CHOLECYSTOGRAPHICAGENTS, 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

Another commonly used name for tyropanoate is sodium tyropanoate.

Category

• Antihyperthyroid agent?Ipodate
• Diagnostic aid, radiopaque, gallbladder disorders?Iocetamic Acid; IopanoicAcid; Ipodate; Tyropanoate

Description

Oral cholecystographic (ko-le-sis-to-GRAF-ik)agents are radiopaque agents. Radiopaqueagents are drugs used to help diagnose certain medical problems. These agentscontain iodine, which blocks x-rays. Depending on how the radiopaque agentis given, it localizes or builds up in certain areas of the body. When radiopaqueagents are inside the body they will appear white on the x-ray film. Thiscreates the needed distinction, or contrast, between one organ and other tissues.This will help the doctor see any special conditions that may exist in thatorgan or part of the body.

The oral cholecystographic agents are taken by mouth before x-ray teststo help check for problems of the gallbladder and the biliary tract. Ipodatemay also be used for other conditions as determined by your doctor.

These radiopaque agents are to be given only by or under the direct supervisionof 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 weighedagainst 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 cholecystographicagents, the following should be considered:

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

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

Breast-feeding?Iocetamic acid, iopanoic acid, and tyropanoatepass into the breast milk, and the other agents may pass into the breast milkalso. However, these radiopaque agents have not been reported to cause problemsin nursing babies.

Children?Although there is no specific information comparinguse of cholecystographic agents in children with use in other age groups,tests using iopanoic acid and ipodate in children have not shown that theseagents cause different side effects or problems in children than they do inadults.

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

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your doctor ifyou are taking any other prescription or nonprescription (over-the-counter[OTC]) medicine.

Other medical problems?The presence of other medicalproblems may affect the use of cholecystographic agents. Make sure you tellyour 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?Patientswith these conditions have a greater chance of having a reaction, such asan allergic reaction

• Heart disease?Other problems, such as low blood pressure orslow heartbeat, may occur

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

• Overactive thyroid?A sudden increase in symptoms, such as fastheartbeat or palpitations, fatigue, nervousness, excessive sweating, and muscleweakness may occur

Preparation for This Test

Dosing?Take this radiopaque agent with water afterdinner the evening or evenings before the examination, following the directionsof your doctor. Keep drinking an adequate amount of water, unless otherwisedirected 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 preparationfor your test, depending on the type of test. If you have not received suchinstructions 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 thyroidtests. The results of the thyroid test may be affected, even weeks or monthslater, 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 sideeffects may occur, if they do occur they may need medical attention.

Check with your healthcare professional immediately if any of the following side effectsoccur:

Rare

Itching; skin rash or hives; swelling of skin; unusual bleeding orbruising (with iopanoic acid only)

Symptoms of overdose

Diarrhea (severe); nausea and vomiting(severe); problems with urination

Other side effects may occurthat usually do not need medical attention. These side effects should go awayas the effects of the radiopaque agent wear off. However, check with yourdoctor if any of the following side effects continue or are bothersome:

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 urgeto urinate; headache; heartburn; nausea and vomiting (severe or continuing)

Other side effects not listed abovemay also occur in some patients. If you notice any other effects, check withyour doctor.

Additional Information

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

• Graves' disease

In addition to the above information, for patients with Graves' diseasetaking ipodate:

• Ipodate is used in patients with Graves' disease, who have an overactivethyroid, 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 takeit for a longer period of time than your doctor ordered. To do so may increasethe chance of side effects.
• In order for it to work properly, ipodate mustbe 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 relatingto proper use, precautions, or side effects for these uses.