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Published on: December 26, 2013
Pharmacokinetics of ticarcillin-clavulanate in premature infants
Kevin M Watt1,2, Christoph P Hornik1,2, Stephen J Balevic1,2
1Duke University Medical Center, Durham, NC, USA.
Insights
Optimizing ticarcillin-clavulanate dosing in premature infants is crucial. New dosing regimens based on postnatal age can achieve target drug exposure, improving treatment outcomes for vulnerable newborns.
Area of Science:
- Neonatal pharmacology
- Infectious disease in neonates
- Antibiotic pharmacokinetics
Background:
- Ticarcillin-clavulanate is a broad-spectrum antibiotic used in premature infants.
- Limited pharmacokinetic data exists for dosing ticarcillin-clavulanate in infants under 30 weeks gestational age.
Purpose of the Study:
- To determine pharmacokinetic parameters of ticarcillin-clavulanate in premature infants.
- To perform dosing simulations for optimal ticarcillin-clavulanate dosing strategies.
Main Methods:
- Enrolled 15 premature infants (<30 weeks gestational age).
- Determined pharmacokinetic parameters.
- Conducted dosing simulations to identify optimal dosing regimens.
Main Results:
- Infant clearance of ticarcillin-clavulanate varied with postnatal age, indicating renal function maturation.
- Simulations suggest ticarcillin 75 mg/kg q12h (PNA <14 days) or q8h (PNA ≥ 14-45 days) achieves target exposure (>90% of infants) for MIC ≤16 μ/mL.
- Higher doses or extended infusions may be needed for highly resistant organisms (MIC 32 μ/mL).
Conclusions:
- Established age-based dosing recommendations for ticarcillin-clavulanate in premature infants.
- These findings provide guidance for optimizing antibiotic therapy in this vulnerable population.
- Further studies may be needed to address dosing for highly resistant pathogens.
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.
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