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Ультравист

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Ультравист

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

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Overview of Ультравист

Quick Facts

Property Description
Active ingredient Iopromide
Form Sterile aqueous solution for injection and infusion
Pharmacological class Radiographic Contrast Agent
Common use Visualization of internal structures (diagnostic aid)
Origin Synthetic, non-ionic, low-osmolar compound

What Type of Agent is Ультравист?

Ультравист is a specialized, prescription-only Radiographic Contrast Agent containing the active ingredient Iopromide, utilized exclusively as a diagnostic tool rather than a therapeutic drug. The substance belongs to the pharmacological class of X-Ray Contrast Media and is classified as a low-osmolar, water-soluble agent. This indicates that Iopromide is a synthetic, non-ionic compound, meaning it dissociates minimally in solution and possesses a low osmolarity. Low-osmolar agents like Iopromide are utilized to facilitate contrast-enhanced imaging across various medical settings.

Iopromide: Composition and Form

The core component of the agent is Iopromide, an organoiodine compound that functions as the single active ingredient. Its function is dependent on the three atoms of tightly bound iodine within the molecule, as iodine absorbs X-ray radiation. Ультравист is formulated as a sterile aqueous solution for injection and infusion, primarily administered intravascularly or intracavitary. The solution's low-osmolar property is maintained across its available concentrations, such as 300 and 370 milligrams of iodine per milliliter, a characteristic used for modern, high-speed imaging.

What is the General Purpose of Ультравист?

The primary function of Ультравист is to enable the visualization of internal structures that are normally radiolucent on standard X-ray images, such as blood vessels and organs. By utilizing the X-ray absorption capabilities of the iodine, the agent creates a temporary contrast between the filled body areas and the surrounding tissues. This capability allows for detailed anatomical assessment and the achievement of a radiological diagnosis necessary for determining subsequent clinical treatment plans.

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What side effects are possible with Ультравист?

Possible Side Effects and Safety Information

The safety profile for Ультравист (Iopromide) is based strictly on data documented in authoritative government regulatory sources, such as the FDA Prescribing Information and the European Summary of Product Characteristics (SmPC).

Common and Less Common Adverse Reactions

The officially listed adverse reactions are categorized by frequency, reflecting incidence rates observed in clinical studies and post-marketing surveillance.

Classification Examples of Reactions
Common (ge 1/100) Headache, Nausea, Vomiting, Vasodilatation, Injection site reactions, Urinary urgency.
Rare/Postmarketing Convulsion, Syncope, Confusion, Bronchospasm, Cardiac arrhythmia, Urticaria.

These reactions affect multiple organ systems, including the Nervous System (e.g., headache, confusion), Gastrointestinal System (e.g., nausea, vomiting), and Vascular System (e.g., vasodilatation).

Serious Adverse Reactions and Safety Constraints

The regulatory documents highlight certain rare but clinically significant adverse events, categorized as serious adverse reactions. These include life-threatening events such as Anaphylactic Shock, Cardiac Arrest, Respiratory Arrest, and Acute Kidney Injury (AKI). Severe neurological events like Convulsions and severe skin reactions (e.g., Stevens-Johnson Syndrome) are also documented.

Safety limitations explicitly stated in the regulatory label include a mandatory Contraindication for intrathecal use of the agent. Furthermore, the label specifies that patients must be kept under observation for at least 30 to 60 minutes following administration due to the risk of both immediate and delayed adverse events.

Population-Specific Safety Notes

The official labeling includes specific warnings for certain patient groups:

  • Pediatric Patients (0-3 years): The agent carries a documented risk of Thyroid Dysfunction (hypothyroidism or transient suppression) in this age group.
  • Patients with Renal Impairment/Diabetes: There is an increased risk of Acute Kidney Injury in patients with pre-existing renal insufficiency, particularly those with diabetes mellitus.

Note: This information is a summary of the official safety profile and does not include usage instructions or therapeutic benefits.

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Overdose and Emergency Response

Overdose and When to Seek Urgent Medical Help

Overdose Risk and Presentation

The most severe, life-threatening risk associated with this contrast agent is related to the route of administration, not solely the dose. This product is for intravenous or intra-arterial use only and must not be administered into the spinal fluid (intrathecally). Inadvertent intrathecal use, even if accidental, has been documented to cause severe overdose presentations, including death, cardiac arrest, cerebral hemorrhage, coma, seizures, paralysis, acute renal failure, rhabdomyolysis, and brain edema.

