Lipiodol3 (Injection)

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

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

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.

In deciding to use a diagnostic test, any risks of the test must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. Also, other factors may influence test results. For this test, the following should be taken into account:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Research done so far has not shown any pediatric-specific issues that would limit the usefulness of ethiodized oil injection for lymphography in children.

Geriatric

No appropriate studies have been conducted on how age affects the results of ethiodized oil injection in older adults. However, no specific problems related to older age have been documented so far.

Breast Feeding

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

Interactions with Medicines

While some 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 situations, 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 for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on 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 choose not to use this diagnostic test or may change some of the other medicines you take.

• Metformin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or certain types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk with your healthcare professional about how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this diagnostic test. Make sure to inform your doctor if you have any other medical problems, especially:

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

• Recent bleeding or
• Hyperthyroidism (overactive thyroid) or
• Trauma—Should not be used in patients with these conditions.

• Advanced cancer or
• Heart problems (e.g., cardiac shunt) or
• Advanced lung or breathing problems or
• Recent radiation treatment or
• Recent surgery—Patients with these conditions should not receive Lipiodol® for lymphography.

• Cervix problems or
• Near or after menstrual period or
• Pelvic disease or
• Surgery (e.g., 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 worsen these conditions.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects will happen, but if they do, you may need medical attention.

Check with your doctor or nurse right away if you notice any of the following side effects:

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 happen 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 also have ways to prevent or lessen 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.

In the U.S.

• Ethiodol
• Lipiodol3

Available Dosage Forms:

• Oil

Therapeutic Class: Diagnostic Agent, Radiological Contrast Media

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.