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

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Phase 2
Completed
Conditions
Wound Surgical
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Wound Bleeding
Wound Dehiscence
Interventions
Biological: Honey Dressing
First Posted Date
2024-01-23
Last Posted Date
2024-01-25
Lead Sponsor
HITEC-Institute of Medical Sciences
Target Recruit Count
80
Registration Number
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Locations
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Heavy Industry Taxila Hospital, Rawalpindi, Punjab, Pakistan

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Phase 1
Conditions
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SARS-CoV-2
Corona Virus Infection
Interventions
Drug: Placebo
Drug: Idoine Complex
First Posted Date
2020-07-16
Last Posted Date
2021-07-07
Lead Sponsor
Sohaib Ashraf
Target Recruit Count
200
Registration Number
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Locations
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Shaikh Zayed Hospital, Lahore, Pakistan

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First Posted Date
2019-03-01
Last Posted Date
2023-05-10
Lead Sponsor
Universidad de El Salvador
Target Recruit Count
18
Registration Number
NCT03859908
Locations
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Hospital Nacional Rosales, San Salvador, El Salvador

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Phase 2
Conditions
Breast Cancer
Interventions
Drug: FEC/TE Placebo
Drug: Placebo
First Posted Date
2018-09-28
Last Posted Date
2018-09-28
Lead Sponsor
Universidad Nacional Autonoma de Mexico
Target Recruit Count
120
Registration Number
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Locations
🇲🇽

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First Posted Date
2018-09-04
Last Posted Date
2018-09-04
Lead Sponsor
Rothman Institute Orthopaedics
Target Recruit Count
100
Registration Number
NCT03656588
Locations
🇺🇸

Rothman Institute, Philadelphia, Pennsylvania, United States

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Phase 4
Withdrawn
Conditions
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Interventions
First Posted Date
2018-08-15
Last Posted Date
2022-04-20
Lead Sponsor
GE Healthcare
Registration Number
NCT03631771

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Completed
Conditions
Contrast Medium
Interventions
First Posted Date
2018-08-09
Last Posted Date
2020-02-17
Lead Sponsor
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Target Recruit Count
133331
Registration Number
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Locations
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Phase 4
Terminated
Conditions
Hysterectomy
Interventions
First Posted Date
2018-01-26
Last Posted Date
2021-01-11
Lead Sponsor
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Target Recruit Count
94
Registration Number
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Locations
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Good Samaritan Hospital, Cincinnati, Ohio, United States

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Completed
Conditions
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Cardiovascular Diseases
Interventions
First Posted Date
2017-06-07
Last Posted Date
2020-02-13
Lead Sponsor
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Target Recruit Count
120
Registration Number
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Locations
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Phase 3
Completed
Conditions
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Cariostatic Agents
Interventions
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First Posted Date
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Last Posted Date
2019-12-24
Lead Sponsor
University of California, Los Angeles
Target Recruit Count
48
Registration Number
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