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GALANTAMINE HYDROBROMIDE


DIR Classification


Classification:Most-DIQT concern
Severity Score:4.0

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

  • OVERDOSAGE
  • In one postmarketing report, one patient who had been taking 4 mg of galantamine daily for a week inadvertently ingested eight 4 mg tablets (32 mg total) on a single day. Subsequently, she developed bradycardia, QT prolongation, ventricular tachycardia and torsades de pointes accompanied by a brief loss of consciousness for which she required hospital treatment. Two additional cases of accidental ingestion of 32 mg (nausea, vomiting, and dry mouth; nausea, vomiting, and substernal chest pain) and one of 40 mg (vomiting), resulted in brief hospitalizations for observation with full recovery. One patient, who was prescribed 24 mg/day and had a history of hallucinations over the previous two years, mistakenly received 24 mg twice daily for 34 days and developed hallucinations requiring hospitalization. Another patient, who was prescribed 16 mg/day of oral solution, inadvertently ingested 160 mg (40 mL) and experienced sweating, vomiting, bradycardia, and near-syncope one hour later, which necessitated hospital treatment. His symptoms resolved within 24 hours.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
QT Prolongation
14
24078
Other ADRs
3281
38378306

Odds Ratio = 6.802

Drug Property Information



ATC Code(s):
  • N06DA04 - galantamine hydrobromide
    • N06DA - Anticholinesterases
    • N06D - ANTI-DEMENTIA DRUGS
    • N06 - PSYCHOANALEPTICS
    • N - NERVOUS SYSTEM
Active Ingredient:galantamine hydrobromide
Active Ingredient UNII:MJ4PTD2VVW
Drugbank ID:DB00674
PubChem Compound:9651
CTD ID:D005702
PharmGKB:PA449726
CAS Number:357-70-0
Dosage Form(s):capsule, extended release; tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
  • 16.0 mg/day N06DA04
Chemical Structure:
SMILE Code:
[H][C@]12C[C@@H](O)C=C[C@]11CCN(C)CC3=C1C(O2)=C(OC)C=C3

Reference

N/A

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