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Урографин

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Урографин

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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 Урографин

Property Description
Active ingredient Sodium Amidotrizoate, Meglumine Amidotrizoate
Form Aqueous solution for injection/infusion
Pharmacological class Iodinated X-ray contrast medium
Common use Visualization for X-ray examination (Diagnostic)
Origin Synthetic Organoiodine compound

Урографин is a highly specialized diagnostic agent classified as an X-ray contrast medium, and its sole role is to improve the visualization of internal body structures during medical imaging. This preparation is used exclusively for non-therapeutic purposes, designed to temporarily enhance the visual clarity of specific anatomical regions for diagnosis. Its established clinical utility for this purpose is supported by pharmacological studies recognizing its efficacy in contrast procedures.

This medication belongs to the pharmacological class of iodinated contrast media, designated by the Anatomical Therapeutic Chemical (ATC) code V08AA01. As a nephrotropic, high osmolar, ionic agent, its distinguishing feature is its high concentration of salts derived from diatrizoic acid, making it a classic example of this older generation of water-soluble agents. The substance itself provides essential information for diagnosis but does not alter the underlying physiological condition.

The primary active ingredients in Урографин are the synthetic organoiodine compounds Sodium Amidotrizoate (Diatrizoate Sodium) and Meglumine Amidotrizoate (Diatrizoate Meglumine). The product is manufactured as a combination product in the form of a clear, aqueous solution for injection or infusion, making it suitable for intravascular administration. This specific formulation, containing a blend of both salts, is essential to balance the required iodine density with appropriate viscosity for safe injection. The compound is known to achieve rapid distribution within the vascular and extracellular space following administration.

The general purpose of Урографин is to utilize the unique physical property of its iodine content to block X-rays and create a distinct, visible outline of structures normally invisible to radiation. By physically obstructing the radiation, the agent facilitates the diagnostic enhancement of complex, soft-tissue anatomy. For instance, it is typically used in a scenario where a doctor needs to assess the integrity of a patient's renal function by observing the flow and elimination pattern of the contrast agent through the kidneys (Urography). This physical shadowing action provides critical, non-invasive information regarding the integrity of these vital internal systems.

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What side effects are possible with Урографин?

Possible side effects and safety information

The safety profile of Урографин (Diatrizoate Salts) is formally documented in regulatory texts, categorizing possible adverse reactions by frequency and the body system affected. As an ionic, high-osmolar contrast agent, its use is associated with a distinct set of reactions compared to newer agents.

Documented Adverse Reactions

The majority of side effects are categorized as Common or Uncommon in official prescribing information, but the potential for serious reactions is also documented.

Frequency Category Examples of Documented Reactions
Common (≥ 1% to < 10%) Sensation of warmth or flushing, nausea, vomiting, metallic taste.
Uncommon (≥ 0.1% to < 1%) Urticaria (hives), pruritus (itching), headache, dizziness.
Rare (< 0.1%) Anaphylactic shock, cardiac arrest, severe hypotension, pulmonary oedema, convulsions.

Systemic and Serious Safety Concerns

Adverse reactions are grouped by System-Organ Class (SOC) in regulatory documents, with key areas being Immune System, Vascular, Cardiac, Renal, and Nervous System disorders. The most serious adverse reactions explicitly documented include anaphylactic shock, acute renal failure (nephropathy), and cardiac arrest. Most severe incidents are documented to occur within the first 30 minutes following administration, though some skin and renal effects may be delayed.

Population-Specific Safety Statements

Official labeling identifies specific patient groups with an increased safety risk. This includes individuals with pre-existing renal impairment, who face a heightened risk of contrast-induced nephropathy. Patients with a history of allergy or asthma are documented to have a higher likelihood of experiencing hypersensitivity reactions. Furthermore, older adults may show increased sensitivity to the agent’s osmotic load, which affects the cardiovascular and renal systems.

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Overdose and Emergency Response

Overdose and When to Seek Help

An overdose of Diatrizoate (Урографин) is defined by severe systemic toxicity stemming from excessively high concentrations of the contrast medium. Regulatory documents define the toxicity profile by the risk of life-threatening systemic failure, citing severe outcomes across multiple systems.

Documented manifestations include serious neurological events such as convulsions, seizures, hyperthermia, and coma. The toxicity profile also covers severe adverse effects on the cardiovascular system, potentially leading to cardiac arrest and death, and on the renal system, resulting in acute renal failure or anuria. Severe CNS outcomes like cerebral hemorrhage and paralysis are also officially noted.

