Eletam (Levetiracetam) is indicated as monotherapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 16 years of age with newly diagnosed epilepsy. Eletam (Levetiracetam) is indicated as adjunctive therapy in the treatment of partial onset seizures with or withoutt secondary generalisation in adults and children from 4 years of age with epilepsy. In the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy. In the treatment of primary- generalised tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.
Dosage and administration
Tablet: The film-coated tablet must be taken orally, swallowed with a sufficient quantity of liquid and may be taken with or without food. The daily dose is administered in two equally divided doses.
Oral solution: The oral solution may be diluted in a glass of water and may be taken with or without food.
Monotherapy: Adults and adolescents from 16 years of age: The recommended starting dose is 250mg twice daily which should be increased to an initial therapeutic dose of 500mg twice daily after two weeks. The dose can be further increased by 250mg twice daily every two weeks depending upon the clinical response. The maximum dose is 1500mg twice daily.
Add-on therapy: Adults (³18 years) and adolescents (12 to 17 years) weighing 50kg or more: The initial therapeutic dose is 500mg twice daily. This dose can be started on the first day of treatment. Depending upon the clinical response and tolerability, the daily dose can be increased upto 1500mg twice daily. Dose changes can be made in 500mg twice daily increases or decreases every two to four weeks.
Elderly (65 years and older): Adjustment of the dose is recommended in elderly patients with compromised renal function. Children aged 4 to 11 years and adolescents
(12 to I7 years) weighing less than 50kg: The initial therapeutic dose is 10mg/kg twice daily. Depending upon the clinical response and tolerability, the dose can be increased up to 30mg/kg twice daily. Dose changes should not exceed increases or decreases of 10mg/kg twice daily every two weeks. The lowest effective dose should be used. Dosage in children 50kg or greater is the same as in adults.
Dosage recommendations for children and adolescents :
(1) Children 20kg or less should preferably start the treatment with Eletam100mg/ml oral solution.
(2) Dosage in children and adolescents 50kg or more is the same as in adults. Infants and children less than 4 years: Levetiracetam is not recommended for use in children below 4 years of age due to insufficient data on safety and efficacy.
Patients with renal impairment: The daily dose must be individualised according to renal function.
Dosing adjustment for adult patients with impaired renal function:
(1) A 750mg loading dose is recommended on the first day of treatment with Levetiracetam.
(2) Following dialysis, a 250 to 500mg supplemental dose is recommended.
Patients with hepatic impairment: No dose adjustment is needed in patients with mild to moderate hepatic impairment.
Drug interactions: Levetiracetam did not influence the serum concentrations of existing antiepileptic medicinal products (phenytoin, carbamazepine, valproic acid, phenobarbital, lamotrigine, gabapentin and primidone) and that these antiepileptic medicinal products did not influence the pharmacokinetics of Levetiracetam. The extent of absorption of Levetiracetam was not altered by food, but the rate of absorption was slightly reduced.
Use in pregnancy and lactation: There are no adequate data from the use of Levetiracetam in pregnant women. Studies of potential risk for human is unknown. Levetiracetam should not be used during pregnancy unless clearly necessary. Discontinuation of antiepileptic treatments may result in exacerbation of the disease which could be harmful to the mother and the foetus. Levetiracetam is excreted in human breast milk. Therefore, breast-feeding is not recommended.
Side-effects: Nausea, vomiting, dyspepsia, diarrhoea, abdominal pain, anorexia, weight gain, cough, drowsiness, asthenia, amnesia, ataxia, seizures, dizziness, headache, tremor, hyperkinesia, depression, insomnia, anxiety, impaired attention, aggression, irritability, thrombocytopenia, myalgia, visual disturbances, pruritus, rash, also reported confusion, psychosis, hallucinations, suicidal ideation, leucopenia, pancytopenia and alopecia.