Pronunciation:

eth-EYE-oh-dyzd oyl

Brand Names:

• Ethiodol
• Lipiodol3

Dosage Forms:

• Oil

Warnings:

Inadvertent intravascular injection or intravasation of ethiodized oil may cause pulmonary and cerebral embolism. Inject slowly with radiologic monitoring; do not exceed recommended dose .

Classifications:

Therapeutic—

Diagnostic Agent, Radiological Contrast Media

Uses of This Medicine:

Ethiodized oil injection is used to help diagnose or find problems in the uterus, fallopian tubes, lymphatic vessels, and for looking at tumors in adults with liver cancer. It is an oil-based radiopaque contrast agent. Contrast agents are used to help create a clear picture of the body during different medical procedures.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a diagnostic test, any risks of the test must be weighed against the good it will do. This is a decision you and your doctor will make. Also, other things may affect test results. For this test, 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 ethiodized oil injection for lymphography in children.

Older adults—

Appropriate studies on the relationship of age to the effects of ethiodized oil injection have not been performed in the geriatric population. However, no geriatric-specific problems have been documented to date.

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 diagnostic test, 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.

Receiving this diagnostic test with any of the following medicines is not recommended. Your doctor may decide not to use this diagnostic test or change some of the other medicines you take.

• 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 diagnostic test. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to iodinated contrast agents or
• Asthma—Use with caution. May increase risk of having allergic reactions.

• Bleeding, recent or
• Hyperthyroidism (overactive thyroid) or
• Trauma—Should not be used in patients with these conditions.

• Cancer, advanced or
• Heart problems (eg, cardiac shunt) or
• Lung or breathing problems, advanced or
• Radiation treatment or
• Surgery, recent—Patients with these conditions should not receive Lipiodol® for lymphography.

• Cervix problems or
• Menstrual period, near or after or
• Pelvic disease or
• Surgery (eg, conization, curettage) within 30 days—Patients with these conditions should not receive Lipiodol® for hysterosalpingography.

• Dilated bile ducts without external drainage—Patients with this condition should not receive Lipiodol® for liver tumor imaging.

• Heart disease or
• Liver disease or
• Lung disease or
• Portal hypertension (high blood pressure in the liver portal vein) or
• Thyroid problems—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A doctor or other trained health professional will give you this medicine in a hospital. It is given through a needle placed within the uterus, into a lymphatic vessel, or into an artery of the liver.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.

This medicine may cause pulmonary embolism (blood clots in the lungs). Tell your doctor right away if you have anxiety, chest pain, cough, dizziness or lightheadedness, fainting, fast heartbeat, sudden trouble breathing.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have 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.

This medicine may cause thyroid problems (eg, overactive or underactive thyroid). Check with your doctor right away if you have depressed mood, dry skin and hair, feeling cold, hair loss, hoarseness or a husky voice, muscle cramps and stiffness, nervousness, sensitivity to heat, slowed heartbeat, sweating. weight gain or loss, or unusual tiredness or weakness.

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:

Incidence not known

Anxiety

bloated stomach

changes in vision

chest pain or tightness

cough

decreased frequency or amount of urine

depressed mood

difficulty with swallowing

dizziness or lightheadedness

fainting

fast heartbeat

fever

headache

inflamed tissue from infection

loss of appetite

lower back or side pain

muscle cramps and stiffness

nausea or vomiting

pain and fullness in the right upper abdomen or stomach

pain, tenderness, or swelling of the foot or leg

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

skin rash, hives, itching, or redness

stomach pain

sudden trouble breathing

sweating

swelling of the face, fingers, or lower legs

trouble sleeping

unusual tiredness or weakness

weight gain or loss

yellow eyes and skin

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:

Incidence not known

Delayed healing at the incision site

diarrhea

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.