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.
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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/01/23 | Phase 2 | Completed | HITEC-Institute of Medical Sciences | ||
2020/07/16 | Phase 1 | UNKNOWN | |||
2019/03/01 | Phase 4 | Terminated | |||
2018/09/28 | Phase 2 | UNKNOWN | Universidad Nacional Autonoma de Mexico | ||
2018/09/04 | Not Applicable | UNKNOWN | |||
2018/08/15 | Phase 4 | Withdrawn | |||
2018/08/09 | N/A | Completed | |||
2018/01/26 | Phase 4 | Terminated | |||
2017/06/07 | N/A | Completed | |||
2017/02/23 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Newton Laboratories, Inc. | 55714-2596 | ORAL | 15 [hp_X] in 1 mL | 5/21/2025 | |
| CooperSurgical, Inc. | 59365-6064 | TOPICAL | 0.05 g in 1 mL | 4/15/2020 | |
| BM Private Limited | 85816-2250 | ORAL | 30 [hp_X] in 1 mL | 7/31/2025 | |
| Newton Laboratories, Inc. | 55714-4862 | ORAL | 15 [hp_X] in 1 mL | 5/21/2025 | |
| Bayer HealthCare Pharmaceuticals Inc. | 50419-344 | INTRA-ARTERIAL | 300 mg in 1 mL | 8/1/2019 | |
| Dr. Donna Restivo DC | 62185-0059 | ORAL | 6 [hp_X] in 1 mL | 5/23/2025 | |
| Deseret Biologicals, Inc. | 43742-0240 | ORAL | 12 [hp_X] in 1 mL | 5/27/2025 | |
| Bayer HealthCare Pharmaceuticals Inc. | 50419-346 | INTRA-ARTERIAL | 370 mg in 1 mL | 8/1/2019 | |
| Bayer HealthCare Pharmaceuticals Inc. | 50419-342 | INTRAVENOUS, INTRA-ARTERIAL | 240 mg in 1 mL | 5/21/2023 | |
| Bayer HealthCare Pharmaceuticals Inc. | 50419-346 | INTRA-ARTERIAL | 370 mg in 1 mL | 8/1/2019 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ULTRAVIST 370 INJECTION 370 mg Iodine/ml | SIN05845P | INJECTION | 370 mg/ml | 5/14/1991 | |
| ULTRAVIST 300 INJECTION 300 mg Iodine/ml | SIN05841P | INJECTION | 300 mg/ml | 5/14/1991 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| ULTRAVIST 370 INJ 370MGI/ML | N/A | N/A | N/A | 11/27/1998 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ULTRAVIST 300 Iopromide 12.468g/20mL injection vial | 47382 | Medicine | A | 1/4/1994 | |
| ULTRAVIST 370 iopromide 384.5 g/500 mL solution for injection bottle | 321040 | Medicine | A | 9/22/2020 | |
| ORION IODINE 1% IN ALCOHOL 70% application bottle | 21232 | Medicine | A | 10/8/1991 | |
| ULTRAVIST 300 Iopromide 31.17g/50mL injection | 15757 | Medicine | A | 9/12/1991 | |
| ULTRAVIST 300 Iopromide 62.34g/100mL injection | 48507 | Medicine | A | 6/8/1994 | |
| MICROGUARD 475 Povidone Iodine Solution 0.75% w/w iodine bottle | 203573 | Medicine | A | 12/3/2012 | |
| ULTRAVIST 370 Iopromide 38.443g/50mL injection | 15681 | Medicine | A | 9/12/1991 | |
| ORION IODINE 0.5% IN ALCOHOL 70% application bottle | 21255 | Medicine | A | 10/8/1991 | |
| ULTRAVIST-240 iopromide 49.872g/100mL injection bottle | 76908 | Medicine | A | 8/13/2001 | |
| ULTRAVIST 370 Iopromide 76.88g/100mL injection | 48499 | Medicine | A | 6/8/1994 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| LM-TONIC III | bio active canada ltd. | 02233646 | Liquid - Oral | 12 X | 1/19/1998 |
| HOMEOPATHIC MEDICINE (S125) DPS 30C | total health centre | 02071657 | Drops - Oral | 30 C / ML | 12/31/1994 |
| CATALIGO NO.1-LIQ | laboratoires holis inc. | 02132281 | Liquid - Oral | 4 D / ML | 12/31/1986 |
| ADAPTAGEN | bio active canada ltd. | 02233546 | Liquid - Oral | 12 X | 5/26/1998 |
| VITALGINE STAM | produits francais labs inc. | 00166308 | Liquid - Oral | .44395 MG / 30 G | 12/31/1930 |
| IODUM GOUTTE 2CH-30CH | boiron laboratoires | 00680176 | Drops - Oral | 2 CH / CH | 12/31/1987 |
| TINCTURE OF IODINE 2.5% | rw consumer products ltd | 00892084 | Tincture - Topical | 2.5 % | 12/31/1995 |
| TINCTURE OF IODINE | lawton's drug stores ltd. | 00728683 | Liquid - Topical | 2.5 % | 12/31/1987 |
| PHYDERM LIQ | produits phyto inc. | 00295922 | Liquid - Topical | 1 % | 12/31/1974 |
| POUR IT ON THICK | kootenay born botanicals | 02232067 | Syrup - Oral | 12 X | 5/25/1998 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| ULTRAVIST 300 mg/ml SOLUCION INYECTABLE Y PARA PERFUSION EN VIAL | Bayer Hispania S.L. | 59611 | SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN | Uso Hospitalario Y Centros De Diagnóstico Autorizados | Commercialized |
| ULTRAVIST 370 mg/ml SOLUCION INYECTABLE Y PARA PERFUSION EN VIAL | Bayer Hispania S.L. | 59614 | SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN | Uso Hospitalario Y Centros De Diagnóstico Autorizados | Commercialized |
| ULTRAVIST 240 mg /ml, SOLUCION INYECTABLE Y PARA PERFUSION EN VIAL | Bayer Hispania S.L. | 59613 | SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN | Uso Hospitalario Y Centros De Diagnóstico Autorizados | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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