Due to the severity of these risks, regulatory guidance mandates that you seek immediate medical attention or contact emergency services immediately upon suspicion of overdose or if severe symptoms manifest. The official prescribing information states that no specific antidote is known for this toxicity. Management is therefore entirely supportive and requires the prompt institution of symptomatic therapy and the support of all vital functions under continuous medical observation. A specific consideration noted in official documents is the increased risk of anuria and potentially fatal renal failure for patients with underlying conditions such as multiple myeloma or pre-existing severe renal impairment if overdose occurs.

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Therapeutic Uses of Урографин

Quick Facts

  • Main Use: Functions as a diagnostic aid for radiological examinations.
  • Key Benefit: Helps healthcare professionals visualize specific organs and structures.
  • Clinical Domains: Used for imaging of the vascular and renal systems.

Урографин is a contrast medium used in various diagnostic X-ray procedures. Its primary benefit is to support the production of clear, detailed images that assist in the evaluation of a patient’s internal structures. This medication is essential for specific diagnostic applications where enhanced visualization is required.

It is used to support the management of conditions by providing images for:

  • The renal and urinary system: Procedures such as excretion urography and retrograde urography to aid in the assessment of the kidneys, ureters, and bladder.
  • The cardiovascular system: Angiographic examinations to assist in the visualization of blood vessels, including the aorta and peripheral arteries.
  • Other internal structures: Used in specialized examinations like arthrography (joints), cholangiography (bile ducts), and hysterosalpingography (uterus and fallopian tubes) to provide diagnostic support.

Урографин is approved for use in these radiographic examinations to support diagnostic efforts across multiple clinical domains.

Regulatory References

  1. EMA therapeutic overview
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Eligibility and Restrictions for Use

Who Can and Cannot Use Урографин?

Regulatory documents establish strict population eligibility criteria for Урографин (Diatrizoate Meglumine and Diatrizoate Sodium Injection), defining who may use the product and who is excluded.

Contraindicated Populations

Use is strictly prohibited in patients with a proven or suspected hypersensitivity to iodine-containing contrast media or with uncontrolled thyrotoxicosis. The medicine is also contraindicated for patients with decompensated cardiac insufficiency and for all patients requiring intrathecal use (spinal injection) due to neurotoxicity risk.

Age- and Condition-Based Restrictions

While generally established for use in adults and documented for specific pediatric procedures, regulatory documents identify several high-risk groups requiring special caution.

  • High-Risk Conditions: Patients with severe renal insufficiency, multiple myeloma, diabetes mellitus, and a history of epilepsy are subject to special eligibility considerations.
  • Age: Geriatric patients (aged over 60 years) are classified as a high-risk population.
  • Reproductive Status: The specific procedure of hysterosalpingography is contraindicated during pregnancy. For other uses during pregnancy, the agent should be used only if clearly needed. For lactation, official guidance advises deciding whether to discontinue breastfeeding or discontinue the drug, as the agent is excreted into human milk.
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What should I know about interactions with other medicines?

The interaction profile for Урографин (Sodium Amidotrizoate, Meglumine Amidotrizoate) is defined by its effects on renal clearance and pharmacodynamic potentiation, strictly according to regulatory labeling. Furthermore, the product is not indicated for intrathecal administration due to the severe neurotoxic risk associated with this prohibited route.


Documented Interaction Constraints

Interacting Substance Official Constraint Description Required Action or Restriction
Metformin (Biguanides) Risk of lactic acidosis due to transient renal impairment, causing drug accumulation. Must be withheld 48 hours after administration; reinstate only after confirmed normal renal function.
Vasopressors Strongly potentiate neurologic effects when co-administered in certain procedures. Co-administration is prohibited in specific procedural contexts.

