Generic name: ursodiol (ur so DY all)
Brand name: Actigall, Urso, Urso Forte, Urso DS, Reltone
Dosage forms: oral capsule (300 mg); oral tablet (250 mg; 500 mg)
Drug class: Gallstone solubilizing agents
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.
Warnings
You should not use ursodiol if you have an obstruction in your liver or gallbladder.
Before taking this medicine
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 ursodiol 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.
Ursodiol dosing information
Usual Adult Dose for Biliary Cirrhosis:
Tablets: 13 to 15 mg/kg orally per day, given in 2 to 4 divided doses with food
Comments:
-The dose should be adjusted to the patient's needs.
-Scored tablets may be broken in half to provide recommended doses.
Use: Treatment of patients with primary biliary cirrhosis (PBC)
Usual Adult Dose for Gallbladder Disease:
Capsules:
Gallstone dissolution: 8 to 10 mg/kg orally per day, given in 2 to 3 divided doses
Gallstone prevention: 300 mg orally 2 times a day
-Maximum dose: 600 mg/day
Comments:
-Safety in the dissolution of gallstones has not been established in patients using this drug beyond 24 months.
-Ultrasound images should be obtained every 6 months for the first year.
-If gallstones appear to have dissolved, treatment should be continued, and dissolution should be confirmed on a repeat ultrasound in 1 to 3 months.
-Most patients who achieve complete dissolution show partial or complete dissolution at the first on-treatment reevaluation.
-If partial stone dissolution is not observed after 12 months of treatment, the likelihood of treatment is significantly reduced.
Uses:
-Patients with radiolucent, noncalcified gallbladder stones less than 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to advanced age, idiosyncratic reaction to general anesthesia, systemic disease, or those who refuse surgery
-For the prevention of gallstone formation in obese patients experiencing rapid weight loss
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.