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|Ursofalk

URSODIOL (Systemic)

Some commonly used brand names are:

In the U.S.—

• Actigall
• URSO 250

In Canada—

• URSO
• Ursofalk

Other commonly used names are ursodeoxycholic acid and UDCA .

Category

• Anticholelithic

Description

Ursodiol (ur-so-DYE-ole) is used in the treatment of gallstone disease. It is taken by mouth to dissolve the gallstones.

Ursodiol is used in patients with gallstones who do not need to have their gallbladders removed or in those in whom surgery should be avoided because of other medical problems. However, ursodiol works only in those patients whose gallstones are made of cholesterol and works best when these stones are small and of the “floating” type.

Ursodiol is also used to help prevent gallstones in patients who are on rapid weight-loss programs.

Ursodiol is also used in patients with cirrhosis of the liver. Cirrhosis causes a patient"s liver to have problems and not work properly.

Ursodiol is available only with your doctor"s prescription, in the following dosage form:

• Oral
• Capsules (U.S. and Canada)
• Tablets (U.S. and Canada)

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 ursodiol, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to ursodiol or other products containing bile acids.

Pregnancy—Ursodiol has not been studied in pregnant women. However, ursodiol has not been shown to cause birth defects or other problems in animal studies. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether ursodiol passes into the breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Although there is no specific information comparing use of ursodiol in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Older adults—This medicine has been tested in a limited number of patients over 65 years of age and has not been shown to cause different side effects or problems in older people than it does in younger adults. However, elderly patients may be more sensitive than younger adults to the effects of ursodiol.

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 health care professional 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 ursodiol. Make sure you tell your doctor if you have any other medical problems, especially:

• Biliary tract problems or
• Pancreatitis (inflammation of pancreas)—These conditions may make it necessary to have surgery since treatment with ursodiol would take too long

• Liver problems or
• Liver damage (from not having a certain chemical in your liver to break down a substance called lithocholate)—May make condition worse

Proper Use of This Medicine

Take ursodiol with meals for best results, unless otherwise directed by your doctor.

Take ursodiol for the full time of treatment, even if you begin to feel better . If you stop taking this medicine too soon, the gallstones may not dissolve as fast or may not dissolve at all.

It is thought that body weight and the kind of diet the patient follows may affect how fast the stones dissolve and whether new stones will form. However, check with your doctor before going on any diet.

Dosing—The dose of ursodiol 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 ursodiol. If your dose is different, do not change it unless your doctor tells you to do so .

The number of capsules 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 taking ursodiol .

• For oral dosage form (capsules or tablets):
  • For gallstone disease:
    • Adults and children 12 years of age and older—The dose is based on body weight and must be determined by your doctor. The usual dose is 8 to 10 milligrams (mg) per kilogram (kg) (3.6 to 4.5 mg per pound) of body weight a day, divided into two or three doses. Each dose is usually taken with a meal.
    • Children up to 12 years of age—Use and dose must be determined by your doctor.
  • For prevention of gallstones during rapid weight loss:
    • Adults—Oral, 300 mg two times a day.
    • Children up to 12 years of age—Use and dose must be determined by your doctor.
  • For cirrhosis of the liver:
    • Adults—The dose is based on body weight and must be determined by your doctor. The usual dose is 13 to 15 milligrams (mg) per kilogram (kg) (5.85 to 6.75 mg per pound) of body weight a day, divided into two to four doses. Each dose should be taken with a meal.
    • Children up to 12 years of age—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 or double your next dose.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is important that your doctor check your progress at regular visits. Laboratory tests will have to be done every few months while you are taking this medicine to make sure that the gallstones are dissolving and your liver is working properly.

Do not take aluminum-containing antacids (e.g., ALternaGEL, Maalox) while taking ursodiol. To do so may keep ursodiol from working properly. Before using an antacid, check with your health care professional.

Check with your doctor immediately if severe abdominal or stomach pain, especially toward the upper right side, or severe nausea and vomiting occur . These symptoms may mean that you have other medical problems or that your gallstone condition needs your doctor"s attention.

Side Effects of This Medicine

Check with your doctor as soon as possible if any of the following side effects occur:

Less common

Along with its needed effects, a medicine may cause some unwanted effects. The following side effects may go away during treatment as your body adjusts to the medicine. 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 these uses are not included in product labeling, ursodiol is used in certain patients with the following medical conditions:

• Chronic liver disease
• Liver transplant (to help reduce the risk of rejection)

There is no additional information relating to proper use, precautions, or side effects for these uses.

Revised: 01/08/2004

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