Cases of somnolence, agitation, aggression, depressed level of consciousness, respiratory depression, and coma were observed with levetiracetam overdoses. The highest known dose of levetiracetam received in the clinical development program was 6,000 mg/day. Other than drowsiness, there were no adverse events in the few known cases of overdose in clinical trials.
There is no antidote for levetiracetam overdose; treatment is symptomatic and may include hemodialysis. After an acute overdose, the stomach may be emptied by gastric lavage or by induction of emesis; usual precautions should be observed to maintain airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient. The dialyzer extraction efficiency is 60% for levetiracetam and 74% for the primary metabolite.
Standard hemodialysis procedures result in significant clearance of levetiracetam (approximately 50% in four hours) and should be considered in cases of overdose. Although hemodialysis has not been performed in the few known cases of overdose, it may be indicated by the patient's clinical state or in patients with significant renal impairment.
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