Omnipaque 140 (Injection, Intrathecal, Intravenous)

Iohexol injection is used to help diagnose or find issues in the brain, back, heart, head, blood vessels, stomach, joints, pancreas, bladder, reproductive tract, and other areas of the body. It is an iodinated contrast agent. Contrast agents are used to provide a clear image of the various parts of the body during specific medical procedures (e.g., CT scans).

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

It is very important for your doctor to monitor your progress closely while you are receiving this medicine. This will help your doctor determine if the medicine is working correctly and whether you should continue receiving it.

You should not receive this medicine for a procedure called hysterosalpingography (a type of imaging of the reproductive tract) if you are pregnant or think you may be pregnant, if you are close to or have your menstrual period, if you had an abortion in the last 6 months, or if you had surgery or another procedure in your reproductive tract in the last 30 days.

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, 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 issues with vision, speech, or walking after receiving this medicine.

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

This medicine may cause hypothyroidism (an underactive thyroid) in children aged 3 years and younger. Children with congenital (from birth) heart conditions may have a higher risk of hypothyroidism. Contact your doctor right away if your child shows signs of a depressed mood, dry skin and hair, feeling cold, hair loss, hoarseness or a husky voice, muscle cramps and stiffness, a slowed heartbeat, weight gain, or unusual tiredness or weakness.

This medicine may lead to serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical help. Inform your doctor right away if you experience chest tightness, cough, difficulty swallowing, dizziness, rapid heartbeat, hives, itching, skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness after receiving this medicine.

Serious skin reactions, such as 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.

Ensure your doctor is aware if you have had an allergic reaction to any dye or medicine used during a test or procedure.

Inform your doctor immediately if you or your child has mild, burning pain, a feeling of warmth or coldness, skin peeling, 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 iohexol injection. This medicine may influence the results of certain medical tests.

Do not take other medicines unless you have discussed 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, it is important to balance the risks of taking the medicine against the benefits it may provide. This is a decision 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 reactions 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, read the label or package ingredients carefully.

Pediatric

Studies done so far have not shown any specific problems in children that would limit the use of iohexol injection. However, some pediatric patients with certain medical conditions (such as asthma, heart failure, or kidney problems) may experience more side effects, which may require careful monitoring when using this medicine.

Geriatric

Research has not shown any specific problems in elderly patients that would limit the use of iohexol injection. However, older adults are more likely to experience side effects (such as liver, kidney, or heart problems), which may need careful monitoring and possible dose adjustments when using this medicine.

Breast Feeding

Studies suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others can be used together even if there is a chance of interaction. In these cases, your doctor may adjust the dose or take other precautions. It is especially important that your healthcare professional knows if you are taking any of the medicines listed below when you are receiving this medicine. The following interactions have been chosen based on their potential significance and may not include all possible interactions.

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

• Metformin

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Acebutolol
• Amiodarone
• Atenolol
• Betaxolol
• Bisoprolol
• Carteolol
• Carvedilol
• Celiprolol
• Esmolol
• Labetalol
• Levobunolol
• Metipranolol
• Metoprolol
• Nadolol
• Nebivolol
• Oxprenolol
• Penbutolol
• Pindolol
• Practolol
• Propranolol
• Sotalol
• Timolol

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around mealtime, or with certain foods, as interactions may happen. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Alcohol abuse or
• 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
• Pulmonary hypertension or
• Sickle cell anemia (inherited blood disorder)—Use with caution. May worsen these conditions.

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

• Cancer in the reproductive tract or
• Infection in the genital area—Should not be used for hysterosalpingography in patients with these conditions.

• Congestive heart failure or
• Dehydration or
• Diabetes or
• Kidney disease or
• Multiple myeloma (cancer of plasma cells) or
• Paraproteinemia (high amount of paraprotein in the blood)—May increase the risk of kidney failure.

• Homocystinuria (genetic disease)—Patients with this condition should avoid angiography due to the increased risk of blood clotting problems.

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

• Arm, back, or jaw pain
• Chest pain, discomfort, tightness, or heaviness
• Difficulty breathing
• Fainting
• Fast, slow, or irregular heartbeat
• Nausea
• Pain or discomfort in the arms, jaw, back, or neck
• Sweating
• Swelling in the throat

Less common

• Blurred vision
• Dizziness
• Fast, pounding, or irregular heartbeat or pulse
• Temporary vision loss
• Vomiting

Rare

• Confusion
• Dilated neck veins
• Dizziness or lightheadedness
• Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• Extreme tiredness or weakness
• Feeling cold
• Feeling of constant movement of self or surroundings
• Fever
• Irregular breathing
• Pale skin
• Seizures
• Sensation of spinning
• Swelling of the face, fingers, feet, or lower legs
• Trouble breathing
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Weight gain

Incidence not known

• Agitation
• Black, tarry stools
• Blistering, peeling, or loosening of the skin
• Bloating
• Bluish color of the fingernails, lips, skin, palms, or nail beds
• Changes in skin color, pain, tenderness, or swelling of the foot or leg
• Chills
• Constipation
• Cough
• Darkened urine
• Decreased urine output
• Depressed mood
• Diarrhea
• Difficulty swallowing
• Discouragement
• Drowsiness
• Dry skin and hair
• Feeling sad or empty
• Hair loss
• Headache
• Hoarseness or husky voice
• Hives, itching, skin rash
• Indigestion
• Irritability
• Joint or muscle pain
• Lack of appetite
• Large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• Loss of consciousness
• Loss of interest or pleasure
• Lower back or side pain
• Mood or mental changes
• Muscle twitching, cramps, and stiffness
• Nervousness
• Pale skin, pain, redness, or swelling at the injection site
• Painful or difficult urination
• Pains in the stomach, side, or abdomen, possibly radiating to the back
• Puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• Rapid weight gain
• Red, irritated eyes
• Red skin lesions, often with a purple center
• Seeing, hearing, or feeling things that are not there
• Sensitivity to heat
• Slowed heartbeat
• Sore throat
• Sores, ulcers, or white spots in the mouth or on the lips
• Stiff neck
• Swollen glands
• Throat irritation or tightness
• Trouble concentrating
• Trouble sleeping
• Unusual drowsiness, dullness, or feeling of sluggishness
• Weight loss
• Yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Bad, unusual, or unpleasant (after) taste
• Change in taste

Rare

• Anxiety
• Belching
• Cold sweats
• Dry mouth
• Heartburn
• Increased hunger
• Indigestion
• Nightmares
• Redness of the skin
• Shakiness
• Sleepiness or unusual drowsiness
• Slurred speech
• Sneezing
• Stomach discomfort, upset, or pain
• Stuffy or runny nose
• Uncontrolled eye movements

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.

• Omnipaque 140
• Omnipaque 180
• Omnipaque 240
• Omnipaque 300
• Omnipaque 350
• Omnipaque Flexipak

Available Dosage Forms:

• Solution

Therapeutic Class: Radiological Non-Ionic Contrast Media

A doctor or other trained health professional will give you this medicine in a hospital. It is given through a needle placed into a vein, into your back, into a joint, or other parts of your body.

Your doctor may also give you medicines (eg, allergy medicine, steroids) to help prevent allergic reactions.

Drink extra fluids so you will pass more urine while you are receiving this medicine. This may help prevent kidney problems.