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Ursodiol (Oral route)

Pronunciation:

ur-soe-DYE-ol

Brand Names:

  • Actigall
  • Urso
  • Urso 250
  • Urso Forte

Dosage Forms:

  • Tablet
  • Capsule

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—

No information is available on the relationship of age to the effects of ursodiol in geriatric patients.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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 abdominal or stomach cavity) or
  • Bleeding varices (veins that enlarge and bleed) 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—Should not be used in patients with this condition.
  • Biliary tract problems or
  • Pancreatitis (swelling or inflammation of the pancreas)—These conditions may make it necessary to have surgery since treatment with ursodiol would take too long.

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 forms (capsules or tablets):
    • For gallstone disease:
      • Adults and children 12 years of age and older—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 two or three doses.
      • Children younger than 12 years of age—Use and dose must be determined by your doctor.
    • For prevention of gallstones during rapid weight loss:
      • Adults—300 milligrams (mg) two times a day.
      • Children younger than 12 years of age—Use and dose must be determined by your doctor.
    • 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 two to four 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.

If you miss a dose of this medicine, take it as soon as possible or double your next dose.

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.

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.

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
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
tightness in the chest
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
congestion
constipation
general feeling of discomfort or illness
heartburn
loss of voice
muscle aches
muscle or bone pain
pain, swelling, or redness in the joints
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
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.


Last Updated: 9/4/2017
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