II. Mechanism

  1. Bile Acid Oral Dissolution Therapy in general
    1. Decreases biliary Cholesterol hepatic secretion
    2. Forms unsaturated bile
    3. Promotes dissolution of Cholesterol crystals and Gallstones
  2. Ursodeoxycholic Acid (UDCA, Ursodiol)
    1. Naturally occurring hydrophilic bile acid
    2. Protects bile ducts by detoxifying hydrophobic bile acids
    3. Decreases cholic acid and increases Chenodeoxycholic Acid levels
      1. Reverses the effects of Intrahepatic Cholestasis of Pregnancy

III. Indications

  1. Intrahepatic Cholestasis of Pregnancy (Ursodeoxycholic Acid only)
  2. Cholelithiasis
    1. Comorbid condition that precludes safe Cholecystectomy and symptomatic Gallstones
    2. Symptomatic patient unwilling to undergo surgery
      1. Small Gallstones (<5mm) with functioning gallbladder and no cystic duct obstruction

IV. Contraindications

  1. Excludes the 85% of patients who cannot meet the following criteria
    1. Gallstones >0.5mm (as opposed to the normal small, floating, CholesterolGallstones)
    2. Non-functional Gallbladder

V. Dosing: Ursodiol or Ursodeoxycholic Acid (UDCA, Actigal)

  1. Dose: 8-15 mg/kg/day or 500 mg orally twice daily
  2. Course: 6-12 months (in symptomatic Gallstones) or until delivery in Intrahepatic Cholestasis of Pregnancy

VI. Dosing: Chenodeoxycholic Acid

  1. Do NOT use in pregnancy (Pregnancy Category X)
  2. Start: 250 mg twice daily for 2 weeks
  3. Titrate
    1. Increase by 250 mg/day each week
    2. Maximum: 13-16 mg/kg/day divided bid (or until sub-maximal dose that is tolerated)

VII. Efficacy: Cholelithiasis

  1. Stones dissolving over 6-12 months: 60-90%
  2. Stones reoccuring within 5 years: 25-50%
  3. Better prognosis associated factors
    1. Single Gallstone AND
    2. Non-obese AND
    3. Young patient

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Related Studies

Cost: Medications

ursodiol (on 5/17/2017 at Medicaid.Gov Survey of pharmacy drug pricing)
URSODIOL 250 MG TABLET Generic $1.21 each
URSODIOL 300 MG CAPSULE Generic $3.34 each
URSODIOL 500 MG TABLET Generic $2.25 each