Neurocet(Levetiracetam)

Therapeutic Group: Drugs of Nervous System

Presentation

Neurocet 250: Each tablet contains Levetiracetam USP 250 mg.

Neurocet 500: Each tablet contains Levetiracetam USP 500 mg.

Description

The precise mechanism(s) by which Levetiracetam exerts its antiepileptic effect is unknown. Levetiracetam showed only minimal activity in submaximal stimulation and in threshold tests. Protection was observed, however, against secondarily generalized activity from focal seizures induced by pilocarpine and kainic acid, two chemoconvulsants that induce seizures that mimic some features of human complex partial seizures with secondary generalization. In vitro and in vivo recordings of epileptiform activity from the hippocampus have shown that Levetiracetam inhibits burst firing without affecting normal neuronal excitability, suggesting that Levetiracetam may selectively prevent hypersynchronization of epileptiform burst firing and propagation of seizure activity.

Indications

Levetiracetam is indicated for adjunctive therapy in the treatment of:

• Partial onset seizures in patients one month of age and older with epilepsy

• Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy

• Primary generalized tonic-clonic seizures in patients

Dosage & Administration

Partial Onset Seizures
• 1 Month to < 6 Months: 7 mg/kg twice daily; increase by 7 mg/kg twice daily every 2 weeks to recommended dose of 21 mg/kg twice daily
• 6 Months to < 4 Years: 10 mg/kg twice daily; increase by 10 mg/kg twice daily every 2 weeks to recommended dose of 25 mg/kg twice daily
• 4 Years to < 16 Years: 10 mg/kg twice daily; increase by 10 mg/kg twice daily every 2 weeks to recommended dose of 30 mg/kg twice daily
• Adults 16 Years and Older: 500 mg twice daily; increase by 500 mg twice daily every 2 weeks to a recommended dose of 1500 mg twice daily
Myoclonic Seizures in Adults and Pediatric Patients 12 Years and Older
• 500 mg twice daily; increase by 500 mg twice daily every 2 weeks to recommended dose of 1500 mg twice daily
Primary Generalized Tonic-Clonic Seizures
• 6 Years to < 16 Years: 10 mg/kg twice daily, increase in increments of 10 mg/kg twice daily every 2 weeks to recommended dose of 30 mg/kg twice daily.
Adults 16 Years and Older:
• 500 mg twice daily, increase by 500 mg twice daily every 2 weeks to recommended dose of 1500 mg twice daily
Adult Patients with Impaired Renal Function
• Dose adjustment is recommended, based on the patient’s estimated creatinine clearance.

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

Precautions

Levetiracetam may cause behavioral abnormalities and psychotic symptoms. Patients treated with Levetiracetam should be monitored for psychiatric signs and symptoms.

Use in Pregnancy & Lactation

Pregnancy: Pregnancy Category C.

Nursing mothers: Levetiracetam is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Levetiracetam, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use
The safety and effectiveness of Levetiracetam in the adjunctive treatment of partial onset seizures in pediatric patients’ age 1 month to 16 years old with epilepsy have been established.