Iopromide Injection

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© Ultravist Patient Information is supplied by Cerner Multum, Inc. and Ultravist Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Iopromide 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.

iopromide is to be used only by or under the direct supervision of a doctor.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For iopromide, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to iopromide or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of iopromide injection in children. However, safety and efficacy have not been established in children 2 years of age and younger.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of iopromide injection in the elderly. However, elderly patients are more likely to have kidney problems, which may require caution and an adjustment in the dose for patients receiving iopromide injection.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving iopromide, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using iopromide with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Metformin

Using iopromide with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Iocetamic Acid
• Iopanoic Acid
• Ipodate
• Tyropanoate Sodium

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of iopromide. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergic rhinitis (hay fever) or
• Allergy to a contrast agent, or history of or
• Allergy to food or
• Allergy to iodine or
• Asthma—Use with caution. May increase risk of having allergic reactions.

• Blood clotting problems (e.g., phlebitis, thrombosis) or
• Heart or blood vessel disease or
• Hyperthyroidism (overactive thyroid) or
• Pheochromocytoma (adrenal problem) or
• Sickle cell anemia (inherited blood disorder)—Use with caution. May make these conditions worse.

• Blood vessel disease, severe or
• Congestive heart failure or
• Dehydration or
• Diabetes or
• Kidney disease or
• Multiple myeloma (cancer of plasma cells) or
• Paraproteinemia (high amount of paraprotein in the blood)—May increase risk of having kidney failure.

• Dehydration (caused by prolonged fasting or use of laxatives)—Should not be given in pediatric patients with this condition.

• Homocystinuria (genetic disease)—Patients with this condition should avoid undergoing angiography because of the increase risk of having blood clotting problems.

• Kidney problems—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

A doctor or other trained health professional will give you or your child iopromide in a hospital. iopromide 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 iopromide. This may help prevent kidney problems.

Along with its needed effects, a medicine 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:

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• chest pain
• feeling faint, dizzy, or lightheadedness
• feeling of warmth or heat
• flushing or redness of the skin, especially on the face and neck
• frequent strong or increased urge to urinate
• headache
• sweating

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• bluish lips or skin
• chest discomfort or tightness
• convulsions
• cough
• decreased frequency or amount of urination
• difficult or painful urination
• difficulty breathing
• excessive thirst
• fever or chills
• nausea or vomiting
• noisy breathing
• pain or discomfort in the arms, jaw, back, or neck
• pale skin at injection site
• irregular heartbeat
• tingling of the hands or feet
• unusual tiredness or weakness
• unusual weight gain or loss

• Blistering, peeling, or loosening of the skin
• bloody urine
• blue lips and fingernails
• coughing that sometimes produces a pink frothy sputum
• diarrhea
• difficult, fast, noisy breathing, sometimes with wheezing
• difficulty with swallowing or sore throat
• dilated neck veins
• extreme fatigue
• irregular breathing
• joint or muscle pain
• loss of appetite
• lower back or side pain
• nervousness
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• red, irritated eyes
• red skin lesions, often with a purple center
• sensitivity to heat
• skin rash, hives, or itching
• sores, ulcers, or white spots in the mouth or on the lips
• swelling of the face, fingers, feet, or lower legs
• trouble sleeping

Some side effects 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:

• Change in taste
• changes in vision
• loss of taste

• Abdominal or stomach discomfort or pain
• acid or sour stomach
• agitation
• belching or passing of gas
• body aches or pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• difficulty with moving
• dry mouth
• excessive muscle tone
• general feeling of discomfort or illness
• lack of coordination
• loss of strength or energy
• muscle tension or tightness
• sleepiness or unusual drowsiness
• tender, swollen glands in the neck
• voice changes

• Bigger, dilated, or enlarged pupils (black part of the eye)
• burning, dry, or itching eyes
• continuing ringing or buzzing or other unexplained noise in the ears
• discharge, excessive tearing
• feeling of constant movement of self or surroundings
• headache, severe and throbbing
• hearing loss
• increased sensitivity of the eyes to light
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• sensation of spinning

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Consult your pharmacist.

How to use Iopromide Solution

Consult your pharmacist.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Missed Dose

Consult your pharmacist.

Storage

Consult your pharmacist.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.

There are no data on the excretion of iopromide into human milk. However, many injectable contrast agents are excreted unchanged in human milk. Although it has not been established that serious adverse reactions occur in nursing infants, caution should be exercised when intravascular contrast agents are administered to nursing women because of potential adverse reaction, and consideration should be given to temporarily discontinuing nursing.