Visipaque 320mg/ml Inj, 500ml

Iodixanol is a dimeric, iso-osmolar, nonionic, water-soluble iodinated X-ray contrast medium. It enhances the visibility of structures or fluids within the body during diagnostic imaging procedures by absorbing X-rays. The iodine atoms in the molecule absorb X-rays, creating a temporary difference in density between the area containing the contrast agent and surrounding tissues, thus improving visualization.

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
+ Excessive 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

In rare cases, this medication can cause severe skin reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which can be life-threatening. Seek immediate medical attention if you experience:

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
Swollen glands

Other Side Effects

Most people do not experience severe side effects, but some may occur. 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

If you have questions or concerns about side effects, 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 laxatives or diuretics (water pills) before starting this medication.
If you have experienced 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 adjust the dosage of any medication without consulting your doctor first.

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 interfere with certain laboratory tests, so it is vital to inform all your child's healthcare providers and lab 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, 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 it with 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 renal impairment or acute kidney injury): Increased 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, flu-like symptoms, rash, oliguria, renal dysfunction).

• Beta-blockers: Increased risk of anaphylactoid reactions and reduced efficacy of epinephrine in treating such reactions.
• Diuretics: May increase the risk of contrast-induced nephropathy due to dehydration.
• Nephrotoxic drugs (e.g., NSAIDs, aminoglycosides, cisplatin): Concomitant use may increase the risk of contrast-induced nephropathy.
• Oral cholecystographic agents: May interfere with visualization due to residual contrast.

• Rash
• Urticaria (hives)
• Pruritus (itching)
• Dyspnea (shortness of breath)
• Bronchospasm (wheezing)
• Angioedema (swelling of face, lips, tongue)
• Hypotension
• Nausea
• Vomiting
• Headache
• Dizziness
• Flushing
• Metallic taste
• Pain or warmth at injection site
• Signs of extravasation (swelling, pain, redness at injection site)

Use during pregnancy only if clearly needed and the potential benefit outweighs the potential risk to the fetus. Iodinated contrast agents cross the placenta. Fetal thyroid function should be monitored if exposure occurs.

Minimal amounts of iodixanol are excreted into breast milk. It is generally considered safe for breastfeeding. A decision should be made whether to discontinue breastfeeding for a short period (e.g., 24 hours) or to continue, taking into account the importance of the drug to the mother and the potential risk to the infant.

Dosing is weight-based. Pediatric patients, especially neonates and infants, may be more susceptible to fluid shifts, electrolyte imbalances, and thyroid dysfunction. Careful monitoring of hydration and renal function is essential. Risk of contrast-induced nephropathy is generally lower than in adults but still a concern in vulnerable populations.

Increased risk of contrast-induced nephropathy due to age-related decline in renal function, comorbidities (e.g., diabetes, heart failure), and polypharmacy. Careful assessment of renal function and hydration status is crucial. Use the lowest effective dose and ensure adequate pre- and post-hydration.

• Visipaque is iso-osmolar to blood, which may lead to a lower incidence of discomfort (e.g., warmth, pain) and potentially a lower risk of contrast-induced nephropathy compared to hyperosmolar contrast agents, especially in high-risk patients.
• Always ensure adequate hydration before and after contrast administration, particularly in patients with pre-existing renal impairment, diabetes, or heart failure.
• Carefully screen patients for allergies to iodine or previous contrast reactions. Pre-medication with corticosteroids and antihistamines may be considered for patients with a history of moderate to severe reactions.
• Metformin should be withheld in patients with renal dysfunction or acute kidney injury at the time of or prior to the procedure and for 48 hours after, and reinstituted only after renal function is stable.
• Monitor for delayed hypersensitivity reactions, which can occur hours to days after administration.
• Extravasation can occur; monitor injection site and manage according to institutional protocol.

• Other iodinated contrast agents (e.g., Iohexol, Iopamidol, Iopromide, Iodixanol (other concentrations))
• Gadolinium-based contrast agents (for MRI)
• Ultrasound with contrast
• Non-contrast imaging modalities (e.g., non-contrast CT, MRI, ultrasound)

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, avoid flushing medications down the toilet or pouring 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.