Levetiracetam

What it is and how it works

Mechanism of Action The precise mechanism(s) by which levetiracetam exerts its antiepileptic effect is unknown. A saturable and stereoselective neuronal binding site in rat brain tissue has been described for levetiracetam. Experimental data indicate that this binding site is the synaptic vesicle protein SV2A, thought to be involved in the regulation of vesicle exocytosis. Although the molecular significance of levetiracetam binding to SV2A is not understood, levetiracetam and related analogs showed a rank order of affinity for SV2A which correlated with the potency of their antiseizure activity in audiogenic seizure-prone mice.

Indications

Levetiracetam tablets USP are indicated for the treatment of partial-onset seizures in patients 1 month of age and older Levetiracetam tablets USP are indicated for adjunctive therapy for 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 6 years of age and older with idiopathic generalized epilepsy Partial Onset Seizures Levetiracetam tablets USP are indicated for treatment of partial-onset seizures in patients 1 month of age and older. Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy Levetiracetam tablets USP are indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy.

Dosage and administration (summary)

Use the oral solution for pediatric patients with body weight ≤ 20 kg . For pediatric patients, use weight-based dosing for the oral solution with a calibrated measuring device (not a household teaspoon or tablespoon) Partial Onset Seizures (monotherapy or adjunctive therapy) 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.

Contraindications

Known hypersensitivity to levetiracetam; angioedema and anaphylaxis have occurred ( 4 , 5.4 ) Levetiracetam is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema .

Warnings and precautions

Behavioral abnormalities including psychotic symptoms, suicidal ideation, irritability, and aggressive behavior have been observed; monitor patients for psychiatric signs and symptoms Suicidal Behavior and Ideation: Monitor patients for new or worsening depression, suicidal thoughts/behavior, and/or unusual changes in mood or behavior Monitor for somnolence and fatigue and advise patients not to drive or operate machinery until they have gained sufficient experience on levetiracetam Serious Dermatological Reactions: Discontinue levetiracetam at the first sign of rash unless clearly not drug re…

Pregnancy

Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), including Levetiracetam, during pregnancy.

Storage and supply

Product: 50090-6378 NDC: 50090-6378-0 30 TABLET, FILM COATED in a BOTTLE NDC: 50090-6378-1 60 TABLET, FILM COATED in a BOTTLE NDC: 50090-6378-2 180 TABLET, FILM COATED in a BOTTLE

Source: Levetiracetam (Levetiracetam) — US FDA prescribing information, 2026-03-23, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.