Levetiracetam — 500 mg in 5 mL, Solution for injection, carton of 10 × 5 mL vials

Levetiracetam — 500 mg in 5 mL, Solution for injection, carton of 10 × 5 mL vials

Levetiracetam is a solution for injection for intravenous use. • Levetiracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1 ) • Levetiracetam injection is indicated for adjunctive therapy for the treatment of: o Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2 ) o Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3 ) • Levetiracetam injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible ( 1.4 ) 1.1 Partial-Onset Seizures Levetiracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy Levetiracetam injection is indicated as adjunctive therapy for the treatment of myoclonic seizures in

• Active ingredient or product type: LEVETIRACETAM
• Strength/concentration: 500 mg in 5 mL
• Dosage form and route: Solution for injection, Intravenous
• Exact package presentation: carton of 10 × 5 mL vials
• NDC/item number: 55150-177-05
• Manufacturer: EUGIA US LLC
• Storage/handling: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
• Status: Rx only

Important safety information: Behavioral abnormalities including psychotic symptoms, suicidal ideation, irritability, and aggressive behavior have been observed; monitor patients for psychiatric signs and symptoms (5.1) Monitor for somnolence and fatigue; advise patients not to drive or operate machinery until they have sufficient experience on levetiracetam (5.2) Serious Dermatological Reactions: Discontinue levetiracetam at the first sign of rash unless clearly not drug related (5.4) Drug Reaction with Eosinophilia and Sys

Refer to the current product labeling for complete indications, preparation or administration instructions, contraindications, warnings, precautions, and storage requirements.