ULTRAVIST 300 (iopromide)
Ultravist 300 is an iodinated contrast agent used to enhance the visibility of internal structures during diagnostic imaging procedures. It helps patients by making blood vessels, organs, and specific tissues clearer during CT scans, mammography, and various types of angiography. This agent is used in both adults and children aged two and older to assist in the evaluation of cardiac health, urinary function, and potential lesions throughout the body.
How ULTRAVIST 300 Works
This agent works by opacifying blood vessels, which allows for clearer radiographic visualization of internal structures by attenuating X-ray photons. Once injected, the substance typically moves from the blood vessels into the surrounding body tissues, though it remains contained within the vessels of the brain unless the blood-brain barrier has been damaged.
Details
- Status
- Prescription
- First Approved
- 1995-05-10
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
ULTRAVIST 300 Approval History
What ULTRAVIST 300 Treats
6 indicationsULTRAVIST 300 is approved for 6 conditions since its original approval in 1995. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cerebral and peripheral blood vessel imaging
- Heart and coronary artery imaging
- Imaging of the aorta and internal organs
- Urinary tract imaging
- Head and body CT scans for tumors or other lesions
- Breast lesion visualization (contrast mammography)
ULTRAVIST 300 Boxed Warning
NOT FOR INTRATHECAL USE WARNING: NOT FOR INTRATHECAL USE See full prescribing information for complete boxed warning. Intrathecal administration, even if inadvertent, may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. ULTRAVIST is not approved for intrathecal use. (5.1)...
WARNING: NOT FOR INTRATHECAL USE WARNING: NOT FOR INTRATHECAL USE See full prescribing information for complete boxed warning. Intrathecal administration, even if inadvertent, may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. ULTRAVIST is not approved for intrathecal use. (5.1)
ULTRAVIST 300 Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03631771 | GE-012-103/19476/OPY-44-002 | Ph 4 | withdrawn | Pediatric Risk of Hypothyroidism With Iodinated Contrast Media |
| NCT01255722 X-ACT results posted | ISO-44-012 | Ph 4 | completed | Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography |
| NCT00827788 CONTRAST-AMI | Arezzo001 EUDRACT 2008-008491-13 | Ph 4 | completed | Comparison Between Iso-Osmolar and Ipo-Osmolar Contrast Agents in Patients With Acute Myocardial Infarction (AMI) Undergoing Primary Percutaneous Coronary Intervention (PCI) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ULTRAVIST 300 FDA Label Details
Indications & Usage
FDA Label (PDF)ULTRAVIST 300 is indicated for the treatment of Cerebral and peripheral blood vessel imaging; Heart and coronary artery imaging; Imaging of the aorta and internal organs; Urinary tract imaging; Head and body CT scans for tumors or other lesions; Breast lesion visualization (contrast mammography).
WARNING: NOT FOR INTRATHECAL USE WARNING: NOT FOR INTRATHECAL USE See full prescribing information for complete boxed warning. Intrathecal administration, even if inadvertent, may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seiz...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.