Pharmacodynamic and Efficacy Interactions

  • Radioactive Iodine Compounds: The iodinated contrast agent interferes with thyroid uptake of radiopharmaceuticals, which diminishes their therapeutic or diagnostic efficacy. A discontinuation period for the contrast agent is necessary prior to radioactive iodine administration.
  • Aldesleukin (Interleukin): Co-administration enhances the potential for allergic or hypersensitivity reactions to the contrast medium.
  • Beta-blockers: Patients receiving these agents may experience aggravated hypersensitivity reactions and may be refractory to standard emergency treatment.
  • Oral Cholecystographic Agents: Use is associated with a risk of renal toxicity when followed by an intravascular iodinated contrast agent, necessitating postponement of administration.
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Mechanism of Action

The mechanism of action for Урографин is founded upon its properties as a radiopaque contrast agent, functioning primarily through physical interaction with electromagnetic radiation. The molecule contains a high concentration of bound iodine moieties. These iodine atoms act as a physical target for incident X-ray photons, leading to high-level attenuation and absorption of the radiation. This differential absorption creates an area of reduced beam intensity compared to surrounding tissues, which is the biophysical basis for image contrast. Following intravenous administration, the compound enters the systemic circulation and undergoes a rapid, non-metabolized mechanistic cascade of renal excretion. This systemic process is mediated by glomerular filtration, resulting in the compound's selective and concentrated accumulation within the renal pelvis and ureters. This transient, high concentration of the radiopaque substance at the targeted anatomical site allows for the necessary X-ray attenuation to occur, thereby modulating the signal received by the detector.

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Dosage and Administration Information

Official Administration Guidelines

Urografin is a diagnostic agent used under strict procedural control, with administration guided by the specific radiological examination being performed. The solution is supplied as various concentrations, such as 76% (370 mg I/mL) and 60%, which dictate the procedure type and required volume.

Administration Scope and Dosing

Administration Route Standard Adult Dosing Principle
Intravenous (IV) Injection 20 mL to 50 mL of 76% solution for Urography.
Intravenous (IV) Infusion 250 mL of 30% solution for Infusion Urography.
Intra-arterial / Cavity Varies by procedure; total dose generally limited to 300 to 350 mL.

The agent is administered as a single event for the diagnostic procedure. For general intravenous injection, a rate of up to 20 mL/minute is typically applied. The solution must be warmed to body temperature (37 C) immediately before use to facilitate easier administration and tolerance. Additionally, patient hydration must be assured both before and after the administration of the contrast medium.

Population-Specific Use

Dosing for pediatric patients is weight-based, using specific mL/kg volumes that vary by the child’s age. For patients with cardiac insufficiency, the labeled instruction mandates that the injection or infusion time must be extended to 20 to 30 minutes to manage the delivery rate. The administration container is designed for single-use withdrawal only, and the agent is strictly prohibited from use in intrathecal procedures, such as myelography.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Урографин


Evidence for Use in Kidney and Urinary System Imaging

The research supporting the use of Урографин for visualizing the kidneys, ureters, and bladder—a procedure known as urography—primarily relies on Comparative Clinical Trials and Randomized Controlled Trials (RCTs). These studies were designed to examine the visualization ability of the agent in creating clear images of the renal anatomy. Research examined Diagnostic Image Quality and the agent’s immediate Hemodynamic effects following its injection in both adult and pediatric patients.

Findings describe patterns of visualization clarity that align with the agent's fundamental physical property of blocking X-rays, which is used to outline the structures of the urinary tract. Some comparative trials, which compared Урографин with newer contrast media, measured how image quality varied between the formulations. Much of the research examining this agent is composed of older comparative trials, which may limit the direct context of these findings for current high-level diagnostic assessments.


Evidence for Use in Blood Vessel Imaging (Angiography)

For procedures that visualize blood vessels, known as angiography, research has explored the agent's qualities mainly through Randomized Controlled Trials (RCTs) and specialized Comparative Hemodynamic Studies. These studies were primarily conducted in adult populations, including some individuals with pre-existing cardiovascular considerations. Researchers examined both the Diagnostic Image Quality for clarity of the vessels and measured acute Hemodynamic Parameters following intravascular administration.

Studies reported measurements of vessel clarity that helped contextualize visualization. Comparative studies described patterns of greater hemodynamic change compared to non-ionic contrast agents. The evidence highlights that the agent's known high osmolarity leads to the examination of more pronounced physiological effects in studies compared to lower-osmolar agents.


What Remains Unknown or Uncertain in the Research Landscape

Studies describe the agent's fundamental diagnostic characteristic—its physical property of blocking X-rays. However, there are several key limitations in the existing research. A major limitation is the reliance on older comparative trials against newer contrast media. These studies often described the high osmolarity of Urografin as a factor associated with more patient discomfort and greater hemodynamic changes when compared to newer formulations. Furthermore, the available follow-up durations were limited, focusing on acute rather than long-term consequences. Data for other specific patient subgroups remain insufficient across the broader evidence landscape.