While this specific misuse presents the highest critical risk, an overdose from an excessive intravascular dose can lead to symptoms of fluid and electrolyte imbalance, renal failure, and severe cardiovascular or pulmonary complications. The maximum recommended total dose of iodine for adults can be up to 86 grams, depending on the procedure and concentration used.

Emergency Actions

If any accidental administration of this agent occurs, particularly intrathecally, or if an overdose from an excessive intravascular dose is suspected, immediate, urgent medical attention is required. Healthcare providers will treat any resulting symptoms, which may involve prompt supportive therapy for vital functions. The agent is removable by dialysis, which may be initiated in cases of significant overdose to assist elimination from the body.

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Therapeutic Uses of Ультравист

Ультравист is a diagnostic aid relevant in contexts where increased information is required for clinical assessment. It is considered relevant for easing assessment processes. The compound is applied in clinical contexts marked by increased discomfort or tension.

It is applied within clinical settings that involve acute or disruptive symptom patterns, including the assessment of conditions associated with systemic imbalance, heightened physiological activity, and organ-specific functional stress. This supportive approach is common in clinical scenarios where symptoms become more noticeable. As part of this process, the medicine may assist with managing symptoms related to systemic imbalance.

“It helps maintain a sense of stability when symptoms are more noticeable” by supporting the collection of essential diagnostic data.


Quick Fact: Supportive management for increased discomfort or tension

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Eligibility and Restrictions for Use

The eligibility for using Ультравист (Iopromide) is strictly defined by government regulatory documents, outlining who is approved and who is formally prohibited from receiving the contrast agent. It is intended for use in adults and pediatric patients aged 2 years and older for established diagnostic procedures. The safety and effectiveness for most procedures have not been established in children under 2 years of age.

Contraindicated Populations

Official labeling mandates that Ультравист must not be used in patients with:

  • Known hypersensitivity to Iopromide or any ingredient.
  • Manifest hyperthyroidism (clinically overt thyrotoxicosis).
  • Intrathecal use (inadvertent injection into the spinal fluid).
  • Pediatric patients requiring preparatory dehydration (prolonged fasting or laxatives) for a procedure.

Restricted or Conditional Use

Use is highly restricted for patients with certain conditions:

Condition Restriction/Rule (Label-Based)
Renal Impairment Requires caution due to risk of Acute Kidney Injury (CI-AKI).
Pregnancy Use only if clearly needed; safety is generally not established.
Lactation Mother may pump and discard breast milk for 12 to 24 hours.
High-Risk Comorbidities Caution is mandatory for patients with pheochromocytoma or a history of severe allergic disorders.
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What should I know about interactions with other medicines?

Interactions with other medicines and products

Regulatory documents define the official interaction profile for Ультравист (Iopromide) based on its high iodine load and renal elimination, resulting in several documented constraints with co-administered substances. The profile is primarily characterized by effects on renal function, additive pharmacodynamic risks, and chemical incompatibilities.

Documented Interaction Patterns

Interaction Type Interacting Agent Official Regulatory Statement
Renal Clearance Interference Biguanides (Metformin) Intravascular administration may acutely reduce renal function, increasing the official risk of Metformin accumulation and subsequent lactic acidosis.
Pharmacodynamic Risk Interleukin-2 Previous treatment is associated with a documented increase in the risk of delayed hypersensitivity reactions to the contrast agent.
Functional Interference Radioiodine Products The high iodine concentration can impede the effectiveness of radioiodine-based thyroid assessment and therapy for a period of up to several weeks.

Administration Constraints and Timing Rules

Administration of Iopromide requires strict adherence to mandatory timing rules for co-administered medicines. Metformin must be temporarily discontinued at the time of or prior to the radiographic study and should not be resumed until at least 48 hours after the procedure, following confirmation of normal renal function. Furthermore, due to chemical incompatibility, Iopromide must not be mixed or injected in the same intravenous administration line with any other drug, solution, or total nutritional admixture, with the sole exception of saline.

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Mechanism of Action

The functional effect of Ультравист (Iopromide) is achieved through a physico-chemical mechanism, as it operates purely as a diagnostic medium rather than a substance that alters biological signaling. The fundamental mechanism relies on the iodine atoms within the molecule, which serve as the primary targets for X-ray photons. Iodine's high atomic number enables it to efficiently absorb and attenuate the X-ray beam through the photoelectric effect, a physical process that creates a localized area of high radiopacity when the agent fills a structure. This interaction is the first step in the cascade, modifying the physical properties of the internal environment to enable visualization.

