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ESLICARBAZEPINE ACETATE
DIR Classification
Classification:Ambiguous
Severity Score:1.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- CLINICAL PHARMACOLOGY
- Pharmacodynamics
- The effect of APTIOM on cardiac repolarization was evaluated in a randomized, double-blind, placebo- and active-controlled 4-period crossover trial in healthy adult men and women. Subjects received APTIOM 1200 mg once daily × 5 days, APTIOM 2400 mg once daily × 5 days, an active-control, moxifloxacin 400 mg × 1 dose on Day 5, and placebo once daily × 5 days. At both doses of APTIOM, no significant effect on the QTc interval was detected.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
4
24088
Other ADRs
4050
38377537
Odds Ratio = 1.574
Drug Property Information
ATC Code(s):
- N03AF04 - eslicarbazepine acetate
- N03AF0 -
- N03AF - Carboxamide derivatives
- N03A - ANTIEPILEPTICS
- N03 - ANTIEPILEPTICS
- N - NERVOUS SYSTEM
Active Ingredient:ESLICARBAZEPINE ACETATE
Active Ingredient UNII:BEA68ZVB2K
Drugbank ID:DB09119
PubChem Compound:179344
CTD ID:C416835
CAS Number:236395-14-5
Dosage Form(s):kit; tablet
Route(s) Of Administrator:oral
Daily Dose:
- 800.0 mg/day N03AF04
Chemical Structure: 
SMILE Code:
CC(=O)O[C@H]1CC2=CC=CC=C2N(C(N)=O)C2=CC=CC=C12
CC(=O)O[C@H]1CC2=CC=CC=C2N(C(N)=O)C2=CC=CC=C12
Reference
N/A
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