Key Studies & References

  1. Licence PA1410-012-001 for Urografin (Diatrizoate), containing therapeutic overview and evidence basis (HPRA/EU Regulator)
  2. Diatrizoate Sodium and Diatrizoate Meglumine Injection (NIH DailyMed official drug label/monograph)
  3. Anatomical Therapeutic Chemical (ATC) Classification Code: V08AA01 Diatrizoic acid (WHO Collaborating Centre)
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Frequently Asked Questions (FAQ)

Common questions about Урографин (FAQ)


Q: Is Урографин the same thing as other contrast agents like Gastrografin or Visipaque?

According to official product information, Урографин is a type of iodine-containing contrast medium, or dye, used to help certain parts of the body show up on X-rays. It belongs to a specific chemical group called diatrizoate salts. The regulatory documents do not provide direct comparisons or differences between this product and other named contrast agents.


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

Official information indicates that after intravenous administration, Урографин is eliminated from the body relatively quickly, primarily through the kidneys (renal clearance). For kidney and urinary tract imaging (urography), the visualization of the structures typically begins around 3 to 5 minutes after the injection.


Q: Can Урографин cause an allergic reaction, and what are the signs to watch for?

Yes, allergic reactions or signs of shock are a documented risk. These signs can include swelling of the face or neck, difficulty breathing, a rash, hives, or dizziness. Medical staff are prepared to manage and treat any adverse reactions that may occur, which includes stopping the procedure.


Q: Is it safe to use Урографин if I am currently taking blood pressure medication?

Official product information cautions that patients with poor heart function or blood circulation have an increased risk of severe reactions. Patients taking certain medications, such as beta-blockers (a common type of blood pressure medicine), may experience aggravated hypersensitivity reactions and may be less responsive to standard emergency treatment.


Q: Can Урографин be used for imaging different parts of the body, not just the urinary tract?

Yes, while Урографин is commonly known for its use in urography (imaging the kidneys, ureters, and bladder), it is also used for imaging blood vessels (angiography). Its use for other established examinations of the body is determined by the healthcare provider based on the procedure required.


Q: Is Урографин safe for older patients, or is there a higher risk of side effects?

Official safety data indicates that older patients may have an increased risk of severe reactions due to the potential for pre-existing conditions, such as reduced kidney function or cardiac disease. Reactions are noted to be more common in older patients who have a history of heart conditions.


Q: Is it safe to drive after having a procedure with Урографин?

To minimize risk, the official patient information advises against driving or operating machinery for 24 hours after the medical examination. This caution is in place because there is a possibility of a delayed reaction that could affect attention or physical ability.


Q: Why is hydration important when you are given Урографин?

Regulatory guidance emphasizes that adequate fluid intake helps the body process and eliminate the contrast agent and is a necessary measure to support kidney function. Patients are typically advised not to reduce their fluid intake before and after the examination.


Q: What should I do if I notice a rash after leaving the clinic, post-procedure?

While severe reactions often occur immediately, skin changes like rashes or hives can sometimes be delayed. Official safety information advises that a healthcare provider should be contacted if delayed reactions are noticed after leaving the clinic.


Q: Is it safe to use Урографин during pregnancy or while breastfeeding?

Certain specific procedures, such as hysterosalpingography, are strictly prohibited during pregnancy. Official information states the agent is transmitted in only minimal amounts into breast milk. For all other uses, regulatory information indicates that consultation with the healthcare provider is necessary to determine the appropriate course of action.


Q: What is the difference in how Урографин is used for an intravenous pyelogram versus an angiography?

The method of administration differs based on the type of imaging. For a pyelogram (urography), the agent is typically given via an Intravenous Injection (into a vein). For angiography (imaging blood vessels), it is administered via an Intra-arterial injection (into an artery), which is a key difference noted in the administration principles.


Q: Can the procedure be stopped if I have a bad reaction to Урографин?

Yes, regulatory documents confirm that if signs of an allergic reaction or shock occur during the administration of the contrast agent, the procedure will be stopped immediately. Medical staff are prepared to manage any adverse reactions, including stopping the administration of the contrast agent immediately.


Q: If I have a history of heart problems, is Урографин still safe for my procedure?

