Oraltag (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 produce a clear image of the different parts of the body during specific medical procedures.

This medicine should only be administered by or under the supervision of your doctor.

Your doctor will keep a close watch on you or your child's progress while you are taking this medicine. This will help your doctor see if the medicine is working well and decide if you or your child should keep receiving it.

This medicine may cause heart attack, stroke, and blood clotting issues. Tell your doctor immediately if you or your child experiences chest pain that could spread to the arms, jaw, back, or neck, trouble breathing, nausea, unusual sweating, fainting, 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 taking this medicine.

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

This medicine may cause hypothyroidism (underactive thyroid) in children 3 years old and younger. Children with congenital (from birth) heart issues may have a higher risk of hypothyroidism. Contact your doctor right away if your child has a low mood, dry skin and hair, feels cold, experiences hair loss, has a hoarse voice, muscle cramps and stiffness, a slow heartbeat, weight gain, or unusual tiredness or weakness.

Contact your doctor immediately if you have bloody urine, less frequent or less urine, higher 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.

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. Contact your doctor right away if you have black, tarry stools, blistering, peeling, or loosening 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.

Make sure any doctor or dentist treating you knows that you are using iohexol. This medicine may change the results of certain medical tests.

While using this medicine, you may be exposed to radiation. Talk to your doctor if you have any concerns about this.

Do not take any other medicines unless your doctor has discussed them with you. 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 need to consider the risks of the test compared to the benefits it may provide. Other factors may also influence the test results. For this test, keep the following in mind:

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 types of allergies, such as to foods, dyes, preservatives, or animals. When using non-prescription products, check the label or package ingredients closely.

Pediatric

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

Geriatric

Studies so far have not shown any specific problems in the elderly that would limit the usefulness of iohexol. However, older patients are more likely to experience unwanted side effects (e.g., liver, kidney, or heart issues) which may require caution and a dose adjustment for those taking iohexol.

Breast Feeding

Research in women indicates that this medication presents 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 an interaction may happen. In these cases, your doctor may adjust the dose, or other precautions may be necessary. It is particularly important for your healthcare professional to know if you are taking any of the medicines listed below when you are having this diagnostic test. The following interactions have been chosen based on their potential significance and are not necessarily a complete list.

Receiving this diagnostic test with any of the following medicines is usually not recommended, but may be necessary in some situations. If both medicines are prescribed together, your doctor may modify the dose or frequency of use for 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 the time of eating food or specific types of food due to potential interactions. 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

Other medical issues may affect the use of this diagnostic test. Be sure to inform your doctor if you have any additional medical problems, 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.

• History of allergy to a contrast agent or
• Asthma—Use with caution. May raise 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 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:

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. 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 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.