Ioversol

Since ioversol is used only during your radiologic test, you will not be on a dosing schedule.

• If you have an allergy to ioversol or any other part of ioversol.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have overactive thyroid disease.
• If you are dehydrated, have been eating poorly, or have used a laxative or water pill before this medicine.
• If you have had a skin reaction to ioversol or another drug like it in the past.
• If you are taking metformin, talk with doctor.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take ioversol with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

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

• Your doctor will give 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 ioversol. Check with your doctor to see if you need to drink extra fluids before getting this medicine.
• Drink lots of noncaffeine liquids after using ioversol 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.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling of warmth.
• Headache.
• Upset stomach.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Applies to ioversol: injection solution

Along with its needed effects, ioversol 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

Ioversol injection 68% (marketed as Optiray 320) is recommended for visceral arteriography, renal arteriography, and aortography procedures. The usual individual injection volumes for visualization for the aorta and various visceral arteries are as follows:

aorta - 45 mL (range 10 to 80 mL)
celiac - 45 mL (range 12 to 60 mL)
superior mesenteric - 45 mL (range 15 to 60 mL)
renal or inferior mesenteric - 9 mL (range 6 to 15 mL)

These doses may be repeated as necessary. Total procedural doses should not usually exceed 250 mL.

In aortography, depending on the technique employed, the risks of this procedure also include the following: injury to the aorta and neighboring organs, pleural puncture, renal damage including infarction and acute tubular necrosis with oliguria and anuria, retroperitoneal hemorrhage from the translumbar approach and spinal cord injury and pathology associated with the syndrome of transverse myelitis. Under conditions of slowed aortic circulation there is an increased likelihood for aortography to cause muscle spasm. Occasional serious neurologic complications, including paraplegia, have also been reported in patients with aortoiliac obstruction, femoral artery obstruction, abdominal compression, hypotension, hypertension, spinal anesthesia, and injection of vasopressors to increase contrast. In these patients the concentration, volume, and number of repeat injections of the medium should be maintained at a minimum with appropriate intervals between injections. The position of the patient and catheter tip should be carefully monitored.

Entry of a large aortic dose into the renal artery may cause, even in the absence of symptoms, albuminuria, hematuria, and an elevated creatinine and urea nitrogen. Rapid and complete return of function usually follows.

Ioversol injection 74%, 68%, 64%, or 51% may be administered by bolus injection, by rapid infusion, or by a combination of both.

Usual doses:
ioversol injection 74% (marketed as Optiray 350) - bolus injection: 25 to 75 mL, infusion: 50 to 150 mL
ioversol injection 68% (marketed as Optiray 320) - bolus injection: 25 to 75 mL, infusion: 50 to 150 mL
ioversol injection 64% (marketed as Optiray 300) - bolus injection: 25 to 75 mL, infusion: 50 to 150 mL
ioversol injection 51% (marketed as Optiray 240) - bolus injection: 35 to 100 mL, infusion: 70 to 200 mL
Dosage should not usually exceed 150 mL of ioversol injection 74%, 68% or 64% or 250 mL of 51%.

Ioversol may be useful for enhancement of computed tomographic images for detection and evaluation of lesions in the liver, pancreas, kidneys, aorta, mediastinum, pelvis, abdominal cavity, and retroperitoneal space. Enhancement of computed tomography with ioversol may be of benefit in establishing diagnoses of certain lesions in these sites with greater assurance than is possible with CT alone. In other cases, the contrast agent may allow visualization of lesions not seen with CT alone (i.e., tumor extension) or may help to define suspicious lesions seen with unenhanced CT (i.e., pancreatic cyst).

Recommended dose: 1 mL/kg to 3 mL/kg of ioversol injection 68% (marketed as Optiray 320), with a usual dose of 2 mL/kg.

Ioversol may be useful for enhancement of computed tomographic images for detection and evaluation of lesions in the liver, pancreas, kidneys, aorta, mediastinum, pelvis, abdominal cavity, and retroperitoneal space. Enhancement of computed tomography with ioversol may be of benefit in establishing diagnoses of certain lesions in these sites with greater assurance than is possible with CT alone. In other cases, the contrast agent may allow visualization of lesions not seen with CT alone (i.e., tumor extension) or may help to define suspicious lesions seen with unenhanced CT (i.e., pancreatic cyst).

Children: Ioversol injection 68% (marketed as Optiray 320) at doses of 0.5 mL/kg to 3 mL/kg of body weight has produced diagnostic opacification of the excretory tract.

Usual dose for children: 1 mL/kg to 1.5 mL/kg. Dosage for infants and children should be administered in proportion to age and body weight. The total administered dose should not exceed 3 mL/kg.

Preparatory dehydration is dangerous and may contribute to acute renal failure.

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