Optiray 350 is a radiopaque contrast agent. This medicine contains iodine, a substance that absorbs x-rays. 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.

Optiray 350 is used to help diagnose certain disorders of the heart, brain, and blood vessels.

Optiray 350 may also be used for purposes not listed in this medication guide.

You should not be treated with Optiray 350 if you have symptoms of an overactive thyroid. Tell your doctor if you have ever had any type of reaction to another contrast agent.

Optiray 350 is given as an infusion into a vein or artery. A healthcare provider will give you this injection.

Drink extra fluids before and after your radiologic test. Optiray 350 can cause you to get dehydrated, which can lead to dangerous effects on your kidneys. Follow your doctor's instructions about the types and amount of fluids you should drink before and after your test.

Older adults may need special care to avoid becoming dehydrated. Your kidney function may need to be checked after you have received Optiray 350.

Children younger than 3 years may need to have their thyroid function checked after exposure to Optiray 350. Talk with your doctor if you have any questions.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when Optiray 350 is injected.

Some people receiving Optiray 350 have had delayed reactions 30 to 60 minutes after injection. Your caregivers will watch you during this time to make sure you do not have unwanted side effects or delayed reactions.

Optiray 350 can cause unusual results with certain medical tests for up to 16 days after you receive Optiray 350. For up to 8 weeks after you receive this medicine, your body may not respond as well as usual to radioactive iodine thyroid treatment. Tell any doctor who treats you that you have recently received this medicine.

You should not be treated with Optiray 350 if you are allergic to it, or if you have:

• symptoms of an overactive thyroid.

Tell your doctor if you have ever had:

• any type of reaction to another contrast agent

• liver or kidney disease;

• a stroke, blood clot, or coronary artery disease (hardened arteries);

• a seizure;

• heart disease, high blood pressure, congestive heart failure;

• diabetes;

• homocystinuria;

• sickle cell anemia;

• asthma, hay fever, food allergies;

• multiple myeloma (bone cancer);

• pheochromocytoma (tumor of the adrenal gland);

• a thyroid disorder; or

• if you are dehydrated.

Tell your doctor if you are pregnant.

You should not breastfeed within 8 hours after receiving Optiray 350. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

Since Optiray 350 is used only during your radiologic test, you will not be on a dosing schedule.

Since Optiray 350 is given by a healthcare professional in a medical setting, an overdose is unlikely to occur. You will be watched closely for any signs of an overdose.

Do not allow yourself to become dehydrated during the first few days after receiving Optiray 350. 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.

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.

Some of the side effects of ioversol can occur up to 24 hours after you receive the medication.

Tell your caregivers or call your doctor at once if you have:

• trouble breathing;

• a light-headed feeling, like you might pass out;

• slow heartbeats;

• unexplained muscle pain, tenderness, or weakness;

• a skin rash;

• pain, bleeding, or skin changes where the injection was given;

• sudden numbness or weakness (especially on one side of the body), problems with vision or speech;

• chest pain or pressure, pain spreading to your jaw or shoulder; or

• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath.

Side effects may be more likely in older adults.

Common side effect may include nausea.

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.

Tell your doctor about all your current medicines, especially:

• diabetes medicine that contains metformin.

This list is not complete. Other drugs may affect Optiray 350, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.