Chemodissolution of bile duct stone.
Gallstone, During rapid weight loss; Prophylaxis.
Primary biliary cholangitis.

Anticholelithic：it is known that when administered orally ursodiol is concentrated in bile and decreases biliary cholesterol saturation by suppressing hepatic synthesis and secretion of cholesterol, and by inhibiting its intestinal absorption.

[Absorption]
Bioavailability：Oral: 90%
[Distribution]
Protein binding: 70%

[Metabolism]
Hepatic: first-pass.

[Excretion]
Fecal: primary.

biliary obstruction, complete.
hypersensitivity or intolerance to ursodiol or any components of the formulation.

B [FDA]

Infant risk cannot be ruled out. [MDX]

Dermatologic: Rash (2.63% ).
Gastrointestinal: Constipation (9.7% to 26.4% ), Diarrhea (25.2% to 27.1% ), Indigestion (16.8% ), Nausea (17.4% ), Vomiting (9.7% to 13.7% ).
Musculoskeletal: Backache (11.8% ).
Neurologic: Dizziness (16.5% ).
Respiratory: Bronchitis (6.5% ), Cough (7.1% ), Pharyngitis (8.4% ), Upper respiratory infection (12.4% to 15.5% ).

Gallstone：300 mg ORALLY twice daily.
Hepatitis, chronic：450 to 600 mg/day ORALLY in divided doses with food.
Primary biliary cholangitis：13 to 15 mg/kg/day ORALLY in 2 to 4 divided doses with food.

Safety and effectiveness in pediatric patients have not been established.

Dose reduction is not required in renal failure.

Dose reduction is not required in Hepatic Insufficiency.

Store at 20 to 25 degrees Celsius