Ursodiol 300 mg TDS for Hyperbilirubinemia with Bilirubin of 36
For a patient with hyperbilirubinemia (bilirubin level of 36), Ursodiol (Ursodeoxycholic acid) at 300 mg TDS (three times daily) is an appropriate dosage, as it aligns with the recommended total daily dose of 10-15 mg/kg/day for cholestatic liver conditions.
Dosage Considerations for Hyperbilirubinemia
- The recommended dosage of Ursodiol for cholestatic liver conditions is 10-15 mg/kg/day, which for an average adult would typically equate to 600-900 mg daily, divided into multiple doses 1.
- 300 mg TDS (900 mg daily) falls within this recommended range for most adults, assuming an average weight of 60-90 kg 2.
- For primary biliary cirrhosis, the optimal dose has been established as 13-15 mg/kg/day, which corresponds to approximately 900 mg daily for a 70 kg adult 3, 4.
Efficacy of Ursodiol at This Dosage
- Studies have demonstrated that a dosage of 13-15 mg/kg/day (approximately 900 mg daily for a 70 kg adult) provides optimal biochemical improvement in cholestatic liver conditions 5.
- Comparative studies of different Ursodiol doses have shown that 900 mg/day provides the greatest enrichment of UDCA in serum bile acids and significant improvements in liver function tests 3.
- Lower doses (250-500 mg/day) show some benefit but are less effective than the 900 mg/day dosage 6.
Cautions and Considerations
- Higher doses of Ursodiol (28-30 mg/kg/day) have shown potential harm in late-stage primary sclerosing cholangitis, with increased risk of reaching endpoints such as liver transplantation or development of varices 1.
- For intrahepatic cholestasis of pregnancy, the recommended dosage is also 10-15 mg/kg/day, supporting the appropriateness of the 300 mg TDS regimen 1.
- Increasing the dose beyond 900 mg/day (to 1200 mg/day) does not provide additional significant benefits in most patients 3, 4.
Monitoring Recommendations
- Regular monitoring of liver function tests is essential to assess response to therapy 1.
- Bilirubin levels should be closely monitored as they are an important prognostic factor in cholestatic liver disease 6.
- If inadequate response is observed after several months of treatment, increasing the dose is unlikely to provide additional benefit 7.
Special Considerations
- For patients with primary sclerosing cholangitis specifically, the American Association for the Study of Liver Diseases does not recommend routine use of UDCA 1.
- For patients with primary biliary cirrhosis, the 300 mg TDS dosage is appropriate and supported by clinical evidence 1, 5.
- If the patient has intrahepatic cholestasis of pregnancy, this dosage is appropriate and has been shown to improve outcomes 1.
The 300 mg TDS dosage of Ursodiol is appropriate for treating hyperbilirubinemia with a bilirubin level of 36, as it aligns with evidence-based recommendations for cholestatic liver conditions 2, 4.