This resulting radiodensity enhancement initiates the diagnostic cascade: the high concentration of iodine causes a sharp differential X-ray transmission between the filled structure (e.g., blood vessel) and the surrounding soft tissue. This physiological consequence—a temporary increase in physical visibility—contributes to the visualization effect by establishing a high-contrast gradient between the filled structure and surrounding tissue.

A critical mechanistic feature is the drug's low-osmolar, non-ionic formulation. This design minimizes the osmotic load on the circulatory system, resulting in minimal osmotic pressure exerted on the circulatory system compared to high-osmolar agents. This mechanistic choice maintains the physical stability of the circulatory fluid dynamics during the distribution phase.

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Dosage and Administration Information

How to Use Ультравист (Iopromide)

Ультравист is a specialized contrast agent used only as a diagnostic aid and administered strictly according to standardized protocols. It is never used as a therapeutic medicine or taken orally.

Official Administration and Dosing Principles

The usage of Ультравист is determined by the specific imaging procedure being performed, the patient's weight, and the chosen concentration (e.g., 300 or 370 mgI/mL). There are no multi-day or repeated regimens.

Usage Instruction Domain Standard Requirement
Route Intravenous (IV), Intra-arterial (IA), or Intracavitary administration. Must not be administered intrathecally.
Frequency Single-use administration for a one-time diagnostic procedure.
Dosing Basis Procedure-specific volume ranges, with defined maximum total doses (e.g., 100 mL for certain IV procedures, 225 mL for certain IA procedures).

Administration Requirements and Patient Preparation

Administration must take place in a controlled clinical environment, such as a hospital or specialized clinic, by trained personnel. Key procedural requirements must be followed:

  • Warming and Handling: The solution is often warmed to body temperature before injection to reduce viscosity and must be handled using aseptic technique. It is prohibited to mix Ультравист with other medicines in the same administration line.
  • Hydration: Patients should be adequately hydrated before and after the procedure; preparatory dehydration is generally contraindicated.
  • Specific Populations: Dosing for pediatric patients (aged 2 years and older) is based on body weight (1 to 2 mL/kg). For patients with renal impairment, the dose should be kept as low as possible.
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Recent Clinical Evidence

Research evidence / Overview of studies for Ультравист


Evidence for Visualization in Blood Vessels and Cardiac Structures (Angiography)

Controlled clinical trials and extensive observational studies explored the temporary visualization of blood vessels, including coronary and peripheral arteries, and heart chambers when the agent was used. Research examined image quality and the ability to establish a diagnosis. Studies reported visualization and opacification across observed populations, which is aligned with the studied role of the agent. In comparative trials of high-risk patients, research described patterns related to measured short-term changes in kidney function markers.


Evidence for Use in Cross-Sectional and Urinary Tract Imaging (CT and Urography)

Initial trials and extensive non-interventional observational studies evaluated Iopromide's role in computerized tomography (CT) of the head and body, and in excretory urography. The research examined visualization clarity metrics for structural lesions and monitored the time course of opacification. Regulatory findings indicate that research exploring the use of enhancement for investigating certain types of low-grade brain tumors has not been supported by available data.


Evidence for Use in Dedicated Breast Imaging (Contrast-Enhanced Mammography)

Supporting clinical trials and systematic reviews explored diagnostic performance metrics for the detection and confirmation of breast lesions when the agent was used alongside standard imaging. Research examined the use of the agent alongside standard imaging and reported visualization and enhancement of lesions in the breast tissue.


Duration of Evidence: Long-Term Studies and Follow-up

Research primarily comprises short-term clinical trials. Follow-up durations are limited to the immediate diagnostic period or up to 30 days post-procedure for major events. The long-term effects and diagnostic reliability are not fully established, and this represents an area where more research is needed.


Evidence in Special Populations and Specific Patient Cohorts

Specific research has examined the agent's use in pediatric patients aged 2 years and older for certain procedures. Controlled clinical trials also studied adults with pre-existing moderate impairment of kidney function. However, data for certain groups, such as pregnant populations, remain insufficient.


