URSODOX

What it is

URSODOX is a medicine containing 250 mg of ursodeoxycholic acid per capsule. It is supplied as white hard gelatine capsules containing white or almost white powder.

Approved indications —

Chronic cholestatic liver diseases

Dosing overview

For primary biliary cirrhosis and chronic cholestatic liver diseases other than cystic fibrosis-related cholestasis and primary sclerosing cholangitis, the recommended dosage is 12–16 mg/kg body weight per day. For cystic fibrosis-related cholestasis, the recommended dose is 20 mg/kg per day. For primary sclerosing cholangitis, the dosage of 10–15 mg/kg body weight per day is recommended. A dosage of 20 mg/kg body weight per day has also been shown to improve histology and liver function tests in primary sclerosing cholangitis patients. URSODOX capsules are intended for oral administration and should be swallowed whole with some liquid. For primary biliary cirrhosis patients, capsules should be taken in 2 to 3 doses over the day during the first 3 months of treatment, and with improvement of liver function parameters, the daily dose may be taken as a single dose in the evening. For other cholestatic liver diseases, capsules should be taken in 2 to 3 doses over the day.

Key safety warnings

During the first three months of therapy, it is advisable to monitor liver parameters of AST, ALT and GGT every 4 weeks, subsequently every 3 months. This monitoring enables identification of responders and non-responders in patients being treated for primary biliary cirrhosis, and enables early detection of potential hepatic deterioration, particularly in patients with advanced stage primary biliary cirrhosis. If diarrhoea occurs, the dose must be reduced and in cases of persistent diarrhoea, the therapy should be discontinued. Long periods of high dose URSODOX therapy (28–30 mg/kg) in patients with primary sclerosing cholangitis may be associated with a higher rate of serious adverse events. Some drugs, such as cholestyramine, charcoal, colestipol and certain antacids containing aluminium hydroxide and/or smectite bind to ursodeoxycholic acid in the intestine and inhibit its absorption and efficacy. If the use of a preparation containing one of these substances is necessary, it must be taken at least 2 hours before or after URSODOX.

Contraindications

URSODOX must not be used if there is hypersensitivity to the active ingredient or any of the excipients.

PBS listing

URSODOX 500 mg capsules are listed on the PBS with streamlined authority restrictions at an ex-manufacturer price of A$255.00.

Regulatory history

URSODOX was first listed on the Australian Register of Therapeutic Goods in February 2016, with registrations for 250 mg and 500 mg capsule formulations.