MedPath

Iopromide

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

Overview

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.

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

FDA Approved Products

Ultravist
Manufacturer:Bayer HealthCare Pharmaceuticals Inc.
Route:INTRAVENOUS, INTRA-ARTERIAL
Strength:240 mg in 1 mL
Approved: 2023/05/21
NDC:50419-342
Ultravist
Manufacturer:Bayer HealthCare Pharmaceuticals Inc.
Route:INTRAVENOUS, INTRA-ARTERIAL
Strength:370 mg in 1 mL
Approved: 2023/05/21
NDC:50419-346
Ultravist
Manufacturer:Bayer HealthCare Pharmaceuticals Inc.
Route:INTRAVENOUS, INTRA-ARTERIAL
Strength:300 mg in 1 mL
Approved: 2023/05/21
NDC:50419-347
LUGOLS SOLUTION
Manufacturer:Gordon Laboratories
Route:TOPICAL
Strength:0.4 g in 1 g
Approved: 2010/02/01
NDC:10481-0111
Vitafol Nano
Manufacturer:Exeltis USA, Inc.
Route:ORAL
Strength:150 ug in 1 1
Approved: 2023/02/14
NDC:0642-0094

Singapore Approved Products

ULTRAVIST 370 INJECTION 370 mg Iodine/ml
Manufacturer:Bayer AG (Berlin, Müllerstraße)
Form:INJECTION
Strength:370 mg/ml
Online:Yes
Approved: 1991/05/14
Approval:SIN05845P
ULTRAVIST 300 INJECTION 300 mg Iodine/ml
Manufacturer:Bayer AG (Berlin, Müllerstraße)
Form:INJECTION
Strength:300 mg/ml
Online:Yes
Approved: 1991/05/14
Approval:SIN05841P

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