Dataset from Use of Lorazepam for the Treatment of Pediatric Status Epilepticus

An open-label, multi-center study to evaluate the single dose pharmacokinetics of intravenous lorazepam in pediatric patients aged 3 months to less than 18 years treated for status epilepticus (SE) or with a history of SE. Cohort assignment was based on medical history: Cohort 1 included Emergency Department or hospital patients in SE receiving lorazepam; Cohort 2 included patients with epilepsy admitted for an elective dose of lorazepam. Subjects were stratified by age in each cohort. Participants in Cohort 1 received lorazepam 0.1 mg/kg up to a maximum dose of 4 mg/kg. Participants in Cohort 2 received lorazepam 0.05 mg/kg up to a maximum dose of 2 mg/kg. This study was conducted under the Best Pharmaceuticals for Children Act Program.