What is visipaque. Visipaque: Uses, Side Effects, and Essential Information for Patients
What is Visipaque used for. How is Visipaque administered. What are the potential side effects of Visipaque. Is Visipaque safe during pregnancy and breastfeeding. How should Visipaque be stored. What precautions should be taken when using Visipaque. How does Visipaque work in diagnostic imaging.
Understanding Visipaque: A Comprehensive Guide to This Diagnostic Imaging Agent
Visipaque, also known by its generic name iodixanol, is a widely used contrast medium in diagnostic imaging procedures. This article delves into the various aspects of Visipaque, including its uses, administration, side effects, and important considerations for patients and healthcare providers.
The Role of Visipaque in Medical Imaging
Visipaque plays a crucial role in enhancing the visibility of internal structures during various diagnostic imaging procedures. Its primary function is to improve the contrast of images, allowing healthcare professionals to obtain clearer and more detailed views of organs, blood vessels, and other bodily structures.
Common Diagnostic Procedures Using Visipaque
- Angiocardiography
- Peripheral arteriography
- Visceral arteriography
- Cerebral arteriography
- Contrast-enhanced computed tomography (CT) of the head and body
- Excretory urography
- Venography
In addition to these procedures, Visipaque is also utilized in digital subtraction angiography (DSA) and conventional radiography. For pediatric patients, it is indicated for cardioangiography, urography, CT enhancement, and studies of the upper gastrointestinal tract.
Administration and Dosage of Visipaque
Visipaque is administered intravenously through a needle or catheter inserted into a vein. The dosage and administration method may vary depending on the specific diagnostic procedure and the patient’s individual characteristics.
How is the proper dosage of Visipaque determined. Healthcare providers consider several factors when determining the appropriate dosage, including:
- The type of diagnostic procedure being performed
- The patient’s age, weight, and overall health status
- The specific area of the body being examined
- Any previous reactions to contrast media
It is crucial for patients to follow their healthcare provider’s instructions carefully and inform them of any allergies or medical conditions before receiving Visipaque.
Potential Side Effects and Adverse Reactions
While Visipaque is generally considered safe when used as directed, like all medications, it can cause side effects in some individuals. It’s important for patients and healthcare providers to be aware of potential adverse reactions.
Common Side Effects
What are the most frequently reported side effects of Visipaque. Some common side effects include:
- Discomfort at the injection site (reported in 1-10% of patients)
- Headache
- Nausea
- Dizziness
- Taste disturbances (dysgeusia, reported in about 4% of patients)
- Skin reactions such as itching (pruritus, reported in about 2% of patients) and rash
Serious Adverse Reactions
While rare, more serious adverse reactions can occur. These may include:
- Cardiovascular issues: Cardiac arrest, palpitations, coronary artery spasms, hypertension
- Endocrine disorders: Thyroid function changes, including hypothyroidism or transient thyroid suppression
- Immune system reactions: Hypersensitivity reactions, including anaphylactic shock (which can be life-threatening)
- Neurological effects: Tremors, disturbances in consciousness, transient contrast-induced encephalopathy
- Respiratory problems: Cough, throat irritation, laryngeal edema, bronchospasm
- Severe skin reactions: In rare cases, conditions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms (DRESS) may occur
Patients should seek immediate medical attention if they experience any severe or concerning symptoms after receiving Visipaque.
Precautions and Contraindications
Before administering Visipaque, healthcare providers must carefully evaluate the patient’s medical history and current health status to ensure its safe use.
Important Considerations
What factors should be taken into account before using Visipaque. Healthcare providers should consider:
- History of allergies or previous reactions to iodinated contrast media
- Kidney function, as patients with impaired renal function may be at higher risk for adverse effects
- Thyroid disorders, particularly in patients with hyperthyroidism or goiter
- Cardiac conditions, especially in patients with heart failure or severe arrhythmias
- Diabetes, as there may be a risk of lactic acidosis in patients taking metformin
- Pregnancy and breastfeeding status
In some cases, the benefits of using Visipaque may outweigh the potential risks, but this decision should be made on a case-by-case basis by qualified healthcare professionals.
Visipaque in Special Populations
The use of Visipaque requires special consideration in certain patient groups, including pregnant women, nursing mothers, and pediatric patients.
Pregnancy and Breastfeeding
Is Visipaque safe for use during pregnancy and breastfeeding? The safety of Visipaque in pregnant women has not been conclusively established. It should only be used during pregnancy if the potential benefits justify the potential risks to the fetus. For breastfeeding mothers, it is recommended to discontinue breastfeeding for 24 hours after receiving Visipaque, as iodinated contrast media can be excreted in breast milk.
Pediatric Use
Visipaque is approved for use in pediatric patients for specific procedures, including cardioangiography and urography. However, dosing and administration should be carefully adjusted based on the child’s age, weight, and the specific diagnostic procedure being performed.
Storage and Handling of Visipaque
Proper storage and handling of Visipaque are essential to maintain its efficacy and safety. Healthcare facilities and pharmacies must adhere to specific guidelines to ensure the integrity of the product.
Storage Conditions
How should Visipaque be stored? The following storage conditions should be observed:
- Store below 30 degrees Celsius (86 degrees Fahrenheit)
- Do not freeze
- Protect from light
- Observe the shelf life, which is typically 2-3 years from the date of manufacture
It’s crucial to inspect the solution visually before use. Visipaque should appear as a clear to practically clear, colorless to slightly yellow solution. Any changes in color or the presence of particulate matter may indicate that the product should not be used.
The Science Behind Visipaque: How It Works
Understanding the mechanism of action of Visipaque can help healthcare providers and patients appreciate its role in diagnostic imaging.
Iodixanol: The Active Ingredient
Visipaque’s active ingredient, iodixanol, is a non-ionic, dimeric contrast medium. Its molecular structure contains iodine atoms, which are responsible for its contrast-enhancing properties.
How does iodixanol enhance image contrast? When introduced into the body, iodixanol:
- Absorbs X-rays more effectively than surrounding tissues
- Creates a density difference between the contrast-filled areas and the surrounding structures
- Allows for better visualization of blood vessels, organs, and other anatomical structures
The non-ionic nature of iodixanol contributes to its lower osmolality compared to some other contrast media, which may result in fewer adverse reactions in some patients.
Pharmacokinetics and Excretion
After administration, Visipaque is distributed throughout the extracellular fluid space. It does not undergo significant metabolism and is primarily excreted unchanged through the kidneys. This renal excretion makes Visipaque particularly useful for urographic procedures and allows for its eventual elimination from the body.
What is the typical timeline for Visipaque excretion? In patients with normal renal function:
- Approximately 97% of the administered dose is excreted within 24 hours
- Less than 2% is eliminated after 3 days
This rapid excretion profile contributes to the overall safety profile of Visipaque when used as directed.
Visipaque in Clinical Practice: Optimizing Diagnostic Outcomes
The effective use of Visipaque in clinical practice involves more than just administration of the contrast medium. Healthcare providers must consider various factors to optimize diagnostic outcomes and patient safety.
Preprocedural Considerations
What steps should be taken before administering Visipaque? Healthcare providers should:
- Conduct a thorough patient history review, focusing on allergies and previous reactions to contrast media
- Assess the patient’s hydration status and encourage adequate fluid intake before the procedure
- Consider prophylactic measures for high-risk patients, such as those with a history of moderate to severe contrast reactions
- Ensure that emergency equipment and medications are readily available in case of adverse reactions
During the Procedure
Careful monitoring during the administration of Visipaque is crucial. Healthcare providers should:
- Use the lowest effective dose of contrast medium necessary for diagnostic accuracy
- Monitor the patient for signs of immediate adverse reactions
- Be prepared to adjust the procedure or intervene if complications arise
Post-Procedure Care
After the diagnostic imaging procedure, patients should be monitored for a period of time to ensure no delayed reactions occur. Instructions for post-procedure care may include:
- Increasing fluid intake to help eliminate the contrast medium
- Watching for signs of allergic reactions or other adverse effects
- Following up with healthcare providers as directed
By following these best practices, healthcare providers can maximize the diagnostic value of Visipaque while minimizing potential risks to patients.
Future Developments and Research in Contrast Media
As medical imaging technology continues to advance, research into contrast media like Visipaque remains an active field of study. Scientists and healthcare professionals are constantly seeking ways to improve the safety, efficacy, and versatility of contrast agents.
Emerging Trends in Contrast Media Research
What are some of the current areas of focus in contrast media research? Ongoing studies are exploring:
- Development of contrast agents with even lower osmolality to further reduce the risk of adverse reactions
- Creation of targeted contrast agents that can highlight specific tissues or pathologies
- Investigation of alternatives to iodine-based contrast media for patients with iodine allergies or renal impairment
- Exploration of dual-energy CT techniques that may allow for reduced contrast medium doses
- Integration of artificial intelligence to optimize contrast media use and image interpretation
These advancements may lead to more personalized and efficient use of contrast media in the future, potentially improving diagnostic accuracy while minimizing patient risk.
The Role of Visipaque in Evolving Imaging Technologies
As imaging technologies continue to evolve, the role of contrast media like Visipaque may also change. For example:
- Advanced CT and MRI techniques may require new formulations or administration protocols for optimal results
- Molecular imaging approaches may incorporate contrast agents with specific targeting capabilities
- The integration of imaging with other diagnostic modalities may lead to new applications for contrast enhancement
Staying informed about these developments is crucial for healthcare providers to ensure they are providing the most up-to-date and effective diagnostic services to their patients.
Patient Education and Informed Consent
Effective communication between healthcare providers and patients is essential when using contrast media like Visipaque. Proper patient education and informed consent can help alleviate anxiety, improve compliance, and ensure better overall outcomes.
Key Points for Patient Education
What information should be conveyed to patients before administering Visipaque? Healthcare providers should discuss:
- The purpose of the contrast medium and its role in the diagnostic procedure
- Potential risks and benefits of using Visipaque
- Common side effects and what to do if they occur
- The importance of disclosing any allergies or medical conditions
- Instructions for before, during, and after the procedure
- Signs and symptoms that should prompt immediate medical attention
Obtaining Informed Consent
The process of obtaining informed consent should be thorough and documented. It should include:
- A clear explanation of the procedure and the use of Visipaque
- Discussion of alternative options, if available
- Opportunity for the patient to ask questions and express concerns
- Documentation of the patient’s understanding and agreement to proceed
By prioritizing patient education and informed consent, healthcare providers can foster a collaborative approach to diagnostic imaging and enhance patient satisfaction and safety.
Visipaque (iodixanol) dosing, indications, interactions, adverse effects, and more
>10%
Discomfort at injection site (
1-10%
Angina pectorin (
Chest pain (
Headache (
Migraine (
Vertigo (
Parethesia (1%)
Pruritus (2%)
Skin rash (
Erythema (
Dysguesia (4%)
Postmarketing Reports
Cardiovascular Disorders: Cardiac arrest, palpitations, spasms of coronary arteries, hypertension, and flushing
Endocrine Disorders: Thyroid function tests indicative of hypothyroidism or transient thyroid suppression have been uncommonly reported following iodinated contrast media administration to adult and pediatric patients, including infants; some patients were treated for hypothyroidism; hypoglycemia, hyperthyroidism
Eye Disorders: Transient visual impairment including cortical blindness, diplopia, and blurred vision
Gastrointestinal Disorders: Abdominal pain, pancreatitis, salivary gland enlargement
General Disorders and Administration Site Conditions: Chills, pyrexia, pain and discomfort, administration site reactions including extravasation
Immune System Disorders: Hypersensitivity reactions, anaphylactic shock including, life-threatening or fatal anaphylaxis
Nervous System Disorders: Tremor (transient), coma, disturbance in consciousness, transient contrast-induced encephalopathy caused by extravasation of contrast media (including amnesia, hallucination, paralysis, paresis, transient speech disorder, aphasia, dysarthria)
Psychiatric Disorders: Anxiety, agitation
Respiratory, Thoracic, and Mediastinal Disorders: Cough, sneezing, throat irritation or tightness, laryngeal edema, pharyngeal edema, bronchospasm
Skin and subcutaneous tissue disorders: Reactions range from mild (e. g. rash, erythema, pruritus, urticaria, and skin discoloration) to severe: [e.g. Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), acute generalized exanthematous pustulosis (AGEP) and drug reaction with eosinophilia and systemic symptoms (DRESS)]
Visipaque | healthdirect
What it is used for
This medicinal product is for diagnostic use only. Visipaque is indicated in adult patients for angiocardiography, peripheral arteriography, visceral arteriography, cerebral arteriography, contrast-enhanced computed tomography of the head and body, excretory urography and venography. In arteriography, Visipaque may be used for both conventional radiography and digital subtraction angiography (DSA). In children, Visipaque is indicated for cardioangiography, urography, CT enhancement and studies of the upper gastrointestinal tract.
How to take it
The way to take this medicine is: Intravenous.
This medicine or fluids is given through a needle or tube (catheter) inserted into a vein.
- Store below 30 degrees Celsius
- Do not Freeze
- Protect from Light
- Shelf lifetime is 2 Years.
- Store below 30 degrees Celsius
- Do not Freeze
- Protect from Light
- Shelf lifetime is 3 Years.
You should seek medical advice in relation to medicines and use only as directed by a healthcare professional.
Always read the label. If symptoms persist see your healthcare professional.
Visual appearance
A clear to practically clear, colourless to slightly yellow solution
Do I need a prescription?
What is the medicines and poisons schedule?
All medicines and poisons in Australia are categorised by how they are made available to the public. Medicines with a low safety risk are usually less tightly controlled than medicines with a higher safety risk. This system is called ‘scheduling’.
You can read more about the scheduling of medicines as well as the different scheduling categories on our Scheduling of medicines and poisons information page.
close tooltip Ok
We are unable to tell you if you need a prescription for this medicine. You can ask your pharmacist.This medicine is
Not Scheduled.
open tool tip to find out more
Pregnant or planning a pregnancy?
For the active ingredient iodixanol
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Download leaflet
For side effects, taking other medicines and more
Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website
Reporting side effects
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
What it is used for
This medicinal product is for diagnostic use only. Visipaque is indicated in adult patients for angiocardiography, peripheral arteriography, visceral arteriography, cerebral arteriography, contrast-enhanced computed tomography of the head and body, excretory urography and venography. In arteriography, Visipaque may be used for both conventional radiography and digital subtraction angiography (DSA). In children, Visipaque is indicated for cardioangiography, urography, CT enhancement and studies of the upper gastrointestinal tract.
How to take it
The way to take this medicine is: Intravenous.
This medicine or fluids is given through a needle or tube (catheter) inserted into a vein.
- Store below 30 degrees Celsius
- Do not Freeze
- Protect from Light
- Shelf lifetime is 2 Years.
- Store below 30 degrees Celsius
- Do not Freeze
- Protect from Light
- Shelf lifetime is 2 Years.
You should seek medical advice in relation to medicines and use only as directed by a healthcare professional.
Always read the label. If symptoms persist see your healthcare professional.
Visual appearance
A clear to practically clear, colourless to slightly yellow solution.
Do I need a prescription?
What is the medicines and poisons schedule?
All medicines and poisons in Australia are categorised by how they are made available to the public. Medicines with a low safety risk are usually less tightly controlled than medicines with a higher safety risk. This system is called ‘scheduling’.
You can read more about the scheduling of medicines as well as the different scheduling categories on our Scheduling of medicines and poisons information page.
close tooltip Ok
We are unable to tell you if you need a prescription for this medicine. You can ask your pharmacist.This medicine is
Not Scheduled.
open tool tip to find out more
Pregnant or planning a pregnancy?
For the active ingredient iodixanol
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Download leaflet
For side effects, taking other medicines and more
Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website
Reporting side effects
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
What it is used for
This medicinal product is for diagnostic use only. Visipaque is indicated in adult patients for angiocardiography, peripheral arteriography, visceral arteriography, cerebral arteriography, contrast-enhanced computed tomography of the head and body, excretory urography and venography. In arteriography, Visipaque may be used for both conventional radiography and digital subtraction angiography (DSA). In children, Visipaque is indicated for cardioangiography, urography, CT enhancement and studies of the upper gastrointestinal tract.
How to take it
The way to take this medicine is: Intravenous.
This medicine or fluids is given through a needle or tube (catheter) inserted into a vein.
- Store below 30 degrees Celsius
- Protect from Light
- Do not Freeze
- Shelf lifetime is 2 Years.
- Store below 30 degrees Celsius
- Do not Freeze
- Protect from Light
- Shelf lifetime is 2 Years.
You should seek medical advice in relation to medicines and use only as directed by a healthcare professional.
Always read the label. If symptoms persist see your healthcare professional.
Visual appearance
A clear to practically clear, colourless to slightly yellow solution
Do I need a prescription?
What is the medicines and poisons schedule?
All medicines and poisons in Australia are categorised by how they are made available to the public. Medicines with a low safety risk are usually less tightly controlled than medicines with a higher safety risk. This system is called ‘scheduling’.
You can read more about the scheduling of medicines as well as the different scheduling categories on our Scheduling of medicines and poisons information page.
close tooltip Ok
We are unable to tell you if you need a prescription for this medicine. You can ask your pharmacist.This medicine is
Not Scheduled.
open tool tip to find out more
Pregnant or planning a pregnancy?
