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SAFINAMIDE 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
  • The effect of XADAGO on the QTc interval was evaluated in a randomized placebo and positive controlled double-blind, multiple-dose parallel thorough QTc study in 240 healthy subjects. At a dose of 350 mg (3.5 times the maximum recommended dosage), XADAGO did not prolong the QTc interval.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
QT Prolongation
0
24092
Other ADRs
0
38381587

Odds Ratio = N/A

Drug Property Information



ATC Code(s):
  • N04BD03 - safinamide mesylate
    • N04BD0 -
    • N04BD - Monoamine oxidase B inhibitors
    • N04B - DOPAMINERGIC AGENTS
    • N04 - ANTI-PARKINSON DRUGS
    • N - NERVOUS SYSTEM
Active Ingredient:SAFINAMIDE MESYLATE
Active Ingredient UNII:YS90V3DTX0
Drugbank ID:DB06654
PubChem Compound:131682
CTD ID:C092797
PharmGKB:
CAS Number:133865-89-1
Dosage Form(s):tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
  • 75.0 mg/day N04BD03
Chemical Structure:
SMILE Code:
C[C@H](NCC1=CC=C(OCC2=CC(F)=CC=C2)C=C1)C(N)=O

Reference

N/A

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