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Ursodiol (Ursodiol) - Summary

 
 



URSODIOL SUMMARY

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.

  1. 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.

  2. Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.


See all Ursodiol indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Ursodiol

Primary Biliary Cirrhosis Treatment (PBC)
Source: MedicineNet budesonide nasal inhaler-spray Specialty [2014.04.30]
Title: Primary Biliary Cirrhosis Treatment (PBC)
Category: Diseases and Conditions
Created: 8/21/2001 12:00:00 AM
Last Editorial Review: 4/30/2014 12:00:00 AM

Primary Biliary Cirrhosis (PBC)
Source: MedicineNet Liver Cancer Specialty [2014.04.23]
Title: Primary Biliary Cirrhosis (PBC)
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 4/23/2014 2:58:18 PM

more news >>

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 &#38; 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.

more studies >>

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 dysplasia

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 them.

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.

Ursodiol in Huntington's Disease [Recruiting]
The purpose of this study is to evaluate the safety of the drug ursodiol (ursodeoxycholic acid, UDCA) in people with Huntington's disease (HD) and to explore how the compound is processed by the body.

Phase II Pilot Study to Compare the Bioavailability of Buffered, Enteric-Coated Ursodiol With Unmodified Ursodiol for Chronic Cholestatic Liver Disease and Cystic Fibrosis-Associated Liver Disease [Active, not recruiting]
OBJECTIVES: I. Compare the bioavailability of polymer-coated and buffered ursodiol (ursodeoxycholic acid) to unmodified ursodiol in patients with cystic fibrosis-associated liver disease or chronic cholestatic liver disease.

II. Compare the differences in pruritus, weight gain, and liver function for both treatments.

more trials >>

Reports of Suspected Ursodiol Side Effects

Interstitial Lung Disease (7)Cholestasis (6)Jaundice (5)Nausea (5)Maternal Exposure During Pregnancy (5)Dysmorphism (4)Hepatic Function Abnormal (4)Maternal Drugs Affecting Foetus (4)Bile Duct Stone (4)Foetal Exposure During Pregnancy (4)more >>


Page last updated: 2014-04-30

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