Brand Names:

• Bar-Test
• Entero VU
• E-Z-Cat Dry
• E-Z-Disk
• E-Z-HD
• Gastrografin
• Hypaque Sodium
• Kruschen Salts
• MD-Gastroview
• Ocu-Disal
• Omnipaque 12
• Omnipaque 9
• Oraltag
• Perchloracap
• Readi-Cat 2
• Readi-Cat 2 Smoothie
• Tagitol V
• Varibar
• Varibar Pudding
• Volumen
• Acb
• Baro-Cat
• Colobar-100
• Epi-C
• Epi-Stat
• Esobar
• Esopho-Cat Esophageal Cream
• E-Z-Cat
• E-Z-Hd
• E-Z-Jug
• E-Z-Paque
• Gel-Unix 10

Dosage Forms:

• Suspension
• Cream
• Powder for Suspension
• Tablet
• Paste
• Solution

Uses of This Medicine:

Oral cholecystographic agents are radiopaque agents. Radiopaque agents are drugs used to help diagnose certain medical problems. These agents contain iodine, which blocks x-rays. Depending on how the radiopaque agent is given, it localizes or builds up in certain areas of the body. When radiopaque agents are inside the body they will appear white on the x-ray film. This creates the needed distinction, or contrast, between one organ and other tissues. This will help the doctor see any special conditions that may exist in that organ or part of the body.

The oral cholecystographic agents are taken by mouth before x-ray tests to help check for problems of the gallbladder and the biliary tract.

These radiopaque agents are to be given only by or under the direct supervision of a doctor.

Ipodate was discontinued by the United States manufacturer in 1999.

Before Using This Medicine:

In deciding to receive a diagnostic test, the risks of taking the test must be weighed against the good it will do. This is a decision you and your doctor will make. For these tests, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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—

Although there is no specific information comparing use of cholecystographic agents in children with use in other age groups, tests using iopanoic acid in children have not shown that these agents cause different side effects or problems in children than they do in adults.

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of cholecystographic agents in the elderly with use in other age groups, these agents are not expected to cause different side effects or problems in older people than they do in younger adults.

Pregnancy—

Studies on effects in pregnancy have not been done in humans with any of these agents. Studies in animals have been done only with iocetamic acid, which has not been shown to cause birth defects or other problems. However, on rare occasions, other radiopaque agents containing iodine have caused hypothyroidism (underactive thyroid) in the baby when given in late pregnancy. Also, x-rays of the abdomen are usually not recommended during pregnancy. This is to avoid exposing the fetus to radiation. Be sure you have discussed this with your doctor.

Breast-feeding—

Iocetamic acid, iopanoic acid, and tyropanoate pass into the breast milk, and the other agents may pass into the breast milk also. However, these radiopaque agents have not been reported to cause problems in nursing babies.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 diagnostic tests in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Asthma, hay fever, or other allergies (history of) or
• Previous reaction to penicillins or to a skin test for allergies—Patients with these conditions have a greater chance of having a reaction, such as an allergic reaction.

• Heart disease—Other problems, such as low blood pressure or slow heartbeat, may occur.

• Kidney disease or
• Liver disease (severe)—Serious kidney problems may result.

• Overactive thyroid—A sudden increase in symptoms, such as fast heartbeat or palpitations, fatigue, nervousness, excessive sweating, and muscle weakness may occur.

Proper Use of This Medicine:

Take this radiopaque agent with water after dinner the evening or evenings before the examination, following the directions of your doctor. Keep drinking an adequate amount of water, unless otherwise directed by your doctor.

Do not eat or drink anything but water after taking the medicine. Also, avoid smoking or chewing gum.

Your doctor may order a special diet or use of a laxative or enema in preparation for your test, depending on the type of test. If you have not received such instructions or if you do not understand them, check with your doctor in advance.

Precautions While Using This Medicine:

Make sure your doctor knows if you are planning to have any future thyroid tests. The results of the thyroid test may be affected, even weeks or months later, by the iodine in this agent.

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 immediately if any of the following side effects occur:

Rare

Itching

skin rash or hives

unusual bleeding or bruising (with iopanoic acid only)

Symptoms of overdose

Diarrhea (severe)

nausea and vomiting (severe)

problems with urination

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:

More common

Diarrhea (mild)

nausea and vomiting (mild to moderate)

Less common

Abdominal or stomach spasms or cramps

diarrhea (severe)

difficult or painful urination

dizziness

frequent urge to urinate

headache

heartburn

nausea and vomiting (severe or continuing)

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.