Iopromide

Intravascular injection of iopromide opacifies those vessels where the contrast agent is present, permitting radiographic visualization of the internal structures through attenuation of photons. In imaging of the body, iodinated contrast agents diffuse from the vessels into the extravascular space.

• ULTRAVIST ® Injection is an iodinated contrast agent indicated for: ULTRAVIST is a radiographic contrast agent indicated for: Intra-Arterial Procedures † • Cerebral arteriography and peripheral arteriography in adults ( 1.1 ) • Coronary arteriography and left ventriculography, visceral angiography, and aortography in adults ( 1.1 ) • Radiographic evaluation of cardiac chambers and related arteries in pediatric patients aged 2 years and older ( 1.1 ) Intravenous Procedures † • Excretory urography in adults and pediatric patients aged 2 years and older ( 1.2 ) • Contrast computed tomography (CT) of head and body in adults and pediatric patients aged 2 years and older ( 1.2 ) • Contrast mammography in adults as an adjunct following mammography and/or ultrasound ( 1.2 ) † Specific concentrations and presentations are recommended for each type of imaging procedure.

• None Nonecontraindicated

• Individualize the volume and concentration according to the specific dosing tables accounting for factors such as age, body weight, size of the vessel, and the rate of blood flow within the vessel. ( 2.2 , 2.3 , 2.4 ) • For contrast mammography, use ULTRAVIST with a device that is cleared for dual-energy full field digital mammography. ( 2.5 ) • See full prescribing information for important dosage and administration instructions and directions for use of pharmacy bulk packages and imaging bulk packages. ( 2.1 , 2.6 , 2.7 ) 2.1 Important Dosage and Administration Information • ULTRAVIST is for intra-arterial or intravenous use only and must not be administered intrathecally [see Warnings and Precautions ( 5.1 )] . • Specific concentrations and presentations of ULTRAVIST are recommended for each type of imaging procedure [see Dosage and Administrations ( 2.2 , 2.3 , 2.4 )] . • Hydrate patients, as appropriate, prior to and following the administration of ULTRAVIST [see Warnings and Precautions ( 5.3 )] . • Individualize the volume, concentration, and injection rate of ULTRAVIST according to the specific dosing tables [see Dosage and Administration ( 2.2 , 2.3 , 2.4 )] . Consider factors such as age, body weight, size of the vessel, and the rate of blood flow within the vessel; also consider extent of opacification required, structure(s) or area to be examined, disease processes affecting the patient, and equipment and technique to be employed. • Visually inspect ULTRAVIST for particulate matter and/or discoloration, whenever solution and container permit.

• Hypersensitivity Reactions: Life-threatening or fatal reactions can occur. Always have emergency equipment and trained personnel available. ( 5.2 ) • Acute Kidney Injury : Acute injury including renal failure can occur. Dose minimization and hydration may decrease risk. ( 5.3 ) • Cardiovascular Reactions : Hemodynamic disturbances including shock and cardiac arrest may occur during or after administration. ( 5.4 ) • Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age : Individualize thyroid function monitoring based on risk factors such as prematurity ( 5.8 ) 5.1 Risks Associated with Intrathecal Use Intrathecal administration, even if inadvertent, can cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. ULTRAVIST is for intra-arterial or intravenous use only [see Dosage and Administration ( 2.2 , 2.3 , 2.4 )]. ULTRAVIST is not approved for intrathecal use. 5.2 Hypersensitivity Reactions ULTRAVIST can cause life-threatening or fatal hypersensitivity reactions including anaphylaxis. Manifestations include respiratory arrest, laryngospasm, bronchospasm, angioedema, and shock [see Adverse Reactions ( 6.2 )] . Most severe reactions develop shortly after the start of injection (e.g., within 1 to 3 minutes), but delayed reactions can also occur.

The following adverse reactions are described elsewhere in the labeling: • Risks Associated with Intrathecal Use [see Warnings and Precautions ( 5.1 )] • Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 )] • Acute Kidney Injury [see Warnings and Precautions ( 5.3 )] • Cardiovascular Adverse Reactions [see Warnings and Precautions ( 5.4 )] • Thromboembolic Events [see Warnings and Precautions ( 5.5 )] • Extravasation and Injection Site Reactions [see Warnings and Precautions ( 5.6 )] • Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age [see Warnings and Precautions ( 5.8 )] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.11 )] Common adverse reactions (>1%) are headache, nausea, injection site and infusion site reactions, vasodilatation, vomiting, back pain, urinary urgency, chest pain, pain, dysgeusia, and abnormal vision. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Bayer HealthCare Pharmaceuticals Inc. at 1-888-842-2937 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect or predict the rates observed in practice. The common adverse reactions reported in >1% of patients in clinical studies with ULTRAVIST are shown in Table 4.

8.1 Pregnancy Risk Summary There are no data on ULTRAVIST use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Iopromide crosses the placenta and reaches fetal tissues in small amounts (see Data) . In animal reproduction studies, intravenous administration of iopromide to pregnant rats and rabbits during organogenesis at doses up to0.35 and 0.7 times, respectively, the maximum recommended human dose based on body surface area resulted in no relevant adverse developmental effects (see Data) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defects, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data Limited case reports demonstrate that intravenously administered iodinated contrast agents, including iopromide, cross the placenta and are visualized in the digestive tract of exposed infants after birth.

