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Levetiracetam

LEVETIRACETAM

Manufacturer: Mylan Pharmaceuticals Inc.

Score: 141.0

Quick Summary

Levetiracetam is an antiepileptic drug used for the adjunctive treatment of partial onset seizures in patients 4 years of age and older, myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy. The drug has been shown to be effective in reducing seizure frequency and is generally well-tolerated, but may cause adverse reactions such as somnolence, fatigue, and behavioral changes. Dosing recommendations vary by age and weight, and special considerations are needed for patients with impaired renal function, pregnant women, nursing mothers, pediatric patients, and geriatric patients.

Key Clinical Findings and Indications

  • Adjunctive treatment of partial onset seizures in patients 4 years of age and older
  • Adjunctive treatment of myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy
  • Adjunctive treatment of primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy

Important Safety Information

Warning

Levetiracetam may cause behavioral changes, including aggression, anxiety, and depression, and may worsen suicidal thoughts or behaviors

Contraindications

Adverse Reactions

  • Somnolence
  • Fatigue
  • Aggression
  • Anxiety
  • Depression

Dosing Recommendations

General Guidance

Dose adjustment is recommended for patients with impaired renal function

Partial onset seizures

Adult Dose

500 mg twice daily, increase as needed and tolerated in increments of 500 mg twice daily every 2 weeks to a maximum recommended dose of 1500 mg twice daily

Pediatric Dose

10 mg/kg twice daily, increase in increments of 10 mg/kg twice daily every 2 weeks to a recommended dose of 30 mg/kg twice daily

Myoclonic seizures

Adult Dose

500 mg twice daily, increase by 500 mg twice daily every 2 weeks to a recommended dose of 1500 mg twice daily

Pediatric Dose

Not applicable

Primary generalized tonic-clonic seizures

Adult Dose

500 mg twice daily, increase by 500 mg twice daily every 2 weeks to a recommended dose of 1500 mg twice daily

Pediatric Dose

10 mg/kg twice daily, increase in increments of 10 mg/kg twice daily every 2 weeks to a recommended dose of 30 mg/kg twice daily

Special Population Considerations

Pregnancy

  • Levetiracetam levels may decrease during pregnancy
  • Use during pregnancy only if the potential benefit justifies the potential risk to the fetus

Nursing Mothers

  • Levetiracetam is excreted in human milk
  • A decision should be made whether to discontinue nursing or discontinue the drug

Pediatric Use

  • Safety and effectiveness established in pediatric patients 4 years of age and older
  • Dosing recommendations vary by age and weight

Geriatric Use

  • No overall differences in safety were observed between elderly and younger subjects
  • Dose selection should be cautious in elderly patients with impaired renal function