For the active ingredient iodixanol
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Download leaflet
For side effects, taking other medicines and more
Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website
Reporting side effects
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
What it is used for
This medicinal product is for diagnostic use only. Visipaque is indicated in adult patients for angiocardiography, peripheral arteriography, visceral arteriography, cerebral arteriography, contrast-enhanced computed tomography of the head and body, excretory urography and venography. In arteriography, Visipaque may be used for both conventional radiography and digital subtraction angiography (DSA). In children, Visipaque is indicated for cardioangiography, urography, CT enhancement and studies of the upper gastrointestinal tract.
How to take it
The way to take this medicine is: Intravenous.
This medicine or fluids is given through a needle or tube (catheter) inserted into a vein.
- Store below 30 degrees Celsius
- Do not Freeze
- Protect from Light
- Shelf lifetime is 2 Years.
- Store below 30 degrees Celsius
- Do not Freeze
- Protect from Light
- Shelf lifetime is 3 Years.
You should seek medical advice in relation to medicines and use only as directed by a healthcare professional.
Always read the label. If symptoms persist see your healthcare professional.
Visual appearance
A clear to practically clear, colourless to slightly yellow solution.
Do I need a prescription?
What is the medicines and poisons schedule?
All medicines and poisons in Australia are categorised by how they are made available to the public. Medicines with a low safety risk are usually less tightly controlled than medicines with a higher safety risk. This system is called ‘scheduling’.
You can read more about the scheduling of medicines as well as the different scheduling categories on our Scheduling of medicines and poisons information page.
close tooltip Ok
We are unable to tell you if you need a prescription for this medicine. You can ask your pharmacist.This medicine is
Not Scheduled.
open tool tip to find out more
Pregnant or planning a pregnancy?
For the active ingredient iodixanol
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Download leaflet
For side effects, taking other medicines and more
Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website
Reporting side effects
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
What it is used for
This medicinal product is for diagnostic use only. Visipaque is indicated in adult patients for angiocardiography, peripheral arteriography, visceral arteriography, cerebral arteriography, contrast-enhanced computed tomography of the head and body, excretory urography and venography. In arteriography, Visipaque may be used for both conventional radiography and digital subtraction angiography (DSA). In children, Visipaque is indicated for cardioangiography, urography, CT enhancement and studies of the upper gastrointestinal tract.
How to take it
The way to take this medicine is: Intravenous.
This medicine or fluids is given through a needle or tube (catheter) inserted into a vein.
- Store below 30 degrees Celsius
- Do not Freeze
- Protect from Light
- Shelf lifetime is 3 Years.
- Store below 30 degrees Celsius
- Do not Freeze
- Protect from Light
- Shelf lifetime is 2 Years.
You should seek medical advice in relation to medicines and use only as directed by a healthcare professional.
Always read the label. If symptoms persist see your healthcare professional.
Visual appearance
A clear to practically clear, colourless to slightly yellow solution
Do I need a prescription?
What is the medicines and poisons schedule?
All medicines and poisons in Australia are categorised by how they are made available to the public. Medicines with a low safety risk are usually less tightly controlled than medicines with a higher safety risk. This system is called ‘scheduling’.
You can read more about the scheduling of medicines as well as the different scheduling categories on our Scheduling of medicines and poisons information page.
close tooltip Ok
We are unable to tell you if you need a prescription for this medicine. You can ask your pharmacist.This medicine is
Not Scheduled.
open tool tip to find out more
Pregnant or planning a pregnancy?
For the active ingredient iodixanol
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Download leaflet
For side effects, taking other medicines and more
Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website
Reporting side effects
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
What it is used for
This medicinal product is for diagnostic use only. Visipaque is indicated in adult patients for angiocardiography, peripheral arteriography, visceral arteriography, cerebral arteriography, contrast-enhanced computed tomography of the head and body, excretory urography and venography. In arteriography, Visipaque may be used for both conventional radiography and digital subtraction angiography (DSA). In children, Visipaque is indicated for cardioangiography, urography, CT enhancement and studies of the upper gastrointestinal tract.
How to take it
The way to take this medicine is: Intravenous.
This medicine or fluids is given through a needle or tube (catheter) inserted into a vein.
- Store below 30 degrees Celsius
- Do not Freeze
- Protect from Light
- Shelf lifetime is 3 Years.
- Store below 30 degrees Celsius
- Do not Freeze
- Protect from Light
- Shelf lifetime is 2 Years.
You should seek medical advice in relation to medicines and use only as directed by a healthcare professional.
Always read the label. If symptoms persist see your healthcare professional.
Visual appearance
A clear to practically clear, colourless to slightly yellow solution
Do I need a prescription?
What is the medicines and poisons schedule?
All medicines and poisons in Australia are categorised by how they are made available to the public. Medicines with a low safety risk are usually less tightly controlled than medicines with a higher safety risk. This system is called ‘scheduling’.
You can read more about the scheduling of medicines as well as the different scheduling categories on our Scheduling of medicines and poisons information page.
close tooltip Ok
We are unable to tell you if you need a prescription for this medicine. You can ask your pharmacist.This medicine is
Not Scheduled.
open tool tip to find out more
Pregnant or planning a pregnancy?
For the active ingredient iodixanol
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Download leaflet
For side effects, taking other medicines and more
Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website
Reporting side effects
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
What it is used for
This medicinal product is for diagnostic use only. Visipaque is indicated in adult patients for angiocardiography, peripheral arteriography, visceral arteriography, cerebral arteriography, contrast-enhanced computed tomography of the head and body, excretory urography and venography. In arteriography, Visipaque may be used for both conventional radiography and digital subtraction angiography (DSA). In children, Visipaque is indicated for cardioangiography, urography, CT enhancement and studies of the upper gastrointestinal tract.
How to take it
The way to take this medicine is: Intravenous.
This medicine or fluids is given through a needle or tube (catheter) inserted into a vein.
- Store below 30 degrees Celsius
- Do not Freeze
- Protect from Light
- Shelf lifetime is 18 Months.
You should seek medical advice in relation to medicines and use only as directed by a healthcare professional.
Always read the label. If symptoms persist see your healthcare professional.
Visual appearance
A clear to practically clear, colourless to slightly yellow solution
Do I need a prescription?
What is the medicines and poisons schedule?
All medicines and poisons in Australia are categorised by how they are made available to the public. Medicines with a low safety risk are usually less tightly controlled than medicines with a higher safety risk. This system is called ‘scheduling’.
You can read more about the scheduling of medicines as well as the different scheduling categories on our Scheduling of medicines and poisons information page.
close tooltip Ok
We are unable to tell you if you need a prescription for this medicine. You can ask your pharmacist.This medicine is
Not Scheduled.
open tool tip to find out more
Pregnant or planning a pregnancy?
For the active ingredient iodixanol
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Download leaflet
For side effects, taking other medicines and more
Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website
Reporting side effects
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
What it is used for
Visipaque is indicated, in adult patients, for angiocardiography, peripheral arteriography, visceral arteriography, cerebral arteriography, contrast-enhanced computed tomography of the head and body, excretory urography and venography. In arteriography, Visipaque may be used for both conventional radiography and digital subtraction angiography (DSA).
How to take it
The way to take this medicine is: Intravenous.
This medicine or fluids is given through a needle or tube (catheter) inserted into a vein.
- Store below 30 degrees Celsius
- Do not Freeze
- Protect from Light
- Shelf lifetime is 2 Years.
- Store below 30 degrees Celsius
- Do not Freeze
- Protect from Light
- Shelf lifetime is 30 Months.
You should seek medical advice in relation to medicines and use only as directed by a healthcare professional.
Always read the label. If symptoms persist see your healthcare professional.
Visual appearance
A clear to practically clear, colourless to slightly yellow solution
Do I need a prescription?
What is the medicines and poisons schedule?
All medicines and poisons in Australia are categorised by how they are made available to the public. Medicines with a low safety risk are usually less tightly controlled than medicines with a higher safety risk. This system is called ‘scheduling’.
You can read more about the scheduling of medicines as well as the different scheduling categories on our Scheduling of medicines and poisons information page.
close tooltip Ok
We are unable to tell you if you need a prescription for this medicine. You can ask your pharmacist.This medicine is
Not Scheduled.
open tool tip to find out more
Pregnant or planning a pregnancy?
For the active ingredient iodixanol
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Download leaflet
For side effects, taking other medicines and more
Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website
Reporting side effects
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
What it is used for
This medicinal product is for diagnostic use only. Visipaque is indicated in adult patients for angiocardiography, peripheral arteriography, visceral arteriography, cerebral arteriography, contrast-enhanced computed tomography of the head and body, excretory urography and venography. In arteriography, Visipaque may be used for both conventional radiography and digital subtraction angiography (DSA). In children, Visipaque is indicated for cardioangiography, urography, CT enhancement and studies of the upper gastrointestinal tract.
How to take it
The way to take this medicine is: Intravenous.
This medicine or fluids is given through a needle or tube (catheter) inserted into a vein.
- Store below 30 degrees Celsius
- Do not Freeze
- Protect from Light
- Shelf lifetime is 18 Months.
You should seek medical advice in relation to medicines and use only as directed by a healthcare professional.
Always read the label. If symptoms persist see your healthcare professional.
Visual appearance
A clear to practically clear, colourless to slightly yellow solution
Do I need a prescription?
What is the medicines and poisons schedule?
All medicines and poisons in Australia are categorised by how they are made available to the public. Medicines with a low safety risk are usually less tightly controlled than medicines with a higher safety risk. This system is called ‘scheduling’.
You can read more about the scheduling of medicines as well as the different scheduling categories on our Scheduling of medicines and poisons information page.
close tooltip Ok
We are unable to tell you if you need a prescription for this medicine. You can ask your pharmacist.This medicine is
Not Scheduled.
open tool tip to find out more
Pregnant or planning a pregnancy?
For the active ingredient iodixanol
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Download leaflet
For side effects, taking other medicines and more
Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website
Reporting side effects
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
What it is used for
This medicinal product is for diagnostic use only. Visipaque is indicated in adult patients for angiocardiography, peripheral arteriography, visceral arteriography, cerebral arteriography, contrast-enhanced computed tomography of the head and body, excretory urography and venography. In arteriography, Visipaque may be used for both conventional radiography and digital subtraction angiography (DSA). In children, Visipaque is indicated for cardioangiography, urography, CT enhancement and studies of the upper gastrointestinal tract.
How to take it
The way to take this medicine is: Intravenous.
This medicine or fluids is given through a needle or tube (catheter) inserted into a vein.
- Store below 30 degrees Celsius
- Do not Freeze
- Protect from Light
- Shelf lifetime is 18 Months.
You should seek medical advice in relation to medicines and use only as directed by a healthcare professional.
Always read the label. If symptoms persist see your healthcare professional.
Visual appearance
A clear to practically clear, colourless to slightly yellow solution
Do I need a prescription?
What is the medicines and poisons schedule?
All medicines and poisons in Australia are categorised by how they are made available to the public. Medicines with a low safety risk are usually less tightly controlled than medicines with a higher safety risk. This system is called ‘scheduling’.
You can read more about the scheduling of medicines as well as the different scheduling categories on our Scheduling of medicines and poisons information page.
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We are unable to tell you if you need a prescription for this medicine. You can ask your pharmacist.This medicine is
Not Scheduled.
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Pregnant or planning a pregnancy?
For the active ingredient iodixanol
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Download leaflet
For side effects, taking other medicines and more
Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website
Reporting side effects
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
What it is used for
This medicinal product is for diagnostic use only. Visipaque is indicated in adult patients for angiocardiography, peripheral arteriography, visceral arteriography, cerebral arteriography, contrast-enhanced computed tomography of the head and body, excretory urography and venography. In arteriography, Visipaque may be used for both conventional radiography and digital subtraction angiography (DSA). In children, Visipaque is indicated for cardioangiography, urography, CT enhancement and studies of the upper gastrointestinal tract.
How to take it
The way to take this medicine is: Intravenous.
This medicine or fluids is given through a needle or tube (catheter) inserted into a vein.
- Store below 30 degrees Celsius
- Do not Freeze
- Protect from Light
- Shelf lifetime is 2 Years.
- Store below 30 degrees Celsius
- Do not Freeze
- Protect from Light
- Shelf lifetime is 30 Months.
You should seek medical advice in relation to medicines and use only as directed by a healthcare professional.
Always read the label. If symptoms persist see your healthcare professional.
Visual appearance
A clear to practically clear, colourless to slightly yellow solution
Do I need a prescription?
What is the medicines and poisons schedule?
All medicines and poisons in Australia are categorised by how they are made available to the public. Medicines with a low safety risk are usually less tightly controlled than medicines with a higher safety risk. This system is called ‘scheduling’.
You can read more about the scheduling of medicines as well as the different scheduling categories on our Scheduling of medicines and poisons information page.
close tooltip Ok
We are unable to tell you if you need a prescription for this medicine. You can ask your pharmacist.This medicine is
Not Scheduled.
open tool tip to find out more
Pregnant or planning a pregnancy?
For the active ingredient iodixanol
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Download leaflet
For side effects, taking other medicines and more
Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website
Reporting side effects
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
What it is used for
This medicinal product is for diagnostic use only. Visipaque is indicated in adult patients for angiocardiography, peripheral arteriography, visceral arteriography, cerebral arteriography, contrast-enhanced computed tomography of the head and body, excretory urography and venography. In arteriography, Visipaque may be used for both conventional radiography and digital subtraction angiography (DSA). In children, Visipaque is indicated for cardioangiography, urography, CT enhancement and studies of the upper gastrointestinal tract.
How to take it
The way to take this medicine is: Intravenous.
This medicine or fluids is given through a needle or tube (catheter) inserted into a vein.
- Store below 30 degrees Celsius
- Do not Freeze
- Protect from Light
- Shelf lifetime is 3 Years.
- Store below 30 degrees Celsius
- Do not Freeze
- Protect from Light
- Shelf lifetime is 2 Years.
You should seek medical advice in relation to medicines and use only as directed by a healthcare professional.
Always read the label. If symptoms persist see your healthcare professional.
Visual appearance
A clear to practically clear, colourless to slightly yellow solution
Do I need a prescription?
What is the medicines and poisons schedule?
All medicines and poisons in Australia are categorised by how they are made available to the public. Medicines with a low safety risk are usually less tightly controlled than medicines with a higher safety risk. This system is called ‘scheduling’.
You can read more about the scheduling of medicines as well as the different scheduling categories on our Scheduling of medicines and poisons information page.
close tooltip Ok
We are unable to tell you if you need a prescription for this medicine. You can ask your pharmacist.This medicine is
Not Scheduled.
open tool tip to find out more
Pregnant or planning a pregnancy?
For the active ingredient iodixanol
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Download leaflet
For side effects, taking other medicines and more
Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website
Reporting side effects
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
What it is used for
This medicinal product is for diagnostic use only. Visipaque is indicated in adult patients for angiocardiography, peripheral arteriography, visceral arteriography, cerebral arteriography, contrast-enhanced computed tomography of the head and body, excretory urography and venography. In arteriography, Visipaque may be used for both conventional radiography and digital subtraction angiography (DSA). In children, Visipaque is indicated for cardioangiography, urography, CT enhancement and studies of the upper gastrointestinal tract.
How to take it
The way to take this medicine is: Intravenous.
This medicine or fluids is given through a needle or tube (catheter) inserted into a vein.
- Store below 30 degrees Celsius
- Do not Freeze
- Protect from Light
- Shelf lifetime is 3 Years.
- Store below 30 degrees Celsius
- Do not Freeze
- Protect from Light
- Shelf lifetime is 2 Years.
You should seek medical advice in relation to medicines and use only as directed by a healthcare professional.
Always read the label. If symptoms persist see your healthcare professional.
Visual appearance
A clear to practically clear, colourless to slightly yellow solution
Do I need a prescription?
What is the medicines and poisons schedule?
All medicines and poisons in Australia are categorised by how they are made available to the public. Medicines with a low safety risk are usually less tightly controlled than medicines with a higher safety risk. This system is called ‘scheduling’.
You can read more about the scheduling of medicines as well as the different scheduling categories on our Scheduling of medicines and poisons information page.
close tooltip Ok
We are unable to tell you if you need a prescription for this medicine. You can ask your pharmacist.This medicine is
Not Scheduled.
open tool tip to find out more
Pregnant or planning a pregnancy?
For the active ingredient iodixanol
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Download leaflet
For side effects, taking other medicines and more
Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website
Reporting side effects
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
What it is used for
This medicinal product is for diagnostic use only. Visipaque is indicated in adult patients for angiocardiography, peripheral arteriography, visceral arteriography, cerebral arteriography, contrast-enhanced computed tomography of the head and body, excretory urography and venography. In arteriography, Visipaque may be used for both conventional radiography and digital subtraction angiography (DSA). In children, Visipaque is indicated for cardioangiography, urography, CT enhancement and studies of the upper gastrointestinal tract.
How to take it
The way to take this medicine is: Intravenous.
This medicine or fluids is given through a needle or tube (catheter) inserted into a vein.
- Store below 30 degrees Celsius
- Do not Freeze
- Protect from Light
- Shelf lifetime is 18 Months.
You should seek medical advice in relation to medicines and use only as directed by a healthcare professional.
Always read the label. If symptoms persist see your healthcare professional.
Visual appearance
A clear, to practically clear, colourless to slightly yellow solution
Do I need a prescription?
What is the medicines and poisons schedule?
All medicines and poisons in Australia are categorised by how they are made available to the public. Medicines with a low safety risk are usually less tightly controlled than medicines with a higher safety risk. This system is called ‘scheduling’.
