Levacetam Injection (Levetiracetam)

• Composition :
  Each ml contains 100 mg of levetiracetam. Each 5 ml vial contains 500 mg of levetiracetam.
• Indications :
  As adjunctive therapy in adult (16 years and older) with the following types of seizures when oral administration is temporarily not feasible: Partial onset seizures, Myoclonic seizures in patients with juvenile myoclonic epilepsy, Primary generalized tonic-clonic seizures in adults with idiopathic generalized epilepsy
• Pharmacodynamics :
  The 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 :
  injection (500 mg/5 mL) should be diluted in 100 mL of a compatible diluents. 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
• Contraindications :
  Hypersensitivity to active ingredient or any other excipients of the formulation
• Precautions and warnings :
  Neuropsychiatric Adverse Reactions: Including: 1) Somnolence and fatigue, 2) Coordination difficulties and 3) Behavioral Abnormalities (e.g., psychotic symptoms, suicide ideation, and other abnormalities). Withdrawal Seizures: must be gradually withdrawn
• 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 in patients below the age of 16 years have not 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