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Molecule

Levetiracetam

Decreased Central Nervous System Disorganized Electrical Activity
Available on requestNeurology
Presentations
30
Brands
6
Manufacturers
4
Available from stock
0

Levetiracetam is a prescription medicine indicated for the treatment of partial-onset seizures in patients 1 month of age and older, among other approved uses. MedsAcross supplies Levetiracetam for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

Pharmacological class
Decreased Central Nervous System Disorganized Electrical Activity
ATC classification
N03AX14 Levetiracetam · Anticonvulsant agent, subgroup N03AX
US FDA first approval
30 November 1999
EU status
Authorised
Orphan designation
No
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral, Intravenous
Dosage forms
Tablet, Injection, Extended-release tablet, Oral solution, Tablet for oral suspension
Identifiers
UNII 44YRR34555RxCUI 114477CAS 102767-28-2DrugBank DB01202Q417227

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

KEPPRA is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. KEPPRA is indicated for adjunctive therapy for the treatment of: 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

Source: US FDA prescribing information

How it works

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. These findings suggest that the interaction of levetiracetam with the SV2A protein may contribute to the antiepileptic mechanism of action of the drug.

Source: US FDA prescribing information

Dosing overview

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, 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.

Source: US FDA prescribing information

Contraindications

KEPPRA is contraindicated in patients with a hypersensitivity to levetiracetam. Reactions have included anaphylaxis and angioedema. Known hypersensitivity to levetiracetam, angioedema and anaphylaxis have occurred

Source: US FDA prescribing information

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 KEPPRA. Serious Dermatological Reactions: Discontinue KEPPRA at the first sign of rash unless clearly not drug related. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity: Discontinue if no alternative etiology. Coordination Difficulties: Monitor for ataxia, abnormal gait, and incoordination.

Source: US FDA prescribing information

Side effects

The following adverse reactions are discussed in more details in other sections of labeling: Behavior Abnormalities and Psychotic Symptoms Suicidal Behavior and Ideation Somnolence and Fatigue Anaphylaxis and Angioedema Serious Dermatological Reactions Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Coordination Difficulties Hematologic Abnormalities Increase in Blood Pressure 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

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

30 presentations of Levetiracetam, sorted by availability.

MedicineManufacturerRegisterAvailability
Levetiracetam 500 mg tabletOralGeneric name—US FDAAvailable on request
Levetiracetam 250 mg tabletOralGeneric name—US FDAAvailable on request
Levetiracetam 1000 mg tabletOralGeneric name—US FDAAvailable on request
Levetiracetam 750 mg tabletOralGeneric name—US FDAAvailable on request
Levetiracetam 100 mg/mL oral solutionOralGeneric name—US FDAAvailable on request
Levetiracetam 500 mg extended-release tabletOralGeneric name—US FDAAvailable on request
Levetiracetam 500 mg/5 mL injectionIntravenousGeneric name—US FDAAvailable on request
Levetiracetam 750 mg extended-release tabletOralGeneric name—US FDAAvailable on request
Levetiracetam 1000 mg/100 mL injectionIntravenousGeneric name—US FDAAvailable on request
Levetiracetam 500 mg/100 mL injectionIntravenousGeneric name—US FDAAvailable on request
Levetiracetam 1500 mg/100 mL injectionIntravenousGeneric name—US FDAAvailable on request
Elepsia XR 1000 MG 1000 mg extended-release tabletOralTripoint TherapeuticsUS FDAAvailable on request
Elepsia XR 1500 MG 1500 mg extended-release tabletOralTripoint TherapeuticsUS FDAAvailable on request
Levetiracetam 250 mg tablet for oral suspensionOralGeneric name—US FDAAvailable on request
Spritam 250 mg tablet for oral suspensionOralAprecia PharmaceuticalsUS FDAAvailable on request
Spritam 500 mg tablet for oral suspensionOralAprecia PharmaceuticalsUS FDAAvailable on request
Keppra 100 mg/mL oral solutionOralUCBUS FDAAvailable on request
Keppra 1000 mg tabletOralUCBUS FDAAvailable on request
Keppra 250 mg tabletOralUCBUS FDAAvailable on request
Keppra 500 mg tabletOralUCBUS FDAAvailable on request
Keppra 500 mg/5 mL injectionIntravenousUCBUS FDAAvailable on request
Keppra 750 mg tabletOralUCBUS FDAAvailable on request
Keppra XR 500 mg extended-release tabletOralUCBUS FDAAvailable on request
Keppra XR 750 mg extended-release tabletOralUCBUS FDAAvailable on request
Levetiracetam 1000 mg extended-release tabletOralGeneric name—US FDAAvailable on request
Levetiracetam 500 mg tablet for oral suspensionOralGeneric name—US FDAAvailable on request
Roweepra 250 mg tabletOralOWP PharmaceuticalsUS FDAAvailable on request
Spritam 1000 mg tablet for oral suspensionOralAprecia PharmaceuticalsUS FDAAvailable on request
Spritam 750 mg tablet for oral suspensionOralAprecia PharmaceuticalsUS FDAAvailable on request
Levetiracetam 100 mg/mL injectionIntravenousGeneric name—US FDAAvailable on request

Brands by market

6 brand names across 1 markets.

Brand names by country

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 30 November 1999Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Levetiracetam in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Levetiracetam available for export from India?

Yes, on request. MedsAcross lists 30 presentations of Levetiracetam and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Levetiracetam have?

The catalogue lists 6 brand names for Levetiracetam, including Elepsia XR 1000 MG, Elepsia XR 1500 MG, Keppra, Keppra XR, Roweepra, Spritam.

Is Levetiracetam approved by the US FDA?

Yes. The US FDA first approved Levetiracetam on 30 November 1999, according to Drugs@FDA.

Is Levetiracetam authorised in the European Union?

Yes. Levetiracetam has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Levetiracetam need cold chain shipping?

No listed presentation of Levetiracetam is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Levetiracetam in?

Levetiracetam is classified under ATC code N03AX14 (Levetiracetam).

References

  1. Keppra prescribing information (UCB). U.S. National Library of Medicine, DailyMed. Retrieved 28 January 2026
  2. Keppra: European public assessment report (EPAR). European Medicines Agency. Retrieved 1 April 2026
  3. Levetiracetam Accord: European public assessment report (EPAR). European Medicines Agency. Retrieved 9 December 2025

Request Levetiracetam for export supply

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