Levacetam Tablets ( Levetiracetam)

• Composition :
  Each tablet contains Levetiracetam 250mg /500mg /750mg /1000 mg.
• Indications :
  (i) As monotherapy in partial onset seizures with or without secondary generalization in patients with 16 years of age with newly diagnosed epilepsy. (ii)As adjunctive therapy in myoclonic seizures in adults and adolescents from 12 years of age with Juvenile myoclonic epilepsy. In primary generalized tonic-clonic seizures in adults and adolescents from 12 years of age with idiopathic generalized epilepsy.
• Pharmacodynamics :
  Interaction between levetiracetam and the synaptic vesicle protein 2A seems to contribute to the antiepileptic mechanism of action of the medicinal product.
• Dosage and administration :
  Initiate treatment 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
• Contraindications :
  Known hypersensitivity to levetiracetam; angioedema and anaphylaxis have occurred
• Precautions and warnings :
  Behavioral abnormalities including psychotic symptoms, suicidal ideation, irritability, and aggressive behavior have been observed; monitor patients for psychiatric signs and symptoms; Monitor for somnolence and fatigue and advise patients not to drive or operate machinery.
• Use in pregnancy, lactation & pediatrics :
  Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women,should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Levacetam is excreted in human milk.a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother, Safety and effectiveness adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in pediatric patients 6 years of age and older with idiopathic generalized epilepsy have been established.
• Drug interactions :
  Co-administrationwith other Antiepileptic Drugs,like carbamazepine,gabapentin, lamotrigine, phenobarbital, phenytoin, primidone and valproate, oral Contraceptives, Digoxin and warfarin did not affect the pharmacokinetics of levetiracetam.
• Adverse reactions :
  Most common adverse reactions include: somnolence, asthenia, infection and dizziness.
• Therapy Area :
  Anti-Eplileptics