You can read more about the scheduling of medicines as well as the different scheduling categories on our Scheduling of medicines and poisons information page.
close tooltip Ok
We are unable to tell you if you need a prescription for this medicine. You can ask your pharmacist.This medicine is
Not Scheduled.
open tool tip to find out more
Pregnant or planning a pregnancy?
For the active ingredient iodixanol
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Download leaflet
For side effects, taking other medicines and more
Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website
Reporting side effects
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
What it is used for
This medicinal product is for diagnostic use only. Visipaque is indicated in adult patients for angiocardiography, peripheral arteriography, visceral arteriography, cerebral arteriography, contrast-enhanced computed tomography of the head and body, excretory urography and venography. In arteriography, Visipaque may be used for both conventional radiography and digital subtraction angiography (DSA). In children, Visipaque is indicated for cardioangiography, urography, CT enhancement and studies of the upper gastrointestinal tract.
How to take it
The way to take this medicine is: Intravenous.
This medicine or fluids is given through a needle or tube (catheter) inserted into a vein.
- Store below 30 degrees Celsius
- Do not Freeze
- Protect from Light
- Shelf lifetime is 18 Months.
You should seek medical advice in relation to medicines and use only as directed by a healthcare professional.
Always read the label. If symptoms persist see your healthcare professional.
Visual appearance
A clear to practically clear, colourless to slightly yellow solution
Do I need a prescription?
What is the medicines and poisons schedule?
All medicines and poisons in Australia are categorised by how they are made available to the public. Medicines with a low safety risk are usually less tightly controlled than medicines with a higher safety risk. This system is called ‘scheduling’.
You can read more about the scheduling of medicines as well as the different scheduling categories on our Scheduling of medicines and poisons information page.
close tooltip Ok
We are unable to tell you if you need a prescription for this medicine. You can ask your pharmacist.This medicine is
Not Scheduled.
open tool tip to find out more
Pregnant or planning a pregnancy?
For the active ingredient iodixanol
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Download leaflet
For side effects, taking other medicines and more
Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website
Reporting side effects
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
What it is used for
This medicinal product is for diagnostic use only. Visipaque is indicated in adult patients for angiocardiography, peripheral arteriography, visceral arteriography, cerebral arteriography, contrast-enhanced computed tomography of the head and body, excretory urography and venography. In arteriography, Visipaque may be used for both conventional radiography and digital subtraction angiography (DSA). In children, Visipaque is indicated for cardioangiography, urography, CT enhancement and studies of the upper gastrointestinal tract.
How to take it
The way to take this medicine is: Intravenous.
This medicine or fluids is given through a needle or tube (catheter) inserted into a vein.
- Store below 30 degrees Celsius
- Do not Freeze
- Protect from Light
- Shelf lifetime is 18 Months.
You should seek medical advice in relation to medicines and use only as directed by a healthcare professional.
Always read the label. If symptoms persist see your healthcare professional.
Visual appearance
A clear to practically clear, colourless to slightly yellow solution
Do I need a prescription?
What is the medicines and poisons schedule?
All medicines and poisons in Australia are categorised by how they are made available to the public. Medicines with a low safety risk are usually less tightly controlled than medicines with a higher safety risk. This system is called ‘scheduling’.
You can read more about the scheduling of medicines as well as the different scheduling categories on our Scheduling of medicines and poisons information page.
close tooltip Ok
We are unable to tell you if you need a prescription for this medicine. You can ask your pharmacist.This medicine is
Not Scheduled.
open tool tip to find out more
Pregnant or planning a pregnancy?
For the active ingredient iodixanol
You should seek advice from your doctor or pharmacist about taking this medicine. They can help you balance the risks and the benefits of this medicine during pregnancy.
Download leaflet
For side effects, taking other medicines and more
Download consumer medicine information leaflet (pdf) from the Therapeutic Goods Administration (TGA) website
Reporting side effects
You can help ensure medicines are safe by reporting the side effects you experience.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems
Are There Differences in Nephrotoxicity among Contrast Media?
Iodinated contrast agents are usually classified based upon their osmolality—high, low, and isosmolar. Iodinated contrast agents are also nephrotoxic in some but not all patients resulting in loss of glomerular filtration rate. Over the past 30 years, nephrotoxicity has been linked to osmolality although the precise mechanism underlying such a link has been elusive. Improvements in our understanding of the pathogenesis of nephrotoxicity and prospective randomized clinical trials have attempted to further explore the relationship between osmolality and nephrotoxicity. In this review, the basis for our current understanding that there are little if any differences in nephrotoxic potential between low and isosmolar contrast media will be detailed using data from clinical studies.
1. Introduction
Radiographic contrast agents have been in use for over 60 years. Based upon current data, 2.0 million cardiac catheterizations are performed annually in the USA [1] and nearly 30 million contrast-enhanced CT scans, in addition to the use of contrast for peripheral angiography. An average contrast-enhanced CT uses ~40 grams of iodine chemically bound to an organic molecule that is injected directly into the vascular system. This is a very large dose of foreign material and speaks to the overall safety of these agents.
Over the past decades, modifications in the organic molecule to which the iodine is bound have occurred and have resulted in changes in the physical properties of the product. These physical properties—ionicity, osmolality, and viscosity—are directly related to the number and size of the organic molecules needed to bind the iodine.
In the mid-1950s, it was recognized that some patients develop a rise in serum creatinine (the definition of contrast-induced acute kidney injury or CIAKI) following the administration of high-osmolar contrast media. Most of these patients received intra-arterial infusions, for example, for coronary angiography. The development of CIAKI has been widely documented in the literature and the risk factors for developing such an injury are exhaustively described [2]. It should be noted that these were observational retrospective studies and no control groups were assessed. Furthermore, no adjudication for other potential causes of a rise in serum creatinine was provided. Nevertheless, animal studies and in vitro studies with lines of kidney cells have provided the basis for the conclusion that contrast media can cause kidney injury. We have come to know much about the pathogenesis of this injury; it involves direct tubule cell nephrotoxicity as well as ischemia mediated by decreased availability of NO and the generation of reactive oxygen species particularly in the medulla of the kidney [3]. In this review, the relevance of the physical properties of the contrast media—ionicity, osmolality, and viscosity—to the development of CIAKI will be reviewed.
2. Contrast Media Structure
As noted above, the size and number of organic molecules binding the iodine are the primary determinant of the ionicity, osmolality, and viscosity of the commercial product. Over the past 2 decades, we have moved in the development of contrast media from ionic monomers through nonionic monomers to nonionic dimers increasing the number of iodine atoms per molecule from 1.5 to 6.0 (see Figure 1). These changes have resulted in less total molecules (lower osmolality) necessary to deliver a sufficient amount of iodine for adequate imaging but progressively larger molecules (more viscosity) (see Table 1).
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Before delving into the multiple studies trying to address the relative nephrotoxicity of the contrast media with different physical properties, it is appropriate to first identify whether any of these differences in physical properties translates into something measureable in all patients who receive them.
3. Urine Output
In general, the higher the osmolality of the contrast media, the greater the urine output in the first few hours following their administration. This makes sense physiologically as the contrast medium is a nonreabsorbable solute which acts like an osmotic diuretic, reducing electrolyte reabsorption along the nephron and obligating an increase in urine output. An increase in urine output has been observed when comparing high and low-osmolality contrast media as well as low and isoosmolality contrast media [4].
4. Urine Viscosity
A definite increase in urine viscosity is observed when using contrast medium that is of very large molecular size (e.g., nonionic dimers). This occurs as a result of the progressive concentration of the contrast medium as it travels down the nephron and 99% of the filtered water is reabsorbed. Urine viscosity can be directly measured and increases significantly only with isosmolar contrast media [4, 5].
Could either of these effects contribute in some way to the decrease in glomerular filtration rate (CIAKI) observed in some patients following contrast administration?
The osmotic diuresis with high- and low-osmolality contrast media could result in extracellular volume contraction, stimulation of the intrarenal renin-angiotensin-aldosterone axis, and/or release of other vasoconstrictor hormones (endothelin or adenosine, e.g.) that would augment the direct vasoconstrictor effects of contrast media and further exacerbate ischemia. The increase in urine viscosity could raise the pressure within the tubule lumen and reduce the net driving force for glomerular filtration (capillary hydrostatic pressure—(pressure within tubule + plasma oncotic pressure)) and thus directly decrease GFR. The degree to which these predictable effects contribute to the development of CIAKI will depend upon the amount of contrast medium administered and the unique physiologic environment of each patient. For example, the number of nephrons filtering the contrast media (reduced in chronic kidney disease) and the degree of reabsorption within the nephron (stimulated in extracellular volume depletion and congestive heart failure) might be expected to interact with these physiologic effects. As an example, when there is more reabsorption of filtrate because of volume depletion or heart failure, the viscosity in the urine following administration of a nonionic dimer would be greater. Similarly, if a patient is already volume depleted and receives a high-osmolality agent with subsequent increase in urine output, extracellular volume depletion would be exacerbated resulting in a greater stimulation of intrarenal vasoconstrictor factors.
5. Defining Nephrotoxicity
To date, the vast majority of clinical trials have used serum creatinine, a marker of glomerular filtration rate, to define CIAKI. The underlying assumption is that with injury to the tubules, there is a reduction in GFR mediated by a variety of mechanisms within the kidney. However, there are many problems with using creatinine as a measure of an acute change in GFR including the following.(i)Creatinine is not an ideal marker of GFR because it undergoes secretion and even reabsorption. Changes in serum creatinine could therefore reflect changes in secretion and/or reabsorption without a change in glomerular filtration [6].(ii)There is a lag phase of 1-2 days before creatinine will rise sufficiently to meet the threshold for CIAKI even when GFR is severely affected. This is because the retained creatinine must distribute in total body water resulting in a slow rise in serum levels. Because of the time lag, an acute reduction in GFR can be missed if serial creatinine levels are not determined for at least 72 hours [7].(iii)A true change in GFR might occur as a result of hemodynamic changes without any evidence of tubule injury. In this circumstance, an increase in serum creatinine sufficient to define CIAKI would not be associated with true injury.(iv)Likewise, tubule injury may not always be reflected in a change in GFR. In this circumstance, injury would be missed by reliance on serum creatinine [8].
6. Clinical Studies regarding Nephrotoxicity
In the 1980–1990s, the development of nonionic contrast media (low-osmolality contrast medium, ratio: 3 iodines per molecule) was quickly adopted because of a decrease in nonkidney side effects. In particular, the feelings of warmth, nausea, and itching were all diminished with low-osmolality contrast media (LOCM) compared to high-osmolality contrast media (HOCM). Many randomized controlled trials were performed to evaluate whether LOCM reduced the incidence of nephrotoxicity compared to HOCM. An important milestone was the meta-analysis of these trials performed by Barrett and Carlisle in 1993 [9]. These authors indeed found a reduction in the incidence of CIAKI with the use of a low- compared to the high-osmolality contrast media. However, a more in-depth review of their publication reveals the following.(i)There was no difference in the incidence of CIAKI in patients who had normal kidney function.(ii)There was a 50% reduction in the incidence of CIAKI only in patients with an initial creatinine clearance less than 60 mL/min.(iii)The reduction in the incidence of CIAKI was seen only when the contrast was given intra-arterially but not intravenously.
Despite these findings, this meta-analysis contributed significantly to the disuse of HOCM in all patients and HOCM subsequently faded from the market to be replaced with LOCM.
In the late 1990s, a new class of contrast agent—isosmolar or IOCM—came into clinical use. Based upon the meta-analysis of Barrett and Carlisle that found that osmolality contributed to the nephrotoxicity of contrast media under certain circumstances, it was quite reasonable to hypothesize that the IOCM would be associated with less CIAKI compared to LOCM. A seminal study supporting this claim was the NEPHRIC trial. This was a 129-patient, randomized trial in patients with diabetes and chronic kidney disease (estimated creatinine clearance <60 mL/min) who were undergoing cardiac angiography [10]. The IOCM (iodixanol, Visipaque) was compared to a LOCM (iohexol, Omnipaque) with the primary endpoint of CIAKI defined as a >0.5 mg/dL absolute rise in creatinine over 48–72 hours. The incidence of CIAKI with iodixanol was significantly lower than with iohexol (2% versus 16%, resp.) in this high-risk population.
What followed the publication of the NEPHRIC trial in the New England Journal of Medicine in 2003 can aptly be described as a “war.” Manufacturers of LOCM other than the one studied in the NEPHRIC trial immediately set to work to replicate or repudiate the finding using their own LOCM. Multiple RCTs were conducted in high-risk populations undergoing cardiac angiography, peripheral angiography, or contrast-enhanced CT. Over the past decade, at least 4 meta-analyses of these trials were published with essentially similar findings [11–14] (see Figures 2(a), 2(b), 2(c), and 2(d)). Some meta-analyses mixed intravenous and intra-arterial administration, while others excluded studies presented in abstract. Most meta-analyses found little evidence of heterogeneity strengthening the conclusions of the analyses. The incidence of CIAKI (by any definition) was similar between LOCM and IOCM with the possible exception of the LOCM, iohexol [12].
Was NEPHRIC just wrong? It is always easy to argue that a study with only 129 subjects and in which the primary endpoint occurs in <10% is going to be underpowered and subject to a type-1 error. This is certainly one possibility. Was NEPHRIC correct but used as a comparator a particular LOCM (iohexol) with a higher with a higher incidence of CIAKI? The subsequent studies using other LOCMs would support this conclusion as well. If one refers to Table 1, iohexol has the highest viscosity of the LOCMs. Perhaps, viscosity and osmolality both contribute to nephrotoxicity (see above). To date, there has not been a randomized controlled trial comparing iohexol to any other LOCM in a high-risk population. The updated 2011 AHA/ACC guidelines for use of contrast media in high-risk patients do not favor IOCM over LOCM [15].
Thus, an overall summary of the current database, updated since previous guideline recommendations, is that strength and consistency of relationships between specific isosmolar or low-osmolar agents and CIAKI or renal failure are not sufficient to enable a guideline statement on selection among commonly used low-osmolar and isosmolar media.
What are the limitations of these studies and the subsequent meta-analyses? These randomized prospective trials all used serum creatinine as the marker of injury. They assumed that any increase in creatinine following contrast exposure was caused by the contrast (no adjudication for other causes of a rise in serum creatinine). Katzberg et al. noted persistent global and focal nephrograms on CT performed 24 hours following administration of isosmolar contrast for coronary angiography [17]. Such findings might be explained by microemboli rather than contrast-induced nephrotoxicity. Unfortunately, the study did not measure either serum creatinine or injury markers raising the possibility that the findings are simply a paraphenomenon. Indeed others have noted similar persistent nephrograms following isosmolar contrast and suggested that increased viscosity of isosmolar contrast leads to longer retention times within the kidney [18]. Regardless of mechanism, the findings do not exclude the possibility of direct nephrotoxicity from contrast.
7. Intravenous versus Intra-Arterial Injections
What about differences between contrast media when given by the intravenous route? There is a significant body of literature suggesting an overall lower incidence of nephrotoxicity when iodinated contrast is given intravenously compared to intraarterially [19]. The basis for this difference in nephrotoxicity is multifactorial and includes the following:(i)differences in chronic comorbidities between those getting IV versus IA contrast media,(ii)differences in dose of contrast administered,(iii)ascertainment bias resulting from different follow-up protocols in those receiving IA versus IV contrast,(iv)bias resulting from acute hemodynamic instability, more likely in hospitalized versus nonhospitalized patients and thus more likely in IA versus IV contrast administration.
When prospective randomized trials have specifically addressed patients undergoing contrast-enhanced CT, no differences have been found between IOCM and LOCM (Figure 3). A single exception was a trial by Nguyen, the smallest of the studies that is limited to a single center.
However, it should again be emphasized that the development of a rise in serum creatinine following a contrast-enhanced CT may not reflect kidney injury or specifically injury resulting from contrast (see above regarding limitation of using serum creatinine). Randomized controlled trials using specific injury markers that are known to increase after contrast induced injury. Even with injury markers such as NGAL, IL-18, and KIM-1, there is no specificity for contrast-induced injury.
In addition, a number of authors have found that the incidence of a rise in serum creatinine following a non-contrast-enhanced CT is similar to that following a contrast-enhanced CT, particularly in those without severe reduction in GFR at baseline [20–22]. This suggests that other explanations for a rise in creatinine in these patients should be explored. The most likely explanation would be hemodynamic instability in patients with an indication for a contrast-enhanced CT. Interestingly, a recent abstract found no evidence for an increase in urinary markers of injury (KIM-1 and NGAL) following 511 contrast-enhanced CT exams [23]. In this population, 3.9% developed CIAKI by a usual definition using serum creatinine changes.
8. Other Acute Endpoints
A few studies have focused on the thrombogenicity of different contrast agents. In vitro studies have suggested that ionic low-osmolar contrast is less thrombogenic compared to either isosmolar or low-osmolar nonionic contrast [24]. Clinical trials evaluating potential thrombotic complications have focused on MACE (cardiac death, recurrent nonfatal acute MI, and emergency CABG or repeat PCI) or acute and subacute stent restenosis [25, 26]. Both trials reported a significant reduction in the primary endpoints with ionic low-osmolar contrast. These events occur infrequently which leads to concerns about the power of the individual studies. They were also done during an era when anticoagulation protocols were different than current protocols. Finally a number of other studies could not replicate these results so the issue remains unsettled [27–30].
