What is the dose of Ursodiol (Ursodeoxycholic acid) for cholestasis of pregnancy?

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Last updated: April 25, 2025View editorial policy

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From the Guidelines

Ursodeoxycholic acid (UDCA) should be prescribed at a dose of 10-15 mg/kg/day for intrahepatic cholestasis of pregnancy (ICP), as recommended by the most recent and highest quality study 1. This dosage is supported by the American Gastroenterological Association's clinical practice update on pregnancy-related gastrointestinal and liver disease, which suggests that treatment should be offered with oral ursodeoxycholic acid in a total daily dose of 10–15 mg/kg 1. The typical starting dose for UDCA treatment can be divided into 2 or 3 daily doses, with typical regimens being 300 mg twice or 3 times daily or 500 mg twice daily, as noted in the Society for Maternal-Fetal Medicine consult series 1. Key points to consider when treating ICP with UDCA include:

  • The medication works by improving bile flow, reducing bile acid levels in the maternal bloodstream, and protecting the liver from damage caused by toxic bile acids.
  • UDCA is generally well-tolerated during pregnancy with minimal side effects, which may include mild gastrointestinal symptoms like diarrhea.
  • While UDCA helps relieve maternal itching and may improve liver function tests, it's essential to note that ICP still requires close monitoring of the pregnancy, as it is associated with increased risks of preterm birth, fetal distress, and stillbirth.
  • Regular liver function tests and bile acid measurements should continue throughout treatment, and delivery timing should be considered carefully, often around 37-38 weeks gestation depending on symptom severity and bile acid levels, as suggested by the European Association for the Study of the Liver guidelines and the Society for Maternal-Fetal Medicine consult series 1.

From the Research

Ursodeoxycholic Acid Dosage for Cholestasis of Pregnancy

  • The dosage of ursodeoxycholic acid (UDCA) for the treatment of intrahepatic cholestasis of pregnancy (ICP) varies across studies, but a common dosage is around 8-10 mg/kg body weight daily 2 or 14.0 mg/kg/day 3.
  • One study used a fixed dose of 1 g per day orally 4, while another used 4×250 mg daily 5.
  • The duration of treatment also varies, with some studies treating patients until delivery 5, 2, 4, 3 and others for a specific period, such as 14 days 2 or 2-3 weeks 3.

Efficacy and Safety of UDCA

  • UDCA has been shown to be effective in reducing pruritus, improving liver function tests, and decreasing serum bile acid levels in patients with ICP 6, 5, 2, 4, 3.
  • UDCA is also considered safe for use in pregnancy, with no adverse effects reported in the mothers or babies 5, 2, 4, 3.
  • The response to UDCA treatment may be predicted by factors such as ALT levels before treatment, with higher levels associated with improvement of pruritus and decreased ALT 3.

Comparison with Other Treatments

  • UDCA has been compared to other treatments, such as cholestyramine 2 and S-adenosylmethionine (SAMe) 5, and has been found to be more effective in reducing pruritus and improving liver function tests.
  • UDCA monotherapy is recommended as the first-line therapy for ICP due to its efficacy, cost-effectiveness, and convenience 5.

References

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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