Letta

Levetiracetam

Monotherapy in partial onset seizures w/ or w/o secondary generalization in adult & adolescent from 16 yr w/ newly diagnosed epilepsy. Adjunct to partial onset seizures w/ or w/o secondary generalization in adult, adolescent & childn from 4 yr w/ epilepsy; myoclonic seizures in adult & adolescent from 12 yr w/ juvenile myoclonic epilepsy; primary generalized tonic-clonic seizures in adult & childn from 6 yr w/ idiopathic generalized epilepsy.

Monotherapy Adult & adolescent from 16 yr Initially 250 mg bid, increased to 500 mg bid after 2 wk. May be further increased by 250 mg bid every 2 wk. Max: 1,500 mg bid. Add-on therapy Adult ≥18 yr & adolescent 12-17 yr weighing ≥50 kg Initially 500 mg bid on 1st day of treatment. May be increased up to 1,500 mg bid. 500 mg bid increases or decreases every 2-4 wk for dose changes. Adolescent 12-17 yr & childn 4-11 yr weighing <50 kg Initially 10 mg/kg bid. May be increased up to 30 mg/kg bid. Not to exceed increments or decrements of 10 mg/kg bid every 2 wk for dose changes. Dose recommendations: Adolescent & childn weighing from 50 kg Initially 500 mg bid. Max: 1,500 mg bid, 25 kg Initially 250 mg bid. Max: 750 mg bid. Adult & adolescent w/ renal impairment weighing >50 kg: CrCl >80 mL/min/1.73 m² 500-1,500 mg bid, CrCl 50-79 mL/min/1.73 m² 500-1,000 mg bid, CrCl 30-49 mL/min/1.73 m² 250-750 mg bid, CrCl <30 mL/min/1.73 m² 250-500 mg bid, ESRD patients undergoing dialysis 500-1,000 mg once daily. 750 mg loading dose on 1st day of treatment & 250-500 mg supplement dose following dialysis. Adolescent & childn w/ renal impairment weighing <50 kg: CrCl >80 mL/min/1.73 m² 10-30 mg/kg bid, CrCl 50-79 mL/min/1.73 m² 10-20 mg/kg bid, CrCl 30-49 mL/min/1.73 m² 5-15 mg/kg bid, CrCl <30 mL/min/1.73 m² 5-10 mg/kg bid, ESRD patients undergoing dialysis 10-20 mg/kg once daily. 15 mg/kg loading dose on the 1st day of treatment & 5-10 mg/kg supplement dose following dialysis.

May be taken with or without food: Swallow whole, do not crush/break/chew.

Hypersensitivity to levetiracetam or other pyrrolidone derivatives.

Not to be taken w/ alcoholic drinks or any beverage w/ alcohol. Serious dermatological reactions eg, SJS & TEN. Hematologic disorder; behavioral abnormalities, increased risk of suicidal thought or behavior, coordination difficulties, somnolence, asthenia; decrease in total mean erythrocyte count, Hb & hematocrit. Avoid abrupt w/drawal. Do not drive or operate machinery or engage in other hazardous activities. Hepatic &/or renal impairment. Pregnancy (contraindicated) & lactation. Increased diastolic BP in patients 1 mth to <4 yr. Childn & adolescent <16 yr (as monotherapy). Elderly w/ compromised renal function.

Somnolence, asthenia, headache, infection, dizziness, pain, pharyngitis, depression, nervousness, rhinitis, anorexia, ataxia, vertigo, amnesia, anxiety, emotional lability, hostility, paresthesia, increased cough, sinusitis, diplopia.

Anticonvulsants

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

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