The use of the agent is contraindicated (strictly prohibited) in patients with certain severe heart conditions, such as decompensated cardiac insufficiency. For other heart problems, official information warns that patients with pre-existing severe cardiac disease have an increased risk of severe reactions.


Q: Why is it crucial for the injection site to be monitored after giving Урографин?

Monitoring is necessary to observe the injection site for any local reactions, which can occur if the agent is not injected properly and leaks out of the vein (extravasation). Observation is part of the standard procedure to ensure patient safety following administration.


Q: How long does the iodine from Урографин stay detectable in the body?

The contrast agent is quickly cleared by the kidneys. Regulatory data suggests most of the administered dose is eliminated in the urine within about 3 hours in healthy adults. However, iodine clearance may take longer and could interfere with certain specific thyroid function tests.


Q: Are there any common foods or supplements that might interact with Урографин?

Official information advises that if the procedure is to view the abdomen, patients may be advised to temporarily avoid certain foods that cause flatulence (such as peas, beans, or uncooked vegetables). The regulatory documents do not provide detailed warnings for common supplement interactions.


Q: Is Урографин used in CT scans, MRIs, or both?

Урографин is classified as an X-ray contrast medium. This type of iodinated contrast can be used in procedures like CT (Computed Tomography) scans, which use X-rays. It is not the agent typically used for MRI (Magnetic Resonance Imaging) scans, which use different contrast materials.


Q: Can a patient be allergic to iodine and still safely receive Урографин?

No, official regulatory documentation explicitly states that Урографин is strictly prohibited (contraindicated) for use in patients who are allergic to iodine or any iodine-containing contrast media.


Q: What are the 'off-label' or less common uses of Урографин I see mentioned online?

Official documents confirm the main approved uses, such as urography and angiography. Official documents advise that while the main approved uses are listed, healthcare professionals may refer to specialized literature for information on other established indications.


Q: Does Урографин contain any ingredients that could be dangerous for someone with a sulfite allergy?

The active ingredients are diatrizoate salts, and the excipients are listed as sodium calcium edetate and water for injection. According to regulatory documents, the product does not list sulfites as an ingredient.


Q: Why is it important to tell the doctor about any history of asthma before getting Урографин?

Official information states that patients with a history of allergies or asthma have a higher chance of experiencing an adverse reaction to contrast media. Sharing this history with the medical team allows them to take appropriate precautions before the procedure.


Q: Can Урографин cause temporary changes in blood sugar levels?

Official documents highlight that patients with diabetes mellitus are considered a high-risk group and require special care, particularly regarding kidney protection, when using this contrast agent. However, the regulatory label does not explicitly detail or warn about temporary changes in blood sugar levels.


Q: Are headaches a common side effect of receiving Урографин?

Headaches are documented in the official safety profile. However, they are listed as an uncommon side effect, meaning they are experienced by less than one in 100 people.


Q: Does the temperature of the injection affect how I feel when Урографин is administered?

Yes, official administration guidelines recommend that the contrast medium is better tolerated and administration is easier if it is warmed to body temperature (37 C) immediately before use.


Q: I saw a comment about a delayed reaction to Урографин; how long after the procedure can that happen?

While the majority of severe reactions occur within the first 30 minutes after the injection, regulatory documents state that delayed reactions, such as certain skin or renal effects, are possible. These delayed reactions may appear hours or even days after the procedure.


Q: Is Урографин ever mixed with other fluids before injection?

In some cases, yes. For specific procedures like a retrograde urography, a dilute solution may need to be prepared. This preparation is done by mixing the concentrate with a specific amount of sterile water for injection.

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How should Урографин be stored and disposed of?

How to Store and Dispose of Urografin

Urografin must be stored according to specific regulatory conditions to maintain its sterility and quality as an iodinated contrast agent.

Storage Requirements

The product must be stored at room temperature, typically below 30 C, and requires protection from light and secondary X-rays.

Condition Regulatory Rule
Temperature Store below 30 C or at room temperature.
Protection Must be protected from light and secondary X-rays.
Container Store in the original receptacle; container is not intended for multiple doses.
Child Safety Keep out of the sight and reach of children.
Stability Do not use after the expiry date or if discoloration or particulate matter is present.

Handling and Disposal

To ensure sterility, the rubber stopper should never be pierced more than once. Any solution not used in one examination session must be discarded.

Disposal of unused or expired Urografin must follow official local and national regulations for medicinal waste. It must not be disposed of with household garbage or allowed to reach the sewage system.

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

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