DOI: 10.1002/phar.2898 ISSN: 0277-0008

Evaluation of the safety and tolerability of intravenous undiluted levetiracetam at a pediatric institution

Lily Price, Lisa Garrity, Sarah Stiehl
  • Pharmacology (medical)

Abstract

Background and Objectives

Failure of initial benzodiazepine therapy in patients with status epilepticus warrants urgent administration of a second‐line antiseizure medication. Recent studies suggest rapid administration of high‐dose, undiluted levetiracetam is safe in adults; however, no information exists in pediatric patients. The purpose of this study was to evaluate the safety and tolerability of undiluted levetiracetam at a pediatric institution.

Methods

Retrospective, single‐center, cohort analysis of patients who received high‐dose >60 mg/kg (‐10%) up to 4500 mg diluted or undiluted intravenous levetiracetam between May 6, 2020 to July 31, 2022 at a large pediatric academic medical center. The primary outcome was the assessment of hemodynamic disturbances (bradycardia, hypotension) and/or infusion‐related reactions after administration of the levetiracetam infusion.

Results

A total of 776 levetiracetam doses were included, 358 doses administered and 418 doses wasted. The doses administered (61 undiluted and 297 diluted) accounted for a total of 252 patients (39 received undiluted and 213 received diluted levetiracetam) (median [minimum‐maximum range] age, 2 y [1 d–32.7 y]; mean (standard deviation [SD]) weight, 20.1 kg (22.1 kg)). The incidence of hemodynamic disturbances and infusion‐related reactions was not statistically significant between diluted and undiluted groups (p= 0.87). The median (interquartile range [IQR]) time difference between first‐line antiseizure medication and levetiracetam administration in patients with status epilepticus was 18 minutes (10.5‐30.5) in the undiluted group versus 36.5 minutes (21.8‐67.3) in the diluted group; p<0.01. Additionally, there was a significant amount of drug waste from dispensed but not administered doses of the diluted bag compared to undiluted vials (57.6% diluted versus 18.7% undiluted, p<0.001).

Conclusion

Undiluted levetiracetam was not associated with an increased incidence of adverse effects compared to diluted levetiracetam in high‐doses, up to 4500 mg given over 5 minutes in pediatric patients.

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