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Rifampin Pharmacokinetics and Safety in Preterm and Term Infants

P Brian Smith1,2, C Michael Cotten2, Mark L Hudak3

  • 1Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina, USA brian.smith@duke.edu.

Antimicrobial Agents and Chemotherapy
|March 27, 2019
PubMed

Insights

Intravenous rifampin dosing for infants was studied. Weight and postnatal age-based regimens achieved adult-like exposures for treating staphylococcal infections and tuberculosis (TB) safely.

Area of Science:

  • Pharmacology
  • Neonatal Medicine
  • Infectious Diseases

Background:

  • Rifampin is crucial for treating methicillin-resistant staphylococcal infections and tuberculosis (TB).
  • Limited pharmacokinetic data exists for intravenous rifampin in neonates.
  • Optimizing infant dosing is essential for effective treatment and safety.

Purpose of the Study:

  • To evaluate the pharmacokinetics (PK) and safety of intravenous rifampin in infants.
  • To develop weight and postnatal age-based dosing regimens for neonates.
  • To compare infant rifampin exposure to adult therapeutic levels.

Main Methods:

  • A multicenter, prospective pharmacokinetic and safety study.
  • Enrolled 27 infants with a median gestational age of 26 weeks.
  • Population pharmacokinetic analysis of 102 plasma samples using a one-compartment model.

Main Results:

  • Rifampin clearance increased with body weight and postnatal age.
  • No adverse events related to rifampin were reported.
  • Simulated daily intravenous dosing regimens (8 mg/kg for <14 days PNA, 15 mg/kg for ≥14 days PNA) yielded comparable exposures to adults.

Conclusions:

  • Weight and postnatal age-based intravenous rifampin dosing is safe and effective in infants.
  • These regimens can achieve therapeutic drug exposures similar to those in adults.
  • This study provides evidence for optimized rifampin treatment strategies in neonates.

Keywords:
MRSAinfantspediatricspopulation pharmacokineticsrifampinsafety

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