9. Long-Term Outcomes
While the meta-analysis data seems clear regarding an absence of differences in nephrotoxicity between IOCM and LOCM, there is relatively little data regarding long-term consequences following contrast administration. Since the contrast is eliminated from the body almost completely within 24 hours, any long-term consequences related to contrast administration are likely related to acute kidney injury at the time of administration, for example, nephrotoxicity or the comorbidities present in patients who developed acute kidney injury. Again, the assumption has been that the acute kidney injury is related to the contrast and not some other mechanism. Many observational studies and retrospective reviews of databases have reported on the association between CIAKI and congestive heart failure, mortality, and the long-term loss of kidney function including the need for dialysis. It is beyond the scope of this review to discuss whether this association represents causality or not. The reader is referred to reviews of this topic [31].
Reed et al. [14] in a meta-analysis of 16 trials involving 2763 patients found no differences in postprocedure death or need for dialysis between IOCM and LOCM. However, data was not provided in all studies and very few events actually occurred (a total of 11 and 12 events, resp.).
In an observational study by Per Liss and collaborators, the risk of readmission to the hospital with a diagnosis of acute kidney injury within 1 year following the exposure to an isosmolar or low-osmolar contrast media is described using data from the Swedish Cardiovascular Registry [32]. The Swedish hospital system mandates use of only one contrast agent in each hospital. These authors found a higher incidence of acute kidney injury readmission in hospitals using an IOCM compared to any LOCM. Furthermore, in hospitals that switched from IOCM to LOCM during the years of the study, the incidence of acute kidney injury decreased. Since this is an observational database and not a randomized trial, the results should be taken with caution. However, the uniqueness of the Swedish system eliminates many sources of bias inherent in other observational databases.
The CARE follow-up trial followed patients for one year who were enrolled in a prospective randomized trial comparing iopamidol (low-osmolar contrast media) to iodixanol (isosmolar contrast media) [16]. Prespecified endpoints included death, stroke, myocardial infarction, end-stage kidney disease, percutaneous coronary revascularization, coronary artery bypass graft surgery, other revascularization procedures (e.g., carotid, runoff vessels), and others (e.g., cardiac arrest, development of congestive heart failure or pulmonary edema, and need for permanent pacing). Four events were considered major adverse events: death, stroke, myocardial infarction, and ESRD. When more than one event occurred in the same patient, only the first event was used for analysis. In this study, CIAKI was defined using a number of novel markers: an absolute increase in serum creatinine of 0.3 mg/dL and a 15%, 20%, or 25% increase in serum Cystatin C (to avoid some of the problems mentioned above regarding creatinine). All of these novel definitions were associated with a 2-fold increase in the incidence of adverse events. There were no differences in baseline risk factors, demographics, or procedural characteristics between the two groups. At one year, there was a statistically significant difference in all adverse events and major adverse events in favor of iopamidol. This reduction in adverse events was associated with a reduction in the incidence of CIAKI in the iopamidol group using any of the novel AKI markers.
10. Conclusions
Contrast media are extremely safe but can precipitate acute kidney injury in a small number of high-risk patients. Based upon randomized trial data, there do not appear to be significant differences in the nephrotoxicity between contrast media that differ on the basis of ionicity, osmolality, or viscosity. This conclusion applies to both the intravenous and intra-arterial administration of contrast. Although a few trials have described long-term differences in outcomes based on viscosity and osmolality, further studies are clearly needed to define potential mechanisms and to confirm these preliminary findings.
Conflict of Interests
There were consulting agreements with Bracco Diagnostics Inc. and Guerbet, Inc.
Visipaque Uses and RX Function | Healthgrades
Use In Specific Populations
Risk Summary
There are no data with iodixanol use in pregnant women to inform any drug-associated risks. In animal reproduction studies, no developmental toxicity occurred with intravenous iodixanol administration to rats and rabbits at doses up to 0.24 (rat) or 0.48 (rabbit) times the maximum recommended human intravenous dose (see Data ).
All pregnancies have a background risk of birth defect, 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 2-4% and 15-20%, respectively.
Data
Animal Data
Reproduction studies were performed in rats and rabbits with intravenous administration of iodixanol at doses up to 2 g Iodine/kg, daily, from implantation of the embryo (gestation day 7 in rat; 6 in rabbit) through closure of the hard palate (gestation day 17 in rats; 18 in rabbits). No maternal toxicity occurred, and no adverse effects occurred on fetal survival, embryo-fetal development, or the ability of dams to rear a litter.
Risk Summary
There are no data on the presence of iodixanol in human milk, the effects on the breastfed infant or the effects on milk production. Iodinated contrast agents are poorly excreted into human milk and are poorly absorbed by the gastrointestinal tract of a breastfed infant. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VISIPAQUE and any potential adverse effects on the breastfed infant from VISIPAQUE or from the underlying maternal condition.
Clinical Considerations
Interruption of breastfeeding after exposure to iodinated contrast agents is not necessary because the potential exposure of the breastfed infant to iodine is small. However, a lactating woman may consider interrupting breastfeeding and pumping and discarding breast milk for 10 hours (approximately 5 elimination half-lives) after VISIPAQUE administration in order to minimize drug exposure to a breast fed infant.
The safety and efficacy of VISIPAQUE have been established in pediatric patients down to birth for angiocardiography, cerebral arteriography, visceral arteriography, CT imaging of the head and body, and excretory urography. The safety and efficacy of VISIPAQUE have also been established in pediatric patients 12 years and older for intra-arterial digital subtraction angiography, peripheral arteriography, peripheral venography and CCTA. Use of VISIPAQUE is supported by evidence from adequate and well controlled studies of VISIPAQUE in adults and additional safety data obtained in 459 pediatric patients. In general, the types of adverse reactions reported are similar to those of adults. A higher number of adverse events in patients less than 1 year of age compared to older patients were observed in a study of VISIPAQUE [see Adverse Events (6.3)]. The elimination of VISIPAQUE is slower in this age group [see Clinical Pharmacology (12.3)].
Thyroid function tests indicative of hypothyroidism or transient thyroid suppression have been uncommonly reported following iodinated contrast media administration to pediatric patients, including infants. Some patients were treated for hypothyroidism [See Adverse Reactions (6.2)].
Pediatric patients at higher risk of experiencing an adverse reaction during and after administration of any contrast agent may include those with asthma, hypersensitivity to other medication and/or allergens, cyanotic and acyanotic heart disease, congestive heart failure, or a serum creatinine greater than 1.5 mg/dL. Pediatric patients with immature renal function or dehydration may be at increased risk for adverse events due to slower elimination of iodinated contrast agents [see Clinical Pharmacology (12.3)].
In clinical studies of VISIPAQUE, 254/757 (34%) of patients were 65 and over. No overall differences in safety or effectiveness were observed between these patients and younger patients. Other reported clinical experience has not identified differences in response between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. In general, dose selection for an elderly patient should be cautious usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.
Visipaque 270 mg I/mL Injection
Consumer Medicine Information
What is in this leaflet?
This leaflet answers some common questions about VISIPAQUE. It does not contain all the available information. It does not take the place of talking to your radiologist (the specialist doctor who does X-rays), doctor or pharmacist.
All preparations of this type have risks and benefits. Your radiologist and/or your doctor have weighed the risks of you receiving VISIPAQUE against the benefits they expect it will have for you.
If you have any concerns about being given this preparation, ask your radiologist, doctor or pharmacist.
Keep this leaflet. You may need to read it again.
What VISIPAQUE is used for
VISIPAQUE is one of a group of medicines known as “contrast media” for diagnostic use. VISIPAQUE is used to improve the clarity of X-ray images of the internal organs of the body by increasing the degree of contrast of different structures within the body.
VISIPAQUE is used to study the heart, veins and arteries in the body’s circulatory system and the urinary tract.
VISIPAQUE is intended for use in hospitals and radiology clinics only and will be given to you as an injection. Your doctor may have prescribed VISIPAQUE for another reason. Ask your doctor if you have any questions about why VISIPAQUE has been prescribed for you.
How does VISIPAQUE work?
As VISIPAQUE flows through your blood vessels and organs, the Iodine in VISIPAQUE makes them appear darker during radiographic examinations. This makes them stand out on the X-ray film. This aids the doctor in identifying any problems with a particular organ.
Before you are given VISIPAQUE
When you must not be given it.
VISIPAQUE should not be given to you if:
- You have ever had an allergic reaction to VISIPAQUE or, to any of the ingredients listed at the end of this leaflet (see Product Description) or to any other contrast medium. Symptoms of an allergic reaction may include wheeziness, difficulty in breathing or tightness or pain in the chest, skin rash, swelling or itching.
- You have thyroid gland problems.
- The expiry date on the pack has passed. If you use it after the expiry date, it may have no effect at all, or worse, an entirely unexpected effect.
Before you are given it.
You must tell your doctor if:
- You are pregnant, intend to become pregnant or breast-feeding or plan to breast-feed. If you receive Visipaque whilst pregnant, your newborn should be tested to ensure they are producing the correct amount of thyroid hormone.
- You have, or have had, the following medical conditions:
- Asthma
- Allergies, for example hay fever or hives, or allergies to iodine-containing contrast media, any medicines or other substances, such as foods, preservatives or dyes.
- Thyroid gland problems.
- Sickle cell disease
- Diabetes
- Kidney and/or liver disease
- Epilepsy
- Problems with your body producing certain enzymes (homocystinuria)
- Heart disease and/or circulatory system problems
- Multiple myeloma (cancer of blood cells) and other blood problems (paraproteinaemia)
- Phaeochromocytoma (a tumour which raises blood pressure).
- You plan to have surgery
If you have not told your doctor about any of the above, tell them before you are given VISIPAQUE.
Taking other medicines
Tell the doctor if you are taking any other medicines, including medicines you buy without a prescription from a pharmacy, supermarket or health food shop. Some medicines may interfere with VISIPAQUE. These include:
- Biguanides (eg metformin) a medicine for diabetes. Your doctor may ask you not to take biguanides for 48 hours before receiving an injection of VISIPAQUE.
- Medicines used to treat high blood pressure or irregular heart beats (Adrenergic beta-blockers)
- Contrast agents for the study of the gall bladder and bile ducts
- General anaesthetics
These medicines may interact or affect the way VISIPAQUE works. Your doctor or pharmacist has more information to be careful with or avoid when using VISIPAQUE.
How VISIPAQUE is used
You will be given VISIPAQUE before or during your X-ray examination. VISIPAQUE will be injected into a vein by a qualified person. The amount injected can vary depending on the type of examination used, your age and your weight.
If you receive an overdose
As VISIPAQUE will be administered by a qualified person familiar with the procedure, overdosage is unlikely. In the event of overdosage, qualified personnel will be equipped to handle such an occurrence.
While you are using VISIPAQUE
If you need to have a thyroid function test within the next 14 days after examination with VISIPAQUE, please tell your doctor before the test is done.
If you have any blood or urine tests on the day of your examination with VISIPAQUE, tell your doctor you are using VISIPAQUE. VISIPAQUE may affect the results of some laboratory tests.
If you are about to start on any new medicine within the next day or two, tell your doctor and pharmacist that you have been given VISIPAQUE.
If you plan to have surgery that needs general anaesthetic, tell your doctor or dentist that you have been given VISIPAQUE.
Tell all doctors, dentists and pharmacists who are treating you that you have been given VISIPAQUE.
Things to be careful of
Delayed reactions of iodine-containing dyes may occur.
If you feel light-headed, dizzy or faint as a result of the procedure, get up slowly when getting out of bed or standing up. Be careful if you are elderly, unwell or taking other medicines. Some people may experience side effects such as dizziness and unsteadiness as a result of the procedure, which may increase the risk of a fall.
Side effects
During and after your examination
Tell your doctor or healthcare worker as soon as possible if you do not feel well while you are being given, or after you have been given VISIPAQUE.
Usually, VISIPAQUE does not cause any serious side effects. It can, however, sometimes cause unwanted effects in some people. All medicines can have side effects. You may need medical treatment if you get some of the side effects during or after the procedure. Although there is a risk that you might get an unwanted effect, your doctor will have chosen this contrast medium by considering these risks and the benefits of the examination.
The type of side effect experienced may depend on the area of the body under examination.
The most frequent side effects are headache, nausea, changes in your sensation of taste, dizziness, rash, chest pain, itching and visual disturbances.
If you get any of the following during, or after, the examination:
- swelling of the face, lips, mouth or throat which may cause wheeziness, difficulty in breathing or tightness, pain in the chest or changes in the way your heart beats
- fainting
- hives, lumps, swelling, itching throat or spots or other allergic symptoms,
you should tell the doctor straight away or go to Accident and Emergency at your nearest hospital as delayed reactions may occur occasionally. These are very serious side effects. If you have them, you may have had a serious allergic reaction to VISIPAQUE. You may need urgent medical attention or hospitalisation.
Other unwanted effects which may occur during, or after the examination include:
- pain at the site of injection
- weakness
- fluid retention
- neck stiffness
- numbness
- twitching
- hearing disturbance
- muscle cramps
- confusion, anxiety or trembling
- warmth and rash
- Shortness of breath
and cough - Hypothyroidism (a condition in which your thyroid gland does not product enough thyroid hormone).
These effects are usually mild to moderate and of short duration, resolving without any treatment. If they become severe or last more than a few days, tell your doctor.
If you experience any other unwanted effects, please tell your doctor. Do not be alarmed by this list of possible side effects. You may not experience any of them.
Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.
Product description
What it looks like
VISIPAQUE is a colourless to pale yellow injectable solution.
Ingredients
Active Ingredient:
Iodixanol
Other Ingredients
trometamol, sodium calciumedetate, sodium chloride, calcium chloride, water for injection and hydrochloric acid
Storage
VISIPAQUE should be stored below 30°C, protected from the light. Do not freeze.
Supplier
VISIPAQUE is supplied in Australia by
GE Healthcare Australia Pty Limited
32 Phillip St
Parramatta NSW 2150
PO Box 5079
Parramatta NSW 2150
Tel: 1300 88 77 64
Fax: 1300 434 232
It is available in the following strengths:*
270 mg 1/mL: In pack sizes of
20mL glass vial – AUST R 154369
50mL glass and PPE bottle – AUST R 49603
100mL glass and PPE bottle – AUST R 49604
150mL glass and PPE bottle – AUST R 49605
200mL glass and PPE bottle – AUST R 49606
10mL PPE ampoule – AUST R 75923
20mL PPE ampoule – AUST R 75924
40mL PPE ampoule – AUST R 75929
50mL PPE ampoule – AUST R 75925
100mL injection bag – AUST R 49607
150mL injection bag – AUST R 49608
200mL injection bag – AUST R 49609
320 mg 1/mL: In pack sizes of
20mL glass vial – AUST R 154370
50mL glass and PPE bottle – AUST R 49594
100mL glass and PPE bottle – AUST R 49597
150mL glass and PPE bottle – AUST R 49598
200mL glass and PPE bottle – AUST R 49599
10mL PPE ampoule – AUST R 75927
20mL PPE ampoule – AUST R 75928
40mL PPE ampoule – AUST R 75930
50mL PPE ampoule – AUST R 75926
100mL injection bag – AUST R 49600
150mL injection bag – AUST R 49601
200mL injection bag – AUST R 49602
- Some presentations may not be marketed in Australia
Revision date of the Leaflet
April 2018
Visipaque is a trademark of GE Healthcare
GE and GE Monogram are trademarks of General Electric Company
Published by MIMS June 2018
Uses, Dosage & Side Effects
1 What is Visipaque?
Visipaque is a dye used to make internal organs more visible for imaging procedures like:
Visipaque contains iodine, which shows up clearly in X-ray films. Iodixanol is injected into the veins so they will clearly show up in imaging procedures.
Doctors find this very useful in diagnosing disorders of:
- the brain
- blood vessels
- kidneys
- other organs
According to the U.S Food and Drug Administration, Visipaque has same osmolality (concentration of particles) with the human blood. Visipaque should be used only according to doctor’s instructions.
2 What to Know Before Using
Your doctor will inform you of what you need to know before using Visipaque. Make sure to tell all your allergies before using Visipaque.
Mention allergies to drugs, food, dyes, animal products, and if you previously experienced sensitivities to Visipaque and other contrast medium dyes.
You cannot use Iodixanol if you have an allergy to iodine, iodine dyes, and shellfish. Tell the doctor if you are or suspected to be pregnant before taking Iodixanol.
Visipaque itself may not harm the unborn baby, but X-ray does. Visipaque can be safely used to children at least one year of age. Iodixanol is also safe for elderly patients.
Do not use Iodixanol in children who has recently used a laxative (stool softener) or has not eaten properly. Mention all your health problems before taking Visipaque.
The doctor needs to know if you have the following conditions before using Visipaque:
3 Proper Usage
Proper usage of Visipaque requires strict adherence to your doctor’s orders. Visipaque is injected into the veins (intravenous route).
The doctor will determine the amount of Visipaque to be injected based on the patient’s age and the target organs.
Only a health professional can give you Iodixanol. Care must be taken to avoid contamination and ensure sterility while the medication is administered.
Iodixanol is injected before the x-ray test. The doctor may also give you other medicines to reduce side effects.
After the test, the doctor will teach you to drink plenty of fluids to avoid dehydration. Dehydration can cause complications to the kidneys.
