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Use of chloramphenicol palmitate in neonates
Insights
Oral chloramphenicol palmitate absorption is variable in neonates. Delayed gastric emptying or hydrolysis may cause erratic drug levels, requiring dosage adjustments for preterm infants.
Area of Science:
- Neonatal Pharmacology
- Pharmacokinetics
- Infectious Disease Management
Background:
- Chloramphenicol palmitate is an oral prodrug of chloramphenicol, commonly used for treating serious infections in neonates.
- Neonatal physiology presents unique challenges for drug absorption, distribution, metabolism, and excretion, impacting therapeutic efficacy and safety.
- Understanding the pharmacokinetic variability of chloramphenicol palmitate is crucial for optimizing dosing strategies in this vulnerable population.
Purpose of the Study:
- To investigate the absorption and disposition characteristics of orally administered chloramphenicol palmitate in a cohort of preterm and term neonates.
- To determine the impact of neonatal factors on chloramphenicol serum concentrations, half-life, and urinary excretion.
- To identify potential reasons for observed pharmacokinetic variability, guiding future therapeutic recommendations.
Main Methods:
- Studied oral chloramphenicol palmitate absorption and disposition in seven neonates (four preterm, three term).
- Measured serum chloramphenicol concentrations at various time points post-administration.
- Assessed urinary excretion of chloramphenicol and its glucuronide ester.
Main Results:
- Peak serum chloramphenicol concentrations (5.5–23 µg/ml) were achieved ≥4 hours post-dose at 50 mg/kg/day.
- Preterm neonates required dosage increases from 25 to 50 mg/kg/day for adequate serum levels.
- Apparent half-life was unestimable in 4/7 neonates due to non-declining serum concentrations; observed half-lives were 3 and 6 hours in 2/7 neonates. Urinary excretion ranged from 24% to 55%.
Conclusions:
- Significant variability in neonatal chloramphenicol serum levels from oral chloramphenicol palmitate was observed.
- Delayed maximum serum concentration, non-declining serum curves, and low renal recovery suggest erratic absorption.
- Potential contributing factors include delayed gastric emptying or impaired intraluminal hydrolysis of the palmitate ester.
Abstract:
The absorption and disposition of orally administered chloramphenicol palmitate (chloramphenicol-P) was studied in seven neonates (four preterm, three term). The highest measured chloramphenicol serum concentrations occurred greater than or equal to 4 hours after the dose, and ranged from 5.5 to 23 micrograms/ml after doses of chloramphenicol-P 50 mg/kg/day orally. The dosage had to be increased in all preterm neonates from 25 mg/kg/day to 50 mg/kg/day to obtain adequate serum levels during therapy. In four neonates the apparent half-life could not be estimated, because there was no decline in serum concentrations. The apparent half-life was 3 and 6 hours, respectively, in two neonates in whom the serum concentration declined during the dosing interval. Urinary excretion of chloramphenicol and the glucoronide ester in three neonates varied from 24% to 55% of the total dose administered. These preliminary data suggest considerable variability in serum chloramphenicol levels when chloramphenicol-P is administered orally in neonates. The delay in achieving the maximum serum concentration, nondeclining serum curve, and low renal recovery is indicative of incomplete, prolonged, and erratic absorption, possibly related to delayed gastric emptying or decreased intraluminal hydrolysis of the palmitate ester.