What Remains Unclear or Uncertain About the Research for Ультравист

While research has contributed to the understanding of the agent’s diagnostic utility, several limitations are noted. Long-term outcomes for patients are not well characterized across the board, and comparative results often apply only to the specific high-risk cohorts studied. Additionally, evidence quality varies across some of the systematic reviews conducted for specific indications.

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Frequently Asked Questions (FAQ)

Common questions about Ультравист (FAQ)


Q: How is Ультравист different from other contrast agents used for CT scans?

According to official documents, Ультравист is a low-osmolar, non-ionic contrast agent. This specialized formulation means it dissociates minimally in solution and helps minimize the osmotic load that older, high-osmolar contrast agents may exert. This formulation is noted for minimizing osmotic load compared to older agents.

Q: Do I need to fast before receiving Ультравист?

The official prescribing information generally does not require patients to fast before receiving the contrast agent. However, preparatory dehydration is strictly contraindicated as it can increase certain risks. It is important that patients confirm preparatory instructions with the provider administering the imaging procedure.

Q: How long does the contrast effect from Ультравист last in the body?

Regulatory documents describe the agent's temporary visualization effect as being dependent on its rapid distribution throughout the body and subsequent elimination. This diagnostic effect is generally completed within a few hours, though the specific imaging window varies depending on the procedure being performed.

Q: Does Ультравист affect the results of other blood or lab tests?

The high iodine concentration can potentially interfere with certain laboratory tests, particularly those related to thyroid function, for a period of up to several weeks following administration. While official sources warn of this specific interference, they typically do not list general regulatory warnings regarding routine blood tests.

Q: How long does it typically take for Ультравист to be cleared from the body?

This contrast agent is primarily eliminated by the kidneys. Official pharmacokinetic information indicates that the elimination half-life is typically approximately two hours in healthy adult patients. Near-complete clearance of the agent from the body generally occurs within 24 hours.

Q: Can patients who have asthma or severe allergies use Ультравист?

Official regulatory documents indicate that caution is mandatory for patients with a history of severe allergic disorders, including asthma, due to a documented increased risk of hypersensitivity reactions. The decision regarding use is based on professional medical assessment and typically occurs under close supervision.

Q: Is there a risk of an allergic reaction to Ультравист even if I had a previous scan without issue?

Yes, regulatory documents note that prior uncomplicated exposure does not preclude the possibility of a subsequent allergic reaction. Official guidance requires patient monitoring by clinical staff for at least 30 to 60 minutes after administration because both immediate and delayed reactions are possible.

Q: Does drinking extra water help flush Ультравист out of my system faster?

Regulatory guidance strongly emphasizes the need for adequate hydration before and after the procedure to aid in the elimination process through the kidneys. While sufficient hydration is mandated, official documents do not specify that drinking water beyond adequate levels significantly accelerates the clearance process.

Q: Is Ультравист used for MRI or only for CT scans?

Ультравист is classified as an X-Ray Contrast Medium. Its approved uses include procedures like CT scans, angiography (blood vessel imaging), and urography (urinary tract imaging). The agent is not approved or designed for use in Magnetic Resonance Imaging (MRI).

Q: Is Ультравист safe for older patients?

Official regulatory documents generally indicate that no overall differences in safety or effectiveness have been observed between older and younger adult patients. However, the dose should be selected cautiously due to the higher frequency of decreased kidney function in the elderly population.

Q: Do official sources describe Ультравист as having different safety profiles based on the concentration (e.g., 300 vs 370)?

Official sources acknowledge the availability of different concentrations of the agent. The low-osmolar property is consistent across these concentrations, but official documents do not typically detail a separate, formally differentiated safety profile based solely on the minor variation in iodine concentration.

Q: Is it possible to receive Ультравист if I have a history of heart issues?

Caution is described as necessary for patients with certain severe cardiac conditions, such as heart failure or severe coronary artery disease, due to the potential for transient circulatory effects that may occur during administration. Regulatory documents indicate that use is based on a professional medical assessment.

Q: What is the required preparation for a scan that involves Ультравист?

Required preparation includes ensuring adequate hydration before and after the procedure, which is critical for kidney function. The medical team also needs to review your complete patient history, especially concerning kidney and thyroid conditions and current medications. The administration must take place in a controlled clinical environment.

Q: What should I tell my doctor about my health history related to the use of Ультравист?

You should inform your doctor about a history of severe allergies or asthma, any existing kidney disease or diabetes, and any active thyroid conditions (especially manifest hyperthyroidism). Regulatory guidance recommends disclosing a full list of your current medications, particularly Metformin.

