Omnipaque Flexipak (Injection, Intrathecal, Intravenous)

Iohexol injection is used to help diagnose or identify 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 different body parts 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 that your doctor closely monitors your progress while you are receiving this medicine. This allows your doctor to see if the medicine is working properly and to decide if you should keep receiving it.

You should not receive this medicine for a procedure called hysterosalpingography (reproductive tract imaging) if you are pregnant or think you may be pregnant, if you are near 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 cause heart attack, stroke, and blood clotting problems. Tell your doctor right away 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 problems with vision, speech, or walking after receiving this medicine.

Check with your doctor immediately if you have bloody urine, a decrease in how often you urinate or how much urine you produce, 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 problem.

This medicine may cause hypothyroidism (underactive thyroid) in children 3 years of age and younger. Children with congenital (from birth) heart problems may have a higher risk of hypothyroidism. Check with your doctor right away if your child shows signs of 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.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and need immediate medical attention. Tell your doctor right away if you experience chest tightness, cough, difficulty 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.

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 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.

Make sure your doctor knows if you have had an allergic reaction to any dye or medicine given during a test or procedure.

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. Talk with your doctor if you have concerns about this.

Make sure any doctor or dentist who treats you knows that you are using iohexol injection. This medicine may affect 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, you and your doctor will weigh the risks of taking the medicine against its benefits. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know 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 pediatric-specific problems that would limit the usefulness of iohexol injection in children. However, some children with certain medical conditions (e.g., asthma, heart failure, or kidney problems) may experience more unwanted side effects, which may require extra caution when using this medicine.

Geriatric

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

Breast Feeding

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

Interactions with Medicines

While some medicines should not be used together at all, in other situations, two different medicines may be used together even if an interaction might happen. In these cases, your doctor may want to adjust the dose, or take other precautions. It is very important that your healthcare professional knows if you are taking any of the medicines listed below while receiving this medicine. The following interactions are significant and may not include all possibilities.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medicine or change some of the other medicines you are taking.

• 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

Some medicines should not be used around mealtimes or with certain types of food because interactions may occur. Using alcohol or tobacco with certain medicines can 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:

• 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.

• History of allergy to a contrast agent 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 necessary effects, a medicine may cause some unwanted effects. Not all of these side effects will happen, but if they do, 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 happen 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 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.