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LEVETIRACETAM


DIR Classification


Classification:Ambiguous
Severity Score:1.0

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

  • CLINICAL PHARMACOLOGY
  • Pharmacodynamics
  • Effect on QTc Interval
  • The effect of levetiracetam on QTc prolongation was evaluated in a randomized, double-blind, positive-controlled (moxifloxacin 400 mg) and placebo-controlled crossover study of levetiracetam (1000 mg or 5000 mg) in 52 healthy subjects. The upper bound of the 90% confidence interval for the largest placebo-adjusted, baseline-corrected QTc was below 10 milliseconds. Therefore, there was no evidence of significant QTc prolongation in this study.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
QT Prolongation
135
23957
Other ADRs
104414
38277173

Odds Ratio = 2.066

Drug Property Information



ATC Code(s):
  • N03AX14 - levetiracetam
    • N03AX - Other antiepileptics
    • N03A - ANTIEPILEPTICS
    • N03 - ANTIEPILEPTICS
    • N - NERVOUS SYSTEM
Active Ingredient:LEVETIRACETAM
Active Ingredient UNII:44YRR34555
Drugbank ID:DB01202
PubChem Compound:5284583
CTD ID:D000077287
PharmGKB:PA450206
CAS Number:102767-28-2
Dosage Form(s):tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
  • 1500.0 mg/day N03AX14
Chemical Structure:
SMILE Code:
CC[C@H](N1CCCC1=O)C(N)=O

Reference

N/A

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The content of this database of QT prolongation is intended for educational and scientific research purposes only. It is not intended as a substitute for professional medical advice, diagnosis or treatment.

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