Pfizer Levetiracetam

Levetiracetam

Monotherapy in the treatment of partial onset seizures w/ or w/o secondary generalization in adults & adolescents from 16 yr w/ newly diagnosed epilepsy. Adjunctive therapy in the treatment of partial onset seizures w/ or w/o secondary generalization in adults, adolescents & childn from 4 yr w/ epilepsy; myoclonic seizures in adults & adolescents from 12 yr w/ juvenile myoclonic epilepsy; primary generalized tonic-clonic seizures in adults & adolescents from 12 yr w/ idiopathic generalized epilepsy.

IV Adult ≥18 yr & adolescent 12-17 yr weighing ≥50 kg Initially 500 mg bid, or alternatively 250 mg may be initially given based on seizure reduction vs potential side effects & can be increased to 500 mg bid after 2 wk. Daily dose can be increased up to 1,500 mg bid. Dose changes can be made in 250 mg or 500 mg bid increases or decreases every 2-4 wk. Childn & adolescent ≥50 kg Adult dose. Childn & adolescent from 50 kg 500 mg bid. Max: 1,500 mg bid, 25 kg 250 mg bid. Max: 750 mg bid, 20 kg 200 mg bid. Max: 600 mg bid, 15 kg 150 mg bid. Max: 450 mg bid. Add-on therapy for childn 4-11 yr & adolescent 12-17 yr weighing <50 kg Initially 10 mg/kg bid, can be increased up to 30 mg/kg bid. Dose changes should not exceed increases or decreases of 10 mg/kg bid every 2 wk. Adult & adolescent weighing >50 kg w/ renal impairment CrCl ≥80 mL/min/1.73 m² 500-1,500 mg bid, 50-79 mL/min/1.73 m² 500-1,000 mg bid, 30-49 mL/min/1.73 m² 250-750 mg bid, <30 mL/min/1.73 m² 250-500 mg bid, ESRD & undergoing dialysis 500-1,000 mg once daily. Loading dose: 750 mg on the 1st day of treatment. Supplemental dose: 250-500 mg following dialysis. Childn & adolescent weighing <50 kg w/ renal impairment CrCl ≥80 mL/min/1.73 m² 10-30 mg/kg bid, 50-79 mL/min/1.73 m² 10-20 mg/kg bid, 30-49 mL/min/1.73 m² 5-15 mg/kg bid, <30 mL/min/1.73 m² 5-10 mg/kg bid, ESRD & undergoing dialysis 10-20 mg/kg once daily. Loading dose: 15 mg/kg on the 1st day of treatment. Supplemental dose: 5-10 mg/kg following dialysis. Hepatic impairment CrCl <60 mL/min/1.73 m² 50% reduction of daily maintenance dose.

Hypersensitivity to levetiracetam or other pyrrolidone derivatives.

Monitor for signs of depression &/or suicidal ideation & behaviors; developing psychiatric signs suggesting important mood &/or personality changes. May cause psychotic symptoms & behavioral abnormalities including irritability & aggressiveness. May rarely exacerbate seizure frequency or severity. Patients w/ QTc-interval prolongation, concomitantly treated w/ drugs affecting QTc-interval, or those w/ relevant preexisting cardiac disease or electrolyte disturbances. Patients on a controlled Na diet. CBCs are advised in patients experiencing important weakness, pyrexia, recurrent infections or coagulation disorders. Assessment of renal function is recommended in patients w/ severe hepatic impairment before dose selection. Acute kidney injury (rarely). Minor or moderate influence on the ability to drive & use machines. Women of childbearing potential. Pregnancy. Not recommended during lactation. Monotherapy in childn & adolescent <16 yr. Infants & childn <4 yr. Elderly ≥65 yr.

Nasopharyngitis; somnolence, headache. Anorexia; depression, hostility/aggression, anxiety, insomnia, nervousness/irritability; convulsion, balance disorder, dizziness, lethargy, tremor; vertigo; cough; abdominal pain, diarrhea, dyspepsia, vomiting, nausea; rash; asthenia/fatigue.

Higher clearance w/ enzyme-inducing antiepileptics in childn. Inhibited renal clearance of the primary metabolite w/ probenecid. Decreased MTX clearance, resulting in increased/prolonged blood MTX conc to potentially toxic levels.

Anticonvulsants

N03AX14 - levetiracetam ; Belongs to the class of other antiepileptics.

Rx