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[Studies of rokitamycin in pediatrics]
1Department of Pediatrics, Meitetsu Hospital.
Insights
Administering rokitamycin (RKM) dry syrup to children before meals resulted in higher plasma concentrations compared to post-meal administration. This suggests optimal absorption and dosing for pediatric macrolide antibiotic therapy.
Area of Science:
- Pharmacology
- Pediatric Medicine
- Infectious Diseases
Context:
- Macrolide antibiotics are crucial for treating pediatric infections.
- Understanding drug absorption is vital for effective pediatric dosing.
- Rokitamycin (RKM) is a new macrolide antibiotic for pediatric use.
Purpose:
- To evaluate the pharmacokinetics of rokitamycin (RKM) dry syrup in children.
- To compare RKM absorption when administered before versus after meals.
- To establish optimal dosing guidelines for pediatric rokitamycin therapy.
Summary:
- Five children (6-10 years) received RKM (10 mg/kg) orally before or after meals in a crossover design.
- Plasma concentrations and urinary excretion of RKM were measured.
- Higher RKM plasma concentrations and absorption were observed when administered before meals, similar to adult tablet administration.
Impact:
- Findings suggest that administering RKM before meals optimizes absorption in children.
- Recommends a dosing regimen of 10 mg/kg three times daily on an empty stomach for pediatric patients.
- Provides evidence-based guidance for pediatric rokitamycin prescription and use.
Abstract:
Pharmacokinetic, bacteriological and clinical studies on a new macrolide antibiotic, rokitamycin (RKM) dry syrup for pediatric use, were done, and results as summarized below were observed: 1. Five children with ages between 6 and 10 years were administered orally with RKM at a dose level of 10 mg/kg either at 30 minutes before or 30 minutes after meal on a crossover design, and plasma concentrations and urinary excretion rates of the drug were measured. Plasma concentrations of RKM following the administration before meal were 0.50 microgram/ml at 1/2 hour, 0.43 microgram/ml at 1 hour, 0.15 microgram/ml at 2 hours, 0.03 microgram/ml at 4 hours, and not detectable at 6 hours. Plasma concentrations following the administration after meal were 0.11 microgram/ml at 1/2 hour, 0.15 microgram/ml at 1 hour, 0.09 microgram/ml at 2 hours, 0.03 microgram/ml at 4 hours, and not detectable at 6 hours. The 0-6 hour urinary recovery rates were 1.41% following the administration before meal, and 0.93% following the administration after meal. These results suggested that the drug might be absorbed more rapidly, giving a higher plasma concentration, when administered before meal than when administered after meal. Changes in plasma concentrations of RKM following the administration of 10 mg/kg before meal were similar to those of two 100 mg RKM tablets (TMS-19-Q.GC tablets) to adult patients. Therefore, it seemed optimal to administer 10 mg/kg 3 times daily at fasting to children as a rule.(ABSTRACT TRUNCATED AT 250 WORDS)