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VILAZODONE HYDROCHLORIDE
DIR Classification
Classification:Ambiguous
Severity Score:1.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- CLINICAL PHARMACOLOGY
- Pharmacodynamics
- Cardiac Electrophysiology
- Treatment with VIIBRYD did not prolong the QTc interval. The effect of VIIBRYD [20, 40, 60, and 80 mg (2 times the recommended dosage)] on the QTc interval was evaluated in a randomized, placebo-, and active-controlled (moxifloxacin 400 mg), parallel-group, thorough QTc study in 157 healthy subjects. The study demonstrated an ability to detect small effects. The upper bound of the 90% confidence interval for the largest placebo-adjusted, baseline-corrected QTc interval was below 10 msec, based on the individual correction method (QTcI). Thus, at doses of 2 times the recommended dosage, VIIBRYD did not prolong the QTc interval to a clinically relevant extent.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
3
24089
Other ADRs
12319
38369268
Odds Ratio = 0.388
Drug Property Information
ATC Code(s):
- N06AX24 - vilazodone hydrochloride
- N06AX2 -
- N06AX - Other antidepressants
- N06A - ANTIDEPRESSANTS
- N06 - PSYCHOANALEPTICS
- N - NERVOUS SYSTEM
Active Ingredient:VILAZODONE HYDROCHLORIDE
Active Ingredient UNII:U8HTX2GK8J
Drugbank ID:DB06684
PubChem Compound:6918314
CTD ID:D000069503
CAS Number:163521-12-8
Dosage Form(s):kit; tablet
Route(s) Of Administrator:oral
Daily Dose:
Chemical Structure: 
SMILE Code:
NC(=O)C1=CC2=CC(=CC=C2O1)N1CCN(CCCCC2=CNC3=C2C=C(C=C3)C#N)CC1
NC(=O)C1=CC2=CC(=CC=C2O1)N1CCN(CCCCC2=CNC3=C2C=C(C=C3)C#N)CC1
Reference
N/A
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