Ursodeoxycholic Acid (UDCA)

SECOND INDICATION — Primary biliary cholangitis (stages I-III): 12-15 mg/kg/day, equivalent to four to eight 150 mg tablets or two to four 300 mg tablets taken in two to three portions during the day, or two 450 mg tablets taken in two portions during the day. Primary biliary cholangitis stage IV WITH raised serum bilirubin (> 40 ug/l as stated in the SPC): give only half the normal dose initially (6 to 8 mg/kg/day), then monitor liver function closely for several weeks (once every two weeks for six weeks); if there is no deterioration in liver function (ALP, ALT, AST, gamma-GT, bilirubin) and no increase in itching, the dose may be increased further to the usual level with continued close monitoring. Primary biliary cholangitis stage IV WITHOUT elevated serum bilirubin: the usual starting dose may be given directly, still with accurate liver-function control. DURATION (gallstones): usually not shorter than three to four months; stone size must be measured accurately at the start and rechecked regularly, for example every six months, by contrast X-ray and/or ultrasound. If stones are not reduced in size after six months at the indicated dose, determine the lithogenic index of the bile by duodenal drainage; an index > 1.0 makes a favourable result unlikely and a different treatment should be considered. Continue treatment for three to four months after ultrasound confirms complete dissolution. Interrupting treatment for three to four weeks re-saturates the bile and prolongs overall therapy; recurrence can follow stopping after dissolution. MONITORING: AST, ALT and gamma-GT every 4 weeks for the first three months, then every 3 months. If diarrhoea occurs the dose should be reduced, and treatment discontinued if diarrhoea persists. In PBC, symptoms such as pruritus may worsen in rare cases at the start of treatment — continue at a reduced dose and increase gradually back to the recommended dose. ADMINISTRATION: if swallowing is difficult, the tablet can be halved on the dividing score so that one half is taken twice directly in sequence.

Stated only for children with cystic fibrosis aged 6 years to 18 years, for treatment of hepatobiliary disease as a result of cystic fibrosis. 20 mg/kg/day corresponds to four to ten 150 mg tablets, two to five 300 mg tablets, or two to three 450 mg tablets, to be taken in one or two portions during the day. Contraindicated in children with biliary atresia after unsuccessful portoenterostomy or without recovery of good bile flow. No other paediatric posology is stated in this SPC.