From the Guidelines
The recommended dosage of Ursodeoxycholic acid (UDCA) is 10-15 mg/kg/d, which can be given to patients with SC-CIP or ABCB4 deficiency. This dosage is based on the most recent and highest quality study, which suggests that low-to-medium-dose UDCA can be effective in patients with these conditions 1. The study, published in the Journal of Hepatology in 2022, recommends this dosage range due to the anti-cholestatic and anti-inflammatory effects of UDCA, as well as its protective effects on biliary epithelia.
Some key points to consider when prescribing UDCA include:
- The dosage should be adjusted based on body weight, with heavier patients requiring doses at the higher end of the range
- UDCA should be taken consistently with food to maximize absorption and effectiveness
- Common side effects include diarrhea and stomach discomfort, which typically improve with continued use
- Patients with SC-CIP or ABCB4 deficiency may require long-term or lifelong treatment with UDCA
It's worth noting that while the evidence for UDCA in SC-CIP and ABCB4 deficiency is not yet conclusive, the available data suggest that it can be a useful treatment option for these conditions 1. Additionally, UDCA has been shown to be effective in improving maternal symptoms and reducing the risk of adverse perinatal outcomes in patients with intrahepatic cholestasis of pregnancy 1. However, the most recent and highest quality study should always be prioritized when making treatment decisions, and in this case, the recommended dosage of 10-15 mg/kg/d is based on the study published in the Journal of Hepatology in 2022 1.
From the FDA Drug Label
The recommended dose for ursodiol capsules treatment of radiolucent gallbladder stones is 8 to 10 mg/kg/day given in 2 or 3 divided doses. The recommended dosage of ursodiol capsules for gallstone prevention in patients undergoing rapid weight loss is 600 mg/day (300 mg b.i.d.).
The dosage of Ursodeoxycholic acid (UDCA) is:
- 8 to 10 mg/kg/day in 2 or 3 divided doses for gallstone dissolution
- 600 mg/day (300 mg b.i.d.) for gallstone prevention in patients undergoing rapid weight loss 2
From the Research
Dosage of Ursodeoxycholic Acid (UDCA)
- The optimum dose of UDCA is 900 mg/day, which is equivalent to 13.5 mg/kg/day, as determined by a study on primary biliary cirrhosis 3.
- Another study used a dose range of 10-15 mg/kg/day for patients with primary sclerosing cholangitis 4.
- A meta-analysis of randomized clinical trials found that standard doses of UDCA (around 10-15 mg/kg/day) were used in five studies, while three studies used high doses (>15 mg/kg/day) 5.
- A study on the therapeutic effects of UDCA as an anti-apoptotic agent did not specify a particular dose, but mentioned that UDCA has been in widespread clinical use since the mid 1980s for gallstone dissolution and chronic cholestatic liver diseases 6.
- A prospective, randomized, double-blind clinical trial used a dose of 500 mg of UDCA every 12 hours for 7 days to analyze its effect on liver regeneration capacity after living donor hepatectomy 7.
Key Findings
- The dose of 900 mg/day of UDCA produced the greatest enrichment of UDCA in serum bile acids and trend towards normalization of abnormal liver function tests in a dose-dependent manner 3.
- UDCA withdrawal resulted in significant deterioration in liver biochemistry and increase of Mayo Risk Score for PSC 4.
- Neither standard nor high-dose UDCA influenced favorably the progression of primary sclerosing cholangitis 5.
- Postoperative administration of oral UDCA significantly improved liver function tests and INR among living liver donors 7.