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IOTHALAMATE MEGLUMINE


DIR Classification


Classification:Most-DIR concern
Severity Score:4

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

  • WARNINGS
  • SEVERE ADVERSE EVENTS – INADVERTENT INTRATHECAL ADMINISTRATION: Serious adverse reactions have been reported due to the inadvertent intrathecal administration of iodinated contrast media that are not indicated for intrathecal use. These serious adverse reactions include: death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. Special attention must be given to ensure that this drug product is not administered intrathecally.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
Rhabdomyolysis
7
42905
Other ADRs
335
14116944

Odds Ratio = 6.876

Drug Property Information



ATC Code(s):
  • V08AA04 - iothalamate meglumine
    • V08AA - "Watersoluble, nephrotropic, high osmolar X-ray contrast media"
    • V08A - "X-RAY CONTRAST MEDIA, IODINATED"
    • V08 - CONTRAST MEDIA
    • V - VARIOUS
Active Ingredient:iothalamate meglumine
Active Ingredient UNII:XUW72GOP7W
Drugbank ID:DB09133
PubChem Compound:3737
CAS Number:2276-90-6
Dosage Form(s):injection
Route(s) Of Administrator:ureteral
Daily Dose:
Chemical Structure:
SMILE Code:
CC(=O)NC1=C(C(=C(C(=C1I)C(=O)O)I)C(=O)NC)I

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

N/A

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