Optiray 350

Ioversol is injected into a vein or artery through an IV. A healthcare provider will give you this injection.

Drink extra fluids before and after your radiologic test. Ioversol can cause you to get dehydrated, which can lead to dangerous effects on your kidneys. Follow your doctor's instructions about the types and amount of fluids you should drink before and after your test.

Older adults may need special care to avoid becoming dehydrated. Your kidney function may need to be checked after you have received ioversol.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when ioversol is injected.

Some people receiving ioversol have had reactions that did not start until 30 to 60 minutes after the medicine was first given. Your caregivers may want to watch you during this period of time after your injection. This is to make sure you do not have any unwanted side effects or delayed reactions.

Ioversol can cause unusual results with certain medical tests for up to 16 days after you receive this medicine. Tell any doctor who treats you that have recently received ioversol.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some of the side effects of ioversol can occur up to 24 hours after you have received the medication.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• slow heart rate;

• swelling, rapid weight gain, little or no urinating;

• wheezing or trouble breathing;

• seizure (convulsions);

• thyroid symptoms--extreme tired feeling, dry skin, joint pain or stiffness, muscle pain or weakness, hoarse voice, feeling more sensitive to cold temperatures, weight gain;

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; or

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.

Common side effects may include:

• warmth or pain when the medicine is injected;

• confusion, dizziness, spinning sensation;

• headache; or

• nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to 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

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:

• 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 or discomfort
• chest 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 or welts, 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
• severe, unusual tiredness or weakness
• slow, fast, or irregular heartbeat
• slow or irregular breathing
• stupor
• sudden loss of coordination
• sudden onset of shortness of breath for no apparent reason
• sudden onset of slurred speech
• sudden vision changes
• sweating
• swelling around the eyes
• swelling in the legs and ankles
• unusual tiredness or weakness

• Agitation
• blistering, peeling, or loosening of the skin
• chills
• coma
• confusion
• depression
• diarrhea
• extremely high fever or body temperature
• fast, shallow breathing
• fast, weak heartbeat
• fever
• hostility
• irritability
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lethargy
• 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
• thirst
• unable to move the legs

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:

• Bad taste
• collection of blood under the skin
• deep, dark purple bruise
• dry mouth
• pain, redness, or pale skin at the injection site
• 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.

• It is used before an x-ray or an alike test.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Chest pain or pressure or a fast heartbeat.
• A heartbeat that does not feel normal.
• Very bad dizziness or passing out.
• Shortness of breath.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• This medicine may cause tissue damage if the drug leaks from the vein. Tell your nurse if you have any redness, burning, pain, swelling, blisters, skin sores, or leaking of fluid where the drug is going into your body.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Optiray 350, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Optiray 350. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Optiray 350.

Review Date: October 4, 2017

Applies to ioversol: injection solution

Along with its needed effects, ioversol (the active ingredient contained in Optiray 350) 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 while taking ioversol:

• 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 or discomfort
• chest 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 or welts, 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
• severe, unusual tiredness or weakness
• slow, fast, or irregular heartbeat
• slow or irregular breathing
• stupor
• sudden loss of coordination
• sudden onset of shortness of breath for no apparent reason
• sudden onset of slurred speech
• sudden vision changes
• sweating
• swelling around the eyes
• swelling in the legs and ankles
• unusual tiredness or weakness

• Agitation
• blistering, peeling, or loosening of the skin
• chills
• coma
• confusion
• depression
• diarrhea
• extremely high fever or body temperature
• fast, shallow breathing
• fast, weak heartbeat
• fever
• hostility
• irritability
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• lethargy
• 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
• thirst
• unable to move the legs

Some side effects of ioversol 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:

• Bad taste
• collection of blood under the skin
• deep, dark purple bruise
• dry mouth
• pain, redness, or pale skin at the injection site
• ringing in the ears
• vomiting