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Duration of therapy 6-12 months. After complete dissolution, it is recommended that Ursodeoxycholic Acid (Ursoliv) be continued for at least 3 months to promote dissolution of particles that are too small to image.
Gallstone Prevention: To prevent gall stone formation in obese patients experiencing rapid weight loss the recommended dose is 800 mg twice a day with meals.
Cholestatic liver diseases: The recommended oral dose for treatment of cholestatic liver diseases is 13-15 mg/kg/day given in 2 divided doses with meals.
Primary biliary cirrhosis: The daily dose is 10-15 mg/kg/day in divided dose. (See Table 1.)
Click on icon to see table/diagram/imageUrsoliv 500: There are no age restrictions on the use of Ursodeoxycholic acid (Ursoliv) tablets in the treatment of PBC and for the dissolution of radiolucent gallstones.
The following daily dose is recommended for the various indications: For dissolution of cholesterol gallstones: Approx. 10 mg of ursodeoxycholic acid per kg body weight, equivalent to: See Table 2.
Click on icon to see table/diagram/imageThe film-coated tablets should be swallowed whole with some liquid in the evening at bedtime. They must be taken regularly.
The time required for the dissolution of gallstones is generally 6-24 months. If there is no reduction in the size of the gallstones after 12 months, the therapy should not be continued.
The success of the treatment should be checked by means of ultrasound or X-ray examination every 6 months. At the follow-up examinations, a check should be made to see whether calcification of the stones has occurred in the meantime. Should this be the case, the treatment must be ended.
For the symptomatic treatment of Primary Biliary Cirrhosis (PBC): The daily dose depends on body weight and ranges from 1½ to 3½ film-coated tablets (14 ± 2 mg of ursodeoxycholic acid per kg of body weight).
For the first 3 months of treatment Ursodeoxycholic Acid (Ursoliv) film-coated tablets should be taken divided over the day. When the liver function parameters improve, the daily dose may be taken once daily in the evening. (See Table 3.)
Click on icon to see table/diagram/imageThe film-coated tablets should be swallowed whole with some liquid. They must be taken regularly.
The use of Ursodeoxycholic Acid (Ursoliv) film-coated tablets in primary biliary cirrhosis may be continued indefinitely.
In patients with primary biliary cirrhosis, in rare cases the clinical symptoms may worsen at the beginning of treatment, e.g. the itching may increase. In this event, therapy should first be continued with half an Ursodeoxycholic Acid (Ursoliv) film-coated tablets daily, and the dose then gradually increased (weekly increase of the daily dose by half a film-coated tablet until the dose indicated in the respective dosage regimen is reached again.
