CONRAY-30 (Injection)

Iothalamate meglumine injection is used to help diagnose or locate 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 provide a clear image of different parts of the body during specific medical procedures (e.g., 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 you or your child's progress closely while receiving this medicine to see if it is working correctly and to determine if you should keep receiving it. Blood and urine tests may be necessary to check for any unwanted effects.

This medicine may lead to heart attack, stroke, and blood clotting issues. Tell your doctor immediately if you or your child experiences chest pain that may spread to the arms, jaw, back, or neck, trouble breathing, nausea, unusual sweating, faintness, coughing up blood, numbness or weakness in the 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, increased blood pressure, increased thirst, loss of appetite, pain in the lower back or side, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be signs of a serious kidney issue.

This medicine may cause hypothyroidism (underactive thyroid) in children aged 3 years and younger. Check with your doctor immediately if your child displays a depressed mood, dry skin and hair, feeling cold, hair loss, a hoarse or 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 happen with this medicine. Check with your doctor right away if you have black or 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 experiences mild burning pain, a 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. Discuss any concerns about this with your doctor.

Make sure any doctor or dentist treating 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 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 in your spinal cord.

In deciding to use a medicine, you and your doctor must consider the risks of taking the medicine against the benefits it will provide. For this medicine, here are some important points to think about:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your healthcare professional if you have other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies so far have not shown any specific problems that would limit the use of iothalamate meglumine in children. However, some children may experience more unwanted side effects, so caution may be needed when giving iothalamate meglumine to patients in this age group.

Geriatric

There is no information available about how age affects the use 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. You should weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other situations, two different medicines may be prescribed together even if an interaction might happen. In these cases, your doctor may adjust the dose or take other precautions. When you receive this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are highlighted for their potential significance and may not include all possibilities.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or change some of the other medicines you take.

• Metformin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtime or with certain types of food due to possible interactions. Consuming alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional how to take your medicine in relation to food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to inform 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
• Kidney disease, severe 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 necessary effects, a medicine can cause some unwanted effects. Not all of these side effects will happen, but if they do, they may require medical attention.

Check with your doctor or nurse right away if any of these side effects occur:

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 can 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.