Pronunciation:

eye-oh-PAM-i-dol

Brand Names:

• Isovue-200
• Isovue-250
• Isovue-300
• Isovue-370
• Isovue-M 200
• Isovue-M 300

Dosage Forms:

• Solution

Warnings:

Not for intrathecal use

Classifications:

Therapeutic—

Radiological Non-Ionic Contrast Media

Uses of This Medicine:

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 (eg, CT scans and 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 iopamidol injection in children. Some children 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 on the relationship of age to the effects of iopamidol injection have not been performed in the geriatric population. However, no geriatric-specific problems have been documented to date.

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

• 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:

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

• Anuria (not able to pass urine) or
• Blood vessel disease, severe or
• Congestive heart failure or
• Dehydration or
• Diabetes or
• Diabetic nephropathy 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.

• Blood clotting problems (eg, phlebitis, thrombosis) or
• Heart or blood vessel disease (eg, arteriosclerosis) or
• Hyperthyroidism (overactive thyroid) or
• Kidney disease, severe or
• Liver disease or
• Myasthenia gravis or
• Pheochromocytoma (adrenal problem) or
• Pulmonary hypertension or
• Sickle cell anemia (inherited blood disorder)—Use with caution. May make these conditions worse.

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

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.

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

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

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress closely while you are receiving this medicine to see if the medicine is working properly and to decide if you should continue to receive it. Blood and urine tests may be needed to check for any unwanted effects.

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.

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 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 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.

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.

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.

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.

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:

Less common

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

slow or irregular heartbeat

sudden sweating

trouble breathing

unusual tiredness or weakness

Less common or rare

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

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

Rare

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

vision changes

Incidence not known

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

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

seizures

unable to move the legs

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 or rare

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

Incidence not known

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

stomach cramps

trembling or shaking of the hands or feet

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.