Levetiracetam 500 mg Tablets — Generic For Keppra — Lupin

These highlights do not include all the information needed to use LEVETIRACETAM TABLETS USP safely and effectively. See full prescribing information for LEVETIRACETAM TABLETS USP.

LEVETIRACETAM tablets USP, for oral use

Initial U.S. Approval: 1999

Recent Major Changes

Warnings and Precautions (5.6) 3/2024

Indications And Usage

Levetiracetam tablets USP are indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1)

Levetiracetam tablets USP are indicated for adjunctive therapy for treatment of:

Partial onset seizures in patients one month of age and older with epilepsy (1.1)

Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2)

Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3)

Dosage And Administration

Use the oral solution for pediatric patients with body weight ≤ 20 kg (2.1).

For pediatric patients, use weight-based dosing for the oral solution with a calibrated measuring device (not a household teaspoon or tablespoon) (2.1)

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 (2.2)

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 (2.2)

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 (2.2)

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 (2.2)

Myoclonic Seizures in Adults and Pediatric Patients 12 Years and Older

500 mg twice daily; increase by 500 mg twice daily every 2 weeks to recommended dose of 1500 mg twice daily (2.3)

Primary Generalized Tonic-Clonic Seizures

6 Years to < 16 Years: 10 mg/kg twice daily, increase in increments of 10 mg/kg twice daily every 2 weeks to recommended dose of 30 mg/kg twice daily (2.4)

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 (2.4)

Adult Patients with Impaired Renal Function

Dose adjustment is recommended, based on the patient's estimated creatinine clearance (2.5, 8.6)

Dosage Forms And Strengths

250 mg, 500 mg, 750 mg, and 1000 mg film-coated, scored tablets (3)

Contraindications

Known hypersensitivity to levetiracetam; angioedema and anaphylaxis have occurred (4, 5.4)

Warnings And Precautions

• (5.6) 3/2024 INDICATIONS AND USAGE Levetiracetam tablets USP are indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1) Levetiracetam tablets USP are indicated for adjunctive therapy for treatment of:
• Partial onset seizures in patients one month of age and older with epilepsy (1.1)
• Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2)
• Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3) DOSAGE AND ADMINISTRATION
• Use the oral solution for pediatric patients with body weight ≤ 20 kg (2.1).
• For pediatric patients, use weight-based dosing for the oral solution with a calibrated measuring device (not a household teaspoon or tablespoon) (2.1) 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 (2.2)
• 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 (2.2)

• (5.6) 3/2024 INDICATIONS AND USAGE Levetiracetam tablets USP are indicated for the treatment of partial-onset seizures in patients 1 month of age and older (1.1) Levetiracetam tablets USP are indicated for adjunctive therapy for treatment of:
• Partial onset seizures in patients one month of age and older with epilepsy (1.1)
• Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2)
• Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3) DOSAGE AND ADMINISTRATION
• Use the oral solution for pediatric patients with body weight ≤ 20 kg (2.1).
• For pediatric patients, use weight-based dosing for the oral solution with a calibrated measuring device (not a household teaspoon or tablespoon) (2.1) 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 (2.2)
• 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 (2.2)

Behavioral abnormalities including psychotic symptoms, suicidal ideation, irritability, and aggressive behavior have been observed; monitor patients for psychiatric signs and symptoms (5.1)

Suicidal Behavior and Ideation: Monitor patients for new or worsening depression, suicidal thoughts/behavior, and/or unusual changes in mood or behavior (5.2)

Monitor for somnolence and fatigue and advise patients not to drive or operate machinery until they have gained sufficient experience on levetiracetam (5.3)

Serious Dermatological Reactions: Discontinue levetiracetam at the first sign of rash unless clearly not drug related (5.5)

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity: Discontinue if no alternative etiology (5.6)

Coordination Difficulties: Monitor for ataxia, abnormal gait, and incoordination. Advise patients to not drive or operate machinery until they have gained experience on levetiracetam (5.7)

Withdrawal Seizures: Levetiracetam must be gradually withdrawn (5.8)

Adverse Reactions

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

Adult patients: somnolence, asthenia, infection and dizziness (6.1)

Pediatric patients: fatigue, aggression, nasal congestion, decreased appetite, and irritability (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceutical Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Use In Specific Populations

Pregnancy: Plasma levels of levetiracetam may be decreased and therefore need to be monitored closely during pregnancy. Based on animal data, may cause fetal harm (5.11, 8.1)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.

Revised: 5/2026