Older and elderly patients may need closer monitoring to make sure they do not become dehydrated after the test.
4 Precautions to Take
Before using Visipaque, there are some precautions you must take. If you experienced burning sensation, pain or swelling while Visipaque is injected, tell it to your caregivers immediately.
It is very important not to become dehydrated after taking Visipaque. Drink a glass of water at least every hour and have easy access to the toilet to urinate. Visipaque is eliminated in the urine, and can hurt the kidneys if you become dehydrated or unable to urinate.
Call the doctor right away if you become dehydrated (increased thirst, dry mouth, and weakness), have noticeably reduced urine output or have a fever after the test.
5 Potential Side Effects
Make sure you meet with your doctor in using Visipaque to avoid unwanted potential side effects.
Tell your doctor if you experienced the following after taking Visipaque:
- Lightheadedness
- Swelling
- Rapid weight gain
- Passing too little or no urine
- Wheezing
- Breathing difficulties
- Seizures
- Chest pain
- High fever
- Symptoms of problem in the thyroid – extreme tiredness, dry skin, joint stiffness or pain, muscle pain or weakness, hoarseness of voice, sensitivity to cold temperatures and weight gain
- Heart attack symptoms – pain or pressure in the chest, pain that spreads to the jaw, shoulders or back, nausea and sweating
- Stroke symptoms – sudden numbness or weakness especially on one side of the body, sudden severe headache, slurred speech, vision changes and problems with balance
- Blood clot formation in the leg – sharp chest pain, sudden cough, wheezing, rapid breathing, coughing up blood or pink-colored sputum
You may feel the following after injection of Iodixanol. These side effects are not harmful to your health, but they can be bothersome:
- Pain, warmth or cold sensation while Iodixanol was injected
- Numbness or tingly sensation
- Dizziness or sensation of spinning
- Nausea and vomiting
- A headache, anxiety or nervousness
- Skin rash or itching
- Unusual taste, usually metallic, in the mouth
Contrast Guidelines – Mid Rogue Imaging Center
For a complete overview of current contrast media and other radiological pharmaceuticals administration guidelines per the American College of Radiology, please download the 2013 Contrast Media Manual:
2013 ACR Contrast Media Manual
This is a basic guide to understanding Intra-Vascular Contrast Agents and their use at Mid Rogue Imaging Center.
When medical imaging studies for cross sectional examinations of the body, (i.e., Computed Tomography (CT), Magnetic Resonance Imaging (MRI) are ordered by referring physicians, a question that frequently arises is – “Do I order this With, Without, or With AND Without Contrast?”
To answer the question, we must first define what ordering “contrast” means, what IV contrast is and what it does, and specific safety issues to be addressed when considering the use of IV contrast agents.
What does it mean when I order an exam “with” contrast?
Ordering an examination with contrast for an MRI or CT study means you are specifying that you want Intra Vascular Contrast (IVC) to be used. As opposed to barium sulfate Oral Contrast Media (OCM), which is chemically inert and is administered parenterally, IVC is administered via IV at the time of the exam.
IVC agents are a regulated drug class, and can be only administered by prescription, just like any other controlled medication, this is why the use of IV contrast must be specified or indicated by the physician ordering the examination. The radiology department may alter the prescribed use of IV contrast per department protocol, radiologist orders, or by other safety concerns, but the initial request for the use of IVC must come from the physician ordering the examination.
What is “IV Contrast”?
Intra Vascular Contrast media (IVC) come in two broad categories, those used for MRI, commonly called paramagnetic contrast agents, and those used for CT or diagnostic radiography, also called iodinated contrast agents.
For MRI, IVC are composed of organically bound gadolinium or iron in solution, and are designed to greatly increase the number of protons available in the region of interest being scanned in MRI, so as to make differences in signal intensity between tissues more readily apparent.
A prime example of this would be in a patient undergoing an MRI of the lumbar spine, where the patient has had a prior history of back surgery or current history of a suspected soft tissue mass. In both cases, the need to differentiate between normal, healthy tissue and that of old scar tissue or neoplasm would indicate the use of MR IVC. If the patient has neither history of suspected mass, nor a history of prior surgery in the region of interest, then MR IVC would not be indicated.
In general, MR IVC should only be ordered for:
- Brain studies where a mass, aneurysm, or other demyelenating process is suspected.
- Spine studies where a para spinal soft tissue mass is suspected, for demyelenating disease processes, and for patients with <10 year pat history of having surgery in the region of interest.
- Vascular studies, such as carotid, renal, or peripheral arteriography.
- Evaluation of soft tissue masses in solid organs, such as the liver, or muscle tissue masses such as rhabdosarcoma.
- Routine MRI for spine for pain, radiculopathy, DJD, DDD and the like should be performed without. If need be, IVC can be considered should any incidental findings require it.
Routine MRI for joints should be perform without IVC, as there is usually very good differentiation between tissues within joint capsules, i.e. bone from cartilage, tendons from bone, etc.
For CT scan, IVC is composed of an organically bound iodine / benzene compound in a saline solution, and are designed to make blood and organs more radio-opaque by absorbing a small percentage of X-rays that would normally pass through the body. CT scan images are projected in thousands of shades of gray, whereas the human brain can only discern between 40 and 100 shades. IVC changes the density of tissues, and therefore the perceived image is rendered in what looks to be a more “black and white” image. With increased contrast comes increased visualization between adjacent structures observed in a CT scan image.
A prime example of the use of IVC in CT would be during contrasted studies of the thorax, where there is a need to distinguish between arterial and venous vascular structures of the heart and lungs when looking for pulmonary emboli, or to evaluate blood vessels vs. enlarged lymph nodes in a patient with lymphoma.
In general, CT IVC can be used for any CT study such as:
- Head, neck, and thoracic imaging for suspected mass, lymphadenopathy, vascular injuries such as aneurysm, and CVA.
- Abdomen, Pelvic imaging for same.
- CT angiography, for evaluation of vascular structures.
Routine CT scanning where IVC is not indicated would be:
- Any examination where the patient has a known history of Iodine or IVC allergies.
- Bone or joint imaging
- Imaging for kidney stones.
- Spine imaging where there is no history of suspected soft tissue mass.
Brands of IVC used at Mid Rogue Imaging Center and our safety policy regarding their administration
Mid Rogue Imaging Center uses GE Healthcare’s line of contrast agents for use in the CT and MRI modalities. GE (formerly Amersham) products were selected over all others due to:
- Safety: Omnipaque and Omniscan have been used for nearly 20 years with an unparalleled safety record.
- Patient tolerance: IV administration of Omnipaque, Visipaque, and Omniscan is met with little or no adverse reactions in patients such as nausea, vomiting, or shortness of breath.
- Technical factors, such as Omniscan being the only MRI agent approved for rapid bolus injection, a necessity for MRA, or
Visipaque, being the only iso-osmolar contrast agent for CT, making it ideal for cardiac and “routine” CT Angiography studies. - Omniscan is the paramagnetic, gadolinium based contrast agent used for MRI and MRA applications here at Mid Rogue Imaging Center.
Omnipaque and Visipaque are iodinated contrast agents used for CT and CTA applications. Omnipaque is used for routine CT and low volume CTA (Circle of Willis, Carotid) studies, while Visipaque is used for high volume CTA (aortography, lower extremity runoffs), and in patients whose EGFR is between 30 and 50ml/min.
All patients aged 65 and older, and any patient with a known history of renal dysfunction are required to have a recent (<30 day old) serum creatinine in order to establish that the patient has sufficient renal function to clear the IV contrast from the bloodstream without incurring damage to the kidneys.
For any patient that has an EGFR of less than 30mg/ml, for either CT or MRI, the technologist will consult with the radiologist to determine if the requested exam can be performed without IV contrast, or if another imaging modality would be more appropriate.
Patients who are already on dialysis may receive IVC, but we will schedule the exam to be performed just prior to their scheduled dialysis appointment. Dialysis will remove over 93% of IVC agents in the first pass.
There will be NO exceptions to the 30ml/min. EGFR rule without written consent of the referring physician and the radiologist.
For any questions in regards to the use of IV contrast when ordering a contrasted exam, please feel free to contact your CT or MRI technologist. If they cannot answer your questions, they will refer you to a AIA radiologist.
CT/MRI Technologist: (541) 472-5154 ext. 105
Advanced Imaging Associates (AIA) work center: (541) 472-7140
Visipak instructions, composition, method of application | UA / 4254/01/02
Child.
The drug is used in children for cardioangiography, urography, contrast enhancement in computed tomography (CT) and studies of the digestive tract. For recommended doses, see the section “Dosage and Administration”.
Overdose
Overdose is unlikely in patients with normal renal function.Long-term treatment at high doses of the drug may affect renal function (half-life – 2 hours). In case of accidental overdose, it is necessary to correct the violation of the water-electrolyte balance using infusion therapy. The next 3 days should be monitored for kidney function. If necessary, the excess of the drug is removed by hemodialysis. There is no specific antidote. In case of an overdose, symptomatic therapy is used.
Adverse reactions
The following are possible side effects associated with X-ray procedures, which include the use of Visipak.
Adverse reactions, predetermined by the use of Visipak, usually have a mild and moderate degree of clinical manifestation, as well as a reversible nature. Serious reactions and fatal consequences are rare. They may include: acute chronic renal failure, acute renal failure, anaphylactic or anaphylactoid shock, hypersensitivity reactions that are accompanied by reactions from the heart (acute coronary syndrome), cardiac arrest, cardiac and respiratory arrest, myocardial infarction.
Cardiac reactions may be due to underlying disease or intervention.
Hypersensitivity reactions can occur, which usually manifest themselves in the form of respiratory and skin reactions such as shortness of breath, rash, erythema, spraying, pruritus, severe skin reactions, angioedema, arterial hypotension, fever, laryngeal edema, bronchospasm and pulmonary edema. In patients with autoimmune diseases, cases of vasculitis and signs of Stevens-Johnson syndrome were observed.They can develop both immediately after the administration of the drug, and after a few days. Hypersensitivity reactions can occur regardless of the dose and route of administration. Mild symptoms may be the first signs of a severe anaphylactic reaction / shock.
The administration of the contrast medium should be stopped immediately and, if necessary, specific therapy with the use of intravascular drug administration should be carried out. In patients taking β-blockers, the manifestations of hypersensitivity reactions may be atypical and mistaken for vagal reactions.
A slight transient increase in the level of serum creatinine is a frequent occurrence after the use of iodine-containing contrast media. This is usually not clinically relevant.
Adverse effects by frequency of occurrence are classified into the following categories:
very often (≥ 1/10), often (≥ 1/100, <1/10), infrequently (≥ 1/1000, <1/100), rarely (≥1 / 10000, <1/1000), very rare (<1/10000), unknown (frequency not determined from data).
Adverse reactions associated with intravascular administration.
on the part of the blood and lymphatic system.
Unknown: thrombocytopenia.
From the immune system.
Uncommon: hypersensitivity reactions.
Unknown: anaphylactoid reactions, anaphylactoid shock.
From the side of the psyche.
Very rare: agitation, anxiety.
Unknown: confusion.
From the nervous system.
Uncommon: headache.
Rare: dizziness.
Very rare: stroke, sensory disturbances, including taste disturbances, paresthesia, amnesia, syncope.
Unknown: comma, agile dysfunction, impaired consciousness, seizures, transient contrast-induced encephalopathy (including hallucinations), tremor.
From the side of the organs of vision.
Very rare: transient cork blindness, visual impairment.
From the side of the cardiac system.
Rare: arrhythmia (including bradycardia, tachycardia), myocardial infarction.
Very rare: cardiac arrest.
Unknown: heart failure, ventricular hypokinesia, coronary artery spasm, cardiac arrest and respiration, cardiac conduction disturbances, coronary artery thrombosis, angina pectoris.
From the vascular system.
Uncommon: hot flashes.
Rare: arterial hypotension.
Very rare: arterial hypertension, ischemia.
Unknown: arterial spasm, thrombosis, thrombophlebitis, shock.
On the part of the respiratory system, chest and mediastinum.
Rare: cough.
Very rare: dyspnea.
Unknown: pulmonary edema, respiratory arrest, respiratory failure.
From the digestive system.
Uncommon: nausea, vomiting.
Very rare: abdominal pain / discomfort.
Unknown: acute pancreatitis, exacerbation of pancreatitis, enlargement of the salivary glands.
Skin and subcutaneous tissue disorders.
Uncommon: rash, pruritus, urticaria.
Very rare: angioedema, erythema.
Unknown: bullous dermatitis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug rash with eosinophilia and systemic symptoms, toxidermia, allergic dermatitis, skin peeling.
From the side of the musculoskeletal system and connective tissue.
Very rare: back pain, ointment spasms.
Unknown: arthralgia.
From the kidneys and urinary tract.
Very rare: impaired renal function, including acute renal failure.
General disorders and changes at the injection site.
Uncommon: feeling of heat, chest pain.
Rarely: pain and discomfort, tremors (chills), hyperthermia, reactions at the injection site, including lecturing.
Very rare: feeling of coldness, asthenic condition (for example, malaise, increased fatigue).
Injuries, poisoning and complications of procedures.
Unknown: iodism.
Adverse reactions associated with intrathecal administration.
Adverse reactions are distant and may occur after a few hours or days after intrathecal administration. Their frequency approximately corresponds to the frequency of complications after lumbar puncture without the introduction of contrast medium. When using other non-ionic contrast agents, signs of irritation of the meninges may appear in the form of photophobia, meningism, chemical meningitis. You should also keep in mind the possibility of infectious meningitis.
From the immune system.
Unknown: hypersensitivity reactions, including anaphylactic / anaphylactoid reactions.
From the nervous system.
Uncommon: headache (may be severe and prolonged).
Unknown: dizziness, transient contrast-induced encephalopathy (including hallucinations, amnesia, confusion and other neurological symptoms).
From the digestive system.
Infrequently: vomits.
Unknown: nausea.
From the side of the musculoskeletal system and connective tissue.
Unknown: ointment spasms.
General disorders and changes at the injection site.
Unknown: trembling, pain at the injection site.
Adverse reactions associated with hysterosalpingography (HSG).
From the immune system.
Unknown: hypersensitivity reactions.
From the nervous system.
Often: headache.
From the digestive system.
Very common: abdominal pain.
Often: nausea.
Unknown: vomits.
Reproductive system disorders.
Very common: vaginal bleeding.
General disorders and changes at the injection site.
Often: hyperthermia.
Unknown: trembling, reaction at the injection site.
Adverse reactions associated with arthrography.
From the immune system.
Unknown: hypersensitivity reactions, including anaphylactic / anaphylactoid reactions.
General disorders and changes at the injection site.
Often: pain at the injection site.
Unknown: jitter.
Adverse reactions associated with intracavitary administration.
From the immune system.
Unknown: hypersensitivity reactions, including anaphylactic / anaphylactoid reactions.
From the digestive system.
Often: diarrhea, abdominal pain, nausea.
Uncommon: vomits.
General disorders and changes at the injection site.
Unknown: jitter.
Iodixanol CAS 92339-11-2 Manufacturers and Suppliers – Price
Iodixanol CAS 92339-11-2
China Iodixanol factory, supplier, manufacturer in China.
Synonyms: Iodixanol
CAS Number: 92339-11-2
Characteristics: White powder.
Molecular formula: C35h54I6N6O15
Structural formula:
Packing: 25 kg / Fiber drum
KEY words: Iodixanol
– Iodixanol type of substance. It is used for cardiovascular angiography, cerebral angiography (conventional and intraperitoneal DSA), peripheral arteriography (routine and intraperitoneal angiography), urography, venography, and CT in adults.
Iodixanol is an injection contrast agent that can be used in tapered tube angiography, cardiocerebral angiography and intravenous urography. It works by combining iodine to absorb X-rays in blood vessels or tissues to cause an image to be displayed. The effect of iodixanol on cardiovascular parameters and femoral blood flow is less, but it should be paid attention to in elderly patients with renal failure who have undergone coronary intervention.
Pharmacological actions:
When iodixanol is administered, organically bound iodine absorbs radiation in blood vessels / tissues.
After intravenous administration of iodixanol to healthy volunteers, most of the parameters of hemodynamics, clinical chemistry and blood coagulation did not differ significantly from those before injection. The observed small number of changes in laboratory parameters were minimal and had no clinical significance.
Iodixanol injection had little effect on renal function.For diabetic patients with serum creatinine levels between 1.3 and 3.5 mg / dL, only 3% of patients have increased creatinine levels greater than or equal to 0.5 mg / dL, but no increase in creatinine levels will be greater than or equal to 1.0 mg / dl. The amount of enzymes (alkaline phosphatase and N-acetyl-beta-glucosaminidase) released from adjacent tubular cells was less than the amount of enzymes administered with non-ionic monomeric contrast media and showed the same trend as ionic monomeric contrast media.Iodixanol injection is also well tolerated by the kidneys.
Pharmacokinetics:
Iodixanol was rapidly distributed in vivo with an average elimination half-life of about 21 minutes. The apparent volume of distribution was the same as that of the extracellular fluid (0.26 L / kg body weight), indicating that iodixanol was distributed only in the extracellular fluid.
No metabolites detected. The protein binding rate was less than 2%.
It is a double hexiodine, non-ionic, water-soluble radiopaque contrast agent.Used for urography, cardiovascular angiography and computed tomography.
