What is Ctexli?

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 .

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.

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.

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.

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.

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.

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:

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.

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.

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

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.

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.

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.

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.

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.