Pronunciation:

ur-soe-DYE-ol

Brand Names:

• Actigall
• Urso
• Urso 250
• Urso Forte

Dosage Forms:

• Capsule
• Tablet

Classifications:

Therapeutic—

Gastrointestinal Agent

Pharmacologic—

Bile Acid

Uses of This Medicine:

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

Ursodiol is also used to treat primary biliary cirrhosis (PBC). PBC is an autoimmune disorder that causes a patient's liver to have problems and not work properly.

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 ursodiol in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ursodiol capsules in the elderly. However, elderly patients are more sensitive to the effect of this medicine than younger adults, which may require caution in patients receiving this medicine.

No information is available on the relationship of age to the effects of ursodiol tablets 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

• Ascites (accumulation of fluid in the stomach cavity) or
• Bleeding varices (veins that enlarge and bleed) or
• Bowel problems (eg, Crohn's disease) or
• Hepatic encephalopathy (brain disease due to liver failure) or
• Liver damage (from not having a certain chemical in your liver to break down a substance called lithocholate) or
• Liver transplant—Use with caution. May make these conditions worse.

• Biliary tract blockage or
• Pancreatitis (swelling or inflammation of the pancreas)—Should not be used in patients with this condition.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. 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. To do so may increase the chance of side effects.

It is best to take ursodiol with meals, unless otherwise directed by your doctor.

Take this medicine 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.

If you are using Urso Forte® tablets:

• You may break the tablets into halves. To break the tablet easily, place it on a flat surface with the scored section on top. Hold the tablet with your thumbs placed close to the groove then apply gentle pressure until it breaks apart. Swallow each segment with water. Do not chew it.
• Due to the bitter taste, store the half-tablets or segments separately from the whole tablets. Half-tablets can be used for up to 28 days when kept in the medicine bottle.

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 (capsules):
  • For gallstone disease:
    • Adults—Dose is based on body weight and must be determined by your doctor. The dose is usually 8 to 10 milligrams (mg) per kilogram (kg) of body weight per day, divided into 2 or 3 doses.
    • Children—Use and dose must be determined by your doctor.
  • For prevention of gallstones during rapid weight loss:
    • Adults—300 milligrams (mg) 2 times a day.
    • Children—Use and dose must be determined by your doctor.
• For oral dosage form (tablets):
  • For primary biliary cirrhosis:
    • Adults—Dose is based on body weight and must be determined by your doctor. The dose is usually 13 to 15 milligrams (mg) per kilogram (kg) of body weight per day, divided into 2 to 4 doses. Your doctor may adjust your dose as needed.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

Call your doctor or pharmacist for instructions.

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 important that your doctor check your progress at regular visits. Blood 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 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:

More common

Bladder pain

bloody or cloudy urine

difficult, burning, or painful urination

dizziness

fast heartbeat

frequent urge to urinate

indigestion

lower back or side pain

severe nausea

skin rash or itching over the entire body

stomach pain

vomiting

weakness

Less common

Black, tarry stools

chest pain

chills or fever

cough

pinpoint red spots on the skin

severe or continuing stomach pain

sore throat or swollen glands

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

unusual bleeding or bruising

unusual tiredness or weakness

Incidence not known

Chest tightness

clay-colored stools

dark urine

difficulty with swallowing

headache

hives or welts

hoarseness

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loss of appetite

nausea

redness of the skin

slow or irregular breathing

swelling of hands, ankles, feet, or lower legs

unpleasant breath odor

yellow eyes or skin

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

Back pain

body aches or pain

constipation

general feeling of discomfort or illness

heartburn

loss of voice

muscle aches

muscle or bone pain

pain, swelling, or redness in the joints

stuffy or runny nose

sweating

trouble sleeping

Less common

Diarrhea

Rare

Worsening psoriasis

Incidence not known

Acid or sour stomach

belching bloating or swelling of face, arms, hands, lower legs, or feet

difficulty with moving

loss or thinning of the hair

rapid weight gain

stomach discomfort or upset

tingling of the hands or feet

unusual weight gain or 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.