Ioversol (Injection route)
- Optiray 160
- Optiray 240
- Optiray 300
- Optiray 320
- Optiray 350
Not for intrathecal use; serious adverse reactions, including death, have been reported due to the inadvertent intrathecal administration. Serious, rarely fatal, thromboembolic events have been reported during angiographic procedures; meticulous intravascular administration technique is necessary. The arterial injection of a contrast medium should never be made following the administration of vasopressors since they strongly potentiate adverse neurologic effects. Use extreme caution in patients with pheochromocytoma, severely impaired renal function, combined renal and hepatic disease, severe thyrotoxicosis, myelomatosis, or anuria, particularly when large doses are administered. Ioversol is potentially hazardous in patients with multiple myeloma or other paraproteinemia, particularly in those with therapeutically resistant anuria; maintenance of normal hydration and close monitoring are required. May promote sickling in individuals who are homozygous for sickle cell disease when administered intravascularly. Thyroid storm following intravascular use has been reported in patients with hyperthyroidism or with an autonomously functioning thyroid nodule .
Radiological Non-Ionic Contrast Media
Uses of This Medicine:
Ioversol injection is used to help diagnose or find problems in the brain, heart, head, blood vessels, 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 such as CT scans and angiography.
This medicine is to be given only by or under the supervision of a doctor.
Before Using This Medicine:
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:
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.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Optiray™ 350 and Optiray™ 320 for angiography, and Optiray™ 320 for CT scan of the head and body in children. However, safety and efficacy have not been established in newborns.
Appropriate studies on the relationship of age to the effects of ioversol injection have not been performed in the geriatric population. However, no geriatric-specific problems have been documented to date.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
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:
- Allergic rhinitis (hay fever) or
- Allergy to a contrast agent, history of or
- Allergy to iodine or
- Asthma Use with caution. May increase risk of having allergic reactions.
- Anuria (not able to pass urine) or
- Blood vessel disease, severe or
- 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.
- Blood clotting problems (eg, phlebitis, thrombosis) or
- Heart or blood vessel disease (eg, arteriosclerosis) or
- Hypertension (high blood pressure) or
- Hyperthyroidism (overactive thyroid) or
- Kidney disease, severe or
- Liver disease or
- Pheochromocytoma (adrenal problem) or
- Sickle cell anemia (inherited blood disorder) Use with caution. May make these conditions worse.
- Homocystinuria (genetic disease) Patients with this condition should avoid undergoing angiography because of the increase risk of having blood clotting problems.
Proper Use of This Medicine:
A doctor or other trained health professional will give you or your child this medicine in a hospital. This medicine is given through a needle placed in an artery or a vein.
Drink extra fluids so you will pass more urine while you or your child are receiving this medicine. This may help prevent kidney problems.
Precautions While Using This Medicine:
It is very important that your doctor check the progress of you or your child 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.
This medicine may cause heart attack, stroke, and blood clotting problems during angiographic procedures. Tell your doctor right away if you have 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.
Severe kidney problems may occur after receiving this medicine. This is more likely to occur if you receive too much of this medicine. Tell your doctor right away if you or your child have the following symptoms after receiving the medicine: agitation, confusion, decreased urine output, dizziness, headache, muscle twitching, rapid weight gain, or swelling of the face, ankles, or hands.
This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor or nurse right away if you or your child has a skin rash, itching, shortness of breath, sweating, swelling of the face, tongue, and throat, or tightness in the chest after you get the injection.
Tell your doctor right away if you or your child have mild, burning pain, feeling of warmth or coldness, peeling of the skin, redness, or swelling at the injection site.
Make sure your doctor knows if you or your child have had an allergic reaction to any dye or medicine given during a test or procedure.
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 this medicine. 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.
Side Effects of This Medicine:
- Arm, back, or jaw pain
- blood in the stools or urine
- blue lips and fingernails
- blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- changes in skin color
- chest pain or discomfort
- chest tightness or heaviness
- coughing or vomiting blood
- coughing that sometimes produces a pink frothy sputum
- decrease in the frequency of urination
- decrease in urine volume
- difficult, fast, noisy breathing, sometimes with wheezing
- difficulty in passing urine (dribbling)
- difficulty with swallowing
- dizziness or lightheadedness
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- feeling of constant movement of self or surroundings
- hives or welts, itching, or skin rash
- increased sweating
- painful urination
- pains in the chest, groin, or legs, especially calves of the legs
- pain, tenderness, or swelling of the foot or leg
- pale skin
- persistent bleeding or oozing from puncture sites, mouth, or nose
- pounding in the ears
- rapid weight gain
- redness of the skin
- sensation of spinning
- severe headaches of sudden onset
- severe numbness, especially on one side of the face or body
- severe, unusual tiredness or weakness
- slow, fast, or irregular heartbeat
- slow or irregular breathing
- sudden loss of coordination
- sudden onset of shortness of breath for no apparent reason
- sudden onset of slurred speech
- sudden vision changes
- swelling around the eyes
- swelling in the legs and ankles
- unusual tiredness or weakness
- Incidence not known
- blistering, peeling, or loosening of the skin
- extremely high fever or body temperature
- fast, shallow breathing
- fast, weak heartbeat
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- muscle cramps
- muscle twitching
- no sensation in the legs
- not able to pass urine
- pale, clammy skin
- red, irritated eyes
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
- tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
- unable to move the legs
- Less common or rare
- Bad taste
- collection of blood under the skin
- deep, dark purple bruise
- dry mouth
- pain, redness, or pale skin at the injection site
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:
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:
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.
Last Updated: 9/15/2016