Pronunciation:

eye-oh-THAL-a-mate MEG-loo-meen

Brand Names:

• CONRAY
• CONRAY-30
• CONRAY-43
• CYSTO-CONRAY

Dosage Forms:

• Solution

Warnings:

Not for intrathecal use

Classifications:

Therapeutic—

Radiological Ionic Contrast Media

Uses of This Medicine:

Iothalamate meglumine injection is used to help diagnose or find problems in the brain, back, heart, head, blood vessels, stomach, joints, pancreas, bladder, 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).

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 iothalamate meglumine in children. Some children may have more unwanted side effects which may require caution in patients receiving iothalamate meglumine.

Older adults—

No information is available on the relationship of age to the effects of iothalamate meglumine injection in geriatric patients.

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 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.

• Heart or blood vessel disease or
• Hypertension (high blood pressure) or
• Hyperthyroidism (overactive thyroid) or
• Kidney disease, severe or
• Liver disease or
• Pheochromocytoma (adrenal problem) 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 problem.

• Congestive heart failure or
• Dehydration or
• Diabetes or
• Kidney disease or
• Multiple myeloma (cancer of plasma cells)—May increase risk of having kidney failure.

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 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. 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.

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 iothalamate meglumine injection. 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. You should not receive iohexol injection together with a steroid medicine into your spinal cord.

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:

More 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

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

chest pain or tightness

cough

coughing that sometimes produces a pink frothy sputum

feeling of warmth

increased sweating

noisy breathing

not breathing

pale skin

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

swelling in the legs and ankles

trouble breathing

Rare

Changes in skin color, pain, tenderness, or swelling of the foot or leg

chest discomfort

dizziness

fainting

fast, slow, or irregular heartbeat

lightheadedness

pounding or rapid pulse

stopping of the heart

unconsciousness

Incidence not known

Black, tarry stools

blistering, peeling, or loosening of the skin

blue-green to black skin discoloration

bruising

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

chills

collection of blood under the skin

constipation

deep, dark purple bruise

depressed mood

diarrhea

dry mouth

dry skin and hair

feeling cold

hair loss

hoarseness or husky voice

itching

joint or muscle pain

large, flat, blue or purplish patches in the skin

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

muscle cramps and stiffness

nervousness

painful or difficult urination

partial or slight paralysis

problems with speech or speaking

red irritated eyes

red skin lesions, often with a purple center

seizures

sensitivity to heat

sneezing

sore throat

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

sweating

swollen glands

trouble sleeping

unusual bleeding or bruising

unusual tiredness or weakness

weight gain

weight loss

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.