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IOPROMIDE


DIR Classification


Classification:Most-DIR concern
Severity Score:4

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

  • BOXED WARNING
  • Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. [See Contraindications (4).]
  • CONTRAINDICATIONS
  • Do not administer ULTRAVIST Injection intrathecally. Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.
  • Preparatory dehydration (for example, prolonged fasting and the administration of a laxative) before ULTRAVIST Injection is contraindicated in pediatric patients because of risk of acute renal failure.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
Rhabdomyolysis
10
42902
Other ADRs
7747
14109532

Odds Ratio = 0.425

Drug Property Information



ATC Code(s):
  • V08AB05 - iopromide
    • V08AB - "Watersoluble, nephrotropic, low osmolar X-ray contrast media"
    • V08A - "X-RAY CONTRAST MEDIA, IODINATED"
    • V08 - CONTRAST MEDIA
    • V - VARIOUS
Active Ingredient:iopromide
Active Ingredient UNII:712BAC33MZ
Drugbank ID:DB09156
PubChem Compound:3736
CAS Number:73334-07-3
Dosage Form(s):injection
Route(s) Of Administrator:intra-arterial
Daily Dose:
Chemical Structure:
SMILE Code:
CN(CC(CO)O)C(=O)C1=C(C(=C(C(=C1I)C(=O)NCC(CO)O)I)NC(=O)COC)I

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

N/A

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