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Assessment of Enteral Baclofen Prescribing Practices for Infants With Hypertonia

Hope E DiTaranto1, Astrela Moore1, Rebecca Kendsersky1

  • 1Department of Pharmacy (HED, AM, RK, JZ), Children's Hospital of Philadelphia, Philadelphia, PA.

The Journal of Pediatric Pharmacology and Therapeutics : JPPT : the Official Journal of PPAG
|June 10, 2026
PubMed

Insights

This study analyzed enteral baclofen use in infants under 12 months for hypertonia. Prescribing varied, but baclofen was generally safe and well-tolerated, offering insights for infant dosing.

Area of Science:

  • Pediatric Neurology
  • Pharmacology
  • Clinical Pharmacy

Background:

  • Hypertonia in infants often requires management with medications like baclofen.
  • Existing dosing guidance for infant baclofen is limited, leading to practice variability.

Purpose of the Study:

  • To describe the enteral baclofen prescribing patterns in infants 12 months of age and younger.
  • To assess the safety and tolerability of baclofen regimens in this population.

Main Methods:

  • A single-center, retrospective review of infants receiving enteral baclofen from January 2013 to December 2022.
  • Analysis of regimen details: dose, frequency, age, weight, and treatment duration.
  • Evaluation of outcomes including place in therapy, safety, and tolerability.

Main Results:

  • 108 infants with 423 baclofen regimens were analyzed.
  • Initiation doses were generally lower than recommended, with a median weight-based total daily dose (wTDD) of 0.5 mg/kg/day.
  • The longest-tolerated regimen had a median wTDD of 1.3 mg/kg/day; adverse effects were infrequent (3.7%).

Conclusions:

  • Infant baclofen prescribing for hypertonia shows significant variability in practice.
  • The analyzed baclofen regimens were found to be safe and well-tolerated in infants.
  • Findings offer valuable insights into current baclofen dosing strategies for pediatric hypertonia.
Abstract

Keywords:
baclofenbrain injuriesbrain ischemiamuscle hypertoniamuscle spasticity

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