Pronunciation:

kee-noe-DYE-ol

Brand Names:

• Chenodal

Dosage Forms:

• Tablet

Warnings:

Because of the potential hepatotoxicity of chenodiol, poor response rate in some subgroups of chenodiol treated patients, and an increased rate of a need for cholecystectomy in other chenodiol treated subgroups, chenodiol is not an appropriate treatment for many patients with gallstones. Chenodiol should be reserved for carefully selected patients and treatment must be accompanied by systematic monitoring for liver function alterations. Aspects of patient selection, response rates and risks versus benefits are given in the insert .

Classifications:

Therapeutic—

Gastrointestinal Agent

Pharmacologic—

Bile Acid

Uses of This Medicine:

Chenodiol is used to treat gallstones in certain patients who will be having gallbladder surgery.

Chenodiol is a bile acid naturally found in the body. It works by preventing the production of cholesterol in the liver and dissolves the cholesterol that makes the gallstones.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, 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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of chenodiol in the pediatric population. Safety and efficacy have not been established.

Older adults—

No information is available on the relationship of age to the effects of chenodiol in geriatric patients.

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.

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. When you are taking this medicine, 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.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Levoketoconazole
• Methotrexate

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bile duct problems (e.g., blockage, fistula, swelling, intrahepatic cholestasis, primary biliary cirrhosis) or
• Gallbladder problems (e.g., gallbladder that cannot be viewed using a special dye, gallstone complications) or
• Liver problems (e.g., liver failure, sclerosing cholangitis)—Should not be used in patients with these conditions.

• Colon cancer or
• Liver disease (including hepatitis), or history of or
• Liver enzymes, elevated—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This medicine should not be taken for longer than 24 months.

Follow carefully your doctor's instructions about any special diet.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For treatment of gallstones:
    • Adults—Dose is based on body weight and must be determined by your doctor. The dose is usually 13 to 16 milligrams (mg) per kilogram (kg) of body weight per day, divided into two doses, taken in the morning and in the evening. Your doctor may increase your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This is to make sure that the medicine is working properly and to decide if you should continue to take it. Blood tests and certain laboratory tests (e.g., ultrasounds, X-rays) are needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Stop using this medicine and check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

Mild diarrhea may occur during treatment with chenodiol. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

Incidence not known

Black, tarry stools

chest pain

chills

cough

fever

painful or difficult urination

shortness of breath

sore throat

sores, ulcers, or white spots on the lips or in the mouth

swollen glands

unusual bleeding or bruising

unusual tiredness or weakness

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

Less common

Abdominal or stomach pain

acid or sour stomach

belching

bloated

cramps

difficulty having a bowel movement (stool)

excess air or gas in the stomach or intestines

full feeling

heartburn

indigestion

loss of appetite

nausea and vomiting

pain in the chest below the breastbone

pain or discomfort in chest, upper stomach, or throat

passing gas

stomach discomfort or upset

weight loss

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.