Q: Where can I find the official prescribing information for Ультравист?

The complete, authoritative prescribing information for the active ingredient (Iopromide) is published by government drug agencies. These sources include the FDA (via DailyMed) in the United States and the EMA (via the Summary of Product Characteristics or SmPC) in Europe.

Q: Why is hydration mentioned frequently when preparing for a procedure with Ультравист?

Adequate hydration is mandated because the agent is eliminated primarily via the kidneys. Official information notes an increased risk of Acute Kidney Injury (AKI), particularly in patients with pre-existing renal impairment or diabetes. Proper hydration helps support kidney function during the elimination process.

Q: Is the feeling of metallic taste normal after receiving Ультравист?

Yes, the official Summary of Product Characteristics (SmPC) lists a taste disturbance (dysgeusia) as a less common or rare reported adverse reaction. This can include the temporary feeling of a metallic taste immediately following administration.

Q: Is there an antidote or specific treatment if someone has a reaction to Ультравист?

Regulatory documents advise that clinical teams must have procedures and medications readily available for the treatment of severe contrast reactions during and immediately following administration. The official documents do not specify a single antidote for the agent itself.

Q: How soon after receiving Ультравист can I resume my normal activities?

Due to the risk of immediate and delayed adverse events, regulatory documents require that the patient must be kept under observation for at least 30 to 60 minutes following administration. Resumption of normal activities is generally determined by the medical professional after the required observation period is complete.

Q: Are there any drug classes that have a known interaction warning with Ультравист?

Regulatory documents specifically detail warnings for two classes of agents. This includes the drug class Biguanides (such as Metformin) due to the risk of lactic acidosis, and drugs like Interleukin-2, which can increase the risk of delayed hypersensitivity reactions.

Q: Does having a history of kidney disease mean I definitely cannot use Ультравист?

Having a history of kidney disease does not automatically prohibit its use. Regulatory guidance mandates that caution must be exercised due to the increased risk of Acute Kidney Injury. In such cases, the administered dose should be kept as low as possible, based on professional judgment.

Q: What general expectations should I have regarding the experience of receiving Ультравист?

Patients can generally expect the administration to occur in a controlled clinical environment by trained personnel. Common feelings include a warm sensation, and possibly temporary nausea or headache. Official guidance requires patients to undergo observation for 30 to 60 minutes afterwards.

Q: Is Ультравист associated with any temporary changes in vision?

Yes, official documents, such as the Summary of Product Characteristics, list visual disturbances as an uncommon or rare reported adverse reaction. Patients are advised to inform clinical staff if they experience temporary changes in vision.

Q: Are there special considerations for using Ультравист in patients with multiple myeloma?

Regulatory documents mandate that caution must be exercised when administering the agent to patients with multiple myeloma. This is due to a documented increased risk of renal toxicity in this patient group. Regulatory documents indicate that use is based on a professional medical assessment.

Q: What are the signs of a delayed allergic reaction to Ультравист?

The label advises informing a medical professional if signs of a delayed allergic reaction are experienced in the days following the procedure. These signs can include symptoms such as fever, rash, or joint pain.

Q: How is the risk of side effects from Ультравист minimized in a clinical setting?

Risks are minimized by clinical procedures such as warming the solution and using aseptic technique during administration. Other steps include ensuring the patient is adequately hydrated, using the dose as low as possible for high-risk patients, and monitoring the patient for at least 30 to 60 minutes afterwards.

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How should Ультравист be stored and disposed of?

Storage and Disposal of ULTRAVIST (Iopromide) Injection

ULTRAVIST storage is governed by strict regulatory requirements to maintain product integrity.

Official Storage Conditions

ULTRAVIST should be stored at 25 C (77 F), with permitted excursions between 15 C and 30 C. The solution must be protected from light and must not be frozen.

Stability and Handling

  • Visually inspect the solution for particulate matter or crystallization before use; do not administer if observed.
  • Any unused portion in a single-dose container must be discarded after initial use.
  • Contents of a bulk package must be used within 10 hours after the closure has been entered; any remaining portion must then be discarded.
  • Keep out of the sight and reach of children.

Disposal

Dispose of unused or expired ULTRAVIST product and solutions according to federal, state, and local environmental control laws. The product should not be allowed to enter surface waters or groundwater.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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