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|Colebrin Diagnostic

CHOLECYSTOGRAPHIC AGENTS, ORAL (Diagnostic)

Some commonly used brand names are:

In the U.S.—

• Bilivist ³
• Bilopaque ⁴
• Cholebrine ¹
• Oragrafin Calcium ³
• Oragrafin Sodium ³
• Telepaque ²

In Canada—

• Telepaque ²

• Biloptin ³
• Cistobil ²
• Colebrin ¹
• Colebrina ¹
• Colegraf ²
• Felombrine ²
• Jopanonsyre ²
• Lumopaque ⁴
• Neocontrast ²

Another commonly used name for tyropanoate is sodium tyropanoate .

Category

• Antihyperthyroid agent—Ipodate
• Diagnostic aid, radiopaque, gallbladder disorders—Iocetamic Acid; Iopanoic Acid; Ipodate; Tyropanoate

Description

Oral cholecystographic (ko-le-sis-to-GRAF-ik) 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. Ipodate may also be used for other conditions as determined by your doctor.

These radiopaque agents are to be given only by or under the direct supervision of a doctor. They are available in the following dosage forms:

• Oral
• Iocetamic acid
  • Tablets (U.S.)
• Iopanoic acid
  • Tablets (U.S. and Canada)
• Ipodate
  • Capsules (U.S.)
  • Oral suspension (U.S.)
• Tyropanoate
  • Capsules (U.S.)

Before Having This Test

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, test results may be affected by other things. For cholecystographic agents, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to iodine, to products containing iodine (for example, iodine-containing foods, such as seafoods, cabbage, kale, rape [turnip-like vegetable], turnips, or iodized salt), or to other radiopaque agents. Also tell your doctor if you are allergic to any other substances, such as preservatives.

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.

Children—Although there is no specific information comparing use of cholecystographic agents in children with use in other age groups, tests using iopanoic acid and ipodate 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.

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

Other medical problems—The presence of other medical problems may affect the use of cholecystographic agents. 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

Preparation for This Test

Dosing—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 After Having This Test

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 health care professional immediately if any of the following side effects occur:

Other side effects may occur that usually do not need medical attention. These side effects should go away as the effects of the radiopaque agent wear off. However, check with your doctor if any of the following side effects continue or are bothersome:

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Additional Information

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although not specifically included in product labeling, ipodate is used in certain patients with the following medical condition:

• Graves" disease

In addition to the above information, for patients with Graves" disease taking ipodate:

• Ipodate is used in patients with Graves" disease, who have an overactive thyroid, to reduce the amount of thyroid hormone produced by the thyroid gland.
• Use this medicine only as directed by your doctor . Do not take more of it, do not take it more often, and do not take it for a longer period of time than your doctor ordered. To do so may increase the chance of side effects.
• In order for it to work properly, ipodate must be taken every day, as ordered by your doctor .
• The information given above in the section Preparation For This Test will not apply to you.

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for these uses.

Revised: 06/29/1995

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