Visipaque 320mg/ml Inj, 200ml

Iodixanol is a non-ionic, dimeric, iso-osmolar iodinated contrast medium. It enhances the visibility of structures or fluids within the body during X-ray based diagnostic procedures by absorbing X-rays. The iodine atoms in the molecule are responsible for the X-ray attenuation. Its iso-osmolarity to blood helps minimize osmotic fluid shifts and associated adverse effects.

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: 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, or swelling of the mouth, face, lips, tongue, or throat. In rare cases, allergic reactions can be fatal.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or significant weight gain.
Signs of thyroid problems: weight changes, feeling nervous, excitable, restless, or weak, hair thinning, depression, eye or neck swelling, difficulty focusing, trouble with heat or cold, menstrual changes, shakiness, or sweating.
Chest pain or pressure, rapid heartbeat, 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 immediately 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), and other serious reactions. These reactions can affect internal organs and be life-threatening. Seek medical help right away if you experience symptoms such as red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your 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 bothered by any of the following side effects or if they persist, contact your doctor or seek medical attention:

Feeling of warmth
* Irritation at the injection site

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, 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 and its symptoms.
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 or any other medications that may interact with this drug.

This is not an exhaustive list of potential interactions. Therefore, it is crucial to discuss all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure that it is safe to take this medication in conjunction with your other medications and health conditions.

Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to confirm that it is safe to do so.

Important Warnings and Cautions for Patients Taking This Medication

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. 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 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 after injection. If you have any questions or concerns, consult your child's doctor.

• Metformin (in patients with renal impairment or acute kidney injury risk)
• Interleukin-2 (IL-2)

• Beta-blockers
• Diuretics
• Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides, cisplatin)

• Rash
• Hives (urticaria)
• Itching (pruritus)
• Swelling of face, lips, tongue, or throat (angioedema)
• Difficulty breathing (dyspnea)
• Wheezing
• Cough
• Chest tightness
• Lightheadedness
• Dizziness
• Nausea
• Vomiting
• Flushing
• Headache
• Pain or warmth at injection site

Use during pregnancy only if clearly needed and the potential benefits outweigh the potential risks to the fetus. Iodixanol crosses the placenta. Category B.

Iodixanol is excreted in human milk in small amounts. The amount absorbed by the infant is minimal. Generally considered compatible with breastfeeding. A temporary interruption of breastfeeding (e.g., for 24 hours) is an option but not typically required.

Dosing is weight-based. Safety and efficacy have been established in pediatric patients. Particular attention should be paid to hydration status and renal function, especially in neonates and infants due to immature renal function. Risk of thyroid dysfunction in neonates/infants should be considered, especially in premature infants or those with underlying thyroid conditions.

No specific dose adjustment based on age alone. However, elderly patients are more likely to have impaired renal function, cardiovascular disease, and diabetes, which are risk factors for contrast-induced acute kidney injury and other adverse reactions. Careful assessment of renal function and hydration status is crucial.

• Visipaque is iso-osmolar to blood, which may lead to a lower incidence of discomfort, pain, and heat sensation upon injection compared to hyperosmolar contrast agents.
• Pre-hydration is critical for all patients, especially those at risk for contrast-induced acute kidney injury (CI-AKI).
• Always assess renal function (eGFR) before administering iodinated contrast, particularly in patients with risk factors for CI-AKI.
• Patients on metformin should have their renal function assessed. If eGFR is <30 mL/min/1.73m² or if acute kidney injury is anticipated, metformin should be withheld at the time of or prior to the procedure and for 48 hours afterward, and reinstituted only after renal function is stable.
• Be prepared for hypersensitivity reactions, even in patients with no prior history. Have emergency equipment and medications readily available.
• Consider alternative imaging modalities for patients at very high risk for CI-AKI or severe allergic reactions.

• Other iodinated contrast media (e.g., Iohexol, Iopamidol, Iopromide, Iomeprol, Iodixanol)
• Gadolinium-based contrast agents (for MRI)
• Ultrasound
• Non-contrast CT or MRI

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 quantity, and the time of the incident.