Urso 250 (Oral)

Ursodiol is used to dissolve gallstones in patients who do not need to have their gallbladders removed or in those who should avoid surgery due to other medical issues. However, ursodiol only works for patients whose gallstones are made of cholesterol and is most effective 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 problems with the liver, preventing it from working properly.

This medicine is available only with your doctor's prescription.

It is important for your doctor to monitor your progress during regular visits. Blood tests will need to be done every few months while you are taking this medicine to ensure that the gallstones are dissolving and your liver is functioning properly.

Do not take other medicines unless your doctor has discussed them with you. This includes both prescription and nonprescription (over-the-counter [OTC]) medicines, as well as herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks and benefits of the medicine. For this medicine, think about the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know 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.

Pediatric

Studies have not been done to understand how age affects the effects of ursodiol in children. Safety and effectiveness have not been established.

Geriatric

Studies conducted so far have not shown any specific problems in elderly patients that would limit the use of ursodiol capsules. However, older adults may be more sensitive to this medicine than younger adults, so caution might be needed for patients taking this medicine.

No information is available on how age affects the effects of ursodiol tablets in older patients.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction could happen. In these cases, your doctor may want to adjust 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]) medicines.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used when eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Make sure to inform your doctor if you have any other medical issues, especially:

• Ascites (fluid accumulation in the stomach cavity) or
• Bleeding varices (enlarged and bleeding veins) or
• Bowel problems (e.g., Crohn's disease) or
• Hepatic encephalopathy (brain disease due to liver failure) or
• Liver damage (due to a lack of a certain chemical in your liver to break down lithocholate) or
• Liver transplant—Use with caution. This may worsen these conditions.

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

Along with its necessary effects, a medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, you might need medical help.

Check with your doctor right away if you experience any of the following side effects:

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 all over the 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
• trouble 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 happen that usually do not need medical attention. These side effects may go away as your body adjusts to the medicine. Your health care professional may also have ways to prevent or lessen 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 the face, arms, hands, lower legs, or feet
• difficulty moving
• loss or thinning of hair
• rapid weight gain
• stomach discomfort or upset
• tingling in the hands or feet
• unusual weight gain or loss

Other side effects not mentioned 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.

In the U.S.

• Actigall
• Urso
• Urso 250
• Urso Forte

Available Dosage Forms:

• Capsule
• Tablet

Therapeutic Class: Gastrointestinal Agent

Pharmacologic Class: Bile Acid

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.