What is the recommended dose of Udiliv (Ursodiol) for liver disease treatment?

Recommended Dosage of Ursodiol (Udiliv) for Liver Disease Treatment

For patients with cholestatic liver diseases such as primary sclerosing cholangitis (PSC), the recommended dose of Ursodiol (Udiliv) ranges from 13-15 mg/kg/day for primary biliary cirrhosis, while higher doses of 20-25 mg/kg/day may be considered for PSC, though evidence for efficacy is mixed and high doses may be harmful in late-stage disease. 1, 2

Dosage Recommendations by Condition

Primary Biliary Cirrhosis (PBC)

• 13-15 mg/kg/day is the standard recommended dose for PBC, typically administered in 2-3 divided doses 2, 3
• A dose-response study found that 13.5 mg/kg/day (approximately 900 mg/day for average weight adults) was the optimal dose for early-stage PBC 4
• Lower doses (8-10 mg/kg/day) show some biochemical improvement but may be less effective than higher doses 4, 5

Primary Sclerosing Cholangitis (PSC)

• Initial studies used 10-15 mg/kg/day, showing biochemical improvement but limited histological benefit 1
• Higher doses of 20-25 mg/kg/day demonstrated improvements in liver fibrosis histology and cholangiographic appearances 1
• Very high doses (28-30 mg/kg/day) showed potential harm in late-stage disease, with increased risk of reaching endpoints such as liver transplantation or development of varices 1
• Current evidence does not support routine use of UDCA in adult PSC patients 1

Gallstone Dissolution

• 8-10 mg/kg/day given in 2-3 divided doses is recommended 2
• Treatment should be monitored with ultrasound at 6-month intervals 2
• For gallstone prevention during rapid weight loss, 600 mg/day (300 mg twice daily) is recommended 2, 6

Administration Considerations

• Ursodiol should be administered in divided doses (typically 2-3 times daily) for better tolerance and efficacy 2, 3
• Treatment duration varies by condition:
  • For gallstone dissolution: continue until confirmed dissolution, typically requiring at least 6-12 months 2, 6
  • For chronic liver diseases: long-term therapy is generally required 1, 3
• If taking with other medications, maintain appropriate timing between doses to prevent potential interaction with absorption of other medications 7

Monitoring During Treatment

• Liver function tests should be monitored regularly to assess biochemical response 1, 8
• For gallstone treatment, ultrasound imaging should be obtained at 6-month intervals for the first year 2
• If partial stone dissolution is not seen by 12 months, the likelihood of success is greatly reduced 2

Efficacy and Safety Considerations

• Biochemical improvement (reduced liver enzymes) is typically seen within 3 months of initiating therapy 8, 3
• The efficacy of UDCA appears to be dose-dependent up to a certain threshold, with minimal additional benefit beyond optimal dosing 4, 5
• High-dose UDCA (28-30 mg/kg/day) may be harmful in late-stage PSC 1
• Common side effects are minimal, with most patients tolerating the medication well 3, 6

Special Populations

• For patients with cirrhosis, UDCA may have more pronounced effects on lowering serum liver enzymes 8
• In patients with PSC and ulcerative colitis, UDCA may have a role in reducing the risk of colonic dysplasia, though evidence is limited 1