Pharmacokinetics of ticarcillin-clavulanate in premature infants

Br J Clin Pharmacol. 2019 May;85(5):1021-1027. doi: 10.1111/bcp.13882. Epub 2019 Mar 6.

Abstract

Ticarcillin-clavulanate covers a broad spectrum of pathogens that are common in premature infants. In infants <30 weeks gestational age, pharmacokinetic data to guide ticarcillin-clavulanate dosing are lacking. We enrolled 15 premature infants <30 weeks gestational age, determined pharmacokinetic parameters, and performed dosing simulations to determine optimal dosing for ticarcillin-clavulanate. The infants had a median (range) postnatal age (PNA) of 18 days (6-44 days) and gestational age of 25 weeks (23-28 weeks). Clearance was lower in infants with a PNA <14 days (0.050 L/kg/h [range 0.043-0.075]) compared with a PNA ≥14-45 days (0.078 L/kg/h [0.047-0.100]), consistent with maturation of renal function. Dosing simulations determined that ticarcillin 75 mg/kg q12h (PNA <14 days) or q8h (PNA ≥ 14-45 days) achieved the target exposure for organisms with a minimum inhibitory concentration ≤16 μ/mL in >90% of simulated infants. For highly resistant organisms (minimum inhibitory concentration 32 μg/mL), increased dosing frequency or extended infusion are necessary.

Keywords: clavulanate; infants; pharmacokinetics; premature; ticarcillin.

Publication types

  • Clinical Trial, Phase I
  • Multicenter Study
  • Research Support, N.I.H., Extramural

MeSH terms

  • Clavulanic Acids / administration & dosage
  • Clavulanic Acids / pharmacokinetics
  • Computer Simulation
  • Dose-Response Relationship, Drug
  • Drug Dosage Calculations
  • Female
  • Humans
  • Infant, Extremely Premature
  • Infant, Newborn
  • Male
  • Microbial Sensitivity Tests
  • Models, Biological
  • Prospective Studies
  • Staphylococcal Infections / drug therapy*
  • Staphylococcal Infections / microbiology
  • Staphylococcus / drug effects*
  • Staphylococcus / physiology
  • Ticarcillin / administration & dosage
  • Ticarcillin / pharmacokinetics
  • beta-Lactamase Inhibitors / administration & dosage
  • beta-Lactamase Inhibitors / pharmacokinetics*

Substances

  • Clavulanic Acids
  • beta-Lactamase Inhibitors
  • ticarcillin-clavulanic acid
  • Ticarcillin