Iodixanol is not absorbed when taken orally, but is rapidly distributed in the body. The volume of distribution is close to the extracellular fluid, is distributed only in the extracellular fluid, practically does not bind to protein in vivo and is not metabolized in vivo. Mainly excreted through glomerular filtration in the prototype.
Synthetic routine:
Chemical names:
1,3-bis (acetylamino) -N, N ‘-bis [3,5-bis (2,3-dihydroxypropylaminocarbonyl) -2,4,6-triiodophenyl ] -2-hydroxypropane; Visipaque;
Top quality, pure iodixanol powders / substances factory, supplier, manufacturer in China.
If you are looking for iodixanol cas 92339-11-2, please contact us. We are one of the leading and professional China manufacturers and suppliers in this field. Competitive prices and good after-sales service are available.
Hot Tags: iodixanol cas 92339-11-2, manufacturers, suppliers, price
Optimization of radiological examinations for patient safety
Based on the materials of the European Congress of Radiologists, March 6-10, St.Vienna, Austria
The scientific and educational program of the congress included individual sessions and master classes, interactive training lectures on new directions in radiology. A special feature of the current forum was the session on visualization and performing interventions on the spinal cord using the methods of imaging the heart and mammary gland. The congress also highlighted new advances in computed tomography (CT) and magnetic resonance imaging (MRI) for trauma, as well as ways to visualize joints.
Within the framework of the congress, with the support of GE Healthcare, a session was held on the problems of the use of contrast agents. It was discovered by a leading US radiologist, professor of radiology and oncology Elliot Fishman (Johns Hopkins University School of Medicine, USA). The topic of his presentation was CT to improve image quality and patient safety.
– Radiation diagnostics is heavily dependent on technological innovation. Currently, all methods of radiological diagnostics are digital; methods of three-dimensional imaging have become widespread.Thanks to the new capabilities of CT and MRI, they began to be used as screening techniques for detecting violations at the preclinical stage. Thus, CT angiography allows obtaining high-resolution images of blood vessels up to images of coronary arteries and coronary artery bypass grafts. CT angiopulmonography has become the leading method for the diagnosis of pulmonary embolism. With the help of CT, it is possible to identify and characterize pathological foci in organs, and the volumetric image allows you to study perfusion and microcirculation in them, which is especially important for the diagnosis of diseases of the brain and heart.
Despite all these advantages, patients are still suspicious of radiation research methods, especially those requiring the administration of contrast agents. Among the reasons for such fears are reluctance to receive radiation exposure, fear of a foreign chemical introduced into the body (contrast), and the likelihood of side effects. Indeed, improper use of contrast agents is associated with significant complications, especially from the kidneys, heart, and also directly examined organs.It is extremely important to choose the right contrast agent that meets all the requirements; the tolerance of the contrast agent and its ability to provide the required level of contrast should be taken into account. CT contrast medium should not adversely affect renal function in high-risk patients and tissue damage in the event of extravasation, nor should it cause patient discomfort when administered.
Recently, indications for radiological studies have expanded significantly.The proportion of high-risk patients has increased: these are elderly people, patients with diabetes mellitus (DM) and chronic kidney disease; in clinical practice, non-steroidal anti-inflammatory drugs, ACE inhibitors, diuretics, etc. are widely used, which is also a risk factor for the development of such complications as contrast-induced nephropathy.
Evidence-based studies [1, 2] indicate that the isoosmolar contrast agent iodixanol is the least nephrotoxic for high-risk patients with impaired renal function and diabetes mellitus.The drug is used for diagnostic studies with contrast enhancement both in angiography and contrast enhancement with CT.
In modern radiology, the volumes of contrast media used have increased, which also places special demands on safety. Currently, contrast agents are used not only for diagnostic procedures, but also for the treatment of patients, in particular, without them, it is impossible to carry out percutaneous coronary interventions.
The choice of the dose of the contrast medium depends on the purpose of the study, the general condition of the patient, his age, body weight and the technique of administration.
Professor Donal Reddan (University of Galway Hospital, Ireland) devoted his report to the assessment of renal function in radiological studies:
– CT has the highest radiation load among all radiological research methods. The use of contrast in this case is associated with the risk of developing another complication – contrast-induced nephropathy, which is the third most frequent cause of the development of renal failure in the hospital [3].The risk of this complication among patients with already reduced renal function, the presence of diabetes mellitus, dehydration, congestive heart failure, and also when taking nephrotoxic drugs can reach 50%.
Before carrying out the procedure, it is necessary to carefully select patients, and in patients with the listed risk factors, take preventive measures. According to the recommendations of the European Society of Urogenital Radiology, today, the measure of prevention of the development of contrast-induced nephropathy is the hydration of patients before and after the administration of a contrast agent.However, it is also important to understand that often the benefits of doing research far outweigh the risk of side effects. Thanks to contrast imaging, many dangerous diseases, including cancer, can be detected in the early stages.
Currently, it has been proven that contrast agents with low osmolarity are more preferable than high osmolarity [4], since they are characterized by a better safety profile and their use is associated with a lower risk of side effects.
In the study by Shaun A. Nguyen et al. [5] studied the effect of iso-osmolar contrast agent iodixanol and low-osmolar iopromide on renal function (assessed serum creatinine level and glomerular filtration rate) in high-risk patients during CT. When evaluating the results, it turned out that the serum creatinine level in the iodixanol isoosmolar contrast agent group was lower than in the iopromide group. Thus, in this study, according to the authors, the use of iodixanol did not increase the incidence of renal side effects in the high-risk group of patients.
Dr. Filippo Cademartiri (St. Erasmus Medical Center, Rotterdam, The Netherlands) presented methods for optimizing image contrast in cardiac imaging.
– The advent of multislice computed tomography (MSCT), initially with four-row detectors, and its widespread introduction into clinical practice has opened up new possibilities for non-invasive imaging of the heart, in particular for diagnostic studies of coronary arteries. Many studies demonstrate the possibility of using MSCT in the diagnosis of coronary heart disease, especially among low-risk patients with a reduced heart rate (HR).The advantages of MSCT are associated with improved spatial and temporal resolution in combination with ECG synchronization of the data obtained. Further development of the technology made it possible to achieve a narrower collimation and slice thickness in the submillimeter range, as well as an increase in the rotation speed. This resulted in a steady improvement in spatial and temporal resolution, while wider detectors provided coverage of larger areas. However, step-by-step scanning with prospective ECG synchronization does not provide the possibility of multisegment reconstruction at high heart rate.At a low heart rate with a normal rhythm, good image quality is provided, but at a high heart rate and arrhythmia, artifacts are likely to appear, which lead to “blurring” of the vascular contours due to the difference in the degree and rate of deviation of the coronary artery.
A completely new area in non-invasive diagnostic imaging of the heart is the imaging of myocardial perfusion by CT. Further research is needed to assess the accuracy of this regimen in detecting myocardial perfusion disorders, its benefits for clinical practice, and its significance compared to other imaging techniques.
Literature
1. Aspelin P., Aubry P., Fransson S.G. et al. Nephrotoxic effects in high-risk patients undergoing angiography. N Engl J Med 2003; 348: 491-9.
2. Jo S.H., Youn T.J., Koo B.K. et al. Renal toxicity evaluation and comparison between visipaque (iodixanol) and hexabrix (ioxaglate) in patients with renal insufficiency undergoing coronary angiography: The RECOVER study: A randomized controlled trial. J Am Coll Cardiol 2006; 48: 924-30.
3. Rihal C.S., Textor S.C., Grill D.E. et al. Incidence and prognostic importance of acute renal failure after percutaneous coronary intervention. Circulation 2002; 105: 2259-64.
4. Schrott et al. Fortschritte der Medizin 1986; 104: 153-6.
5. Shaun A. Nguyen et al. Iso-Osmolality versus Low-Osmolality Iodinated Contrast Medium at Intravenous Contrast-enhanced CT: Effect on Kidney Function. Radiol 2008 Jul; 248 (1).
Prepared by Tatiana Kantsidailo
TOPIC STATTS
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Pulmonology and otorhinolaryngology
Post-hospital bacterial pneumonia: vibration of the scheme of empirical antibacterial therapy in the context of outpatient treatment
Post-hospital pneumonia (PP) is a type of hospitalization, which is characterized by lesions of parenchymal diseases and swelling in a community, so that the posture of a medicalPP є we are widely expanding and potentially serious ailments, as they associate with high mortality, especially in the middle of the lithuanian, curtsy people, people from fellow patients and immunodepression. Clinical manifestations of PP are variable: from an easy interruption with a feverish and productive cough to distress and sepsis. PP is a part of differential diagnostics of practically all respiratory illnesses, as well as one of the main causes of illness and mortality in the world. Timely diagnostics, assigned to the regime of treatment and an innocent ear of antibiotic therapy (ABT) є key lanks to the management of the PP.In materials, the principle of PP management in outpatient minds is based on the recommendations published in UpToDate. Writing material based on statti Julio A. Ramirez and spivavt. “Overview of community-acquired pneumonia in adults”, published 13 March 2020
…
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Pulmonology and otorhinolaryngology
Syndrome of coughing of the upper spirits
2006 for the American College of Pulmonary Medicine (ACCP), in the presence of upper dysfunctional cough syndrome (SCVDS), earlier – postnasal obstruction syndrome (SPNZ), which is one of the most pathogenic pathogens in chronic cough (HC).The ailments on the SPSH have a cough due to the use of the VDSH, a deep congestion of the nose and sinuses. There can also be a lot of anatomical symptoms, rhinitis of physical or chemical etiology, as well as throat pain [4-6]. …
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Pulmonology and otorhinolaryngology
Effectiveness of povidone-iodine intake for nasal and oral cavity waste: focus on antiseptic agents against SARS-CoV-2
The cause of severe severe respiratory syndrome – SARS-CoV-2 – became the cause of the new pandemic, so it was bare on the cob in 2020.In the breast of 2019, the rock has been registered for the decay of the COVID-19 virus, but for the last few years it has grown rapidly and inevitably. The mechanism of transmission of SARS-CoV-2-infection is also a bit-droplet. Inflammation is also possible when in contact with contaminated surfaces. The key to the employees in the fight against COVID-19 is to reduce the transmission of the virus, as well as to reduce the intake of antiseptics, as it is possible to vikoristovuvati both in medicine and in the booth. In the presented pre-adolescent vivchali wasted povidone-iodine (PVP-I) as an antiseptic (in concentrations from 1 to 5%), which has a virulicidal activity against the COVID-19 pathogen, for rinsing the nasal and oral pores….
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Chronic obstructive disease and cancer
Chronic obstructive disease of the leg (COPD) is a price for anyone who can get it and who can get it.Vin is characterized by persistent respiratory symptoms and a strong fiery reaction to small particles and gases. Uninvolved for those COPDs, they often associate with other chronic ailments, with emphysema and bronchitis; The increase in the frequency of severe COPD aggravations is associated with the reduction of the results of the vision. On COPD there are 8-10% of the overgrown population of the country due to a high income and 15-20% of chickens.All-day organizing of health predictions, as well as not living through life important visits to change the main factors of the risk, good health and well-being in the future, due to the third reason until 2030
…
Spiral computed tomography – part 4
content ….
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3
4
5 ..
Power supply for internal use
Sandler C.M. [42] in the editorial commentary on the article by P. Aspelina [43]
writes that iodixanol is the first dimeric isoosmolar con
trust substance.
In October 1995, Schering AG discontinued iotrolan for angiography.
use for finding out the causes of delayed reactions, especially
but allergic-like skin [7].Therefore, the properties of nonionic dimers
in this section will be mainly represented by research, dedicated to
with iodixanol (visipaca).
For contrast media of a new class – non-ionic dimers, character
nonionicity, isoosmolarity in all concentrations used
in clinic, low chemotoxicity and organ specific toxicity, you
juice hydrophilicity and viscosity compared to the same concentration
mi nonionic monomers.However, for non-ionic dimers, the size of
ry molecules in solution [42].
Osmolarity is known to be associated with subjective adverse reactions
tions, such as pain and discomfort during arterial administration and around
objective changes, such as expansion of plasma volume, ejection
vasopressors and endothelial damage [44]. Osmolarity Optimization
and the hydrophilicity of iodixanol caused an increase in the viscosity of the finish
solution at the same iodine concentration (when compared with neion
monomers).
However, how clinically relevant is the viscosity of iodixanol? Clinics
studies show that radiographs obtained with is
use of visipack 320 mgI / ml, have the same quality characteristics
ki, as X-ray images obtained with the use of other substances
with an iodine concentration of 350-370 mgI / ml. Visipak 270 mgI / ml gives the same pe
results for image quality as well as 300 mgI / ml compared contra
stale substances [44].
With an equivalent diagnostic efficiency in clinical
practice viscosity of the final solution of iodixanol (visipack 270 and
320 mgI / ml, respectively) the same as the viscosity of non-ionic monomers
(300 and 350-370 mgI / ml) [44].
In modern conditions, no data has been received about any su
Significant effect of iodixanol viscosity on blood flow or rheology
In vivo properties of blood. Conversely, iodixanol is likely to cause
less changes in rheological properties of blood and hemodynamic
body balance than non-ionic monomers, giving it an additional
significant advantages in the effectiveness of the application [44].
Clinical studies confirm the low effect of iodixanol
for the most important parameters of the functions of the heart, kidneys and central nervous system in comparison with
with nonionic monomeric contrast agents [44].
The most significant effect of a contrast agent is its osmolar
ness – manifested by a feeling of heat and pain in the injection area when inside
arterial administration. These manifestations are sharply reduced when using
The name of iodixanol [44].
53
Chapter 2
Finally, the isotonicity, viscosity and dimeric nature of iodixanol
provide improved bolus concentration in the absence of os
motic dilution when injected into an artery or
vein, providing improved image quality in the
diagnostic range
situations [44]. One cannot but agree with this statement, since it is
is the key point for spiral CT with bolus end
trust reinforcement.
Studies carried out at our institute have shown that with is
using equal volumes of contrast media with comparable con
iodine centralization, bolus density in the arterial phase of contrast agent
gains are higher with the introduction of non-ionic dimers than non-ionic monomers
ditch [45].
Since non-ionic dimers contain 6 iodine atoms in one molecule
contrast agent versus 3 iodine atoms in non-ionic monomes
pax, only half of the number of molecules required
to achieve the same iodine content as non-ionic monomers,
and clinically even higher concentrations of iodixanol are possible
(320 mgI / ml), isotonic to blood [46].
In the presence of iodixanol, even hypoosmolar contractions can be created
stale substances [47]. Visipack available normo-osmolar space,
containing iodine (320 mgI / ml), filled with NaCl 19 mmol and CaCl2 0.3 mmol.
There are three reasons for the inclusion of ions (electrolytes)
in Visipack clinically used for angiography: to achieve
normo-osmolarity (salts of NaCl and CaCl2), to avoid cardiac arrhythmias
(ions Na and Ca), to prevent contractile insufficiency of myo
card (Ca ions) [47].
Thus, non-ionic contrast agents have a lower current
more viscous than ionic contrast agents. However, non-ionic properties and
the lowest osmolarity of the contrast medium does not guarantee
no toxicity, therefore even iso-osmolar contrast agents
plants possess toxic properties [48]. Low osmolarity and isoos
molar contrast agents are more comfortable for patients and more than
are safer than high osmolarity contrast media.Virtues
low-osmolarity and iso-osmolar contrast media continue os
Be a topic for discussion, discussion, in particular the definition of Cree
teriev of selective use of various contrast agents for
different procedures [49].
Overall differences between non-ionic dimers and non-ionic monomers
mi are probably more important than the differences between it and
monomers [17]. The main obstacle to the total
the transition to the use of non-ionic contrast media is you
low price [7, 50].
54
Power supply for internal use
However, if we discuss the cost problem, then, for example, for urogra
fii, a typical dose is 15 grams of iodine (50 ml of Omnipaque 300). At the same
time cost of 9 grams of iodixanol (33 ml of Visipack 270), possessing
with the same diagnostic efficiency, about 27% cheaper than
standard doses of iohexol [51].
Literature
1.
Dawson P. Radiological contrast agents in interventional radiology // J. Intervent. Radiol.
1987. V. 2.p. 51-58.
2.
Christiansen C., Pichle W. J., Skotland T. Delayed allergy like reactions to X ray contrast
media: mechanistic considerations // Eur.Radiol. 2000. V. 10. P. 1965-1975.
3.
Sovak M., Ranganathan R., Speck U. Non ionic dimmer. Development and initial testing
of intrathecal contrast agents // Radiology.1982. V. 142. P. 115-119.
4.
Dawson P., Howell M.J. Pharmacology of the non ionic dimmers // Br. J. Radiol. 1986.
V. 59. P. 987-991.
5.
Pollack H.M. History of iodinated contrast media. In: Thomsen H.S., Muller R.N., Mattrey
R.F. (eds) Trends in contrast media. Springer. Berlin Heidelberg New York. 1999. P. 1-19.
6.
Cohan R.H., Ellis J.H. Iodinated contrast material in uroradiology. Choice og Agent and
Management of Complications // Urologic Clinics of North America.1997. V. 24. P. 1-27.
7.
Stacul F. Current iodinated contrast media // Eur. Radiol. 2001. V. 11. P. 690-697.
8.
Almen TL. Development of nonionic contrast media // Invest Radiol. 1985. V. 20. Suppl.
P. S2-S9.
9.
Morcos S.K. and Thomsen H.S. Adverse reactions to iodinated contrast media // Eur.
