Brand Name
US Brand Name
Omnipaque 140
Omnipaque 180
Omnipaque 240
Omnipaque 300
Omnipaque 350
Omnipaque Flexipak
Description
Iohexol injection is used to help diagnose or find problems in the brain, back, heart, head, blood vessels, stomach, joints, pancreas, bladder, reproductive tract, and other parts of the body. It is an iodinated contrast agent. Contrast agents are used to create a clear picture of the different parts of the body during certain medical procedures (eg, CT scans).
This medicine is to be given only by or under the supervision of a doctor.
This product is available in the following dosage forms:
- Solution
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of iohexol injection in children. Some pediatric patients with certain medical conditions (eg, asthma, heart failure, or kidney problems) may have more unwanted side effects which may require caution in patients receiving this medicine.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of iohexol injection in the elderly. However, elderly patients are more likely to have unwanted side effects (eg, liver, kidney, or heart problems) which may require caution and an adjustment in the dose for patients receiving this medicine.
Breastfeeding
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acebutolol
- Amiodarone
- Atenolol
- Betaxolol
- Bisoprolol
- Carteolol
- Carvedilol
- Celiprolol
- Esmolol
- Labetalol
- Levobunolol
- Metformin
- Metipranolol
- Metoprolol
- Nadolol
- Nebivolol
- Oxprenolol
- Penbutolol
- Pindolol
- Practolol
- Propranolol
- Sotalol
- Timolol
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell 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
- Kidney disease, severe or
- Liver disease or
- Pheochromocytoma (adrenal problem) or
- Pulmonary hypertension or
- Sickle cell anemia (inherited blood disorder)—Use with caution. May make these conditions worse.
- Allergy to a contrast agent, history of or
- Asthma—Use with caution. May increase risk of having 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 risk of having kidney failure.
- Homocystinuria (genetic disease)—Patients with this condition should avoid undergoing angiography because of the increase risk of having blood clotting problem.
Proper Use
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.
Precautions
It is very important that your doctor check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive 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 a surgery or other 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 has 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 your 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 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 you receive 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.
Side Effects
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.
CON-XXXXXXXX
