Levetiracetam Injection, USP is a sterile, clear, colorless antiepileptic solution for intravenous use, supplied as 500 mg per 5 mL (100 mg/mL) in single-dose vials. It is indicated as an IV alternative when oral administration is temporarily not feasible, and is chemically unrelated to other antiepileptic drugs (AEDs).

Indicated for partial-onset seizures in patients 1 month of age and older, adjunctive treatment of myoclonic seizures in patients 12 years and older with juvenile myoclonic epilepsy (JME), and adjunctive treatment of primary generalized tonic-clonic (PGTC) seizures in patients 6 years and older with idiopathic generalized epilepsy.

Key Benefits

• Broad Seizure Indication Coverage: Clinically indicated across three seizure types — partial-onset, myoclonic, and primary generalized tonic-clonic — spanning pediatric patients as young as 1 month through adults.
• Bioequivalent IV Alternative: Equivalent IV and oral levetiracetam doses produce equivalent systemic exposure, enabling seamless transitions when oral administration is not feasible.
• Predictable, Linear Pharmacokinetics: Low intra- and inter-subject variability with a plasma half-life of approximately 6–8 hours in adults; not liver cytochrome P450 dependent, minimizing drug–drug interaction risk.
• Pediatric Weight-Based Dosing Available: Established dosing protocols for patients from 1 month of age, with weight-based calculations and age-stratified titration schedules.
• Sterile, Latex-Free Single-Dose Vials: Preservative-free solution in 5 mL vials; vial stopper contains no natural rubber latex.

Dosage and Administration

Levetiracetam Injection is for intravenous use only. Must be diluted in 100 mL of a compatible diluent (0.9% sodium chloride, lactated Ringer's, or 5% dextrose) prior to administration. Administer as a 15-minute IV infusion. Maximum levetiracetam concentration in diluted solution must not exceed 15 mg/mL (relevant for pediatric patients requiring smaller volumes). Diluted solution is stable for up to 4 hours at controlled room temperature (15–30°C). Discard any unused portion.

• Partial-Onset Seizures — Adults (≥16 years): Initiate at 500 mg twice daily; titrate by 500 mg twice daily every 2 weeks to recommended dose of 1,500 mg twice daily (max 3,000 mg/day).
• Partial-Onset Seizures — Pediatric (1 month to <6 months): 7 mg/kg twice daily; increase by 7 mg/kg twice daily every 2 weeks to 21 mg/kg twice daily.
• Partial-Onset Seizures — Pediatric (6 months to <4 years): 10 mg/kg twice daily; increase every 2 weeks to 25 mg/kg twice daily.
• Partial-Onset Seizures — Pediatric (4 to <16 years): 10 mg/kg twice daily; increase every 2 weeks to 30 mg/kg twice daily.
• Myoclonic Seizures (≥12 years) / PGTC — Adults: Initiate at 500 mg twice daily; titrate by 500 mg twice daily every 2 weeks to 1,500 mg twice daily (3,000 mg/day recommended).
• PGTC — Pediatric (6 to <16 years): 10 mg/kg twice daily; increase by 10 mg/kg twice daily every 2 weeks to 30 mg/kg twice daily.
• Renal Impairment (Adults): Dose adjustment required based on creatinine clearance. ESRD patients on dialysis: 500–1,000 mg every 24 hours; supplemental dose of 250–500 mg recommended following dialysis.
• Switching from/to Oral Levetiracetam: Total daily IV dosage and frequency should be equivalent to the oral regimen.

Why Choose Levetiracetam Injection 100 mg/mL?

• Critical Care IV Bridge: Provides a clinically validated intravenous option for epilepsy patients temporarily unable to take oral medications, with no dose conversion required.
• Minimal Drug Interaction Profile: Not metabolized via cytochrome P450 pathways; does not alter plasma concentrations of commonly co-administered AEDs including valproate, phenytoin, carbamazepine, and lamotrigine.
• Convenient Unit-of-Use Packaging: Supplied as 10 single-dose 5 mL vials per tray (NDC 55150-177-05), supporting accurate dosing and reducing waste.

Warnings

• Behavioral and Psychiatric Effects: Levetiracetam may cause behavioral abnormalities (aggression, irritability, depression) and psychotic symptoms in both adult and pediatric patients. Monitor closely for psychiatric signs and symptoms throughout treatment; do not abruptly discontinue.
• Serious Hypersensitivity Reactions: Anaphylaxis, angioedema, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and DRESS/multiorgan hypersensitivity have been reported. Discontinue immediately at the first sign of rash or systemic hypersensitivity if no alternative etiology is established.
• Gradual Withdrawal Required: Abrupt discontinuation increases the risk of seizure frequency and status epilepticus. Taper dose gradually unless rapid withdrawal is necessitated by a serious adverse reaction.

Disclaimer: This product description was generated by AI and is intended for informational purposes only. Please consult the latest package insert.