Radiol. 2001. V. 11. P. 1267-1275.
10. Thomsen H.S., Morcos S.K. Radiographic contrast media // B.J.U. Int. 2000. V. 86.
Suppl. 1.P. 1-10.
11. Nyman U., Elmstahl B., Leander P. et al. Are gadolinium based contrast media really safer
than iodinated media for digital subtraction angiography in patients with azotemia? //
Radiology. 2002. V. 223. P. 311-318.
12. Bettmann M.A. Causes of complications of iodinated contrast agents. Advances in X
ray // Contrast. 1997. V. 4. P. 48-53.
13. Violon D. Stabilization of the hydrophilic sphere of non ionic monomers: are all protected
in a similar way? // Br.J. Radiol. 2001. V. 74. P. 1097-1102.
14. Pugh N.D. Haemodynamic and rheological effects of contrast media: the role of viscosity
and osmolality // Eur. Radiol. 1996. V. 6. P. S13-S16.
15. Morris T.W. The physiologic effects of nonionic contrast media on the heart // Invest.
Radiol. 1993. V. 28. P. S45.
16. Laurent A., Durussel J. J., Dufaux J. et al. Effects of contrast media on blood rheology:
comparison in humans, pigs, and sheep // Cardiovasc Intervent Radiol.1999. V. 22.
P. 62-66.
17. Stacul F., Thomsen H.S. Nonionic monomers and dimers // Eur. Radiol. 1996. V. 6.
P. 756-761.
18. Speck U. Preclinical findings with Iotrolan: a short review // Eur. Radiol. 1995. V. 5.
Suppl. 2. P. S8-S13.
19. Mutzel W., Press W.R., Weinmann H.J. Physicochemical properties and general pharma
cology of the non ionic dimmer iotrolan. In: Taenzer V., Wende S. (eds) Recent develop
ments in nonionic contrast media.Thieme, Stuttgart. 1989. P. 28-32.
55
Chapter 2
20. Amon E.U., Ennis M., Lorenz W. et al. Histamine release induced by radiographic contrast
media: comparison between pulmonary and peritoneal mast cells derived from nor
motensive and spontaneously hypertensive rats // Int. Arch. Allergy Appl. Immunol. 1990.
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21. Beynon H.L.C., Walport M.J., Dawson P. Vascular endothelial injury by intravascular con
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22. Korotkina R.N., Karmazanovsky G.G., Shurakova A.B. et al. Investigation of collateral
the effects of certain radio-opaque substances on the function of liver cells and
check using organ-specific enzymes // Med. visual. 2004. No. 5.
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23. Korotkina R.N., Papin A.A., Karelin A.A. Effect of phene zepam and seduxen on
phenomenon in the blood of histidase and urocaninase // Vopr. honey. chemistry.1983. No. 6. S. 93-96.
24. Dawson P. The non ionic isotonic contrast agents. Prospectives and controversies // Eur.
Radiol. 1996. V. 6. P. S20-S24.
25. Almen T. The etiology of contrast medium reactions // Invest Radiol. 1994. V. 29. P. S37.
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M (ed) Handbook of experimental pharmacology. 1985. V. 73. Springer, Heidelberg Berlin
New York.P. 1.
27. Thomsen H.S., Dorph S., Mygind T., Sovak M. et al. Intravenous injection of ioxilan, iohex
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28. Caille J. M., Leonardi M., Holland I. Contrast selection key to safety of CNS imaging //
Diagnostic Imaging Eur. 1995. June. P. 15.
29. Dawson P. Contrast agents in interventional radiology // Adv. X ray Contrast. 1994. V. 2.
P.18.
30. Junck L., Marshall W.H. Neurotoxicity of radiological contrast agents. Ann. Neurol. 1983.
V. 13. P. 469.
31. Rosati G., Leto di Priolo S., Tirone P. Serious or fatal complications after inadvertent
administration of ionic water soluble contrast media in myelography // Eur. J. Radiol.
1992. V. 15. P. 95.
32. Trevan J.W. The error of determination of toxicity // Proc. R. Soc. Lond. (Biol). 1927.
V.101. P. 483-514.
33. Almen T. Contrast agent design. Some aspects on the synthesis of water soluble contrast
, agents of low osmolality, J. Theor. Biol. 1969. V. 24. P. 216-226.
34. Almen T. Relationship between chemical structure, animal toxicity and clinical adverse
effects of contrast media. In: Enge I., Edgren J. (eds) Patients Safety and Adverse
Events in Contrast Medium Examinations. Excerpta Medica International Congress Series
816.Elsevier Sciences Publisher. Amsterdam. 1989. P. 25-45.
35. Katayama H., Yamaguchi K., Kozuka T. et al: Adverse reactions to ionic and nonionic con
trast media. A report from the Japanese Committee on the safety of contrast media //
Radiology. 1990. V. 175. P. 621-628.
36. Russel W.M.S., Burch R.L. The principles of Human Experimental Technique. Meuthen.
1959. London.
37. Heglund I.F., Blazak W., Michelet A.A. et al.Preclinical pharmacokinetics and general tox
icology of iodixanol // Acta Radiol. 1995. Suppl. 399. P. 69-82.
38. Karlsson J.O.G. Preclinical safety assessment of contrast media: predictive value // Eur.
Radiol. 1996. V. 6. Suppl. 2. P. S3-S7.
39. Hull R.M. Guideline limit volumes for dosing animals in the preclinical stage of safety eval
uation // Human Exp. Toxicol. 1995. V. 14. P. 305-307.
56
Power supply for internal use
40.Katzberg R.W. Contrast medium induced nephrotoxicity: which pathway? // Radiology.
2005. V. 235. P. 752-755.
41. Galtung H. K., Sorlundsengen V., Sakariasen K.S., Benestad H.B. Effect of radiologic con
trast media on cell volume regulatory mechanisms in human red blood cells // Acad
Radiol. 2002. V. 9. P. 878-885.
42. Sandler C.M. Contrast agent induced acute renal dysfunction – is iodixanol the
answer? // N. Engl.J. Medicine. 2003. V. 348. P. 551-556.
43. Aspelin P., Aubry P., Fransson S. G. et al. Nephrotoxic effects in high risk patients under
going angiography // N. Engl. J. Med. 2003. V. 348. P. 491-499.
44. Simonetti G. Introduction // Eur. Radiol. 1996. V. 6. Suppl. 2. P. S1-S2.
45. Guzeeva E.B. 3D modeling from spiral computer
results
tomography with bolus contrast enhancement as the basis for viral
total surgical operations on the abdominal and retroperitoneal organs
space: Author’s abstract.dis
doct. honey. sciences. M .: IHV, 2002.48 p.
46. Karlsson J.O.G., Gregersen M., Refsum H. Visipaque is isotonic to human and rat blood
plasma // Acta Radiol. 1995. Suppl. 399. P. 39-42.
47. Jynge P. Sodium calcium balance in coronary angiography and experimental experience
with iodixanol // Eur. Radiol. 1996. V. 6. Suppl. 2.P. S8-S12.
48. Dawson P. Design plays major role in new contrast media // Diagn. Imaging Eur.1995.
June. P. 3.
49. Thomsen H.S. Universal use of low osmolar contrast media: a European perspective //
Acad. Radiol. 1994. V. 1. P. 295-297.
50. Ellis J.H., Cohan R.H., Sonnad S.S., Shafiroff Cohan N. Selective use of radiographic low
osmolality contrast media in the 1990s // Radiology. 1996. V. 200. P. 297-311.
51. Skehan S. J., Rasmussen F., Gibney R. G. et al. A comparison of non ionic dimer, iodixanol
with a non ionic monomer, iohexol in low dose inravenous urography // Br.J. Radiol. 1998.
V. 71. P. 910-917.
57
Chapter 3. Side effects
radiopaque substances
Any pathological effect of a medicinal substance on an organ
Low can be classified as manifesting only in susceptible
th patient or manifested in any person [1]. Reactions that
can manifest in any person on the administration of any drug
substances, this is an overdose of a drug – a toxic reaction associated with
with an excessive dose of the drug or with a reduced excretion of it, or with that
and with another, side effect of the drug – undesirable pharmacologists
ical effect of the recommended dose, drug interaction
substances – the effect of one medicinal substance on the effectiveness or
toxicity of other drugs [1].
Drug intolerance is a low level of normal headlights
macological activity of a medicinal substance, and medicinal
idiosyncrasy – genetically determined, qualitatively pathological
reaction to a medicinal substance associated with metabolic or
enzyme deficiency, drug allergy – immunologically
conditioned response characterized by specificity, preceding
active manifestations, carried out by antibodies or lymphocytes and
repetitive upon repeated exposure to the stimulus, and pseudoal
Lergic (or allergic-like) reaction – the same as allergic
reaction, but it lacks immunological specificity (activizi
nonspecific complement is emitted, and the release of nonspecific hist
mine imitates type I allergic reaction) [1, 2].
Side effects of iodine contrast agents may manifest
in the form of anaphylactoid and chemotoxic reactions [4].
Anaphylactoid reaction is caused by activation of the kinin system and
by activation of basophils or mast cells. It can be or directly
stimulated with a contrast agent or indirectly, non-specific
activated complements such as anaphylatoxins C3a and
C5a. Anaphylactic shock occurs as a result of the release from activiro
mast cells and basophils of vasoactive amines, macaw metabolites
chidonic acid and other inflammatory mediators.Sometimes it shows
after sensitization of these cells with antigen-specific IgE, and already
is then exposed to antigen [5].
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Working action
Chemotoxic reaction is caused by hydrophobicity and hyperosmo
the potency of the contrast agent itself [6] and is usually dose-related,
molecular toxicity of each agent included in the contrast
substance, and physiological characteristics of contrast medium
substances (such as osmolarity, viscosity, hydrophilicity, tropism
to proteins, the ability to block calcium and its sodium content).
The chemotoxic effect of iodine contrast agents is most ve
Potentially manifested in malnourished patients or medically induced nesting
strong [6].
In patients who have not previously received contrast media (not Sep
sibilized), there may also be side reactions (as in the cases of
with allergens) [7]. Conversely, not all patients who previously had re
action for contrast agents, the reaction will develop once again when repeating
Nominal X-ray contrast study [7].
Although some reactions to the administration of contrast medium are difficult from
fall into one category or another, most common adverse reactions at
contrast agents are idiosyncrasies [7]. Despite the fact that the development of
lazy idiosyncratic reactions are identical to those observed in na
patients with anaphylactic reactions, reactions to contrast agents
VA are not truly allergic reactions, in the majority of patients
ent are pseudoallergic, anaphylactoid reactions [3, 7], since
antibodies against contrast agents were not detected [9, 10].Even in sick
with the most acute reaction to contrast agents, anti-contrast IgE
antibodies, the presence of which is manifested by an allergic reaction
food were not identified [8, 9, 10, 11]. Although Laroche et al. [12] and
believe that some allergic-like manifestations caused by contra
stubborn substances, are anaphylactic reactions, mediator
of which are specific IgE antibodies.
Idiosyncrasies are unpredictable, potentially life-threatening, they are
are independent of dose [9].Typical idiosyncrasy begins during
20 minutes after contrast medium injection, (severe idiosyncrasy
a reaction may develop even after the introduction of less than 1 ml of contra
stony substance) [13].
Lasser suggests idiosyncratic reactions can be caused by
cypitized by activation of endothelial cells of the contact system, h
cut which releases a cascade of powerful vasoactive substances [14,
15].This triggers the release of histamine and other active biologists
cc mediators such as serotonin, prostaglandins, bradykinin,
leukotrienes, adenosines and endothelin [9]. Also possible activation and in
gibitation of various enzyme systems.
Common manifestations of idiosyncratic reactions are nettles
face, bronchospasm, edema of the upper respiratory tract, decreased arteries
pressure [13] (see Tables 3.1, 3.2).
Non-idiosyncratic reactions are less likely, and if
they appear, then they are less severe, if small doses are used
59
Chapter 3
Table 3.1. Linear Controls of Allergic and Pseudo-Allergic Responses on Non-
ionic antistatic tests [16].
Organ system
Clinical symptoms
Skin
Erythema, pruritus, urticaria, vascular edema,
various types of exanthema, such as
measles rash, erythematous rash,
fixed drug rashes
and cutaneous vasculitis
Respiratory
Sneezing, cough, bronchospasm, shortness of breath, laryngeal edema
Cardiovascular
dizziness, fever, chills,
vascular dilation, tachycardia,
hypotension, cardiac arrest, shock
Gastrointestinal
Nausea, vomiting *
* nausea, vomiting and decreased blood pressure may also result from chemotoxic
effects of contrast agent
Table.3.2. Tasks and symptomes of anaphylactoid reactions [18].
Organ system
Symptoms
Light
Nausea, vomiting, local urticaria, moderate
common urticaria
Medium
Weakness, vomiting, severe urticaria, Quincke’s edema
Heavy
Bronchospasm, lowering blood pressure,
shock, convulsions
contrast agent [13]. We consider this factor to be very important and
in our work, as a rule, we do not use volumes of contrast agents,
exceeding 100 ml.
Common manifestations of non-idiosyncratic reactions include sensation
fever, metallic taste in the mouth, nausea and vomiting.
In general, the side effects of contrast media are dose-dependent and mo-dependent
can be manifested by changes in the cardiovascular system,
morphology and function of erythrocytes, endothelium, hematoencephalic
barriers, functions of the renal glomeruli and tubules and the central nervous system [19].
Side effects of contrast agents are observed in 0.4-22% [20-27],
but it manifests itself with different frequencies – on ionic in 9-54% [28],
14-30% [29, 30] and in 2-17% [28], 8-10% [25, 29] for non-ionic contrast agents
substances.
Adverse reactions to contrast agents can be divided into renal
and generalized (general), and the latter, in turn, subdivision
for immediate reactions developing within 1 hour after
injections of contrast medium, and delayed reactions that manifest
is applied no earlier than 1 hour after the administration of a contrast agent.
Some patients may experience both immediate and
urgent adverse reactions to contrast agents [25, 31].
Muth, Henseke [32] believe that the majority of adverse reactions manifest
is already on within 10 minutes after the injection of contrast medium,
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Working action
and 70% of the side effects of contrast agents, according to Katayama et al.
[33], is observed within the first 5 minutes after their introduction.
Repeated reactions of immediate type are observed in 6-11% for neion
contrast agents and in 16-44% for ionic [17, 33].Yoshikawa otme
It is believed that repeated delayed-type reactions were 27% after within
intravenous administrations of both iohexol and iopamidol, while in total
, the rate of delayed adverse reactions was 8%. In patients with ra
she already had adverse reactions, their probability is 5 times higher than in individuals,
in which there were no reactions [33], however, repeated administration of the same con
trust substance to a patient who has already had a reaction to this contra
stale substance, will not inevitably result in the same or heavier re
shares, as if it would be with a true allergy [35].
An important role in the development of severe systemic reactions to contrast vein
the substance probably plays the spatial configuration of its molecule,
due to the location of side chains and their nature, which in total
and determines the function of these side chains during the interaction of the
molecule
contrast media with cell membranes, proteins and other ma
cromolecules [36]. Iodine itself, embedded in the counter
molecule
non-toxic substance, as well as inorganic iodine in the form of iodine
da sodium is well tolerated when taken orally, but toxic to
endothelium with parenteral administration [37, 38].
The hydrophilicity of the contrast medium also plays an important role
in the development of adverse reactions due to the interaction of contrast
substances with circulating macromolecules and with cells, since
interaction of contrast medium with biological structures
is due to its hydrophobic properties [39, 40, 41]. Well known,
that a safe contrast agent must have a high hydrophilic profile
nature, which provides minimal chemotoxicity [42].
Such a contrast medium should have minimum hydrophobic ha.
characteristics for reducing, as far as possible, its systemic value
and actions in the body. High hydrophilicity of non-ionic contrast
substances can be explained by the presence of hydroxyl (HO) groups, located
Applied symmetrically and providing good coverage of benzoic
rings and limited access to lipophilic zones (benzoic
itself
ring and carboxyl groups) iodide contrast agent molecules
states [9, 10, 36, 43].
All cell membranes are lipids, therefore increase guide
Decrease in contrast medium lipophilicity and decrease in lipophilicity
is the degree of its interaction with cells [36]. Hydroxyl groups
in the contrast agent molecule, their number and position determine the power of
its solubility in water and control the spatial configuration
tion of the contrast agent molecule, affecting the manifestations of side
reactions [44].
Other things being equal, the greater the hydrophilicity of the molecule,
the better the contrast agent tolerance with its clinical
61
Chapter 3
using [42]. Low hydrophilicity can reduce biological
contrast agent tolerance as it is associated with magnification
low lipophilicity and high affinity of the contrast agent molecule
properties to plasma proteins and cell membranes [9, 10, 43].
High osmolarity facilitates the movement of fluids from in
tracellular into the extracellular space and is the cause of
cellular dehydration, increasing the viscosity of the intracellular fluid and
accelerating cellular dysfunction [9, 10].
Osmolarity per se can “disturb” the vascular endothelium and spo
emit compounds that can accelerate byproducts
reactions. Complement release in case of an adverse reaction to contrast agents
substance has been postulated but not proven in clinical studies.
[36].Many agonists may be involved in the adverse reaction,
including slow anaphylactic reaction substance and actin factor
platelet thromboxane A2.
