Omnipaque 12 (Oral)

Iohexol is used to help identify issues in the bowels during a CT scan of the stomach, bowels, and pelvis. 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.

This medicine should only be given by your doctor or under their supervision.

Your doctor will closely monitor you or your child's progress while receiving this medicine. This helps your doctor determine if the medicine is effective and if treatment should continue.

This medicine may lead to heart attack, stroke, and blood clotting issues. Notify 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 one side of the body, sudden or severe headache, or issues with vision, speech, or walking after the treatment.

This medicine can cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical care. Tell your doctor right away if you have chest tightness, cough, trouble swallowing, dizziness, fast 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.

This medicine may lead to hypothyroidism (underactive thyroid) in children aged 3 years and younger. Children with congenital (from birth) heart conditions may be at higher risk for hypothyroidism. Contact your doctor immediately if your child has a depressed mood, dry skin and hair, feels cold, experiences hair loss, has a hoarse voice, muscle cramps and stiffness, a slowed heartbeat, weight gain, or unusual tiredness or weakness.

Contact your doctor right away if you have bloody urine, a decrease in urine frequency or amount, 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 indicate a serious kidney issue.

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 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 that any doctor or dentist treating you is aware that you are using iohexol. This medicine may affect the results of specific medical tests.

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

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.

In deciding to use a diagnostic test, you and your doctor will weigh the risks of the test against its benefits. Other factors may also influence test results. For this test, consider the following:

Allergies

Inform your doctor if you have had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know about any other allergies, including foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Studies conducted so far have not shown any pediatric-specific problems that would limit the usefulness of iohexol in children.

Geriatric

Studies conducted so far have not shown any geriatric-specific problems that would limit the usefulness of iohexol in older adults. However, older patients are more likely to experience unwanted side effects (such as liver, kidney, or heart issues), which may require caution and dose adjustments for those receiving iohexol.

Breast Feeding

Research in women suggests that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may 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 for your healthcare professional to know if you are taking any of the medicines listed below while receiving this diagnostic test. The following interactions are notable and are not necessarily all-inclusive.

Using this diagnostic test 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 around meal times or with specific types of food due to possible interactions. Drinking alcohol or using tobacco with certain medicines can also lead to interactions. Talk to your healthcare professional about taking your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical conditions may affect the use of this diagnostic test. 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
• 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.

• 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.

Along with its necessary effects, this medicine may 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 immediately if any of the following side effects occur:

Less common

• Blurred vision
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• unusual tiredness or weakness

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
• 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. Your health care professional may also provide ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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 12
• Omnipaque 9
• Oraltag

Available Dosage Forms:

• Solution

Therapeutic Class: Radiological Non-Ionic Contrast Media

A doctor or other trained health professional will give you or your child this medicine in a hospital. It is given by mouth. You will swallow the prepared oral liquid just before a CT scan.

Protect the prepared oral liquid from light and direct exposure to sunlight.

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 before and after taking this medicine. This may help prevent kidney problems.