MedPath

Iopromide

Generic Name
Iopromide
Brand Names
Ultravist
Drug Type
Small Molecule
Chemical Formula
C18H24I3N3O8
CAS Number
73334-07-3
Unique Ingredient Identifier
712BAC33MZ
Background

Iopromide is a low osmolar, non-ionic X-ray contrast agent for intravascular administration. It functions as a contrast agent by opacifying blood vessels in the flow path of the contrast agent, permitting radiographic visualization of the internal structures until significant hemodilution occurs. Although iopromide can cause several serious adverse effects, including cardiac events, thromboembolism, hypersensitivity reaction, and even death if administered intrathecally inadvertently, it is still deemed to have a favorable safety profile, with only 0.7% of patients in a 2 years study experiencing adverse events. Although the mechanism is unclear, women and outpatients tend to have a higher incidence of adverse events compared to other population groups.

Approved by the FDA in 1995 and Health Canada in 1994 under the brand name ULTRAVIST, iopromide is used in radiological diagnosis, including, but not limited to, intra-arterial digital subtraction angiography (IA-DSA), cerebral and peripheral arteriography, peripheral venography, excretory urography, brain computer tomography (CT), coronary arteriography, left ventriculography, visceral angiography, and orthography.

Indication

Iopromide, as the product IOVIST, is approved by the FDA for use as an intra-arterial or intravenous X-ray contrast agent. For intra-arterial administration, iopromide is indicated for cerebral arteriography, peripheral arteriography, coronary arteriography, left ventriculography, visceral angiography, and aortography in adults and radiographic evaluation of cardiac chambers and related arteries in pediatric patients aged 2 years and older. For intravenous administration, iopromide is indicated for excretory urography in adults and pediatric patients aged 2 years and older, contrast Computed Tomography (CT) of the head and body (intrathoracic, intra-abdominal, and retroperitoneal regions) for the evaluation of neoplastic and non-neoplastic lesions in adults and pediatric patients aged 2 years and older, and contrast mammography to visualize known or suspected lesions of the breast in adults, as an adjunct following mammography and/or ultrasound.

Iopromide is also approved by Health Canada as an intravascular contrasting agent, although the indications differ depending on the dosage. At 300 mg I/mL, iopromide is indicated for computed tomography (CT), excretory urography, pediatric excretory urography, renal arteriography, peripheral arteriography (bifemoral pelvis/leg), cerebral arteriography, phlebography of the extremities, and arthrography.

Associated Conditions
Breast Lesions, Neoplastic lesion, Non-neoplastic lesion

A Cluster-randomized Cross-over Trial Evaluating the Comparative Effectiveness of Three Skin Antiseptic Interventions

Not Applicable
Completed
Conditions
Bacteremia
Interventions
First Posted Date
2010-10-07
Last Posted Date
2017-01-11
Lead Sponsor
University of Michigan
Target Recruit Count
3879
Registration Number
NCT01216761

The Safety and toleRability of UltraviSt in Patients Undergoing Cardiac CaTheterization (TRUST)

Completed
Conditions
Angiocardiography
Interventions
First Posted Date
2010-09-21
Last Posted Date
2013-06-11
Lead Sponsor
Bayer
Target Recruit Count
17513
Registration Number
NCT01206257

Clinical Research Study Efficacy of a Prototype Oral Rinse

Phase 3
Completed
Conditions
Dental Plaque
Interventions
Other: water
First Posted Date
2009-11-26
Last Posted Date
2009-12-01
Lead Sponsor
Colgate Palmolive
Target Recruit Count
67
Registration Number
NCT01021007
Locations
🇺🇸

New Institutional Service Company, Northfield, New Jersey, United States

A Safety Comparison of Iopromide and Iodixanol in Renal Impaired Patients

Phase 4
Completed
Conditions
Kidney Failure, Chronic
Interventions
First Posted Date
2009-06-23
Last Posted Date
2011-06-27
Lead Sponsor
Chinese PLA General Hospital
Target Recruit Count
592
Registration Number
NCT00926562
Locations
🇨🇳

Tianjin Chest Hospital, Tianjin, Tianjin, China

🇨🇳

Henan Provincial People's Hospital, Zhengzhou, Henan, China

🇨🇳

China-Japan Union Hospital of Jilin University, Changchun, Jilin, China

and more 16 locations

PMS Study Ultravist-IMAGE, IoproMide (UltrAvist) to Gain Further Information on Tolerability and Safety in X-ray Examination

Completed
Conditions
Diagnostic Imaging
Interventions
First Posted Date
2009-04-06
Last Posted Date
2011-02-28
Lead Sponsor
Bayer
Target Recruit Count
44920
Registration Number
NCT00876083

Comparison Between Iso-Osmolar and Ipo-Osmolar Contrast Agents in Patients With Acute Myocardial Infarction (AMI) Undergoing Primary Percutaneous Coronary Intervention (PCI)

Phase 4
Completed
Conditions
Contrast Induced Nephropathy
Acute Myocardial Infarction
Interventions
First Posted Date
2009-01-23
Last Posted Date
2010-11-16
Lead Sponsor
Ospedale San Donato
Target Recruit Count
432
Registration Number
NCT00827788
Locations
🇮🇹

Cardiovascular Department, Ospedale S.Donato, Arezzo, AR, Italy

Haploidentical Stem Cell Transplantation in Neuroblastoma

Early Phase 1
Conditions
Neuroblastoma
Interventions
Procedure: T-cell depletion
Procedure: Haploidentical stem cell transplantation
Procedure: Donor Lymphocyte Infusion
Procedure: Co-transplantation of mesenchymal stem cells
First Posted Date
2008-11-13
Last Posted Date
2021-02-21
Lead Sponsor
Lund University Hospital
Target Recruit Count
15
Registration Number
NCT00790413
Locations
🇸🇪

Lund University Hospital, Department of Pediatric Oncology and Bone Marrow Transplantation, Lund, Sweden

Study to Treat Relapsed Follicular Non-Hodgkin's Lymphoma With Radiation and Bexxar

Phase 2
Terminated
Conditions
Non-Hodgkin's Lymphoma
Follicular Lymphoma
First Posted Date
2007-05-21
Last Posted Date
2012-02-15
Lead Sponsor
University of Florida
Target Recruit Count
2
Registration Number
NCT00475332
Locations
🇺🇸

University of Florida, Gainesville, Florida, United States

High-Dose Iodine I 131 Metaiodobenzylguanidine, Topotecan, and Peripheral Stem Cell Transplant in Treating Young Patients With Relapsed Stage 4 Neuroblastoma or Primary Resistant High-Risk Neuroblastoma

Phase 2
Withdrawn
Conditions
Neuroblastoma
First Posted Date
2006-10-19
Last Posted Date
2013-07-10
Lead Sponsor
Children's Cancer and Leukaemia Group
Registration Number
NCT00389766

Renal Effects of Three Iodinated Contrast Media (CM) in Patients at Risk Undergoing Coronary Angiography

Phase 4
Withdrawn
Conditions
Coronary Artery Disease (CAD)
Renal Impairment
Diabetes Mellitus
First Posted Date
2006-06-08
Last Posted Date
2019-04-29
Lead Sponsor
GE Healthcare
Registration Number
NCT00335101
Locations
🇩🇪

GE Healthcare, Munich, Germany

© Copyright 2025. All Rights Reserved by MedPath