Ursodiol

Brand Names

Ursodiol, Actigall, Urso, Urso Forte

What is Ursodiol

Ursodiol is used to dissolve gallstones in patients who do not want surgery or cannot have surgery to remove gallstones. Ursodiol is also used to prevent the formation of gallstones in overweight patients who are losing weight very quickly. Ursodiol is a bile acid, a substance naturally produced by the body that is stored in the gallbladder. It works by decreasing the production of cholesterol and by dissolving the cholesterol in bile so that it cannot form stones.

Side effects of Ursodiol

Ursodiol can cause such side effects as:

• diarrhea
• constipation
• upsetstomach
• indigestion
• dizziness
• vomiting
• cough
• sorethroat
• runnynose
• backpain
• muscleandjointpain
• hairloss
• frequent urination or pain when you urinate
• cough with fever

Indication

Ursodiol is used to treat small gallstones in people who cannot have gallbladder surgery and to prevent gallstones in overweight patients undergoing rapid weight loss. Ursodiol is also used to treat primary biliary cirrhosis.

Precautions

It is very important to tell your doctor if you:

• Have an allergic reaction to ursodiol, bile acids or any other drugs
• Are taking any other prescription and non-prescription medications,especially antacids that contain aluminum (Amphojel, Gaviscon, Maalox, Mylanta, others), cholestyramine (LoCHOLEST, Prevalite, Questran), clofibrate (Atromid-S), colestipol (Colestid), medications that lower lipid or cholesterol levels, medications that contain estrogen (including birth control pills), vitamins and herbal products
• Have or have ever had disease of the liver, gallbladder, pancreas or bile duct
• Are pregnant, plan to become pregnant or are breast-feeding

Dosage forms

Usual Adult Dose for Biliary Cirrhosis

Primary biliary cirrhosis: 13-15 mg/kg/day in 3 to 4 divided doses.

Usual Adult Dose for Gallbladder Disease

Gallstone prevention: 300 mg orally twice a day.

Cholestasis of Pregnancy: 1.5-2 g/day (20-25 mg/kg/day), given in 3 divided doses.

Gallbladder stone dissolution: 8-10 mg/kg/day orally in 2 or 3 divided doses; maintenance therapy: 250 mg daily at bedtime for 6 months to 1 year; use beyond 24 months is not established.

Usual Pediatric Dose for Gallbladder Disease

Less than 1 month: Parenteral nutrition induced cholestasis treatment: 30 mg/kg/day orally in 3 divided doses; some centers divide in 2 daily doses prevention: 5 mg/kg/day orally in 4 divided doses beginning on day of life 3 with initiation of parenteral nutrition; increase dose to 10 mg/kg/day orally in 4 divided doses with initiation of enteral feeding; increase dose to 20 mg/kg/day in 4 divided doses when full enteral feedings reached.

1 month or older: Biliary atresia: 10-15 mg/kg orally once a day. TPN induced cholestasis treatment: 30 mg/kg/day orally in 3 divided doses.

1 year or older: Improvement in the hepatic metabolism of essential fatty acids in cystic fibrosis: 30 mg/kg/day orally in 2 divided doses.