The population mean clearance and mean volume of distribution were 18.2 L/h and 167 L, respectively. The oral absorption was described by a first-order process. The estimated extent of oral bioavailability was highly variable (range 20-91%). Total body weight was identified as a covariate on clearance and volume of distribution, and substantially reduced the random unexplained inter-individual variability for both parameters. No participants experienced suspected serious adverse reactions related to moxifloxacin.
Conclusion:
These data add to the existing literature to support use of moxifloxacin in children in certain situations; however, further prospective studies on the safety and efficacy of moxifloxacin are needed.
Insights
This study characterized moxifloxacin pharmacokinetics in children, finding total body weight influences drug clearance and distribution. These findings support cautious use in pediatric patients when necessary.
Area of Science:
- Pediatric pharmacology
- Antibiotic pharmacokinetics
- Drug safety in children
Background:
- Moxifloxacin, a fluoroquinolone, is not typically used in children due to toxicity concerns and limited pharmacokinetic data.
- Clinical scenarios necessitate moxifloxacin use in pediatric patients, highlighting a need for better understanding of its behavior in this population.
Purpose of the Study:
- To characterize the pharmacokinetics (PK) of moxifloxacin in pediatric patients.
- To identify factors influencing moxifloxacin PK parameters in children.
Main Methods:
- An open-label, population PK study was conducted in pediatric patients (<18 years) receiving moxifloxacin.
- Nonlinear mixed-effects modeling was used to analyze moxifloxacin concentrations and explore PK models.
- Covariates, including total body weight, were investigated for their impact on PK parameters.
Main Results:
- Data from 14 pediatric participants (43 concentrations) were analyzed.
- Population mean clearance was 18.2 L/h and mean volume of distribution was 167 L.
- Total body weight was a significant covariate for clearance and volume of distribution, reducing inter-individual variability. Oral bioavailability was highly variable (20-91%). No serious adverse reactions were reported.
Conclusions:
- The study provides valuable PK data to support the judicious use of moxifloxacin in children in specific clinical situations.
- Further prospective research is recommended to evaluate the safety and efficacy of moxifloxacin in pediatric populations.
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