ursodiol

Pronunciation

Generic Name: ursodiol (ur so DY all)
Brand Name: Actigall, Urso, Urso Forte, Urso DS

What is ursodiol?

Ursodiol is a bile acid that decreases the amount of cholesterol produced by the liver and absorbed by the intestines. Ursodiol helps break down cholesterol that has formed into stones in the gallbladder. Ursodiol also increases bile flow in patients with primary biliary cirrhosis.

Ursodiol is used to treat primary biliary cirrhosis.

Ursodiol capsules are used to treat small gallstones in people who cannot have gallbladder surgery, and to prevent gallstones in overweight patients undergoing rapid weight loss. Ursodiol capsules are not for treating gallstones that are calcified

Ursodiol may also be used for purposes not listed in this medication guide.

What is the most important information I should know about ursodiol?

You should not use ursodiol if you have an obstruction in your liver or gallbladder.

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What should I discuss with my healthcare provider before taking ursodiol?

You should not use ursodiol if you are allergic to it, or if you have an obstruction in your liver or gallbladder.

To make sure ursodiol is safe for you, tell your doctor if:

  • you have been coughing up blood; or

  • you have gained weight rapidly, especially in your face and midsection.

FDA pregnancy category B. Ursodiol is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether ursodiol passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take ursodiol?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take the ursodiol tablet with food.

You may need to break a tablet in half to get your correct dose. Each tablet is scored in the middle and should break apart easily.

Swallow the tablet piece whole with a glass of water. A broken tablet can have a bitter taste.

Use ursodiol regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

To treat gallstones, you may have to take ursodiol for several months before your gallstones dissolve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Not all gallstones completely dissolve with ursodiol treatment, and you may develop new gallstones within 5 years after treatment. Talk to your doctor about your specific risks.

While using ursodiol, you may need gallbladder ultrasound exams, or frequent blood tests to check your liver function. Your doctor may also want to check your liver function every 6 months after you stop using ursodiol.

Store at room temperature away from moisture and heat. Tablets that are broken in half can be kept at room temperature for up to 28 days.

If you split your tablets, keep them separate from any whole tablets.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking ursodiol?

Ask your doctor before using an antacid, and use only the type your doctor recommends. Some antacids can make it harder for your body to absorb ursodiol.

If you also take cholestyramine or colestipol, avoid taking ursodiol at the same time. Ask your doctor how many hours apart you should take your medicines.

Ursodiol side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  • signs of a new infection--sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, skin sores, trouble swallowing.

Common side effects may include:

  • headache, dizziness;

  • mild stomach pain or discomfort;

  • nausea, diarrhea, constipation;

  • cold symptoms such as stuffy nose, sneezing, sore throat;

  • hair loss; or

  • mild itching or rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Ursodiol dosing information

Usual Adult Dose for Biliary Cirrhosis:

Tablets: 13 to 15 mg/kg/day orally in 2 to 4 divided doses with food

Comments:
-Dose should be adjusted according to patient's need at physician's discretion.

Approved indication: For treatment of patients with primary biliary cirrhosis

Usual Adult Dose for Gallbladder Disease:

Capsules:
Gallbladder stone dissolution: 8 to 10 mg/kg/day orally in 2 or 3 divided doses
Gallstone prevention: 300 mg orally twice a day

Comments:
-Ultrasound images of gallbladder recommended at 6-month intervals for first year of therapy to monitor gallstone response. If gallstones appear to have dissolved, therapy should be continued and dissolution confirmed on a repeat ultrasound examination within 1 to 3 months.
-Most patients who eventually achieve complete stone dissolution show partial or complete dissolution at the first on-treatment reevaluation.
-If partial stone dissolution is not seen by 12 months of therapy, likelihood of success is greatly reduced.
-Safety of use beyond 24 months is not established.

Approved indications:
-For dissolution of gallstones in patients with radiolucent, noncalcified gallbladder stones less than 20 mm in greatest diameter who are not candidates for cholecystectomy due to increased surgical risk (e.g., systemic disease, advanced age, idiosyncratic reaction to general anesthesia) or who refuse surgery
-For gallstone prevention in obese patients undergoing rapid weight loss

Usual Pediatric Dose for Gallbladder Disease:

(Not approved by FDA)

Some experts recommend:
Parenteral nutrition-induced cholestasis in neonates:
Treatment: 30 mg/kg/day orally in 3 divided doses; some centers divide in 2 daily doses

Prevention:
With initiation of parenteral nutrition: 5 mg/kg/day orally in 4 divided doses beginning on day of life 3
With initiation of enteral feeding: Increase dose to 10 mg/kg/day orally in 4 divided doses.
When full enteral feedings reached: Increase dose to 20 mg/kg/day orally in 4 divided doses.

Biliary atresia:
Infants: 10 to 15 mg/kg orally once a day

Treatment of TPN-induced cholestasis:
Infants and children: 30 mg/kg/day orally in 3 divided doses

Improvement in the hepatic metabolism of essential fatty acids in cystic fibrosis:
Children: 30 mg/kg/day orally in 2 divided doses

What other drugs will affect ursodiol?

Other drugs may interact with ursodiol, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about ursodiol.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.01. Revision Date: 2013-11-14, 10:32:45 AM.

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