URSODIOL CAPSULES, USP
Ursodiol is a bile acid available as 300-mg capsules suitable for oral administration. Ursodiol USP (ursodeoxycholic acid) is a naturally occurring bile acid found in small quantities in normal human bile and in the biles of certain other mammals. It is a bitter-tasting, white powder freely soluble in ethanol, methanol, and glacial acetic acid; sparingly soluble in chloroform; slightly soluble in ether; and insoluble in water.
Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of ursodiol beyond 24 months is not established.
Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.
Media Articles Related to Ursodiol
Primary Biliary Cirrhosis
Source: MedicineNet Antimitochondrial Antibodies Specialty [2005.09.17]
Title: Primary Biliary Cirrhosis
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 9/17/2005 12:00:00 AM
Published Studies Related to Ursodiol
Colchicine or methotrexate, with ursodiol, are effective after 20 years in a subset of patients with primary biliary cirrhosis. [2011.09]
BACKGROUND & AIMS: The combination of ursodeoxycholic acid (UDCA), colchicine, and methotrexate (MTX) is effective therapy for a subset of patients with primary biliary cirrhosis (PBC) who do not respond to UDCA. However, the durability of the response is unclear. We investigated whether the response to combination therapy was durable... CONCLUSIONS: Treatment with the combination of UDCA and MTX or UDCA and colchicine led to sustained clinical remission in a subset of patients with PBC. The response to the combination of UDCA and MTX appeared to be more durable than to UDCA and colchicine. Copyright (c) 2011 AGA Institute. Published by Elsevier Inc. All rights reserved.
Clinical Trial: Randomized controlled trial of zidovudine and lamivudine for patients with primary biliary cirrhosis stabilized on ursodiol. [2008.07.09]
Background: A human betaretrovirus has been characterized in patients with primary biliary cirrhosis (PBC)... Accordingly, more potent anti-viral regimens will be required to confirm the efficacy of antiviral therapy in PBC patients with human betaretrovirus infection.
Clinical Trials Related to Ursodiol
Ursodiol for Treating Parenteral Nutrition Associated Cholestasis in Neonates [Recruiting]
The purpose of this study is to determine whether ursodiol is effective in the treatment of
parenteral nutrition associated cholestasis in neonates.
Ursodiol in Treating Patients With Barrett Esophagus and Low-Grade Dysplasia [Recruiting]
This phase II trial is studying how well ursodiol works in treating patients with Barrett
esophagus or low-grade dysplasia. Chemoprevention is the use of certain drugs to keep cancer
from forming. The use of ursodiol may in patients with Barrett esophagus or low-grade
The Effect of Ursodeoxycholic Acid in Liver Functional Restoration of Patients With Obstructive Jaundice [Not yet recruiting]
In patients with obstructive jaundice, multi-organ dysfunction may develop. The aim of this
study is to evaluate the effect of ursodeoxycholic acid on liver functional restoration on
patients with obstructive jaundice after surgical or endoscopic treatment.
Patients with obstructive jaundice will be divided into two groups: (A) test group in which
will be administered ursodeoxycholic acid twenty-four hours after endoscopic or surgical
procedure and will last fourteen days, and (B) control group.
Serum-testing will include determination of bilirubin, alanine transaminase, aspartate
transaminase, gama-glutamyl transpeptidase, alkaline phosphatase, albumin, and cholesterol
levels. These parameters will be determined one day prior endoscopic or surgical procedure,
and on the third, fifth, seventh, tenth, twelfth and fourteenth days after endoscopic or
Our hypothesis is that patients with obstructive jaundice under treatment with
ursodeoxycholic acid will have better outcome than patients in control group.
Ursodiol, Combination Chemotherapy, and Bevacizumab in Treating Patients With Stage IV Colorectal Cancer [Recruiting]
RATIONALE: Drugs used in chemotherapy, such as ursodiol, oxaliplatin, leucovorin, and
fluorouracil, work in different ways to stop the growth of tumor cells, either by killing
the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can
block tumor growth in different ways. Some block the ability of tumor cells to grow and
spread. Others find tumor cells and help kill them or carry tumor-killing substances to
PURPOSE: This phase I trial is studying the side effects and best dose of ursodiol when
given together with combination chemotherapy and bevacizumab in treating patients with stage
IV colorectal cancer.
Ursodeoxycholic Acid Plus Budesonide Versus Ursodeoxycholic Acid Alone in Primary Biliary Cirrhosis (PBC) [Recruiting]
The study is aimed to compare the efficacy and tolerability of a combination therapy with
ursodeoxycholic acid (12-16 mg/kg body weight (BW)/d) plus budesonide (9 mg/d) vs.
ursodeoxycholic acid (12-16 mg/kg BW/d) plus placebo in the treatment of PBC. Depending on
ALT values 6 mg/d budesonide are allowed. The study population will be patients with PBC at
risk for disease progression. It is assumed that the combination therapy will result in a
decrease of treatment failures after 3 years of treatment.
Reports of Suspected Ursodiol Side Effects
Interstitial Lung Disease (7),
Maternal Exposure During Pregnancy (5),
Hepatic Function Abnormal (4),
Maternal Drugs Affecting Foetus (4),
Bile Duct Stone (4),
Foetal Exposure During Pregnancy (4), more >>
Page last updated: 2011-12-09