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Pharmacokinetics of azithromycin in pediatric patients with acute otitis media
M C Nahata1, K I Koranyi, D R Luke
1College of Pharmacy, Ohio State University, Columbus 43210, USA.
Insights
This study characterized azithromycin pharmacokinetics in children with acute otitis media. Once-daily dosing achieved sustained serum concentrations, suggesting effective treatment against common pathogens.
Area of Science:
- Pediatric Pharmacology
- Infectious Diseases
- Pharmacokinetics
Background:
- Acute otitis media (AOM) is common in children.
- Azithromycin is frequently prescribed for AOM.
- Understanding azithromycin pharmacokinetics in children is crucial for optimizing treatment.
Purpose of the Study:
- To characterize the pharmacokinetics of azithromycin following oral administration of multiple doses in suspension.
- To evaluate azithromycin serum concentrations and elimination half-life in pediatric patients with AOM.
Main Methods:
- Thirteen children aged 7.5 months to 5 years with AOM received azithromycin orally.
- A 10 mg/kg dose on day 1, followed by 5 mg/kg daily on days 2-5.
- Serum azithromycin concentrations were measured using high-performance liquid chromatography-mass spectrometry after overnight fasting on day 5.
Main Results:
- Mean maximum serum concentration (Cmax) was 224 +/- 120 ng/ml.
- Mean time to Cmax was 1.8 +/- 0.4 hours.
- Mean elimination half-life was 31.6 +/- 6.6 hours.
- Sustained serum concentrations were observed up to 72 hours post-dose.
Conclusions:
- Once-daily oral azithromycin administration in children with AOM leads to sustained systemic exposure.
- The studied dosage regimen is likely to maintain drug concentrations above the minimum inhibitory concentrations (MICs) for common pathogens.
- This supports the efficacy of azithromycin for treating pediatric acute otitis media.
Abstract:
The objective of our study was to characterize the pharmacokinetics of azithromycin after the oral administration of multiple doses in suspension to children with acute otitis media. Thirteen children (ranging in age from 7.5 months to 5 years) received a single oral dose of 10 mg of azithromycin per kg of body weight on day 1 followed by single daily doses of 5 mg/kg on days 2 to 5. Each child fasted overnight before receiving the final dose on day 5. Multiple blood samples were collected after the last dose. Concentrations of azithromycin in serum were measured by a specific high-performance liquid chromatography-mass spectrometry method. The means and standard deviations for the maximum concentration of azithromycin in serum, the time to maximum concentration of azithromycin in serum, the area under the concentration-time curve (from 0 to 24 h), and the elimination half-life were 224 +/- 120 ng/ml, 1.8 +/- 0.4 h, 1,841 +/- 651 ng.h/ml, and 31.6 +/- 6.6 h, respectively. Concentrations in serum (means +/- standard deviations) at 0 h (predose) and at 24, 48, and 72 h after the final dose were 51 +/- 26, 47 +/- 21, 27 +/- 17, and 17 +/- 13 ng/ml, respectively. Thus, the once-daily administration of azithromycin resulted in sustained systemic exposure to the drug. The drug dosage regimen used in this study should lead to tissue drug concentrations exceeding the MICs for common pathogens.