Iodixanol is in a group of drugs called radiopaque (RAY dee oh payk) contrast agents. Iodixanol contains iodine, a substance that absorbs x-rays. Radiopaque contrast agents are used to allow blood vessels, organs, and other non-bony tissues to be seen more clearly on a CT scan or other radiologic (x-ray) examination.

Iodixanol is used to help diagnose certain disorders of the brain, blood vessels, heart, kidneys, and other internal organs.

Iodixanol may also be used for purposes not listed in this medication guide.

Iodixanol should not be given to a child who has recently used a laxative (stool softener) or has not eaten properly.

Tell your doctor if you have ever had any type of reaction to another contrast agent.

To make sure iodixanol is safe for you, tell your doctor if you have:

• liver or kidney disease;
• heart disease, including congestive heart failure;
• a history of stroke, blood clots, or coronary artery disease;
• asthma, food or drug allergies;
• epilepsy or other seizure disorder;
• sickle cell anemia;
• diabetes;
• an active infection;
• a weak immune system (caused by disease or by using certain medicine);
• an autoimmune disorder such as rheumatoid arthritis, lupus, or psoriasis;
• pheochromocytoma (tumor of the adrenal gland);
• multiple myeloma (bone cancer); or
• thyroid disorder, including cancer.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether iodixanol passes into breast milk or if it could affect the nursing baby. You should not breast-feed within 10 hours after receiving iodixanol. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

Use Visipaque Rediflo Cartridge (Injectable) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• swelling, rapid weight gain, little or no urinating;
• wheezing or trouble breathing;
• a seizure (convulsions);
• thyroid symptoms--extreme tired feeling, dry skin, joint pain or stiffness, muscle pain or weakness, hoarse voice, feeling more sensitive to cold temperatures, weight gain;
• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance; or
• signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood.

Common side effects may include:

• pain or warm feeling when the medicine is injected;
• dizziness, spinning sensation;
• numbness or tingly feeling;
• vision changes;
• sleep problems (insomnia);
• headache, migraine;
• chest pain;
• nausea, vomiting, diarrhea;
• agitation, anxiety, nervousness;
• skin rash, itching; or
• changes in your sense of taste or smell.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Do not allow yourself to become dehydrated during the first few days after receiving iodixanol. Call your doctor if you have any vomiting or diarrhea during this time. Follow your doctor's instructions about the types and amount of fluids you should drink.