Isovue-M 300

It is very important that your doctor check the progress of you or your child closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

This medicine may cause heart attack, stroke, and blood clotting problems during angiographic procedures. Tell your doctor right away if you or your child has chest pain that may spread to your arms, jaw, back, or neck, trouble breathing, nausea, unusual sweating, faintness, coughing up blood, numbness or weakness in your arm or leg, or on one side of your body, sudden or severe headache, or problems with vision, speech, or walking after receiving this medicine.

Severe kidney problems may occur after receiving this medicine. This is more likely to occur if you receive too much of this medicine. Tell your doctor right away if you or your child have the following symptoms after receiving the medicine: agitation, confusion, decreased urine output, dizziness, headache, muscle twitching, rapid weight gain, or swelling of the face, ankles, or hands.

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you or your child has a skin rash, itching, shortness of breath, sweating, swelling of the face, tongue, and throat, or tightness in the chest after you get the injection.

Tell your doctor right away if you or your child has mild, burning pain, feeling of warmth or coldness, peeling of the skin, redness, or swelling at the injection site.

Make sure your doctor knows if you or your child have had an allergic reaction to any dye or medicine given during a test or procedure.

While using this medicine, you may be exposed to radiation. Talk with your doctor if you have concerns about this.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

• It is used before an x-ray or an alike test.

All products:

• If you have an allergy to iopamidol or any other part of Isovue-M 300 (iopamidol).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are dehydrated, have been eating poorly, or have used a laxative or water pill before this medicine.
• If you have had a skin reaction to Isovue-M 300 or another drug like it in the past.
• If you are taking metformin, talk with doctor.

Injection (if given into the spine):

• If you have an infection.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Isovue-M 300 with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Very bad and sometimes deadly allergic reactions have rarely happened. Talk with your doctor.
• Blood clots have happened with Isovue-M 300 when used with some heart procedures. Sometimes, blood clots may cause heart attack and stroke, which may be deadly. Talk with the doctor.
• Thyroid problems have happened after use of this medicine. Some people had to be treated for these thyroid problems. Talk with the doctor.
• A very bad and sometimes deadly reaction has happened with Isovue-M 300. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. Talk with the doctor.
• If you have sickle cell disease, talk with your doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
• If you are 65 or older, use Isovue-M 300 with care. You could have more side effects.
• Use with care in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Isovue-M 300, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Isovue-M 300. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Isovue-M 300.

Review Date: October 4, 2017

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

To make sure iopamidol 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, hay fever, food allergies;

• epilepsy or other seizure disorder;

• sickle cell anemia;

• diabetes;

• an active infection;

• pheochromocytoma (tumor of the adrenal gland);

• multiple myeloma (bone cancer); or

• a thyroid disorder.

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

It is not known whether iopamidol passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Tell your doctor about all your current medicines, especially:

• metformin (Glucophage, Glucovance, Actoplus Met, PrandiMet, Avandamet, Kombiglyze, Janumet, Kazano, Invokamet, Jentadueto, Xigduo, Synjardy, Metaglip, and others).

This list is not complete. Other drugs may interact with iopamidol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.