Ursodeoxycholic Acid (Paediatric)

Source: UK SPC (eMC) for Cholurso 250 mg Tablet, §4.2 (https://www.medicines.org.uk/emc/product/101999/smpc). PBC BODY-WEIGHT TABLE (first 3 months morning/midday/evening, then once daily in the evening): 47–62 kg = 12–16 mg/kg/day, 1/1/1 tablets then 3 in the evening; 63–78 kg = 13–16 mg/kg/day, 1/1/2 then 4; 79–93 kg = 13–16 mg/kg/day, 1/2/2 then 5; 94–109 kg = 14–16 mg/kg/day, 2/2/2 then 6; over 110 kg = 2/2/3 then 7. PBC STAGE IV with increased serum bilirubin (>40 µg/L conjugated): only half the normal dosage should initially be given (6 to 8 mg/kg/day, about 2 to 3 tablets), then monitor liver function closely every 2 weeks for 6 weeks and, if there is no deterioration and no increased pruritus, increase gradually to the usual level. Stage IV patients without increased bilirubin may receive the normal starting dose immediately, with the same close monitoring. If clinical symptoms worsen at the start of treatment (e.g. increased itching), continue with one 250 mg tablet daily and increase the daily dose weekly by one 250 mg tablet until the target regimen is reached. DISSOLUTION OF GALLSTONES (adults): approx. 10 mg/kg/day — up to 60 kg 2 tablets, 61–80 kg 3 tablets, 81–100 kg 4 tablets, above 100 kg 5 tablets, swallowed whole in the evening before bedtime; duration of dissolution is 6 months to 2 years; treatment must be continued for 3 to 4 months after ultrasound confirms complete dissolution; stop treatment if the stones calcify. ELDERLY: no evidence that any alteration in the adult dose is needed. FORMULATION NOTE: for patients weighing less than 47 kg or those unable to swallow the 250 mg film-coated tablets, other ursodeoxycholic acid formulations (e.g. oral suspension) should be checked for availability. MONITORING (§4.4): AST, ALT and gamma-GT every 4 weeks for the first 3 months, then every 3 months. If diarrhoea occurs the dose must be reduced, and therapy discontinued if diarrhoea persists.

SPC §4.2 'Paediatric population' states one paediatric regimen only: 'Children with cystic fibrosis aged 6 years to less than 18 years: 20 mg/kg/day in 2-3 divided doses, with a further increase to 30 mg/kg/day if necessary.' No paediatric posology is given for any other indication in this SPC. Note that §4.4 separately warns that ursodeoxycholic acid must not be used at doses beyond 20 mg/kg/day in the context of primary sclerosing cholangitis — a clinician should reconcile this with the 30 mg/kg/day cystic fibrosis ceiling. §4.3 contraindicates use in children with biliary atresia after unsuccessful portoenterostomy or without recovery of good bile flow. For patients weighing less than 47 kg or unable to swallow the tablets, another formulation (e.g. oral suspension) should be used. Verify all paediatric dosing against a children's formulary before prescribing.