There are no age restrictions on the use of Ursodeoxycholic acid 250 mg hard capsules in the treatment of PBC and for the dissolution of radiolucent gallstones.
The following daily dose is recommended for the various indications: For Primary Biliary Cirrhosis (PBC):
The daily dose depends on body weight, and ranges from 3 to 7 capsules (14±2 mg UDCA per kg of body weight).
For the first 3 months of treatment, Ursodeoxycholic acid capsules should be taken divided over the day. With improvement of the liver values the daily dose may be taken once daily in the evening. (See table.)
Click on icon to see table/diagram/image
The capsules should be swallowed whole with some liquid. Care should be taken to ensure that they are taken regularly.
The use of Ursodeoxycholic acid capsules in PBC may be continued indefinitely.
Dissolution of Gallstones: Adults:
The usual dose is 8-12 mg/kg/day to be taken in the evening, e.g. 750 mg, daily in the evening.
The time required for dissolution of gallstones is likely to range from 6 to 24 months depending on stone size and composition.
Follow-up cholecystograms or ultrasound investigation may be useful at 6 month intervals until the gallstones have disappeared. Treatment should be continued until 2 successive cholecystograms and/or ultrasound investigations 4-12 weeks apart have failed to demonstrate gallstones. This is because these techniques do not permit reliable visualisation of stones less than 2 mm in diameter. The likelihood of recurrence of gallstones after dissolution by bile acid treatment has been estimated as up to 50% at 5 years. The efficiency of Ursodeoxycholic acid in treating radio-opaque or partially radio-opaque gallstones has not been tested but these are generally thought to be less soluble than radiolucent stones. Non-cholesterol stones account for 10-15% of radiolucent stones and may not be dissolved by bile acids.
There is no evidence to suggest that any alteration in the adult dose is needed but the relevant precautions should be taken into account.
Cholesterol rich gallstones and PBC are very rare in children but when they occur, dosage should be related to bodyweight. There are no adequate data on the efficacy and safety in this population.
Hepatobiliary Disorders Associated with Cystic Fibrosis: Paediatric Population:
Children with Cystic Fibrosis Aged 6 to 18 Years: 20 mg/kg/day in 2-3 divided doses, with a further increase to 30 mg/kg/day if necessary.