Lipiodol3

In the U.S.

• Ethiodol
• Lipiodol3

Available Dosage Forms:

• Injectable
• Solution

Therapeutic Class: Radiological Non-Ionic Contrast Media

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.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of ethiodized oil injection for lymphography in children.

Geriatric

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.

Pregnancy

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.

Interactions with 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

Interactions with Food/Tobacco/Alcohol

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—May increase risk of having an allergic reaction to occur again.

• Bleeding in the uterus or
• Curettage or conization with 30 days or
• Cervical erosion or
• Endocervicitis (inflammation of the cervix) or
• Immediate premenstrual or postmenstrual time frame or
• Pelvic inflammatory disease
• Pregnant—Patients with these conditions should not receive Lipiodol® for hysterosalpingography.

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

• 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.

• Advanced lung disease or
• Advanced neoplastic disease with expected lymphatic obstruction or
• Radiation therapy to the examined area or
• Right-to-left cardiac shunt or
• Surgery interrupting the lymphatic system, recent—Patients with this condition should not receive Lipiodol® for lymphography.

This section provides information on the proper use of a number of products that contain ethiodized oil. It may not be specific to Lipiodol3. Please read with care.

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

Your doctor will 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 shortness of breath, or troubled breathing.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are receiving 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:

• Abdominal or stomach pain
• anxiety
• bloated abdomen or 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
• sudden shortness of breath or troubled 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:

• 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.