URSODIOL (Systemic)
Some commonly used brand names are:
In the U.S.?
In Canada?
Other commonly used names are ursodeoxycholicacid and UDCA.
Category
Description
Ursodiol (ur-so-DYE-ole) is used in the treatmentof gallstone disease. It is taken by mouth to dissolve the gallstones.
Ursodiol is used in patients with gallstones who do not need to have theirgallbladders removed or in those in whom surgery should be avoided becauseof other medical problems. However, ursodiol works only in those patientswhose gallstones are made of cholesterol and works best when these stonesare small and of the ?floating? type.
Ursodiol is also used to help prevent gallstones in patients who are onrapid weight-loss programs.
Ursodiol is also used in patients with cirrhosis of the liver. Cirrhosiscauses a patient's liver to have problems and not work properly.
Ursodiol is available only with your doctor's prescription, in the followingdosage 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 willdo. This is a decision you and your doctor will make. For ursodiol, the followingshould be considered:
Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to ursodiol or other products containing bile acids.
Pregnancy?Ursodiol has not been studied in pregnantwomen. However, ursodiol has not been shown to cause birth defects or otherproblems in animal studies. Before taking this medicine, make sure your doctorknows if you are pregnant or if you may become pregnant.
Breast-feeding?It is not known whether ursodiol passes into thebreast milk. Although most medicines pass into breast milk in small amounts,many of them may be used safely while breast-feeding. Mothers who are takingthis medicine and who wish to breast-feed should discuss this with their doctor.
Children?Although there is no specific information comparinguse of ursodiol in children with use in other age groups, this medicine isnot expected to cause different side effects or problems in children thanit does in adults.
Older adults?This medicine has been tested in a limited numberof patients over 65 years of age and has not been shown to cause differentside effects or problems in older people than it does in younger adults. However,elderly patients may be more sensitive than younger adults to the effectsof ursodiol.
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 health careprofessional if you 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 ursodiol. Make sure you tell your doctor ifyou have any other medical problems, especially:
- Biliary tract problems or
- Pancreatitis (inflammation of pancreas)?These conditions maymake it necessary to have surgery since treatment with ursodiol would taketoo long
- Liver problems or
- Liver damage (from not having a certain chemical in your liver tobreak down a substance called lithocholate)?May make condition worse
Proper Use of This Medicine
Take ursodiolwith meals for best results, unless otherwise directed by your doctor.
Take ursodiol for the full time of treatment, evenif 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 followsmay 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 fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage 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 timeallowed between doses, and the length of time you take the medicine dependon 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 basedon body weight and must be determined by your doctor. The usual dose is 8to 10 milligrams (mg) per kilogram (kg) (3.6 to 4.5 mg per pound) of bodyweight a day, divided into two or three doses. Each dose is usually takenwith a meal.
- Children up to 12 years of age?Use and dose must be determinedby 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 determinedby your doctor.
- For cirrhosis of the liver:
- Adults?The dose is based on body weight and must be determinedby 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 fourdoses. Each dose should be taken with a meal.
- Children up to 12 years of age?Use and dose must be determinedby your doctor.
Missed dose?If you miss a dose of this medicine, take it assoon 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 otherdamp places. Heat or moisture may cause the medicine to break down.
- Do not keep outdated medicine or medicine no longer needed. Be surethat 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 regularvisits. Laboratory tests will have to be doneevery few months while you are taking this medicine to make sure thatthe gallstones are dissolving and your liver is working properly.
Do not take aluminum-containing antacids (e.g., ALternaGEL, Maalox) whiletaking ursodiol. To do so may keep ursodiol from working properly. Beforeusing an antacid, check with your health care professional.
Check with your doctor immediately if severe abdominalor stomach pain, especially toward the upper right side, or severe nauseaand vomiting occur. These symptoms may mean that you have other medicalproblems or that your gallstone condition needs your doctor's attention.
Side Effects of This Medicine
Check withyour doctor as soon as possible if any of the following side effects occur:
Less common
Black, tarry stools; blood in vomit; chest pain; chills; cough; fever; painful or difficult urination; severe or continuingstomach pain; sore throat; sores, ulcers, or white spots on lips or in mouth; swollen glands; unusual bleeding or bruising; unusual tiredness or weaknessAlong with its needed effects, a medicine maycause some unwanted effects. The following side effects may go away duringtreatment as your body adjusts to the medicine. However, check with your doctorif any of the following side effects continue or are bothersome:
More common
Back pain; body aches or pain; congestion; constipation; cough producing mucus; diarrhea; difficulty in breathing; dryness orsoreness of throat; ear congestion; general feeling of discomfort or illness; hair loss; headache; heartburn; loss of appetite; lossof voice; muscle aches and pains; muscle or bone pain; muscle stiffness; nasal congestion; nausea; pain, swelling, or redness in joints; runny nose; shivering; sneezing; sweating; tightnessin chest; trouble in swallowing; trouble sleeping; voice changes
Other sideeffects not listed above may also occur in some patients. If you notice anyother effects, check with your doctor.
Additional Information
Once a medicinehas been approved for marketing for a certain use, experience may show thatit is also useful for other medical problems. Although these uses are notincluded in product labeling, ursodiol is used in certain patients with thefollowing 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
