Detailed Drug Information:

DRUG CLASS AND MECHANISM: Ursodiol is a naturally-occurring bile acid that is made by the liver in humans and is secreted in small quantities in bile. It is used to dissolve and prevent cholesterol gallstones and to treat primary biliary cirrhosis, a disease of the liver. Ursodiol blocks the enzyme in the liver that produces cholesterol and thereby decreases production of cholesterol by the liver and the amount of cholesterol in bile. It also reduces the absorption of cholesterol from the intestine. By decreasing the concentration of cholesterol in bile, ursodiol prevents the formation and promotes the dissolution of cholesterol-containing gallstones. The mechanism by which it acts in primary biliary cirrhosis is not clear.

GENERIC: No

PREPARATIONS: Actigall capsules, 300 mg. Ursodiol tablets, 250 mg

STORAGE: Store at room temperature, 15-30°C (59-86°F).

PRESCRIBED FOR: Ursodiol is used to prevent cholesterol gallstones from forming during rapid loss of weight. It also is used to dissolve cholesterol gallstones that do not contain calcium and are less than 2 cm in diameter. It does not dissolve gallstones that are composed of pigment rather than cholesterol. Ursodiol must be used for one or more years, and 50% of patients who have successful dissolution of their gallstones will have the gallstones return within five years. The likelihood of having successful dissolution of gallstones is low if partial dissolution is not seen within 12 months of starting treatment. Ursodiol also is used to treat primary biliary cirrhosis.

DOSING: The recommended dose for dissolving gallstones in adults is 8-10 mg/kg/day split into 2 or 3 doses. For treating primary biliary cirrhosis, the recommended dose is 13-15 mg/kg/day split into 4 doses. Ursodiol should be taken with meals.

DRUG INTERACTIONS: Aluminum containing antacids, cholestyramine and colestipol reduce the absorption of ursodiol and therefore reduce its action.

PREGNANCY: The are no adequate studies in pregnant women.

NURSING MOTHERS: It is not known whether ursodiol is secreted in breast milk.

SIDE EFFECTS: The most common side effects are rash, itching, nausea, vomiting, stomach pain, back pain, constipation and diarrhea.