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NALOXEGOL OXALATE


DIR Classification


Classification:Ambiguous
Severity Score:1.0

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

  • CLINICAL PHARMACOLOGY
  • Pharmacodynamics
  • Effect on Cardiac Repolarization
  • In a randomized, double-blind, 4-way cross-over thorough QTc prolongation study with moxifloxacin as a positive control, a single 25 mg therapeutic dose or a 150 mg dose (6 times the maximum recommended dosage) of naloxegol, did not have an effect on the QTc interval compared to placebo. Changes in heart rate, RR, PR, and QRS ECG intervals were similar between placebo and naloxegol 25 or 150 mg.

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):
  • A06AH03 - naloxegol oxalate
    • A06AH -
    • A06A - LAXATIVES
    • A06 - LAXATIVES
    • A - ALIMENTARY TRACT AND METABOLISM
Active Ingredient:NALOXEGOL OXALATE
Active Ingredient UNII:65I14TNM33
Drugbank ID:DB09049
PubChem Compound:56959087
CTD ID:C000589308
PharmGKB:
CAS Number:854601-70-0
Dosage Form(s):tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
  • 25.0 mg/day A06AH03
Chemical Structure:
SMILE Code:
COCCOCCOCCOCCOCCOCCOCCO[C@H]1CC[C@@]2(O)[C@H]3CC4=CC=C(O)C5=C4[C@@]2(CCN3CC=C)[C@H]1O5

Reference

N/A

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