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DABIGATRAN ETEXILATE MESYLATE


DIR Classification


Classification:Ambiguous
Severity Score:1.0

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

  • CLINICAL PHARMACOLOGY
  • Pharmacodynamics
  • Cardiac Electrophysiology
  • No prolongation of the QTc interval was observed with dabigatran etexilate at doses up to 600 mg.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
QT Prolongation
0
24092
Other ADRs
4512
38377075

Odds Ratio = 0.0

Drug Property Information



ATC Code(s):
  • B01AE07 - dabigatran etexilate mesylate
    • B01AE0 -
    • B01AE - Direct thrombin inhibitors
    • B01A - ANTITHROMBOTIC AGENTS
    • B01 - ANTITHROMBOTIC AGENTS
    • B - BLOOD AND BLOOD FORMING ORGANS
Active Ingredient:dabigatran etexilate mesylate
Active Ingredient UNII:SC7NUW5IIT
Drugbank ID:DB06695
PubChem Compound:6445226
CTD ID:
PharmGKB:PA165958369
CAS Number:211915-06-9
Dosage Form(s):capsule
Route(s) Of Administrator:oral
Daily Dose:
  • 300.0 mg/day B01AE07
Chemical Structure:
SMILE Code:
CCCCCCOC(=O)\N=C(\N)C1=CC=C(NCC2=NC3=C(C=CC(=C3)C(=O)N(CCC(=O)OCC)C3=NC=CC=C3)N2C)C=C1

Reference

N/A

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