Visipaque 270mg/ml Inj, 200ml

Iodixanol is a non-ionic, dimeric, water-soluble iodinated contrast medium. When administered intravascularly, it increases the attenuation of X-rays in the areas of the body where it distributes, allowing for visualization of internal structures (e.g., blood vessels, kidneys) on X-ray images. The iodine atoms within the molecule are responsible for the X-ray attenuation.

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 medical attention immediately:

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) and toxic epidermal necrolysis (TEN), which can occur within 1 hour to several weeks after administration. These reactions may cause:
+ 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. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:

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 you experienced, including any symptoms that occurred.
If you are dehydrated, have a poor diet, or have recently used laxatives or diuretics (water pills) before starting this medication.
If you have had a skin reaction to this medication or similar medications in the past.
If you are currently taking metformin or any other medications that may interact with this drug.

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 health conditions and medications. Never 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.

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 interfere with certain laboratory tests, so it is vital to inform all your child's healthcare providers and lab workers 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, planning to become pregnant, or breastfeeding should discuss the benefits and risks of this medication with their doctor, as it may affect 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 thyroid function may need to be monitored for an extended period after receiving the injection. If you have any questions or concerns, consult your doctor.

• Metformin (in patients with acute kidney injury or severe chronic kidney disease, or in patients undergoing arterial studies where high concentrations of contrast media are expected in the renal arteries)
• Interleukin-2 (increased risk of delayed adverse reactions)

• Beta-blockers (may blunt compensatory cardiovascular responses to anaphylaxis)
• Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides, cisplatin - increased risk of CI-AKI)
• Diuretics (may increase risk of CI-AKI due to dehydration)

• Rash
• Urticaria
• Pruritus
• Angioedema
• Dyspnea
• Bronchospasm
• Hypotension
• Tachycardia
• Bradycardia
• Nausea
• Vomiting
• Headache
• Dizziness
• Injection site pain/swelling
• Oliguria/Anuria (post-procedure, indicating CI-AKI)

Category B. Animal reproduction studies have shown no evidence of fetal harm. However, there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed and the potential benefit justifies the potential risk to the fetus. Iodinated contrast media cross the placenta.

Iodixanol is excreted into breast milk in small amounts. The amount absorbed by the infant is minimal. Generally considered safe for breastfeeding. A temporary interruption of breastfeeding (e.g., for 24 hours) is often recommended by some clinicians, but is not strictly necessary based on current evidence for non-ionic contrast agents.

Dosing is weight-based and procedure-specific. Children, especially neonates and infants, are more susceptible to fluid and electrolyte imbalances and may have immature renal function, increasing the risk of CI-AKI. Careful hydration and monitoring are essential.

Elderly patients are at increased risk for contrast-induced acute kidney injury (CI-AKI) due to age-related decline in renal function, comorbidities (e.g., diabetes, hypertension), and concomitant nephrotoxic medications. Careful assessment of renal function and hydration status is crucial.

• Always assess renal function (eGFR) and allergy history prior to administration.
• Ensure adequate hydration before and after the procedure to minimize the risk of contrast-induced acute kidney injury (CI-AKI).
• Patients on metformin should have their renal function assessed; metformin should be withheld in patients with severe renal impairment or acute kidney injury, or for 48 hours after arterial studies until renal function is re-evaluated.
• Be prepared to manage hypersensitivity reactions, ranging from mild urticaria to severe anaphylaxis. Have resuscitation equipment and medications readily available.
• Monitor injection site closely for extravasation, which can cause pain, swelling, and tissue damage. If extravasation occurs, elevate the limb, apply cold compresses, and monitor for complications.

• Iohexol (Omnipaque)
• Iopamidol (Isovue)
• Iopromide (Ultravist)
• Ioversol (Optiray)
• Gadolinium-based contrast agents (for MRI, in patients with contraindications to iodinated contrast or specific clinical indications)
• Ultrasound (non-ionizing imaging alternative)
• Non-contrast CT or MRI (if diagnostic information can be obtained without contrast)

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; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional. If you are unsure about the correct 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 amount, and the time of ingestion.