Visipaque 320mg/ml Inj, 50ml

Iodixanol is a dimeric, iso-osmolar, non-ionic, water-soluble iodinated X-ray contrast medium. It enhances the visibility of structures or fluids within the body during X-ray based diagnostic procedures. The iodine atoms within the molecule absorb X-rays, creating a temporary difference in density that is detectable by imaging equipment, allowing for visualization of blood vessels, organs, and other tissues.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of kidney problems, including:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Signs of thyroid problems, such as:
+ Weight changes
+ Feeling nervous, excitable, restless, or weak
+ Hair thinning
+ Depression
+ Eye or neck swelling
+ Difficulty focusing
+ Sensitivity to heat or cold
+ Menstrual changes
+ Shakiness
+ Sweating
Chest pain or pressure
Fast or abnormal 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
Changes in balance
Drooping on one side of the face
Blurred vision
Tissue damage at the injection site, characterized by redness, burning, pain, swelling, blisters, skin sores, or fluid leakage
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other serious reactions, which can occur anywhere from 1 hour to several weeks after administration and may affect internal organs
+ Signs of severe skin reactions include:
- 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
- Swollen glands

Other Possible Side Effects

Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. 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

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, contact 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 and its symptoms.
If you are dehydrated, have a poor diet, or have recently used a laxative or diuretic (water pill) before starting this medication.
If you have experienced a skin reaction to this medication or a similar medication in the past.
If you are currently taking metformin.

This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter 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 dosage 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 of 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 with your doctor.

This medication may interfere with certain laboratory tests, so it is vital to inform all of 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.

Women who are pregnant, plan to become pregnant, or are breastfeeding should discuss the benefits and risks of this medication with their doctor, as it may affect both the mother and the baby.

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 a period after the injection. If you have any questions or concerns, be sure to discuss them with your child's doctor.

• Metformin (in patients with acute kidney injury or severe chronic kidney disease): 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 has been re-evaluated and found to be normal or baseline.
• Interleukin-2 (IL-2): Increased risk of delayed adverse reactions (e.g., fever, rash, flu-like symptoms, renal dysfunction) in patients who have received IL-2 within 2 weeks prior to contrast administration.

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

• Rash
• Urticaria (hives)
• Pruritus (itching)
• Dyspnea (shortness of breath)
• Wheezing
• Cough
• Angioedema (swelling of face, lips, tongue, throat)
• Hypotension
• Tachycardia
• Bradycardia
• Nausea
• Vomiting
• Dizziness
• Headache
• Flushing
• Chills
• Fever (especially delayed reactions)
• Injection site pain or swelling (extravasation)
• Decreased urine output (signs of AKI)

Category B. Animal studies have not shown evidence of fetal harm. However, there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and the potential benefit outweighs the potential risk to the fetus. Consider non-iodinated imaging alternatives if possible.

L3 (Moderately Safe). Iodixanol is excreted into breast milk in small amounts (less than 0.5% of the administered dose). Due to poor oral absorption by the infant, systemic exposure is minimal. A decision should be made whether to discontinue nursing for a short period (e.g., 24 hours) or to discontinue the drug, taking into account the importance of the drug to the mother. Most guidelines suggest that interruption of breastfeeding is not necessary.

Dosing is weight-based and procedure-dependent. Children, especially neonates and infants, are more susceptible to fluid shifts and temperature changes. Adequate hydration is crucial. Renal function should be assessed. Risk of thyroid dysfunction in neonates/infants should be considered.

Increased risk of contrast-induced nephropathy due to age-related decline in renal function. Increased susceptibility to adverse reactions, including cardiovascular events. Careful assessment of renal function and hydration status is essential. Use the lowest effective dose.

• Iodixanol (Visipaque) is iso-osmolar to blood, which may lead to a lower incidence of pain and warmth during injection compared to hyperosmolar contrast agents, and potentially a lower risk of contrast-induced nephropathy in high-risk patients, though evidence is mixed.
• Always assess patient's renal function (eGFR) before administering iodinated contrast, especially in patients with risk factors for AKI.
• Ensure adequate hydration before and after the procedure, particularly for patients at risk of contrast-induced nephropathy.
• Strictly adhere to guidelines for metformin discontinuation in patients with impaired renal function to prevent lactic acidosis.
• Be prepared for immediate treatment of hypersensitivity reactions, as they can occur rapidly and be severe, even with non-ionic contrast agents.
• Educate patients about potential delayed reactions (e.g., skin rash, flu-like symptoms) that can occur hours to days after contrast administration.

• Other iodinated contrast media (e.g., Iohexol, Iopamidol, Ioversol, Iopromide, Ioxaglate)
• Gadolinium-based contrast agents (for MRI, different mechanism of action, used when iodinated contrast is contraindicated or for specific indications)
• Non-contrast imaging modalities (e.g., ultrasound, non-contrast CT, non-contrast MRI) when appropriate.

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 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 medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.