Chenodiol

Chenodiol is made from bile acid, which is a substance that is naturally found in the body.

Chenodiol is used to dissolve gallstones in people who cannot have gallbladder surgery.

Chenodiol may also be used for reasons that are not included in this medication guide.

Follow all instructions on your prescription label. Do not take chenodiol in larger or smaller amounts or for longer than recommended.

Chenodiol is usually taken 2 times each day until your gallstones are completely dissolved. Follow your doctor's instructions.

Chenodiol is usually given for no longer than 2 years.

Use chenodiol regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

It may take up to 12 months before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 6 months of treatment.

While using chenodiol, you may need frequent blood tests. You may also need an occasional ultrasound or x-ray examination of your gallbladder.

Chenodiol is only part of a complete program of treatment that may also include weight control and a special diet. Follow the diet plan created for you by your doctor or nutrition counselor. Get familiar with the list of foods you must avoid to help control your condition.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

Even with treatment, there is a chance that your gallstones may return within 5 years. Talk to your doctor about your specific risk. Chenodiol will not prevent gallstones from occurring.

You should not use chenodiol if you have liver disease, cirrhosis, or certain conditions that cause an obstruction in your digestive system.

Chenodiol can harm an unborn baby or cause birth defects. Do not use if you are pregnant.

You should not use chenodiol if you are allergic to it, or if:

• you are pregnant;
• you have a bile duct obstruction or other disorder;
• you have pancreatitis related to your gallstones;
• you have cirrhosis or other liver disease; or
• you have a blockage in your digestive tract (stomach or intestines).

To make sure chenodiol is safe for you, tell your doctor if you have a history of liver problems or jaundice.

Do not use chenodiol if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine.

It is not known whether chenodiol passes into breast milk or if it could affect the nursing baby. Tell your doctor if you are breast-feeding.

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Chenodiol may cause serious side effects. Call your doctor right away if you have:

• worsening or no improvement of your gallstone symptoms;
• severe or ongoing diarrhea; or
• liver problems--loss of appetite, upper stomach pain, tiredness, easy bruising or bleeding, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of chenodiol may include:

• mild stomach cramps; or
• abnormal blood tests (low white blood cells, high cholesterol or triglycerides).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Gallbladder Disease:

Initial dose: 250 mg orally 2 times a dayMaintenance dose: 13 to 16 mg/kg/day in 2 divided dosesDuration of therapy: 24 monthsComments:-After the first 2 weeks, the dose should be increased by 250 mg/day each week thereafter until the recommended or maximum tolerated dose is reached.-Doses less than 10 mg/kg were usually ineffective and may be associated with an increased risk of cholecystectomy.-Oral cholecystograms or ultrasonograms should be conducted at 6 to 9 months.-Most patients who achieve complete dissolution will show at least partial dissolution at the first on-treatment test. Complete dissolution should be confirmed with oral cholecystogram or ultrasonogram after 1 to 3 months of continued treatment.Use: Patients with radiolucent stones in well-opacifying gallbladders, in whom selective surgery would be undertaken except for the presence of increased surgical risk due to systemic disease/age

Take the missed dose as soon as you remember. If it is almost time for your next scheduled dose, skip the missed dose. Do not take extra medicine to make up for the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• Follow your doctor's instructions about any restrictions on food, beverages, or activity.
• Avoid eating foods that are high in fat or cholesterol.

Tell your doctor about all the medicines you are currently taking and any that you start or stop using, especially:

• cholestyramine;
• colestipol;
• birth control pills or hormone replacement therapy;
• antacids that contain aluminum--Almacone, Gelusil, Maalox, Mag-al Plus, Mylanta, Rulox, and others; or
• a blood thinner--warfarin, Coumadin, Jantoven.

This list is not complete. Other drugs may interact with chenodiol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.