Leppa

As monotherapy for partial onset seizures w/ or w/o secondary generalisation in adults & adolescents ≥16 yr w/ newly diagnosed epilepsy. Adjunctive therapy for partial onset seizures w/ or w/o secondary generalisation in adults, adolescents, childn & infants ≥1 mth w/ epilepsy; myoclonic seizures in adults & adolescents ≥12 yr w/ juvenile myoclonic epilepsy; primary generalised tonic-clonic seizures in adults & adolescents ≥12 yr w/ idiopathic generalised epilepsy.

Administer daily dose in 2 divided doses. Adult (≥18 yr) & adolescent (12-17 yr) weighing ≥50 kg Initially 500 mg bid starting on 1st day of treatment. Alternatively, lower initial dose of 250 mg bid, based on physician assessment of seizure reduction versus potential side effects, then increased to 500 mg bid after 2 wk. May increase daily dose 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. Adolescent (12-17 yr) weighing <50 kg & childn ≥1 mth Individualized dosage according to wt, age & dose. Childn & adolescent weighing 25 kg Initially 250 mg bid. Max: 750 mg bid. Renal impairment: Adult & adolescent weighing >50 kg: Normal ≥80 mL/min/1.73 m² 500-1,500 mg bid, mild (CrCl 50-79 mL/min/1.73 m²) 500-1,000 mg bid, moderate (CrCl 30-49 mL/min/1.73 m²) 250-750 mg bid, severe (CrCl <30 mL/min/1.73 m²) 250-500 mg bid, ESRD undergoing dialysis Loading dose: 750 mg on 1st day. 500-1,000 mg once daily. Supplemental dose of 250-500 mg is recommended following dialysis. Infant 1 mth to <6 mth weighing <50 kg: Normal (≥80 mL/min/1.73 m²) 7-21 mg/kg bid, mild (CrCl 50-79 mL/min/1.73 m²) 7-14 mg/kg bid, moderate (CrCl 30-49 mL/min/1.73 m²) 3.5-10.5 mg/kg bid, severe (CrCl <30 mL/min/1.73 m²) 3.5-7 mg/kg bid, ESRD undergoing dialysis Loading dose: 10.5 mg/kg on 1st day. 7-14 mg/kg once daily. Supplemental dose of 3.5-7 mg/kg is recommended following dialysis. Infant 6-23 mth, childn & adolescent weighing <50 kg: Normal (≥80 mL/min/1.73 m²) 10-30 mg/kg bid, mild (CrCl 50-79 mL/min/1.73 m²) 10-20 mg/kg bid, moderate (CrCl 30-49 mL/min/1.73 m²) 5-15 mg/kg bid, severe (CrCl <30 mL/min/1.73 m²) 5-10 mg/kg bid, ESRD undergoing dialysis Loading dose: 15 mg/kg on 1st day. 10-20 mg/kg once daily. Supplemental dose of 5-10 mg/kg is recommended following dialysis. Severe hepatic impairment w/ CrCl <60 mL/min/1.73 m² Reduce daily maintenance dose to 50%.

May be taken with or without food.

Hypersensitivity to levetiracetam or other pyrrolidone derivatives.

Consider gradual discontinuation & treatment adaptation if patient develop signs suggesting mood &/or personality disorders. Avoid abrupt discontinuation. Acute kidney injury. Decreased blood cell counts (neutropenia, agranulocytosis, leucopenia, thrombocytopenia & pancytopenia) generally at the beginning of treatment. Suicide, suicide attempt, suicidal ideation & behaviour. Psychotic symptoms & behavioural abnormalities including irritability & aggressiveness. Exacerbated seizure frequency or severity mostly w/in the 1st mth after treatment initiation or increased dose. ECG QT interval prolongation. Patients w/ epilepsy associated w/ Na voltage-gated channel α subunit 8 mutations; QTc-interval prolongation or relevant pre-existing cardiac disease or electrolyte disturbances. Assess renal function in patients w/ severe hepatic impairment. Perform CBC in patients experiencing weakness, pyrexia, recurrent infections or coagulation disorders. Monitor patients for signs & symptoms of depression &/or suicidal ideation & behaviours; developing psychiatric signs suggesting important mood &/or personality changes. Concomitant use w/ drugs affecting the QTc interval. Minor or moderate influence on the ability to drive & use machines. Use lowest effective dose during pregnancy. Not recommended to breastfeed during treatment. Not for use in infant & childn <6 yr. Adjust dose in elderly w/ compromised renal function.

Nasopharyngitis; somnolence, headache. Anorexia; depression, hostility/aggression, anxiety, insomnia, nervousness/irritability; convulsion, balance disorder, dizziness, lethargy, tremor; vertigo; cough; abdominal pain, diarrhoea, dyspepsia, vomiting, nausea; rash; asthenia/fatigue. DRESS, TEN, SJS, erythema multiforme, rhabdomyolysis.

Decreased MTX clearance. Decreased efficacy w/ osmotic laxative macrogol. Reduced absorption rate w/ food.

Anticonvulsants

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

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