Pfizer 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. Alternatively, 250 mg bid 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, 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. Patient w/ hepatic impairment w/ CrCl <60 mL/min/1.73 m² 50% reduction of daily maintenance dose.

Hypersensitivity to levetiracetam or other pyrrolidone derivatives.

Monitor patients for signs of depression &/or suicidal ideation & behaviors; & for 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. Reports of rare cases of ECG QT interval prolongation. Contains 19 mg Na per vial; take this into consideration in patients on 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. Very rarely associated w/ acute kidney injury. Minor or moderate influence on the ability to drive & use machines. Can be used during pregnancy if clinically needed; use the lowest effective dose. Not recommended during lactation. Safety & efficacy of monotherapy in childn & adolescent <16 yr have not been established. Safety & efficacy have not been established in infants & childn <4 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.

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.

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