Omnipaque 350 (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 make a clear image of different body parts 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 monitor your progress closely while you are receiving this medicine. This will help your doctor determine if the medicine is working properly and decide if you should continue 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 within the last 6 months, or if you had surgery or another procedure in your reproductive tract within 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 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 your body, sudden or severe headache, or problems with vision, speech, or walking after receiving this medicine.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in 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 symptoms 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 an increased risk of hypothyroidism. Check with your doctor right away 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.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have 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 occur with this medicine. Check with your doctor right away 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, 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 they have been discussed 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 need to think about the risks and benefits. Here are some important things to consider for this medicine:

Allergies

Let your doctor know if you have ever had any unusual or allergic reaction to this medicine or any others. Also inform your healthcare professional about any other allergies you have, including 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 specific problems in children that would limit the use of iohexol injection. However, some children with certain medical conditions (such as asthma, heart failure, or kidney issues) may experience more side effects, so caution is needed for these patients.

Geriatric

Studies conducted to date have not identified any specific problems in elderly patients that would limit the use of iohexol injection. However, older patients are more likely to experience side effects (such as liver, kidney, or heart issues) which may require caution and possible dose adjustments.

Breast Feeding

Research in women suggests that this medication is low risk for infants when used during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together with precautions. If you are receiving this medicine, it is important for your healthcare professional to know if you are taking any of the following medicines. The interactions listed below are significant but may not include all possible interactions.

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

• 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, your doctor may adjust the dose or frequency of one or both.

• 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 taken at or around mealtimes, as interactions may occur. 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 influence the use of this medicine. Be sure to inform your doctor if you have any other 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 issue) or
• Pulmonary hypertension or
• Sickle cell anemia (inherited blood disorder)—Use with caution. May worsen these conditions.

• History of allergy to a contrast agent
• Asthma—Use with caution. May increase the risk of allergic reactions.

• Cancer in the reproductive area 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 levels of paraprotein in the blood)—May raise the risk of kidney failure.

• Homocystinuria (genetic disorder)—Patients with this condition should avoid angiography due to a higher risk of blood clotting problems.

Along with its necessary effects, this medicine can also cause some unwanted effects. Not all of these side effects will happen, but if they do, you may need medical help.

Contact your doctor or nurse right away if you experience any of the following side effects:

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 standing 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 require medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also have ways to help 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 can 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.