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[Dose estimation for renal-excretion drugs in neonates and infants based on physiological development of renal

Shinya Suzuki1, Yuka Murayama, Erika Sugiyama

  • 1Faculty of Pharmaceutical Sciences, Showa University, Tokyo, Japan. shi-suzuki@umin.ac.jp

Yakugaku Zasshi : Journal of the Pharmaceutical Society of Japan
|July 3, 2009
PubMed

Insights

New dose estimation formulas for infants and neonates use renal function indices like glomerular filtration rate (GFR) and unbound drug fraction (fp) to ensure safe and effective medication. This method improves drug dosing accuracy in young children.

Area of Science:

  • Pharmacology
  • Pediatric Medicine
  • Drug Development

Context:

  • Neonates and infants (<2 years) exhibit significant physiological changes affecting drug pharmacokinetics.
  • Accurate drug dosing in this population is critical due to immature renal function.
  • Existing dose estimation methods often lack precision for pediatric populations.

Purpose:

  • To establish novel dose estimation formulas for renally excreted drugs in neonates and infants.
  • To incorporate key renal function indices: glomerular filtration rate (GFR), tubular secretion clearance (Sc), and unbound drug fraction (fp).
  • To validate these formulas against established drugs and conventional dosing methods.

Summary:

  • Developed dose estimation formulas utilizing GFR, Sc, and fp to account for physiological development in pediatric patients.
  • Applied distinct formulas based on the relationship between Sc and unbound drug fraction (fp) multiplied by GFR (fp.GFR).
  • Validated the formulas using vancomycin, arbekacin, fosfomycin, norfloxacin, digoxin, and amoxicillin, showing favorable consistency in clearance ratios and approximated established doses.

Impact:

  • Demonstrated the validity of a pharmacokinetic-factor-based approach for pediatric drug dosing.
  • Provides a more accurate method for calculating renally excreted drug doses in neonates and infants.
  • Contributes to improved medication safety and efficacy in pediatric populations.

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