Pronunciation:

eye-oh-VER-sol

Brand Names:

• Optiray 160
• Optiray 240
• Optiray 300
• Optiray 320
• Optiray 350

Dosage Forms:

• Solution

Warnings:

Risks with Inadvertent Intrathecal AdministrationFor Intra-arterial and Intravenous Use OnlyInadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema .

Classifications:

Therapeutic—

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:

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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Optiray® 350 and Optiray® 320 for angiocardiography, and Optiray® 320 for CT scan of the head and body, and intravenous excretory urography in children. However, safety and efficacy have not been established in children for Optiray® 300 and in children younger than 1 month of age for Optiray® 350 and Optiray® 320.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ioversol injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving ioversol injection.

Breast-feeding—

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.

Other medicines—

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.

• Metformin

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:

• 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
• Kidney disease, severe or
• Liver disease or
• Pheochromocytoma (adrenal problem) or
• Sickle cell disease (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.

• Hyperthyroidism (overactive thyroid)—Should not be used in patients with this condition.

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.

You may also receive other medicines (eg, allergy medicine, steroids) to help prevent allergic reactions.

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 to see if the medicine is working properly and to decide if you should continue to receive it. Blood and urine tests may be needed to check for any unwanted effects.

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.

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 a serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor or nurse right away if you or your child has 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).

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.

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:

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:

Rare

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

bruising

changes in skin color

chest pain, discomfort, tightness, or heaviness

confusion

coughing

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

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

fainting

feeling of constant movement of self or surroundings

headache

hives, itching, or skin rash

hoarseness

increased sweating

nausea

nervousness

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 the puncture sites, mouth, or nose

pounding in the ears

rapid weight gain

redness of the skin

seizures

sensation of spinning

severe headaches of sudden onset

severe numbness, especially on one side of the face or body

slow, fast, or irregular heartbeat

slow or irregular breathing

stupor

sudden loss of coordination

sudden onset of slurred speech

sudden vision changes

sweating

swelling around the eyes

swelling in the legs and ankles

unusual tiredness or weakness

Incidence not known

Agitation

black, tarry stools

bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

blistering, peeling, or loosening of the skin

chills

coma

confusion

depressed mood

depression

diarrhea

dry skin and hair

extremely high fever or body temperature

fast, shallow breathing

fast, weak heartbeat

feeling cold

fever

hair loss

hoarseness or husky voice

hostility

irritability

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

lethargy

muscle cramps, stiffness, or twitching

no sensation in the legs

not able to pass urine

pale, clammy skin

red, irritated eyes

sensitivity to heat

sore throat

sores, ulcers, or white spots in the mouth or on the lips

swollen glands

tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area

thirst

trouble sleeping

unable to move the legs

unusual bleeding or bruising

weight loss

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

Collection of blood under the skin

deep, dark purple bruise

dry mouth

ringing in the ears

vomiting

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.