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Prevention of Gallstones: 300 mg twice daily.
Mode of Administration: Orally.
Oral suspension: There are no age restrictions on the use of ursodeoxycholic acid (UDCA) suspension in the treatment of PBC and for the dissolution of radiolucent gallstones. The following daily dose is recommended for the various indications: For the treatment of primary biliary cholangitis (PBC): The daily dose depends on body weight, and is approximately 14±2 mg UDCA per kg of body weight.
For the first 3 months of treatment, UDCA suspension should be taken divided over the day.
When the liver function parameters improve, the daily dose can be administered once a day in the evening. (See Table 1.)
Click on icon to see table/diagram/imageUDCA suspension should be taken in accordance with the dosage regimen given in the previous text. The oral suspension must be taken regularly.
The use of UDCA suspension in PBC may be continued indefinitely.
For dissolution of cholesterol gallstones: Approximately 10 mg of UDCA per kg of body weight daily, equivalent to: See Table 2.
Click on icon to see table/diagram/imageUDCA suspension should be taken in the evening at bedtime. The oral suspension must be taken regularly.
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 months 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 stone 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 UDCA in treating radio-opaque or partially radiopaque 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.
Older people: There is no evidence to suggest that any alteration in the adult dose is needed but the relevant precautions should be taken into account.
Paediatric population: Cholesterol rich gallstones and PBC are very rare in children but when they occur, dosage should be related to body weight. There are no adequate data on the efficacy and safety in this population.
Hepatobiliary disorders associated with cystic fibrosis: Children with cystic fibrosis aged 1 month to 18 years: 20 mg/kg/day in 2-3 divided doses, with a further increase to 30 mg/kg/day if necessary.
Very rarely, children under 10 kg body weight are affected. In this case, a commercially available single-use syringe should be used.
(Note: a syringe is not provided in the pack).
Up to 10 kg body weight: Dosing 20 mg UDCA/kg/day.
Measuring device: single-use 2 ml graduated syringe (not provided). (See Table 3.)
Click on icon to see table/diagram/imageMore than 10 kg body weight (BW): Dosing 20-25 mg UDCA/kg/day.
Measuring device: measuring cup. (See Tables 4 and 5.)
Click on icon to see table/diagram/image
Click on icon to see table/diagram/image
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