Pronunciation:

eye-oh-MEP-rol

Brand Names:

• Iomervu

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Radiological Non-Ionic Contrast Media

Uses of This Medicine:

Iomeprol injection is used to help diagnose or find problems in the brain, heart, head, blood vessels, bladder, kidneys, 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 (eg, CT scans, angiography).

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

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of iomeprol injection in children. Some pediatric patients with certain medical conditions (eg, asthma, heart failure, or kidney problems) may have more unwanted side effects which may require caution in patients receiving this medicine.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of iomeprol injection in the elderly. However, elderly patients are more likely to have unwanted side effects (eg, kidney problems) which may require caution and an adjustment in the dose for patients receiving this medicine.

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.

Other 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 this medicine, 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 this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Levothyroxine
• Liothyronine
• Metformin

Other interactions—

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol use disorder or
• Heart failure or
• Heart or blood vessel disease or
• Hypertension (high blood pressure) or
• Hyperthyroidism (overactive thyroid) or
• Liver disease or
• Pheochromocytoma (adrenal problem) or
• Sickle cell anemia (inherited blood disorder)—Use with caution. May make these conditions worse.

• Allergy to a contrast agent, history of or
• Asthma—Use with caution. May increase risk of having allergic reactions.

• 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.

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

Proper Use of This Medicine:

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.

Your doctor may also give you medicines (eg, allergy medicine, steroids) to help prevent allergic reactions.

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

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for 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 you receive this medicine.

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.

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.

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.

Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) 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.

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

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

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.

Side Effects of This Medicine:

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:

Rare

Agitation

bloating or swelling of the face, arms, hands, lower legs, or feet

blue lips and fingernails

blurred vision

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

burning sensation

changes in patterns and rhythms of speech

chest pain or tightness

coma

confusion

coughing that sometimes produces a pink frothy sputum

decrease or change in vision

decreased urine output

depression

dilated neck veins

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

enlarged pupils

fainting

fast, slow, or irregular heartbeat

fear, nervousness

feeling of warmth

frequent strong or increased urge to urinate

hallucinations

headache

holding false beliefs that cannot be changed by fact

hostility

increased sensitivity of the eyes to light

increased sweating, possibly with fever or cold, clammy skin

irritability

lethargy

muscle twitching

nausea

no breathing

pale skin

redness of the face, neck, arms and occasionally, upper chest

seizures

stiff or sore neck

sudden loss of coordination

sudden slurring of speech

swelling of the face, fingers, feet, or lower legs

tingling of the hands or feet

trouble breathing

trouble speaking

trouble sleeping

unusual excitement, nervousness, or restlessness

unusual tiredness or weakness

unusual weight gain or loss

Incidence not known

Back pain

black, tarry stools

bleeding, blistering, burning, coldness, discoloration of 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

bleeding gums

blistering, peeling, or loosening of the skin

blood in the urine or stools

bluish color of the fingernails, lips, skin, palms, or nail beds

change or loss of consciousness

chest discomfort

chills

constipation

cough

diarrhea

difficulty swallowing

drowsiness

dry skin and hair

feeling cold

fever

general feeling of illness

hair loss

hives, itching, skin rash

hoarseness or husky voice

joint or muscle pain

loss of memory

mood or mental changes

muscle cramps and stiffness

pain or discomfort in the arms, jaw, back, or neck

painful or difficult urination

pinpoint red spots on the skin

problems with memory

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

red irritated eyes

red skin lesion, often with a purple center

sensitivity to heat

sore throat

sores, ulcers, or white spots in the mouth or on the lips

stiff neck

stomach pain

swollen glands

trouble healing

trouble speaking, thinking, or walking

unusual bleeding or bruising

voice changes

vomiting

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:

Less common

Feeling hot

Rare

Difficulty moving

dry mouth

feeling of constant movement of self or surroundings

jaw pain

muscle pain

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.