Indicated for the dissolution of Radiolucent collestral gall stone, chronic cholestatic liver disease in particular primary biliary cirrhosis, primary sclerosing cholangitis & cholestasis associated with cystic fibrosis.
Ursodeoxycholic acid suppresses hepatic synthesis and secretion of cholesterol and also inhibits intestinal absorption of cholesterol.
In dissolution of gall-stones: The usual dose is 6 - 12mg/kg/day either as a single night time dose or in divided doses. This may be increased to 15mg/kg/day in obese patients, if necessary; In primary biliary cirrhosis: 10 - 15mg ursodeoxycholic acid (UDCA) per kg per day in two to four divided doses. Children should be dosed based on body-weight. Children with cystic fibrosis aged 6 years to less than 18 years: 20 mg/kg/day in 2-3 divided doses, with further increase to 30 mg/kg/day if necessary.
Patients with complete biliary obstruction of extrahepatic origin; patients with widespread intrahepatic obstruction and patients who are hypersensitive to ursodeoxycholic acid or to any ingredient in the formulation.
Patients with variceal bleeding, hepatic encephalopathy, ascites or in need of an urgent liver transplant, should receive appropriate specific treatment. Caution has to be exercised to maintain the bile flow of the patients taking UDCA.
Pregnancy Category B. It is not known whether Ursodeoxycholic acid is excreted in human milk. The safety and effectiveness in pediatric patients have not been established.
Bile-acid sequestrates such as cholestyramine or cholestipol reduces the absorption of ursodeoxycholic acid. Aluminum based antacids- Reduces ursodiol absorption. Cytochrome P4503A substrates such as cyclosporine, nitrendipine and dapsone exhibit metabolic interactions with urosdeoxycholic acid.
Nausea, vomiting, diarrhea, abdominal pain, headache and itchy skin rash.
Doctors
Nurses
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