Optiray 240

Ioversol is in a group of drugs called radiopaque (RAY dee oh payk) contrast agents. Ioversol contains iodine, a substance that absorbs x-rays. Radiopaque contrast agents are used to allow blood vessels, organs, and other non-bony tissues to be seen more clearly on a CT scan or other radiologic (x-ray) examination.

Ioversol is used to help diagnose certain disorders of the heart, brain, and blood vessels.

Ioversol may also be used for purposes not listed in this medication guide.

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

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

This section provides information on the proper use of a number of products that contain ioversol. It may not be specific to Optiray 240. Please read with care.

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.

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.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Very bad and sometimes deadly allergic reactions have rarely happened. Talk with your doctor.
• Very bad health problems, paralysis, and death have happened when contrast has been given into blood vessels in the spinal cord. Talk with the doctor.
• Blood clots have happened with Optiray 240 when used with some heart procedures. Sometimes, blood clots may cause heart attack and stroke, which may be deadly. Talk with the doctor.
• Very bad kidney problems and sometimes death have happened when contrast has been given to people with multiple myeloma. Talk with the doctor.
• Thyroid problems have happened after use of this medicine. Some people had to be treated for these thyroid problems. Talk with the doctor.
• Heart problems have happened with Optiray 240. Sometimes, these have been life-threatening. Talk with the doctor.
• A very bad and sometimes deadly reaction has happened with this medicine. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. Talk with the doctor.
• If you have sickle cell disease, talk with your doctor.
• Your blood work may need to be checked. Talk with your doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Optiray 240.
• If you are 65 or older, use this medicine with care. You could have more side effects.
• Use with care in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Optiray 240 while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Your doctor will give Optiray 240 (ioversol).
• Other drugs may be given before this medicine to help avoid side effects.
• You will need to be sure that you are not dehydrated before getting Optiray 240. Check with your doctor to see if you need to drink extra fluids before getting this medicine.
• Drink lots of noncaffeine liquids after using Optiray 240 unless told to drink less liquid by your doctor.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

Applies to ioversol: injectable solution

General

Adverse reactions following the use of this drug are generally independent of the dose and usually mild to moderate, of short duration and resolve spontaneously (without treatment).
The most frequently reported adverse reactions were mild discomfort, heat or cold sensation, pain during the injection, transient test perversion, nausea, vomiting, skin reactions such as and urticaria or erythema.[Ref]

Other

Very common (10% or more): Feeling hot
Common (1% to 10%): Pain
Uncommon (0.1% to 1%): Vertigo, extravasation, shaking, chills, fever, feeling cold
Very rare (less than 0.01%): Tinnitus, edema, malaise, tiredness, sluggishness, feeling abnormal
Frequency not reported: Hyperthermia, pyrexia[Ref]

Gastrointestinal

Common (1% to 10%): Nausea
Uncommon (0.1% to 1%): Vomiting, dry mouth
Very rare (less than 0.01%): Sialoadenitis, abdominal pain, tongue edema, dysphagia, hypersalivation
Frequency not reported: Diarrhea[Ref]

Nervous system

Common (1% to 10%): Headache
Uncommon (0.1% to 1%): Cerebral infarct, lightheadedness, vasovagal reaction, disorientation, paresthesia, dysphasia, visual hallucinations, syncope, bad taste
Rare (0.01% to 0.1%): Dizziness, dysgeusia, tremor, convulsions, aphasia, paralysis, coma and death
Very rare (less than 0.01%): Loss of consciousness, speech disorder, somnolence, hypoesthesia, stupor
Frequency not reported: Dyskinesia, amnesia[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Angina pectoris, hypotension, blood pressure fluctuation, arterial spasm, bradycardia, conduction defect, false aneurysm, hypertension, transient, arrhythmia, vascular trauma, hematoma
Rare (less than 0.1%): Arterial thrombosis, displacement of arterial plaques, venous thrombosis, dissection of the coronary vessels, transient sinus arrest, thrombophlebitis, flushing
Very rare (less than 0.01%): Heart block, abnormal ECG, atrial fibrillation, cerebrovascular disorder
Frequency not reported: Tachycardia; T-wave amplitude; ST depression, ST elevation; changes in cardiac output, left ventricular systolic and end-diastolic pressure, right ventricular systolic and pulmonary artery systolic pressure; decreases in systolic and diastolic blood pressure; myocardial infarction; angioneurotic edema, peripheral edema, vasodilation, thrombosis, disseminated intravascular coagulation, shock, cyanosis, extrasystole, palpitations, vasospasm[Ref]

Regardless of the contrast medium employed, the overall incidence of serious adverse reaction is higher with coronary arteriography than with other procedures. Cardiac decompensation, serious arrhythmias, myocardial ischemia, or myocardial infarction may occur during coronary arteriography and left ventriculography.[Ref]

Dermatologic

Uncommon (0.1% to 1%): Urticaria, pruritus, facial edema, erythema
Rare (0.01% to 0.1%): Rash
Very rare (less than 0.01%): Angioedema, hyperhidrosis (including cold sweat)
Frequency not reported: Maculopapular rash, ecchymosis, tissue necrosis, toxic epidermal necrolysis, acute generalized erythematous pustulosis, erythema multiforme, pallor[Ref]

Genitourinary

Uncommon (0.1% to 1%): Polyuria, urinary retention
Very rare (less than 0.01%): Incontinence, hematuria
Frequency not reported: Temporary anuria, dysuria[Ref]

Ocular

Uncommon (0.1% to 1%): Blurred vision, periorbital edema
Very rare (less than 0.01%): Allergic conjunctivitis (including eye irritation, ocular hyperemia, watery eyes, swelling of conjunctiva, etc.)
Frequency not reported: Transient blindness[Ref]

Respiratory

Uncommon (0.1% to 1%): Laryngeal edema, pulmonary edema, sneezing, congestion, coughing, shortness of breath, hypoxia
Rare (0.01% to 0.1%): Laryngeal spasm and obstruction (including throat tightness, stridor, etc.), dyspnea, rhinitis, throat irritation
Very rare (less than 0.01%): Pharyngitis
Frequency not reported: Brachial plexus palsy following auxiliary artery injections, chest pain, choking, wheezing (may be an initial manifestation of more severe and infrequent reactions including asthmatic attack), bronchospasm, apnea, respiratory arrest, asthma, dysphonia[Ref]

Hypersensitivity

Rare (0.01% to 0.1%): Anaphylaxis with loss of consciousness, coma, severe cardiovascular disturbances and death
Very rare (less than 0.01%): Anaphylactoid reactions[Ref]

Musculoskeletal

Rare (less than 0.1%): Muscle spasm[Ref]

Local

Very rare (less than 0.01%): injection site reactions (including pain, erythema, and hemorrhage up to necrosis especially after extravasation)
Frequency not reported: Hemorrhage or pseudoaneurysms at the puncture site[Ref]

Psychiatric

Very rare (less than 0.01%): Agitation, anxiety, confusion[Ref]

Renal

Very rare (less than 0.01%): Acute renal failure, abnormal renal function, decreased creatinine clearance, increased BUN
Frequency not reported: Temporary nephropathy, renal colic[Ref]

Endocrine

Frequency not reported: Thyroid function tests indicative of hypothyroidism or transient thyroid suppression in adult and pediatric patients (including infants)[Ref]

Hepatic

Frequency not reported: Transient changes in hepatorenal chemistry tests[Ref]

Some side effects of Optiray 240 may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.