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Actigall (Ursodiol) - Summary

 
 



ACTIGALL SUMMARY

Actigall is a bile acid available as 300-mg capsules suitable for oral administration. Actigall is ursodiol USP (ursodeoxycholic acid), 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. Actigall 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 Actigall beyond 24 months is not established.

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


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NEWS HIGHLIGHTS

Media Articles Related to Actigall (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

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Published Studies Related to Actigall (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.

Colchicine or methotrexate, with ursodiol, are effective after 20 years in a subset of patients with primary biliary cirrhosis. [2011]
combination therapy was durable... CONCLUSIONS: Treatment with the combination of UDCA and MTX or UDCA and

Low incidence of hepatic veno-occlusive disease in pediatric patients undergoing hematopoietic stem cell transplantation attributed to a combination of intravenous heparin, oral glutamine, and ursodiol at a single transplant institution. [2010.08]
We report the low incidence of hepatic VOD in pediatric patients with various diagnoses including hematologic malignancies and non-malignant conditions transplanted at our institution. Retrospective review of 188 patients who underwent HSCT and received a combined prophylactic regimen of intravenous heparin, oral glutamine, and ursodiol was undertaken...

Ursodiol in patients with parenteral nutrition-associated cholestasis. [2007.11]
CONCLUSIONS: Ursodiol may improve the biochemical signs and clinical symptoms of PNAC. However, optimal dosing, timing, duration of therapy, and long-term effects on PNAC outcome and prognosis require further studies.

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Clinical Trials Related to Actigall (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.

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.

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Page last updated: 2014-04-30

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