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Updated: Jul 13, 2026

Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses
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Published on: August 30, 2018

Optimising piperacillin/tazobactam dosing in paediatrics

Christoffer W Tornøe1, Jeffrey J Tworzyanski, Menfo A Imoisili

  • 1Office of Clinical Pharmacology, Center for Drug Evaluation and Research, FDA, 10903 New Hampshire Avenue, Silver Spring, MD 20993, USA. christoffer.tornoe@fda.hhs.gov

International Journal of Antimicrobial Agents
|July 17, 2007
PubMed

Insights

Piperacillin/tazobactam dosing for children aged 2 months to 17 years is now recommended based on weight and age. Doses are adjusted for younger children (2-9 months) due to immature renal function, ensuring safe and effective antibacterial treatment.

Area of Science:

  • Pharmacology
  • Pediatric Medicine
  • Drug Development

Background:

  • Piperacillin/tazobactam is an intravenous antibacterial agent.
  • Recent US approval for pediatric use (2 months to 17 years).

Purpose of the Study:

  • To establish the pharmacokinetic basis for piperacillin/tazobactam dosing recommendations in pediatric patients.
  • To define optimal dosing strategies for children aged 2 months to 17 years.

Main Methods:

  • Analysis of pharmacokinetic (PK) parameters and demographic covariates from 53 children in two studies.
  • Non-linear regression used to investigate the influence of covariates on drug clearance (CL).
  • Population PK analysis and simulations compared pediatric exposures to adult exposures.

Main Results:

  • Piperacillin/tazobactam clearance (CL) is dependent on body weight.
  • CL is influenced by age in pediatric patients ≤2 years, reflecting renal function maturation.
  • Recommended dose for children ≥9 months: 100/12.5 mg/kg every 8 hours for adult-similar exposures.
  • Recommended dose for children 2-9 months: 80/10 mg/kg every 8 hours (reduced by 0.8).

Conclusions:

  • Established dosing recommendations for piperacillin/tazobactam in pediatric patients down to 2 months of age.
  • Dosing adjustments in younger children account for immature renal function.
  • No data available for patients younger than 2 months.

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