ursodiol, Actigall, Urso Forte, Urso 250

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GENERIC NAME: ursodiol

BRAND NAME: Actigall, Urso Forte, Urso 250

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 into 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. The FDA approved ursodiol in December 1987.

GENERIC: Yes

PRESCRIPTION: Yes

PREPARATIONS: Capsules: 300 mg. Tablets: 250 and 500 mg

STORAGE: Ursodiol should be stored at room temperature, 15-30 C (59-86 F).

PRESCRIBED FOR: Ursodiol is used for dissolving cholesterol gallstones and treating primary biliary cirrhosis. It also is used for preventing gallstones in obese patients who are losing weight rapidly. 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.

DOSING: The recommended dose for dissolving gallstones in adults is 8-10 mg/kg/day split into two or three doses (every 8 or 12 hours). Each dose should not exceed 300 mg. The maintenance dose is 250 mg at bedtime for six months.

For treating primary biliary cirrhosis, the recommended dose is 13-15 mg/kg/day split into 2 to 4 doses. Ursodiol should be taken with meals.

DRUG INTERACTIONS: Aluminum containing antacids, cholestyramine (Questran, Questran Light) and colestipol (Colestid) reduce the absorption of ursodiol and therefore reduce its action. Estrogens, oral contraceptives, clofibrate, and potentially other cholesterol reducing drugs may counteract the effects of ursodiol by increasing cholesterol secretion by the liver and the risk for gallstone formation.

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. Hair loss also may occur. Serious allergic reactions and reduced concentration of white blood cells also have occurred.

Reference: FDA Prescribing Information


Last Editorial Review: 5/4/2012




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