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CLOBAZAM
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
- The effect of clobazam tablets 20 mg and 80 mg administered twice daily on QTc interval was evaluated in a randomized, evaluator-blinded, placebo-, and active-controlled (moxifloxacin 400 mg) parallel thorough QT study in 280 healthy subjects. In a study with demonstrated ability to detect small effects, the upper bound of the one-sided 95% confidence interval for the largest placebo-adjusted, baseline-corrected QTc based on the Fridericia correction method was below 10 ms, the threshold for regulatory concern. Thus, at a dose two times the maximum recommended dose, clobazam tablets did not prolong the QTc interval to any clinically relevant extent.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
QT Prolongation
5
24087
Other ADRs
10010
38371577
Odds Ratio = 0.796
Drug Property Information
ATC Code(s):
- N05BA09 - clobazam
- N05BA0 -
- N05BA - Benzodiazepine derivatives
- N05B - ANXIOLYTICS
- N05 - PSYCHOLEPTICS
- N - NERVOUS SYSTEM
Active Ingredient:CLOBAZAM
Active Ingredient UNII:2MRO291B4U
Drugbank ID:DB00349
PubChem Compound:2789
CTD ID:D000078306
PharmGKB:PA10888
CAS Number:22316-47-8
Dosage Form(s):tablet
Route(s) Of Administrator:oral
Daily Dose:
- 20.0 mg/day N05BA09
Chemical Structure: 
SMILE Code:
CN1C2=C(C=C(Cl)C=C2)N(C2=CC=CC=C2)C(=O)CC1=O
CN1C2=C(C=C(Cl)C=C2)N(C2=CC=CC=C2)C(=O)CC1=O
Reference
N/A
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