Visipaque 270mg/ml Inj, 50ml

Iodixanol is a non-ionic, iso-osmolar, dimeric iodinated contrast medium. It enhances visualization of structures and fluids in the body by absorbing X-rays. When injected intravascularly, it distributes into the extracellular fluid space and provides contrast enhancement based on iodine concentration. Its iso-osmolality (similar to human plasma) is thought to contribute to a lower incidence of adverse events compared to hyperosmolar contrast agents.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or tightness in the chest or throat
+ Difficulty breathing, swallowing, or talking
+ Unusual hoarseness or swelling of the mouth, face, lips, tongue, or throat
Rarely, allergic reactions can be fatal.
Signs of kidney problems, including:
+ Inability to urinate or changes in urine output
+ Blood in the urine or significant weight gain
Signs of thyroid problems, such as:
+ Weight changes
+ Feeling nervous, excitable, restless, or weak
+ Hair thinning or depression
+ Eye or neck swelling
+ Difficulty focusing or trouble with heat or cold
+ Menstrual changes
+ Shakiness or sweating
Chest pain or pressure, rapid or irregular heartbeat
Severe dizziness or fainting
Swelling, warmth, numbness, color changes, or pain in a leg or arm
Weakness on one side of the body, trouble speaking or thinking, balance changes, drooping on one side of the face, or blurred vision
If the medication leaks from the vein, it can cause tissue damage. Inform your nurse if you experience redness, burning, pain, swelling, blisters, skin sores, or fluid leakage at the injection site.
Severe skin reactions can occur anywhere from 1 hour to several weeks after receiving this medication, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions that can affect internal organs and be life-threatening
If you experience any of the following symptoms, seek medical help immediately:
+ Red, swollen, blistered, or peeling skin
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, eyes, genitals, or skin
+ Fever, chills, body aches, shortness of breath, or swollen glands

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people may not experience any side effects or only minor ones. If you are concerned about any of the following side effects or if they persist, contact your doctor:

Feeling of warmth
* Irritation at the injection site

This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently dehydrated, have been experiencing poor nutrition, or have recently used a laxative or diuretic (water pill).
If you have had a skin reaction to this medication or a similar medication in the past.
If you are taking metformin, as this may interact with the medication.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your existing medications and health conditions.

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.

Important Warnings and Cautions for Patients Taking This Medication

If you are taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment. Your doctor may need to monitor your blood work regularly, so be sure to discuss this with them.

Although rare, this medication can cause life-threatening or fatal heart problems, including low blood pressure and heart attack. It is crucial to talk to your doctor about these potential risks.

Additionally, when used in conjunction with certain procedures, this medication can increase the risk of blood clots, which may lead to heart attack and stroke, potentially resulting in death. If you have any questions or concerns, consult your doctor.

This medication may also interfere with certain laboratory tests. Therefore, it is vital to inform all your child's healthcare providers and laboratory personnel that they are taking this medication.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

Pregnant or breastfeeding women, or those planning to become pregnant, should discuss the benefits and risks of this medication with their doctor.

Special Considerations for Children

When administering this medication to children, use caution, as the risk of side effects may be higher in some pediatric patients. In children under 3 years of age, the use of medications like this one has been associated with low thyroid function, which can impact child development. Your child's doctor may recommend regular thyroid function checks for an extended period after the injection. If you have any questions or concerns, consult your child's doctor.

• Metformin (in patients with renal impairment or acute kidney injury): Risk of lactic acidosis. Metformin should be withheld at the time of or prior to the procedure and for 48 hours after, and reinstituted only after renal function is stable.
• Interleukin-2 (IL-2): Increased risk of delayed adverse reactions (e.g., fever, rash, flu-like symptoms, renal dysfunction) due to altered contrast distribution and elimination.

• Beta-blockers: May blunt the compensatory cardiovascular responses to anaphylaxis, making treatment of severe hypersensitivity reactions more difficult.
• Diuretics: May increase the risk of dehydration and subsequent contrast-induced nephropathy, especially in patients with pre-existing renal impairment.
• Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides): Concomitant use may increase the risk of contrast-induced nephropathy.

• Rash
• Hives (urticaria)
• Itching (pruritus)
• Swelling of face, lips, tongue, or throat (angioedema)
• Difficulty breathing or wheezing (bronchospasm)
• Dizziness or lightheadedness
• Nausea
• Vomiting
• Headache
• Fever
• Chills
• Flu-like symptoms (delayed reactions)
• Decreased urine output (sign of CIN)
• Flank pain (sign of CIN)

Category B. Animal studies have not shown harm to the fetus. There are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and the potential benefits outweigh the potential risks.

L2 (Likely Compatible). Minimal amounts of iodixanol are excreted into breast milk. The amount absorbed by the infant is very low. Breastfeeding can generally be continued without interruption. If concerns exist, a temporary interruption of breastfeeding for 12-24 hours after administration can be considered, but is usually not necessary.

Dosing is weight-based. Children, especially neonates and infants, are more susceptible to fluid and electrolyte imbalances and temperature dysregulation. Careful monitoring of hydration status and vital signs is essential. Risk of thyroid dysfunction (transient hypothyroidism) may be higher in neonates and infants, especially premature infants.

No specific dose adjustment is required based on age alone. However, elderly patients are more likely to have pre-existing renal impairment, heart failure, or diabetes, increasing their risk for contrast-induced nephropathy. Careful assessment of renal function and hydration status is crucial. Use the lowest effective dose.

• Iodixanol is iso-osmolar to human plasma, which may lead to a lower incidence of discomfort, pain, and adverse events (e.g., nausea, vomiting, heat sensation) compared to hyperosmolar contrast agents.
• Often preferred for patients at higher risk for contrast-induced nephropathy (CIN), severe allergic reactions, or those with cardiac conditions, although adequate hydration remains the primary preventative measure for CIN.
• Crucial to ensure adequate hydration before and after administration, especially in patients with risk factors for CIN.
• Always inquire about metformin use and ensure appropriate withholding and re-initiation protocols are followed to prevent lactic acidosis.
• Be prepared for immediate treatment of hypersensitivity reactions, even with non-ionic agents, as they can still occur.

• Iohexol (Omnipaque)
• Iopamidol (Isovue)
• Iopromide (Ultravist)
• Ioversol (Optiray)
• Gadolinium-based contrast agents (for MRI, different mechanism)
• Barium sulfate (for GI tract imaging, different route/use)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the quantity, and the time of ingestion.