Isovue-M 200

Iopamidol injection is used to help diagnose or find problems in the brain, heart, head, blood vessels, and other parts of the body. It is an iodinated contrast agent. Contrast agents are used to create a clear picture of the different parts of the body during certain medical procedures such as CT scans and angiography.

This medicine is to be given only by or under the supervision of a doctor.

This section provides information on the proper use of a number of products that contain iopamidol. It may not be specific to Isovue-M 200. Please read with care.

A doctor or other trained health professional will give you or your child this medicine in a hospital. This medicine is given through a needle placed in an artery or a vein.

Drink extra fluids so you will pass more urine while you or your child are receiving this medicine. This may help prevent kidney problems.

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.

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

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

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, iopamidol may cause a severe drug reaction that can affect many parts of the body. This type of reaction can start several weeks after you begin using this medicine. Seek medical treatment if you have new or worsening symptoms of fever, facial swelling, a red or blistering skin rash, flu symptoms, swollen glands, feeling weak or tired, severe tingling or numbness, upper stomach pain, loss of appetite, jaundice (yellowing of the skin or eyes), weight loss, pain or burning when you urinate, lower back pain, swelling in your legs or feet, cough, chest pain, or trouble breathing.

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;

• seizure (convulsions);

• swelling in your neck or throat (enlarged thyroid);

• 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;

• signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

• chest pain;

• slow heart rate;

• hot flashes, burning sensation;

• flushing (warmth, redness, or tingly feeling);

• nausea;

• hives; or

• dizziness.

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.

Applies to iopamidol: injection solution

Along with its needed effects, iopamidol (the active ingredient contained in Isovue-M-200) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking iopamidol:

• Arm, back, or jaw pain
• blurred vision
• chest pain or discomfort
• chest tightness or heaviness
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast or irregular heartbeat
• feeling of warmth
• hives
• lightheadedness, dizziness, or fainting
• nausea
• redness of the face, neck, arms, and occasionally, upper chest
• shortness of breath
• slow or irregular heartbeat
• sudden sweating
• unusual tiredness or weakness

• Blue lips and fingernails
• changes in skin color
• chills
• coughing that sometimes produces a pink frothy sputum
• decrease in the frequency of urination
• decrease in urine volume
• difficult, fast, noisy breathing, sometimes with wheezing
• difficulty in passing urine (dribbling)
• dizziness
• fainting
• fast, pounding, or irregular heartbeat or pulse
• fever
• headache
• hives or welts, itching, or skin rash
• increased sweating
• nervousness
• numbness or tingling in the face, arms, or legs
• pain or discomfort in the arms, jaw, back, or neck
• pain, tenderness, or swelling of the foot or leg
• painful urination
• pale skin
• pounding in the ears
• redness of the skin
• severe, unusual tiredness or weakness
• trouble speaking, thinking, or walking
• vomiting

• Double vision
• inability to move the arms, legs, or facial muscles
• pain in the chest, groin, or legs, especially the calves
• severe, sudden headache
• slow speech
• slurred speech
• sudden loss of coordination
• sudden, severe weakness or numbness in the arm or leg
• sudden, unexplained shortness of breath
• vision changes

• Change in consciousness
• heart stops
• loss of consciousness
• no breathing
• no pulse or blood pressure
• no sensation in the legs
• not able to pass urine
• pain, redness, or pale skin at the injection site
• seizures
• unable to move the legs

Some side effects of iopamidol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Bad, unusual, or unpleasant (after) taste
• change in taste
• discouragement
• disturbed color perception
• feeling sad or empty
• halos around lights
• irritability
• loss of appetite
• loss of interest or pleasure
• loss of vision
• night blindness
• overbright appearance of lights
• stuffy nose
• trouble concentrating
• trouble sleeping
• tunnel vision
• weight loss

• Abdominal or stomach cramps
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• burning, dry, or itching eyes
• discharge or excessive tearing
• general feeling of discomfort or illness
• loss of memory
• problems with memory
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• runny nose
• sneezing
• trembling or shaking of the hands or feet