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.
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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.
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Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.
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NEWS HIGHLIGHTSMedia Articles Related to Ursodiol
Primary Biliary Cirrhosis
Source: MedicineNet ursodiol Specialty [2005.09.17]
Title: Primary Biliary Cirrhosis
Category: Diseases and Conditions
Created: 12/31/1997
Last Editorial Review: 9/17/2005
Published Studies Related to Ursodiol
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 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.
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.
Trial of High-Dose Urso in Primary Sclerosing Cholangitis [Completed]
This is a multicenter, randomized, controlled trial of high dose ursodiol versus placebo for
patients with primary sclerosing cholangitis (PSC). The average duration of follow-up will
be approximately five years with important clinical endpoints such as death, eligibility for
liver transplanation, changes in histology and cholangiogram as well as liver biochemistries
and quality of life data collected.
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.
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Page last updated: 2008-08-10
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