Metabolism

Distribution After intravenous administration to healthy adult subjects, plasma iopromide concentration time profile shows an initial distribution phase with a half-life of 0.24 hour; a main elimination phase with a half-life of 2 hours; and a terminal elimination phase with a half-life of 6.2 hours. The total volume of distribution at steady state is about 16 L suggesting distribution into extracellular space.

The manifestations of overdosage are life-threatening and affect mainly the pulmonary and cardiovascular systems. Treatment of an overdosage is directed toward the support of all vital functions, and prompt institution of symptomatic therapy. Iopromide can be removed by dialysis.

• May 10, 1995NDANDA020220Bayer Hlthcare

1. 1Dyspnoea57315%
2. 2Urticaria50913%
3. 3Pruritus44111%
4. 4Anaphylactic Shock3739.5%
5. 5Erythema3709.4%
6. 6Blood Pressure Decreased3639.3%
7. 7Nausea2987.6%
8. 8Vomiting2616.7%
9. 9Loss Of Consciousness2476.3%
10. 10Dizziness2185.6%
11. 11Rash2175.5%
12. 12Oxygen Saturation Decreased2165.5%
13. 13Contrast Media Allergy2025.2%
14. 14Hypotension1794.6%
15. 15Chest Discomfort1724.4%

The 10 most recently updated of 42 ClinicalTrials.gov registrations naming Iopromide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Low-acid Contrast Media for Preventing Post ERCP Pancreatitis
  Completed · Observational · 3,979 enrolled · Shandong University
  NCT07391787updated 2026-02-06
• Clinical Effectiveness of CEM in Diagnosis of Additional Findings at Preoperative Breast Magnetic Resonance Imaging
  Not yet recruiting · Interventional · 320 enrolled · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  NCT06475066updated 2024-06-26
• Paclitaxel-coated Balloon for Treatment of De-novo Non-complex Coronary Artery Lesions
  Active not recruiting · Interventional · 2,272 enrolled · Xijing Hospital
  NCT04561739updated 2024-03-29
• A Study, Called UV Population, to Learn More About the Safety of the Study Drug Ultravist, Which is Given to Get Clearer X-ray Pictures, in People of Different Sexes, Races, and From Different Countries/Regions
  Completed · Observational · 152,233 enrolled · Bayer
  NCT05428397updated 2023-10-10
• Preoperative Assessment of Pathological Nipple Discharge With Delayed Ductal Imaging of Contrast-enhanced Mammography
  Unknown · Interventional · 60 enrolled · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  NCT06033573updated 2023-09-13
• Multislice CT Angiography of Coronary Bifurcations and Outcomes After Intervention
  Completed · Interventional · 70 enrolled · Clinical Hospital Center Zemun
  NCT01943643updated 2023-06-02
• Serum Thyroid Function After Iodinated Contrast Administration
  Unknown · Observational · 400 enrolled · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  NCT05786846updated 2023-05-30
• Short-Term Exposure to Lipophilic Anti-proliferative Drugs Delivered by Angiographic Contrast Media
  Completed · Phase 1 · Phase 2 · Interventional · 32 enrolled · University Hospital, Saarland
  NCT01140204updated 2023-04-27
• Radiomic fEatures of Pancreas From Contrast Enhanced CT Image Predict One-Year RecUrrence Risk of Acute PancReatitis
  Unknown · Observational · 694 enrolled · Peking University People's Hospital
  NCT05778929updated 2023-03-22
• Techniques and Pitfalls of Multi-Slice CT Coronary Angiography
  Unknown · Interventional · 60 enrolled · Sohag University
  NCT05729490updated 2023-02-15

Frequently asked questions

How does Iopromide work?

Intravascular injection of iopromide opacifies those vessels where the contrast agent is present, permitting radiographic visualization of the internal structures through attenuation of photons. In imaging of the body, iodinated contrast agents diffuse from the vessels into the extravascular space.

What is Iopromide used for?

According to FDA labeling, Iopromide carries indications including: ULTRAVIST ® Injection is an iodinated contrast agent indicated for: ULTRAVIST is a radiographic contrast agent indicated for: Intra-Arterial Procedures † • Cerebral arteriography and peripheral arteriography in adults ( 1.1 ) • Coronary arteriography and left ventriculography, visceral angiography, and aortography in adults ( 1.1 ) • Radiographic evaluation of cardiac chambers and related arteries in pediatric patients aged 2 years and older ( 1.1 ) Intravenous Procedures † • Excretory urography in adults and pediatric patients aged 2 years and older ( 1.2 ) • Contrast computed tomography (CT) of head and body in adults and pediatric patients aged 2 years and older ( 1.2 ) • Contrast mammography in adults as an adjunct following mammography and/or ultrasound ( 1.2 ) † Specific concentrations and presentations are recommended for each type of imaging procedure.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Iopromide?

Iopromide is classified as Watersoluble, nephrotropic, low osmolar X-ray contrast media, Radiographic Contrast Agent, Imaging Contrast Activity, X-Ray Contrast Activity.

What are the contraindications for Iopromide?

Iopromide labeling lists contraindications including: None None. Always consult the full prescribing information and a clinician.