";s:4:"text";s:4965:" No deaths or other serious adverse events occurred, and none of the subjects discontinued the study because of an adverse event.
This product could help youAccessing resources off campus can be a challenge. The authors performed a prospective, single-center study to evaluate the safety of a rapid loading dose of intravenous levetiracetam. Of the 54 drug‐related adverse events, 21 (mostly dizziness and somnolence) started during the first hour after the dose. J Child Neurol. Vital signs and ECGs were performed at screening; predose; at the end of the infusion; 15 and 30 min after the end of the infusion; 1 h, 2 h, 12 h, and 24 h after the dose; and within 7 days after the last day of treatment.Blood samples (5 ml) were collected over lithium heparin, immediately before starting the infusion, and at time points of 5, 10, 15, and 30 min and 1, 2, 3, 6, 9, 12, and 24 h. The plasma was separated at ∼900 Plasma LEV concentrations were determined by using a validated gas chromatographic method with a lower limit of quantification of 0.5 μg/ml (For analyses of safety and tolerability, the six LEV groups were compared mainly descriptively with placebo‐treated subjects who were pooled to form one group of 12. COVID-19 is an emerging, rapidly evolving situation. The proposed dosage of the injectable LEV formulation for IV administration (available as 5 ml of a solution containing 100 mg/ml) in adults is 500–1,500 mg diluted in ≥100 ml of compatible diluent administered as a 15‐min infusion twice daily, with a maximum recommended daily dose of 3,000 mg (same daily dose as recommended for the oral formulation).The results of this study demonstrated that LEV IV at dosages and/or infusion rates higher than those proposed (dosages ≤4,000 mg over 15 min and ≤2,500 mg over 5 min) was well tolerated in healthy subjects, and provided information on the safety margin of LEV IV. Oral doses between 500 mg and 1,500 mg dosed twice daily have been shown significantly to reduce seizure frequency and are generally well tolerated (The only concomitant medications allowed within 2 weeks of administration of study drug were hormonal contraceptives; hormone‐replacement therapy; and paracetamol (acetaminophen), not exceeding 2 g/day up to a total of 10 g/14 days. Each LEV dose was diluted in 100 ml of normal saline and administered in the morning after an overnight fast of ≥10 h. Dose selection was based on clinical experience with oral LEV.