Iopromide (Injection)

Iopromide (Injection) is used to help diagnose or find problems in the brain, breast, heart, head, blood vessels, stomach, 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 used only by or under the direct supervision of a doctor.

It is very important for your doctor to monitor you or your child's progress closely while receiving this medicine. They will check if the medicine is working properly and decide if you should continue to receive it. You may need blood and urine tests to look for any unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have chest tightness, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness after receiving this medicine.

Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis can occur with this medicine. Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

This medicine may cause heart attack, stroke, and blood clotting problems. 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.

This medicine may cause hypothyroidism (underactive thyroid) in children 3 years of age and younger. Children with congenital (from birth) heart problems may have an increased risk of hypothyroidism. Check with your doctor right away if your child has depressed mood, dry skin and hair, feeling cold, hair loss, hoarseness or a husky voice, muscle cramps and stiffness, slowed heartbeat, weight gain, or unusual tiredness or weakness.

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

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 treating you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

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

In deciding to use a medicine, you and your doctor must consider the risks of taking the medicine against the benefits it will provide. The following factors should be taken into account for this medicine:

Allergies

Inform your doctor if you have ever experienced any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

So far, studies have not shown any specific problems in children that would limit the effectiveness of iopromide injection. However, safety and effectiveness have not been confirmed in children aged 2 years and younger.

Geriatric

Studies have not identified any specific problems in elderly patients that would limit the effectiveness of iopromide injection. However, older patients are more likely to have kidney issues, which may require careful monitoring and possible dose adjustments for those receiving iopromide injection.

Breast Feeding

There are no sufficient studies to determine the risk to infants when this medication is used during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others may be used together even if interactions might happen. In such cases, your doctor may adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while receiving this medicine. The following interactions have been selected due to their potential significance and are not necessarily a complete list.

Using this medicine with any of the following medicines is generally not recommended, but may be necessary in some instances. If both medicines are prescribed together, your doctor may adjust the dose or frequency for one or both medicines.

• Levothyroxine
• Liothyronine
• Metformin

Using this medicine with any of the following medicines may increase the 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 adjust the dose or frequency for one or both medicines.

• Iocetamic Acid
• Iopanoic Acid
• Ipodate
• Tyropanoate Sodium

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around mealtime or with certain foods due to possible interactions. Drinking alcohol or using tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Allergy to a contrast agent, history of or
• Asthma—Use with caution. May increase the risk of 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 disease (inherited blood disorder)—Use with caution. May worsen these conditions.

• 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 the risk of kidney failure.

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

• Homocystinuria (genetic disease)—Patients with this condition should avoid angiography due to an increased risk of blood clotting problems.

• Kidney issues—Use with caution. The effects may be heightened due to slower removal of the medicine from the body.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, they may need medical attention.

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

Less common

• 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

Rare

• Bloating or swelling of the face, arms, hands, lower legs, or feet
• Bluish lips or skin
• Chest discomfort or tightness
• Cough
• Decreased frequency or amount of urination
• Difficult or painful urination
• Excessive thirst
• Fever or chills
• Irregular heartbeat
• Nausea or vomiting
• Pain or discomfort in the arms, jaw, back, or neck
• Pale skin at injection site
• Seizures
• Tingling of the hands or feet
• Trouble breathing
• Unusual tiredness or weakness
• Unusual weight gain or loss

Incidence not known

• Black, tarry stools
• Blistering, peeling, or loosening of the skin
• Bloody urine
• Blue lips and fingernails
• Coughing that sometimes produces a pink frothy sputum
• Diarrhea
• Difficulty with swallowing or sore throat
• Dilated neck veins
• 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
• Swollen glands
• Trouble sleeping
• Unusual bleeding or bruising

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, are bothersome, or if you have any questions about them:

Less common

• Change in taste
• Changes in vision
• Loss of taste

Rare

• 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
• Stomach discomfort or pain
• Tender, swollen glands in the neck
• Voice changes

Incidence not known

• 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.

In the U.S.

• Ultravist

Available Dosage Forms:

• Solution

Therapeutic Class: Radiological Non-Ionic Contrast Media

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.