CONRAY-43 (Injection)

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 (for example, CT scans).

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

It is very important that your doctor checks your or your child's progress closely while receiving this medicine to see if it 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.

In deciding to use a medicine, you need to think about the risks of taking it compared to the benefits it can provide. This is a choice you will make with your doctor. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction 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

Studies have not shown any specific problems in children that would limit the usefulness of iothalamate meglumine. However, some children may experience more unwanted side effects, so caution may be needed for patients receiving iothalamate meglumine.

Geriatric

There is no information available about 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 during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together. 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 receiving this medicine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are significant and may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor might choose 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 taken around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Allergy to a contrast agent, history of or
• Asthma—Use with caution. May increase the risk of 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 worsen these conditions.

• Homocystinuria (genetic disease)—Patients with this condition should avoid angiography due to an 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 the risk of kidney failure.

Along with its intended effects, CONRAY-43 (Injection) may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor or nurse right away if any of the following side effects happen:

More common

• Bleeding, blistering, burning, coldness, skin discoloration, 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 sometimes 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.