Levetiracetam Sandoz

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

Adult & adolescent from 16 yr Monotherapy Starting dose: 250 mg bd. Initially increased to 500 mg bd after 2 wk. May be further increased by 250 mg bd every 2 wk depending upon the clinical response. Max: 1,500 mg bd. Adult (≥18 yr) & adolescents (12-17 yr) weighing ≥50 kg Add-on therapy Initially 500 mg bd & may be increased up to 1,500 mg bd. Dose changes can be made in 500 mg bd increases or decreases every 2-4 wk. Childn (4-11 yr) & adolescents (12-17 yr) weighing <50 kg Add-on therapy Initially 10 mg/kg bd. May be increased up to 30 mg/kg bd depending upon the clinical response & tolerability. Dose changes should not exceed increases or decreases of 10 mg/kg bd every 2 wk, from 50 kg 500 mg bd. Max: 1,500 mg bd (adult dose), 25 kg 250 mg bd. Max: 750 mg bd, 20 kg 200 mg bd. Max: 600 mg bd, 15 kg 150 mg bd. Max: 450 mg bd. Renal impairment: Severe (CrCl <30 mL/min/1.73 m²) 250-500 bd, moderate (CrCl 30-49 mL/min/1.73 m²) 250-750 mg bd, mild (CrCl 50-79 mL/min/1.73 m²) 500-1,000 mg bd. ESRD patient undergoing dialysis Loading dose: 750 mg on the 1st day of treatment. 500-1,000 mg once daily. Following dialysis, 250-500 mg supplemental dose is recommended. Hepatic impairment (CrCl <60 mL/min/1.73 m²) Reduce dose to ½ of daily maintenance dose.

May be taken with or without food: Swallow w/ sufficient quantity of liqd.

Hypersensitivity to levetiracetam or other pyrrolidone derivatives.

Anticonvulsants

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

POM