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diazepam rectal gel is a gel formulation of diazepam intended for rectal administration in the management of selected refractory patients with epilepsy on stable regimens of aeds who require intermittent use of diazepam to control bouts of increased seizure activity evidence to support the use of diazepam rectal gel was adduced in two controlled trials see clinical pharmacology clinical studies subsection that enrolled patients with partial onset or generalized convulsive seizures who were identified jointly by their caregivers and physicians as suffering intermittent and periodic episodes of markedly increased seizure activity sometimes heralded by nonconvulsive symptoms that for the individual patient were characteristic and were deemed by the prescriber to be of a kind for which a benzodiazepine would ordinarily be administered acutely although these clusters or bouts of seizures differed among patients for any individual patient the clusters of seizure activity were not only stereotypic but were judged by those conducting and participating in these studies to be distinguishable from other seizures suffered by that patient the conclusion that a patient experienced such unique episodes of seizure activity was based on historical information
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