Levetiracetam Concentrated Solution for injection

【DOSAGE FORMS AND STRENGTHS】Injection: 500 mg/5 mL single-dose vial

【INDICATIONS AND USAGE】

l Levetiracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of

age and older

l Levetiracetam injection is indicated for adjunctive therapy for the treatment of:

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

2. Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic

generalized epilepsy

l Levetiracetam injection is for intravenous use only as an alternative for patients when oral

administration is temporarily not feasible

【DOSAGE AND ADMINISTRATION】

Levetiracetam injection is for intravenous use only

Partial-Onset Seizures (monotherapy or adjunctive therapy)

l 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  

l 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

l 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

l 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

l 500 mg twice daily; increase by 500 mg twice daily every 2 weeks to recommended dose of 1,500 mg

twice daily

Primary Generalized Tonic-Clonic Seizures

l 6 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

l 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

Switching From or To Oral Levetiracetam

When switching from or to oral levetiracetam, the total daily dosage/frequency of levetiracetam injection

should be equivalent to those of oral levetiracetam

See full prescribing information for preparation and administration instructions (2.6) and dosage

adjustment in adults with renal impairment

【ADVERSE REACTIONS】

Most common adverse reactions (incidence ≥ 5% more than placebo) include:

l Adults: somnolence, asthenia, infection, and dizziness

l Pediatric patients: fatigue, aggression, nasal congestion, decreased appetite, and irritability