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AMIFAMPRIDINE PHOSPHATE


DIR Classification


Classification:Ambiguous
Severity Score:1.0

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

  • CLINICAL PHARMACOLOGY
  • Pharmacodynamics
  • The effect of FIRDAPSE on QTc interval prolongation was studied in a double blind, randomized, placebo and positive controlled study in 52 healthy individuals who are slow acetylators. At an exposure 2-fold the expected maximum therapeutic exposure of amifampridine, FIRDAPSE did not prolong QTc to any clinically relevant extent.

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):
  • N07XX05 - amifampridine phosphate
    • N07XX - Other nervous system drugs
    • N07X - OTHER NERVOUS SYSTEM DRUGS
    • N07 - OTHER NERVOUS SYSTEM DRUGS
    • N - NERVOUS SYSTEM
Active Ingredient:amifampridine phosphate
Active Ingredient UNII:8HF8FIN815
Drugbank ID:DB11640
PubChem Compound:N/ADIR Classification
CTD ID: D000077770
PharmGKB:
CAS Number:54-96-6
Dosage Form(s):tablet
Route(s) Of Administrator:oral
Daily Dose:
  • 40.0 mg/day N07XX05
Chemical Structure:
SMILE Code:
NC1=CC=NC=C1N

Reference

N/A

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