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VIGABATRIN
DIR Classification
Classification:Ambiguous
Severity Score:1.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- CLINICAL PHARMACOLOGY
- Pharmacodynamics
- Effects on Electrocardiogram
- There is no indication of a QT/QTc prolonging effect of vigabatrin in single doses up to 6 g. In a randomized, placebo-controlled, crossover study, 58 healthy subjects were administered a single oral dose of vigabatrin (3 g and 6 g) and placebo. Peak concentrations for 6 g vigabatrin were approximately 2-fold higher than the peak concentrations following the 3 g single oral dose.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
0
24092
Other ADRs
17217
38364370
Odds Ratio = 0.0
Drug Property Information
ATC Code(s):
- N03AG04 - vigabatrin
- N03AG0 -
- N03AG - Fatty acid derivatives
- N03A - ANTIEPILEPTICS
- N03 - ANTIEPILEPTICS
- N - NERVOUS SYSTEM
Active Ingredient:VIGABATRIN
Active Ingredient UNII:GR120KRT6K
Drugbank ID:DB01080
PubChem Compound:5665
CTD ID:D020888
PharmGKB:PA10231
CAS Number:68506-86-5
Dosage Form(s):for solution
Route(s) Of Administrator:oral
Daily Dose:
- 2000.0 mg/day N03AG04
Chemical Structure: 
SMILE Code:
NC(CCC(O)=O)C=C
NC(CCC(O)=O)C=C
Reference
N/A
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