CONRAY (Injection)

Iothalamate meglumine injection is used to help diagnose or identify issues in the brain, back, heart, head, blood vessels, stomach, joints, pancreas, bladder, and other areas of the body. It is an iodinated contrast agent. Contrast agents are used to produce a clear image of different parts of the body during specific medical procedures (for example, CT scans).

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

It is very important for your doctor to monitor your or your child's progress closely while receiving this medicine to ensure it is working correctly and to decide if you should keep receiving it. Blood and urine tests may be needed to check for any unwanted effects.

This medicine may lead to heart attack, stroke, and blood clotting issues. Inform your doctor immediately if you or your child experiences chest pain that may spread to the arms, jaw, back, or neck, difficulty breathing, nausea, unusual sweating, faintness, coughing up blood, numbness or weakness in an arm or leg, or on one side of the body, sudden or severe headache, or problems with vision, speech, or walking after receiving this medicine.

Contact your doctor right away if you have bloody urine, a decrease in how often or how much urine you produce, an increase in blood pressure, increased thirst, loss of appetite, pain in the lower back or side, nausea, swelling in the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could indicate a serious kidney issue.

This medicine may cause hypothyroidism (underactive thyroid) in children 3 years old and younger. Notify your doctor immediately if your child shows signs of 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. Contact your doctor right away if you experience 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.

Inform your doctor immediately if you or your child has mild burning pain, a feeling of warmth or coldness, peeling skin, redness, or swelling at the injection site.

While using this medicine, you may be exposed to radiation. Discuss any concerns about this with your doctor.

Ensure that any doctor or dentist treating you is aware that you are using iothalamate meglumine injection. This medicine may influence the results of certain medical tests.

Do not take other medicines unless you have talked about them 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.

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.

Pediatric

Appropriate studies performed to date have not shown any specific problems in children that would limit the usefulness of iothalamate meglumine. Some children may have more unwanted side effects which may require caution when using iothalamate meglumine.

Geriatric

No information is available on how age affects the effects of iothalamate meglumine injection in older patients.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been chosen based on 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

Interactions with Food/Tobacco/Alcohol

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

Other Medical Problems

Having 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
• Severe kidney disease 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 due to the increased risk of blood clotting problems.

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

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.

In the U.S.

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

Available Dosage Forms:

• Solution

Therapeutic Class: Radiological 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 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.