Ursofalk

Generic Name: Ursodeoxycholic acid
Product Name: Ursofalk

Indication

Ursofalk is used in the treatment of chronic liver disease in which the flow of bile has stopped for some reason (eg. primary biliary cirrhosis, primary sclerosing cholangitis and cystic fibrosis-related cholestasis.

Action

The main ingredient of Ursofalk, ursodeoxycholic acid, is a substance that appears naturally in the body. It is used to treat cholestatic liver disease, although the mechanism is not fully understood.

Ursodeoxycholic acid alters the composition of bile, increasing concentrations of itself and decreasing amounts of toxic bile acids. It also increases bile flow.

There is some evidence that ursodeoxycholic acid may also act via an immunological mechanism, details of which are not fully understood.

Dose advice

Adults and the elderly

Diseases other than cystic fibrosis:

• 10-15mg/kg/day in two to four divided doses.

Cystic fibrosis patients:

• 20mg/kg/day in two to four divided doses.
• Ursofalk suspension should be used in patients under 34kg.

Children

• There is limited experience in children.
• Doses of 15-20mg/kg/day have been used in the few available studies.

* In all patients, there may be an initial increase in symptoms, especially itching. In these cases the dose can be reduced to 1 capsule or 5ml of Ursofalk suspension daily, gradually increasing to the recommended dose.

Schedule

Schedule 4

Common side effects

Diarrhoea occurs in up to 3% of cases. Pruritus may be experienced at initiation of treatment.

Uncommon side effects

Allergic reactions have been known to occur.

Other side effects that have been observed include:

• Increased cholestasis
• Nausea and vomiting
• Sleep disturbance

References

1. Orphan Australia Pty Ltd. Ursofalk Product Information. Berwick, Victoria: Orphan Australia Pty Ltd; 2000.
2. MIMS Australia. MIMSOnline Prescribing Information: Ursofalk [Online]. 2000 [cited 21/7/2000]. Available from: [URL Link]
3. [3] Orphan Australia Pty Ltd. Ursofalk Consumer Medicine Information. Berwick, Victoria: Orphan Australia Pty Ltd; 2000.

For further information talk to your doctor.