Each tablet contains: Ursodeoxycholic acid 300 mg.
Pharmacology: Pharmacodynamics: Mechanism of Action: Suppresses the synthesis and secretion of cholesterol by the live and inhibits intestinal absorption of cholesterol.
Dissolution of cholesterol-rich gallstones in patients with functioning gallbladders; for the treatment of primary biliary cirrhosis.
Primary Biliary Cirrhosis (PBC): The recommended adult dosage in the treatment of PBC is 13-15 mg/kg/day administered in two to four divided doses with food. Dosing regimen should be adjusted according to each patient's need at the discretion of the physician.
Dissolution of Gallstone: The usual dose is 6-12 mg/kg/day either as a single night time dose or in divided doses. This may be increased to 15 mg/kg/day in obese patients, if necessary.
Known hypersensitivity or intolerance to Ursodeoxycholic acid or any of the components of the formulation.
Patients with variceal bleeding, hepatic encephalopathy, ascites or in need of an urgent liver transplant, should receive appropriate specific treatment.
Use in Children: The safety and effectiveness of Ursodeoxycholic acid tablets in pediatric patients have not been established.
Use in Pregnancy: Safe use of administration during pregnancy has not been established, therefore, the drug should not be used in women who are or may become pregnant unless the potential benefits justify the possible risks to the fetus.
Use in Lactation: It is not known whether Ursodeoxycholic acid is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ursodeoxycholic acid tablets are administered to a nursing mother.
Use in Pregnancy: Safe use of administration during pregnancy has not been established, therefore, the drug should not be used in women who are or may become pregnant unless the potential benefits justify the possible risks to the fetus.
Use in Lactation: It is not known whether Ursodeoxycholic acid is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Ursodeoxycholic acid tablets are administered to a nursing mother.
Gastrointestinal Disorders: Abdominal discomfort, abdominal pain, constipation, diarrhoea, dyspepsia, nausea, vomiting can occur.
Hypersensitivity: Pruritus can occur, also rash can rarely occur.
Respiratory System: If interstitial pneumonia accompanied with fever, cough, dyspnea, chest X-ray abnormality is observed, discontinue the medicine and take appropriate measures.
Others: General malaise, dizziness, calcified of gallstones, increase liver enzymes (ALT, ALP, AST, GGT), leukocytopenia can occur rarely.
If increase of serum bilirubin is observed, discontinue the medicine and take appropriate measures.
Bile Acid Sequestering Agents: Bile acid sequestering agents such as cholestyramine and colestipol may interfere with the action of Ursodeoxycholic acid tablet by reducing its absorption.
Aluminum-Based Antacids: Aluminum-based antacids have been shown to adsorb bile acids in vitro and may be expected to interfere with Ursodeoxycholic acid tablet in the same manner as the bile acid sequestering agents.
Drugs Affecting Lipid Metabolism: Estrogens, oral contraceptives, and clofibrate (and perhaps other lipid-lowering drugs) increase hepatic cholesterol secretion and encourage cholesterol gallstone formation and hence may counteract the effectiveness of Ursodeoxycholic acid tablet.
Store at temperatures not exceeding 25°C.
A05AA02 - ursodeoxycholic acid ; Belongs to the class of bile acids. Used in bile therapy.
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