What is the dosage and treatment regimen for Actigall (ursodiol)?

Actigall (Ursodiol) Dosage and Treatment Regimen

The recommended dosage of Actigall (ursodiol) varies by indication: 8-10 mg/kg/day for gallstone dissolution, 13-15 mg/kg/day for primary biliary cirrhosis, and 600 mg/day for gallstone prevention during rapid weight loss. 1

Dosage by Indication

Gallstone Dissolution

• 8-10 mg/kg/day divided into 2-3 doses 1
• Ultrasound monitoring should be performed at 6-month intervals for the first year to assess gallstone response 1
• Treatment should continue if partial dissolution is observed, with confirmation ultrasound within 1-3 months if complete dissolution appears to have occurred 1
• If partial dissolution is not seen by 12 months, success is unlikely 1

Primary Biliary Cirrhosis (PBC)

• 13-15 mg/kg/day is the optimal dose for PBC treatment 2, 3
• This dosage has been shown to improve liver biochemistry, slow disease progression, and reduce the need for liver transplantation 3, 4
• Higher doses (23-25 mg/kg/day) offer no additional benefit over the standard dose of 13-15 mg/kg/day 5
• Lower doses (5-7 mg/kg/day) are less effective at improving liver function tests and Mayo risk scores 5

Primary Sclerosing Cholangitis (PSC)

• 15-20 mg/kg/day is commonly used, though evidence of benefit is limited 2
• Doses should not exceed 20 mg/kg/day, as higher doses (28-30 mg/kg/day) have been associated with worse outcomes 6
• UDCA improves liver function tests but not histology or prognosis in PSC 6

Gallstone Prevention

• 600 mg/day (300 mg twice daily) for patients undergoing rapid weight loss 1

Administration Considerations

• Ursodiol should be taken with food to enhance absorption 1
• For PBC, treatment should be continued lifelong to prevent disease recurrence 6
• Regular monitoring of liver biochemistry is essential to assess treatment response 2

Patient Selection Factors

• For gallstone dissolution, best candidates have:
  • Small (<20 mm), radiolucent (cholesterol) stones 1, 7
  • Functioning gallbladder (visualized on imaging) 7
  • Floating or floatable stones (high cholesterol content) have up to 50% dissolution rate 1
• Ursodiol should not be used during pregnancy, in women likely to become pregnant, or in severe acute or chronic intrahepatic cholestasis 7

Monitoring and Follow-up

• For gallstone dissolution: ultrasound imaging at 6-month intervals for the first year 1
• For PBC: regular monitoring of liver biochemistry to assess treatment response 2
• Stone recurrence after dissolution has been observed in up to 50% of patients within 5 years of complete dissolution 1

Safety Profile

• Ursodiol is generally well tolerated with minimal side effects 5
• Common side effects may include nausea and mild dizziness in up to 25% of patients 2
• No patients discontinued ursodiol due to side effects or toxicity in comparative dose studies 5

Remember that treatment success depends on proper patient selection, adherence to the recommended dosage regimen, and regular monitoring to assess response and adjust therapy as needed.