Cysteinyl leukotrienes play a role in the development of adverse reactions, you
called non-ionic contrast agents (iopromide and iotrolan) [45].
Electric charge, increased tendency of contrast medium
to binding to platelets, proteins and other macromolecules also
can cause serious adverse reactions [36].
All modern studies point to a multifactorial pathogen
no early and late adverse reactions [46].
3.1. Comparison of ionic
and non-ionic contrast agents
Contrast agents are very concentrated solutions
derivatives of triiodinated benzoic ring [47]. First non-ionic
radiopaque contrast agents were used in 1977 [48]. At
this did not reveal the interaction of non-ionic contrast molecules
substances with plasma proteins, they are quickly distributed throughout the body and
enter urine almost completely intact within 24 hours [49].
From the very first stages of clinical use, low-osmolarity con
trust substances have been under close critical scrutiny.
A whole series of works appeared in the literature, in which it was evaluated and so far
The frequency of adverse reactions when using this new class of
is given.
contrast media: 3.13% [33] and 2.6% of adverse reactions to iohexol
[34], 5.3% for iomeprol [50, 51], 7.8% for iopromide [51], 3.3% for ioversol
[52] and 2.3% for iopentol [32].
Several large series of studies have shown that neion
low-osmolarity contrast agents cause significantly
fewer light, medium and heavy reactions than ionic high osmolarity
contrast agents (Table 3.3).
Largest interclinical study by Katayama et
al. [33] includes 337647 patients. Among 169,284 patients who received
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Working action
Table 3.3. Equivalence of the frequency of the last reactions to the graduated ionic high-light-
Low (V) and Low Reson (Low) Non-ionic (V) Remote Controls.
Research
Frequency of reactions to VOCV (%)
Frequency of reactions to NOCV (%)
Wolf et al. [53]
n = 6006
n = 7170
lungs
2.5
0.58
average
1.2
0.11
heavy
0.4
0.00
Palmer [54]
n = 76294
n = 29917
lungs
3.4
1.1
average
0.37
0.10
heavy
0.09
0.016
Katayama et al.[33]
n = 169284
n = 168363
total
12.66
3.13
heavy
0.22
0.04
Very heavy
0.04
0.004
injection of ionic contrast agent was 12.66% of all reactions, from
The difference from only 3.13% of all reactions in 168 383 patients, in the study
of which non-ionic contrast agents were used. In this research
, it was first shown that when non-ionic con
trust substances, very important, actually revolutionary achievements
em in radiopaque diagnostics became a decrease in the frequency of severe and
very severe reactions from 0.22% and 0.04% to 0.04% and 0.004%, respectively.
In the interhospital study by Palmer [54], which evaluated the outcome of
examinations of 109 546 patients using contrast agents
companies, the use of non-ionic contrast media has resulted in more than
a threefold decrease in the incidence of adverse reactions.
Similar results from an interhospital study reported by Wolf et al.
[53]. The incidence of reactions of mild, moderate and severe degree was 2.5%, 1.2%
and 0.4% in 6000 patients who received ion contrast agents and roofing
vs 0.58%, 0.11% and 0%, respectively, in 7170 patients who received
non-ionic contrast agents.
In general, moderate immediate reactions are manifested in 3.8-12.7% pa
patients receiving high osmolarity and 0.7-3.1% – low osmolarity
non-ionic contrast agents [55].
Caro et al. [56] performed a meta-analysis of 37 studies comparing the incidence of
and the severity of reactions after the introduction of ionic and non-ionic contrast agents
substances, and found that the risk of severe reactions decreased by 126.
in 100,000 cases where non-ionic contrast media were used.
In a survey of 240 patients, Foord et al. [57] found it sickening
and vomiting were more frequent (14%) in patients who used
for urography.
called the ionic dimer ioxaglate than in patients who used
nonionic monomers iopamidol 300 (4%) and iohexol 300 (5%). Loughran
[58] when examining 220 patients also revealed an increase in the frequency of TOS.
63
Chapter 3
notes and vomiting after using ioxaglate (16%) compared with
by changing iopamidol (8%).
Valls C. et al. [59] got an even slightly lower lung frequency of
and medium reactions (2.2%) to high-osmolar contrast agents,
than other researchers [33, 60]. The frequency they received is heavy by
side reactions when using high osmolarity (0.08%) and low os
molar contrast media (0.05%) comparable to other
authors [56, 60]. Valls C. et al. [59] believe that these differences were due to
study of reactions separately in groups of patients with low risk,
who received high-osmolar contrast agents and
patients
high risk who received low osmolarity contrast agents
numbers, while in the series Katayama et al.[33] shows groups of patients
high and low risk commodities who received contrast media
both types. Valls C. et al. [59] find it interesting that they are not on
there were significant differences between the frequency of severe reactions when using
for the development of high-osmolarity and low-osmolarity contrast media
(p = 0.27), although the frequency of adverse reactions when using low-osmo
contrast media were significantly less.
Valls C. et al. [59] propagandize their electoral methodology
applications of low-osmolar contrast media. Considering that even
after deducting the cost of the antiemetic drug they use
metoclopramide and the increasing cost of treatment for more severe re
shares, the cost of research will be 414,000 euros for every 10,000 pa
cents. Taking into account the increasing costs of medical care
population, before radiologists there are several ways to effectively
use of low-osmolar contrast agents: a) inject less than
doses of low-osmolar contrast agents for each patient, to
so it is necessary to perform CT with contrast enhancement, b) enter
standard doses of low-osmolar contrast agent per sample
patient groups and do not use contrast enhancement in many
numerical patients, c) apply the selective use of low-os
molar contrast agents.
On this occasion, I would like to cite data from the work of Palmer [54], which
ry noted that severe adverse reactions were three times more common in patient
low-risk patients who received ionic contrast agents
(0.09%) than in high-risk patients treated with non-ionic
contrast agents (0.03%).
Significantly higher incidence of urticaria after ICU administration
saglates versus iopamidol reported by Del Favero et al.[61]. They are
pooled the results of 16 comparable randomized trials and
found that the frequency of adverse reactions was 5% when administered with iop
dollars and 18% after the introduction of ioxaglate. Brismar et al. [62] commenting on you
Low frequency of adverse reactions after administration of ioxaglate compared to
with non-ionic monomers, consider real differences in safety
high osmolarity and low osmolarity contrast media actually
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Working action
was blurred by combining research results using
with nonionic monomers and ioxaglate.
The total number of allergic-like reactions is significantly lower when using
The use of non-ionic contrast media than with the introduction of ionic contrast agent
stale substances [27]. When observation lasted 1-24 hours after the introduction of
contrast media, delayed allergic reactions were
in 0.4-0.5% both when using ionic and non-ionic contrast ve
entities [27].
3.2. Selective or universal use
non-ionic contrast agents?
Valls C.et al. [59] believe that low-osmolarity contrast agents
should be used when: previously observed mild or moderate
Adverse reaction to contrast agents, including diffuse edge
pivnice, Quincke’s edema, diffuse skin redness or mild lesion
airways, history of asthma or severe pulmonary under-
abnormalities, including chronic bronchitis, which required treatment.
with inhaled β2 agonists and / or corticosteroids; cardiac dysfunction
tion, including angina pectoris, congestive heart failure and arritis
miyu; severe exhaustion; if known to be acute or chronic
renal failure (serum creatinine level higher than
132.6 μmol / l), which caused a decrease in renal function, in patients, to
hemodialysis was performed first, no absolute indications for prescription
low-osmolar contrast media, the study should be assigned
just before hemodialysis; patients with known or
a suspected tumor of the larynx (in the area of the glottis) with a potential of
but possible severe airway obstruction;
as well as in the presence of specific diseases such as multiple
myeloma, pheochromocytoma and myasthenia gravis.
According to Muth C.P. et al. [32], in patients over 70 years of age, the risk of developing
90,002 adverse reactions are higher, although Katayama et al. [33] found no connection between
age and frequency of adverse reactions. Valls C. et al. [59] do not consider pozhi
is an indication for the appointment of low-osmolar contrast agents
substances, as well as the fact that the high rate of introduction is specific
is an indication for the administration of a low-osmolar contrast agent [59].
In their opinion, the thesis that the widespread use of low-osmolarity
contrast agents reduce the risk of adverse reactions, and their cost is
is less than the cost of treatment of adverse reactions, not solvent,
since it is rather difficult to establish risk groups, therefore Valls C. et al.
[59] support the point of view of Silverman P.M. [63] that selective is
the use of low-osmolar contrast media can be reduced for
spending on contrast agents, while maintaining the quality of research.
However, there is one important problem that needs to be solved, to
mu to inject low-osmolar contrast agents, and to whom not.
65
Chapter 3
Deaths are extremely rare with both types
contrast agents (1: 170,000), differences in mortality also
no [28, 33, 56, 64]. In a study by Katayama et al. [33] there were 2 deaths
after the introduction of ionic and 1 death after the introduction of non-ionic
contrast agent.Meta-analysis not statistically revealed up to
significant difference in fatality rate after you use
high-osmolar and low-osmolar contrast agents [59].
In most US clinics, non-ionic contrast agents are patient
there with an increased risk of developing adverse reactions, elect
is introduced
tally [65]. Various organizations including the American College of Ra
Diology (ACR), American College of Cardiology (ACC) and Society
cardiovascular and interventional radiology (OSSIR) sfor
have duplicated instructions that allow for the implementation of the policy of limitation
use of low-osmolar contrast media [66].In price
scrap these instructions indicate that low-osmolar contrast
substances are administered to patients with previous reactions to contra
stubborn substances, asthma, allergies and patients with diseases, leak
which may worsen with the introduction of a contrast agent. AKR
also indicates that low osmolarity contrast media are needed at
means patients who have an increased risk of aspiration, very much
puppies, in patients who are afraid of injecting a contrast agent,
uncommunicative patients (for whom it is not possible to collect anam
nes), or those who specifically ask them to inject non-ionic contrast agents
substances [67].Although initial research did not show any
significant advantages of low-osmolar contrast media over
high-osmolar contrast agents in prevention times
cases of renal failure [68, 69], in later studies
Benefits of non-ionic contrast media have been identified – they are less than
are nephrotoxic in patients with azotemia [70, 71]. Despite the fact that according to
Chechen insufficiency due to contrast agents, not from
labeled with AKP, AKK and OSSIR as an indication for the use of low osmo
contrast agents,
are now used in many clinics in the USA
low-osmolarity contrast agents in patients with elevated
serum creatinine levels [72].
Despite instructions clearly indicating patient groups,
which should be injected with non-ionic contrast agents, they are using
are becoming more common. So Debatin et al. [73] note that for 22 months they have elected
for the application of non-ionic contrast agents for urography according to
formal criteria, they had to be used in 26% of patients, and the fact
they were used in 55% of cases. Moreover, the authors noted that
the urge to inject non-ionic contrast agents manifests itself from one hundred
Rones of radiologists, nurses and patients themselves for fear of
development of severe adverse reactions to ionic contrast agents and
because of the desire to avoid patient discomfort and the likelihood of developing
adverse reactions.
66
Working action
Hopper, Matthews [74] found that 42% of patients at low risk
development of adverse reactions after studying the forms presented to them from
requests for the introduction of contrast medium and familiarization with possible
Adverse reactions to ionic and non-ionic contrast media you
said their preference for non-ionic contrast media, however
after it was proposed to sign the agreement for the introduction of the end of
trust substances – already 51% of patients preferred non-ionic contrast
substances.
A more systematic approach to the problem of using radiopaque
substances are reflected in a whole series of recommendations of the Committee on Contrast
funds of the European Society of Urogenital Radiology
(ESUR), which are given in this work.
From our point of view, the above data on high osmolarity
and low osmolarity contrast media should be considered as
Information to keep in mind in case of difficulty
using low-osmolar contrast media.
The patient should be informed about the merits and demerits of the relationship
tested using different classes of contrast media. At
choosing a contrast medium for radiopaque examination he
must consciously and actively participate in this process, especially with
conducting outpatient research.
All modern disputes should occur and be resolved in the plane
preferred use of non-ionic monomers and non-ionic di
measures.
3.3. Comparison of low osmolarity
and iso-osmolar contrast agents
Comparison of the type and frequency of side reactions for nonionic monomers and
non-ionic dimers is a difficult task. Safe level, reached
filled with these contrast agents such that it is difficult to show the difference
chia in controlled clinical trials.
Skehan S.J. et al. [75] found late skin reactions to iodixanol
in 1.5% of patients, which is less than according to literature data (1.4-5.5%) for
monomeric contrast agents [20, 25, 29, 33, 75, 76].When using
nii iodixanol less discomfort from the introduction of contrast
substance due to its isotonicity and hydrophilic properties
[75], there are fewer artifacts associated with patient movement [77,
78, 79], the frequency of gastrointestinal manifestations is also significantly reduced
intestinal symptoms [80, 81].
Rydberg et al. [26] analyzed the results of radiopaque
studies in 3048 patients who received iohexol and iodixanol.
Patients were interviewed in writing about the reactions observed during one
weeks after contrast medium injection. Patients were separated
into two groups: those who underwent intravenous and intravenous angiography
67
Chapter 3
by arterial administration of a contrast agent and those for whom
is performed
on CT with intravenous contrast enhancement. Replies have been received from
84% of interviewed patients.There were 72 (2.3%) immediate reactions and
61 (2%) late. There were 1.7% of late reactions to iohexol,
to iodixanol
2% after intravenous and 2.3% late reactions after intra-arterial
th introduction. Thus, the differences were not significant. By level
nude subjectively assessed discomfort differences were also not. All
reactions were mild to moderate, no one needs hospitalization
was working. It was concluded that the number of late reactions to contrast agents was
including iodixanol, low.Differences in late reactions to iodic
sanol and iohexol when administered intravenously no. No difference in reactions
with intra-arterial and intravenous administration of iodixanol.
When the observation period is extended and special attention is paid to
identification of delayed reactions, their frequency also increases [16].
So, with 72-hour observation, the frequency of delayed reactions to neion
monomers and non-ionic dimer iotrolane were 1% and 4.6%, respectively
but [82].Thus, the number and nature of manifestations of side effects
The effects of contrast medium depend on many factors, including
methods of collecting information, therefore, probably in the literature there are
A large number of reports of actually false positive delayed
reactions to radiopaque substances.
Sutton A.G.C. [83] also believes that the non-ionic dimer of iodixanol induces
more late skin reactions than ion dimer ioxaglate or not
ionic monomer iopamidol.However, according to Rydberg J. et al. [26], hour
the total of late reactions for iodixanol is the same as for non-ionic monomes
ry, although in their study treatment with hydrocortisone or antihistamines
With
drugs, more patients received iodixanol.
Fransson et al. [84] found no difference in the incidence of late skin reactions
for iodixanol and ioxaglate.
Immediate review of reports of delayed adverse reactions
for iodixanol indicates that most delayed skin reactions
were of the following types: erythema (9%), urticaria (22%), vascular edema
(29%), exanthema (57%) [16].In the exanthema group, bark-like
rash, nonspecific rashes and urticaria. It was noted that
of a similar type of rash with a similar frequency are observed when taking
and other medicines. In addition, there are several communities
ny where measles rash is indicated as the predominant type
skin rashes caused by drugs in general and
observed after urticaria or vascular edema [85, 86, 87, 88].
Due to the high frequency of late reactions, especially skin reactions,
originally reported from Japan and later from the US non-ionic
iotrolan dimer in 1995 was withdrawn from clinical use for
vascular injections [89, 90].
Following F.Stacul article “Current iodinated contrast media” published
at Eur.Radiol. (2001) [91], there was a letter to the editor [92] in which W. Clauss
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Working action
and C.Harz confirmed that in 1995, due to the increased number of cases
teas of allergic reactions after intravascular administration of iotro
lana Schering AG has decided to withdraw this isotonic contrast medium
substance for intravascular administration from the market pending clarification of the reasons
of these reactions. According to W. Clauss, C. Harz [92], it is still not clear whether
There is an observed decrease in acute reactions and an increase in the incidence of late
of these reactions by the specific property of iotrolan in its intravascular
ostomy introduction or is it typical in general for the whole group of isotonic
non-ionic contrast agents.In doing so, they refer to some
data [93, 94, 95], indicating that the decrease in acute reactions
tions and an increase in the frequency of late reactions is a property specific to
for non-ionic dimers, since iodixanol, which was also introduced
intravascular, caused an increase in the number of late reactions, compared to
with monomeric non-ionic contrast media.
In response, F. Stacul [96] writes that the section on the possible increase in the number from
urgent reactions to iodixanol are a topic of discussion.Tebo
more that there is only one clinical study Rydberg J. et al.
[26] focusing on this issue and not showing any times
lychees between iodixanol and iohexol. Articles cited by W. Clauss
and C. Harz do not reflect the results of clinical trials on this topic.
Fishbach et al. [93] does not deal with the topic of late reactions at all. In article
Pohly [94] collected clinical and experimental data, in the study
The addition of iodixanol showed a significantly higher number of acute than
late adverse reactions, while the study of iotrolan revealed
but more late than acute adverse reactions.F. Stacul [96] believes that
to clarify this problem, it is necessary to carry out further
prospective clinical studies.
3.4. Acute adverse reactions
for iodine contrast agents
Acute (early) adverse reactions are reactions that show
for 1 hour [27], pathophysiology of acute general adverse reactions
on contrast media is not entirely clear yet and is probably a lot
factorial.