Search for drugs:

TAPENTADOL HYDROCHLORIDE


DIR Classification


Classification:Ambiguous
Severity Score:1.0

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

  • CLINICAL PHARMACOLOGY
  • Pharmacodynamics
  • Effects on the Cardiovascular System
  • There was no effect of therapeutic and supratherapeutic doses of tapentadol on the QT interval. In a randomized, double-blind, placebo- and positive-controlled crossover study, healthy subjects were administered five consecutive immediate-release formulation doses of tapentadol 100 mg every 6 hours, tapentadol 150 mg every 6 hours, placebo and a single oral dose of moxifloxacin. Similarly, the immediate- release formulation tapentadol had no relevant effect on other ECG parameters (heart rate, PR interval, QRS duration, T-wave or U-wave morphology).

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
QT Prolongation
9
24083
Other ADRs
14610
38366977

Odds Ratio = 0.982

Drug Property Information



ATC Code(s):
  • N02AX06 - tapentadol hydrochloride
    • N02AX0 -
    • N02AX - Other opioids
    • N02A - OPIOIDS
    • N02 - ANALGESICS
    • N - NERVOUS SYSTEM
Active Ingredient:TAPENTADOL HYDROCHLORIDE
Active Ingredient UNII:71204KII53
Drugbank ID:DB06204
PubChem Compound:9838022
CTD ID: D000077432
PharmGKB:PA166179720
CAS Number:175591-23-8
Dosage Form(s):tablet, film coated, extended release
Route(s) Of Administrator:oral
Daily Dose:
  • 400.0 mg/day N02AX06
Chemical Structure:
SMILE Code:
CC[C@H]([C@@H](C)CN(C)C)C1=CC(O)=CC=C1

Reference

N/A

Disclaimer:

The content of this database of QT prolongation is intended for educational and scientific research purposes only. It is not intended as a substitute for professional medical advice, diagnosis or treatment.

Any mention of commercial products is for clarification and not intended as endorsement.