Lecetam Oral Solution

Levetiracetam

Monotherapy for partial onset seizures w/ or w/o secondary generalisation in adult & adolescents from 16 yr w/ newly diagnosed epilepsy. Adjunctive therapy for 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 generalized tonic-clonic seizures in adults, adolescents & childn from 6 yr w/ idiopathic generalised epilepsy.

Monotherapy Initially 250 mg bid, may be increased to 500 mg bid after 2 wk, then further increased by 250 mg bid every 2 wk. Max: 1,500 mg bid. Adolescent & childn weighing 50 kg Initially 500 mg bid. Max dose: 1,500 mg bid, 25 kg Initially 250 mg bid. Max dose: 750 mg bid, 20 kg Initially 200 mg bid. Max dose: 600 mg bid, 15 kg 150 mg bid. Max dose: 450 mg bid. Partial onset seizures Adult & adolescent ≥16 yr Initially 500 mg bid, increased by 500 mg/dose every 2 wk. Max: 1,500 mg bid. Adolescent & childn 4-16 yr Initially 10 mg/kg/dose bid, increased by 10 mg/kg/dose to recommended dose of 30 mg/kg/dose bid every 2 wk. Myoclonic seizures Adult, adolescent & childn ≥12 yr Initially 500 mg bid, increased by 500 mg/dose to recommended dose of 1,500 mg bid every 2 wk. Tonic-clonic seizures Adult & adolescent ≥16 yr Initially 500 mg bid, increased by 500 mg/dose to recommended dose of 1,500 mg bid every 2 wk. Adolescent & childn 6 to <16 yr Initially 10 mg/kg/dose bid, increased by 10 mg/kg/dose to recommended dose of 30 mg/kg/dose bid every 2 wk. Renal impairment CrCl >80 mL/min/1.73 m² 500-1,500 mg every 12 hr, 50-79 mL/min/1.73 m² 500-1,000 mg every 12 hr, 30-49 mL/min/1.73 m² 250-750 mg every 12 hr, <30 mL/min/1.73 m² 250-500 mg every 12 hr. ESRD in patient requiring hemodialysis 500-1,000 mg every 24 hr. Supplemental dose for post-hemodialysis 250-500 mg. Severe hepatic impairment CrCl <60 mL/min/1.73 m² Reduce maintenance dose by 50%. Adolescent & childn weighing <50 kg w/ impaired renal function 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 in patient undergoing hemodialysis 10-20 mg/kg bid; 15 mg/kg as loading dose on 1st day of treatment, then 5-10 mg/kg as supplemental dose following dialysis.

May be taken with or without food.

Hypersensitivity.

Psychosis, hallucination & behavioral symptoms eg, aggression, anger, anxiety, depersonalization, depression, personality disorder. Monitor for signs/symptoms of depression, suicidal tendencies & other unusual behavior changes during therapy. CNS depression eg, weakness, dizziness & somnolence during 1st mth of therapy. Decreased RBC & WBC counts, Hb, haematocrit & neutrophil. Eosinophilia, agranulocytosis & lymphocytosis. Avoid abrupt w/drawal. May affect ability to drive & use machines. Renal or hepatic impairment. Pregnancy & lactation. Childn <4 yr (oral) or <16 yr (IV).

Increased BP; aggressive behavior, agitation, amnesia, anxiety, ataxia (including abnormal gait & incoordination), behavioral problems (including aggression, agitation, anger, anxiety, apathy, depersonalization, emotional lability, irritability & neurosis), confusion, depression, dizziness, drowsiness, emotional lability, falling, fatigue, headache, hostility, insomnia, irritability, lethargy, mood changes, nervousness, pain, paranoia, parasthesia, psychotic symptoms, sedation, vertigo; anorexia, constipation, decreased appetite, diarrhea, gastroenteritits, nausea, upper abdominal pain, vomiting; bruise, decreased neutrophils & WBCs, eosinophilia; infection, flu; arthralgia, joint sprain, neck pain, weakness; conjunctivitis, diplopia; otalgia; cough, nasal congestion, nasopharyngitis, pharyngolaryngeal pain, pharyngitis, rhinitis, sinusitis; head trauma. SJS, TEN.

Increased side effects/toxicity w/ CNS depressants. Slightly reduced absorption rate w/ food.

Anticonvulsants

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

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