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PERAMPANEL
DIR Classification
Classification:Ambiguous
Severity Score:1.0
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- CLINICAL PHARMACOLOGY
- Pharmacodynamics
- Potential to Prolong QT Interval
- In a placebo-controlled thorough QT study of perampanel in healthy subjects, there was no evidence that perampanel caused QT interval prolongation of clinical significance at doses of 6 or 12 mg (i.e., the upper bound of the 95% confidence interval for the largest placebo-adjusted baseline-corrected QTc was below 10 msec). The exposures observed with the 12 mg dose in this study will not cover the exposures expected in patients with hepatic impairment taking doses over 6 mg/day. At the highest recommended dose (12 mg), perampanel did not prolong the QTc interval to any clinically relevant extent.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
2
24090
Other ADRs
3820
38377767
Odds Ratio = 0.835
Drug Property Information
ATC Code(s):
- N03AX22 - perampanel
- N03AX - Other antiepileptics
- N03A - ANTIEPILEPTICS
- N03 - ANTIEPILEPTICS
- N - NERVOUS SYSTEM
Active Ingredient:PERAMPANEL
Active Ingredient UNII:H821664NPK
Drugbank ID:DB08883
PubChem Compound:9924495
CTD ID:C551441
CAS Number:380917-97-5
Dosage Form(s):suspension; tablet
Route(s) Of Administrator:oral
Daily Dose:
- 8.0 mg/day N03AX22
Chemical Structure: 
SMILE Code:
O=C1N(C=C(C=C1C1=CC=CC=C1C#N)C1=NC=CC=C1)C1=CC=CC=C1
O=C1N(C=C(C=C1C1=CC=CC=C1C#N)C1=NC=CC=C1)C1=CC=CC=C1
Reference
N/A
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