Indications - Levetiracetam is indicated as monotherapy in the treatment of partial-onset seizures with or without secondary generalisation in adults and adolescents from 16 years of age with newly diagnosed epilepsy. Levetiracetam is indicated as adjunctive therapy- in the treatment of partial-onset seizures with or without secondary generalization in adults, adolescents, children and infants from 1 month 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 generalized tonic-clonic seizures in adults and adolescents from 12 years of age with Idiopathic Generalised Epilepsy.
Dosage & Administration - Treatment should be initiated with a daily dose of 1000 mg/day, given as twice-daily dosing (500 mg twice daily). Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. Use in Pediatric Patients Age/weight Initial dose (Daily) Incremental dose (Daily) 1 Month To < 6 Months 7 mg/kg twice daily 21 mg/kg twice daily 6 Months To < 4 Years 10 mg/kg twice daily 25 mg/kg twice daily 4 Years To < 16 Years 10 mg/kg twice daily 30 mg/kg twice daily
Side Effects - Most common adverse reactions (incidence ≥ 5% more than placebo) include: Adult patients: somnolence, asthenia, infection and dizziness Pediatric patients: fatigue, aggression, nasal congestion, decreased appetite, and irritability
Contraindications - Hypersensitivity to the active substance or other pyrrolidone derivatives or to any of the excipients.
Others - Pregnancy & Lactation Levetiracetam is not recommended during pregnancy and in women of childbearing potential not using contraception unless clinically necessary. Levetiracetam is excreted in human breast milk. Therefore, breastfeeding is not recommended. However, if levetiracetam treatment is needed during breastfeeding, the benefit/risk of the treatment should be weighed considering the importance of breastfeeding. No impact on fertility was detected in animal studies. No clinical data are available, the potential risk for humans is unknown.