Iothalamate meglumine (Injection)

Iothalamate meglumine (Injection) is used to help diagnose or find 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 the various parts of the body during certain medical procedures (for example, CT scans).

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

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

This medicine may cause heart attack, stroke, and blood clotting problems. Tell your doctor immediately if you or your child experiences 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 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 you urinate, increased 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 signs of a serious kidney issue.

This medicine may cause hypothyroidism (underactive thyroid) in children 3 years of age and younger. Contact your doctor immediately if your child has a 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 immediately 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, 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 with your doctor.

Make sure any doctor or dentist treating you is aware that you are using iothalamate meglumine (Injection). This medicine may affect the results of certain medical tests.

Do not take any other medicines unless you have talked with your doctor. This includes prescription or 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 and your doctor need to weigh the risks against the benefits. Here are some important things to consider for this medicine:

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 about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies so far 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, which may require caution when they receive iothalamate meglumine.

Geriatric

There is no available information on 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. 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 others may be used together even if an interaction could occur. In these cases, your doctor may want to adjust the dose or take other precautions. It is especially important that your healthcare professional knows if you are taking any of the following medicines when receiving this medicine. The following interactions have been selected for their potential significance and are not necessarily all-inclusive.

Using this medicine with the following medicine 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

Some medicines should not be used around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

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 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 a higher 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 needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, they may need medical attention.

Check with your doctor or nurse right away 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.