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.
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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.
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Actigall is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.
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NEWS HIGHLIGHTSMedia Articles Related to Actigall (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 Actigall (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.
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.
Ursodiol in Patients with Parenteral Nutrition-Associated Cholestasis (November). [2007.10.02] 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.
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]
RATIONALE: 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.
PURPOSE: This phase II trial is studying how well ursodiol works in treating patients with
Barrett esophagus or low-grade dysplasia.
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.
Cholestatic Drug-induced Liver Injury [Recruiting]
Cholestatic drug-induced liver injury (DILI) is the severe form of DILI with a grave
outcome. Drug-metabolizing enzymes play an important role in the metabolism of drugs. The
genetic polymorphism of drug-metabolizing enzymes may influence the activities and
expression of these enzymes and thereby affect the susceptibility and severity of DILI.
UDP-glucuronosyltransferase (UGT) is an important phase 2 detoxification enzyme, which is
related to congenital hyperbilirubinemia. Recently, the genetic polymorphism of UGT1A1 was
reported to be associated with jaundice induced by some drugs, and UGT1A7 was shown to be
related to the susceptibility of hepatocellular carcinoma and other cancers. Ursodeoxycholic
acid (UDCA ) is a hydrophilic bile acid that is increasingly used for the treatment of
various cholestatic disorders. The aims of this study are (1) to assess the association of
the genetic polymorphism of UGT1A1 and 1A7, and the susceptibility and severity of
drug-induced liver injury (DILI), with emphasis on the cholestatic DILI; (2) to evaluate the
treatment effect of UDCA in the DILI, with special reference to the cholestatic
hepatotoxicity.
Safety and Efficacy Study of Ursodeoxycholic Acid Therapy in Pediatric Primary Sclerosing Cholangitis [Recruiting]
Primary sclerosing cholangitis (PSC), although uncommon, is a devastating and insidiously
progressive liver disease, resulting from advancing inflammation, fibrosis and obliteration
of the bile ducts in the liver, leading to cirrhosis and end-stage liver disease. Although
prognosis in children may be somewhat better than that of adults, approximately one third of
pediatric patients require transplantation by adulthood. Other than transplantation, there
is to date no therapy conclusively proven to improve the long-term outcome. Ursodeoxycholic
acid (UDCA) improves biochemical markers of liver disease, although in high doses does not
clearly improve the long-term outcome in adults, and in a recent study may have actually
worsened outcome. Childhood PSC is different from that of adult PSC in many ways, and
children may derive more short-term, as well as long-term, benefit than adults. This unique
multicenter study will carefully monitor the effects of withdrawal and restarting UDCA on
liver injury and inflammation in children with PSC. The preliminary data will help in the
design of a more definitive larger study to determine if UDCA has a beneficial role in the
treatment of PSC in children.
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Page last updated: 2011-12-09
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