Related Experiment Videos
[Pharmacokinetic, bacteriological and clinical studies on azithromycin in children]
1Department of Pediatrics, Teikyo University School of Medicine.
Insights
This study evaluated azithromycin (AZM) in children, finding it effective for various microbial infections with a favorable safety profile. Pharmacokinetic data showed a long elimination half-life, suggesting sustained therapeutic levels.
Area of Science:
- Pharmacology and Therapeutics
- Pediatric Infectious Diseases
Context:
- Azithromycin (AZM) is a widely used antibiotic, but its pharmacokinetic and clinical profile in young children requires ongoing investigation.
- Fine granular formulations may offer advantages in pediatric drug administration.
- Evaluating efficacy across diverse pediatric microbial infections is crucial for treatment guidelines.
Purpose:
- To assess the pharmacokinetics and clinical efficacy of fine granular azithromycin in pediatric patients.
- To determine the safety and tolerability of azithromycin in children aged 1 month to 8 years.
- To evaluate the microbial eradication rates and pharmacokinetic parameters (half-life, AUC) of azithromycin.
Summary:
- Eight pediatric patients (1 month-8 years) received azithromycin (10 mg/kg/day for 3 days). Clinical efficacy was rated 'excellent' in 5/8, 'good' in 2/8. Microbial eradication occurred in 2/3 patients.
- Pharmacokinetic analysis revealed an elimination half-life of 45.8 hours and an AUC0-infinity of 12.6 µg·hr/mL. Urinary azithromycin concentration was 35.0 µg/mL between 48-72 hours.
- One patient experienced a mild increase in GPT, with no other adverse reactions reported, indicating a generally safe profile.
Impact:
- Provides valuable pharmacokinetic and efficacy data for azithromycin in a pediatric population.
- Supports the use of fine granular azithromycin for treating various pediatric microbial infections.
- Contributes to evidence-based prescribing of azithromycin in infants and young children.
Abstract:
Azithromycin (AZM) in fine granules was studied for its pharmacokinetics and clinical efficacies in eight child patients with ages between 1 month and 8 years. Informed consent was received from all of their parents. AZM was administered to the patients once a day at a dose of 10 mg/kg for 3 days. The clinical efficacies of AZM in 8 patients with microbial infections (pneumonia in one, Mycoplasma pneumonia in two, acute tonsillitis in one, pertussis in one, Campylobacter enteritis in one, infectious enteritis in one, Salmonella enteritis in one) were evaluated as "excellent" in five cases, "good" in two and "not evaluable" in one. As for the microbial efficacy, isolated strains were eradicated in 2 out of 3 patients. No adverse reaction was found except for one case with abnormal laboratory change, that is mildly increased GPT value. Plasma samples were collected from 3 cases. The elimination half-life of AZM was 45.8 hours. AUC0-infinity was 12.6 micrograms.hr/ml. Urine sample was collected from one. AZM concentration in urine was 35.0 micrograms/ml during a period between 48 and 72 hours after the start of treatment.