Optiray 160 (Injection)

Ioversol injection is used to help diagnose or identify issues in the brain, heart, head, blood vessels, 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 like CT scans and angiography.

This medicine should only be given by or under the supervision of a doctor.

It is very important for your doctor to closely monitor the progress of you or your child while receiving this medicine to ensure it is working properly and to determine if you should continue treatment. Blood and urine tests may be required to check for any unwanted effects.

This medicine may lead to heart attack, stroke, and blood clotting issues during angiographic procedures. Contact your doctor immediately if you experience chest pain that may spread to your arms, jaw, back, or neck, difficulty breathing, nausea, unusual sweating, fainting, coughing up blood, numbness or weakness in your arm or leg, or on one side of your body, sudden or severe headache, or issues with vision, speech, or walking after receiving this medicine.

Get in touch with your doctor right away if you notice bloody urine, a decrease in how often or how much you urinate, increased blood pressure, increased thirst, loss of appetite, pain in your lower back or side, nausea, swelling of the face, fingers, or lower legs, difficulty breathing, unusual tiredness or weakness, vomiting, or weight gain. These could indicate a serious kidney issue.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Inform your doctor or nurse right away if you or your child experiences 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, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis can occur with this medicine. Consult 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.

This medicine may cause hypothyroidism (underactive thyroid) in children aged 3 years and younger. Children with congenital (from birth) heart problems may be at a higher risk of hypothyroidism. Contact your doctor immediately 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.

Notify your doctor right away if you or your child experience mild burning pain, feelings of warmth or coldness, peeling of the skin, redness, or swelling at the injection site.

Ensure 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, there may be exposure to radiation. Discuss any concerns with your doctor.

Make sure any doctor or dentist treating you is aware that you are using this medicine. This medicine may affect the results of certain medical tests.

Do not take other medicines unless your doctor has discussed them with you. This includes prescription or over-the-counter (OTC) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to think about the risks of taking the medicine compared to the benefits it may provide. Here are some important things to consider:

Allergies

Let your doctor know if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional about any other allergies you may have, like allergies to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies done so far have not shown any specific problems in children that would limit the use of Optiray® 350 and Optiray® 320 for angiocardiography, or Optiray® 320 for CT scans of the head and body, and intravenous excretory urography in children. However, safety and effectiveness have not been established in children for Optiray® 300 and in children younger than 1 month of age for Optiray® 350 and Optiray® 320.

Geriatric

Studies done so far have not shown any specific problems in elderly patients that would limit the use of ioversol injection. However, older adults are more likely to have age-related liver, kidney, or heart issues, which may require caution and possible dose adjustments for patients receiving ioversol injection.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could occur. In these situations, your doctor may need to adjust the dose or take other precautions. It is very important for your healthcare professional to know if you are taking any of the medicines listed below when you receive this medicine. The following interactions are noted for their significance but may not be all-inclusive.

Using this medicine with any of the following medicines is generally 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:

• Metformin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how this medicine works. Be sure to 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 allergic reactions.

• Anuria (not able to pass urine) or
• Severe blood vessel disease 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 kidney failure.

• Blood clotting problems (e.g., phlebitis, thrombosis) or
• Heart or blood vessel disease (e.g., arteriosclerosis) or
• Hypertension (high blood pressure) or
• Severe kidney disease or
• Liver disease or
• Pheochromocytoma (adrenal problem) or
• Sickle cell disease (inherited blood disorder)—Use with caution. May worsen these conditions.

• Homocystinuria (genetic disease)—Patients with this condition should avoid angiography because of the increased risk of blood clotting problems.

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

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, 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. 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.

In the U.S.

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

Available Dosage Forms:

• Solution

Therapeutic Class: Radiological Non-Ionic Contrast Media

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.