Label: URSODIOL capsule

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 8, 2023

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  • SPECIAL NOTE
    Gallbladder stone dissolution with Ursodiol treatment requires months of therapy. Complete dissolution does not occur in all patients and recurrence of stones within 5 years has been observed in ...
  • DESCRIPTION
    Ursodiol Capsules, USP are a bile acid available as 300 mg capsules suitable for oral administration. Ursodiol (ursodeoxycholic acid) is a naturally occurring bile acid found in small ...
  • CLINICAL PHARMACOLOGY
    About 90% of a therapeutic dose of Ursodiol is absorbed in the small bowel after oral administration. After absorption, ursodiol enters the portal vein and undergoes efficient extraction from ...
  • INDICATIONS & USAGE
    1. Ursodiol capsules, USP are indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for ...
  • CONTRAINDICATIONS
    1. Ursodiol capsules will not dissolve calcified cholesterol stones, radiopaque stones, or radiolucent bile pigment stones. Hence, patients with such stones are not candidates for Ursodiol ...
  • WARNINGS
    Enteroliths in Patients with Risk for Intestinal Stenosis or Stasis - There have been rare postmarketing reports of ursodiol-treated patients who developed enteroliths (bezoars) resulting in ...
  • PRECAUTIONS
    Liver Tests - Ursodiol therapy has not been associated with liver damage. Lithocholic acid, a naturally occurring bile acid, is known to be a liver-toxic metabolite. This bile acid is formed in ...
  • ADVERSE REACTIONS
    The nature and frequency of adverse experiences were similar across all groups. The following tables provide comprehensive listings of the adverse experiences reported that occurred with a 5 ...
  • OVERDOSAGE
    Neither accidental nor intentional overdosing with Ursodiol has been reported. Doses of Ursodiol in the range of 16 - 20 mg/kg/day have been tolerated for 6 to 37 months without symptoms by 7 ...
  • DOSAGE & ADMINISTRATION
    Gallstone Dissolution - The recommended dose for Ursodiol capsules treatment of radiolucent gallbladder stones is 8 - 10 mg/kg/day given in 2 or 3 divided doses. Ultrasound images of the ...
  • HOW SUPPLIED
    Ursodiol Capsules, USP are beige opaque color capsule plain on the cap and imprinted with ‘E33’ on the body of the capsule in black ink filled with white to off white granular powder. Bottles ...
  • PRINCIPAL DISPLAY PANEL
    Ursodiol Capsules USP 300 mg 100s Label Text - Ursodiol Capsules, USP - 300 mg - Rx only - 100 CAPSULES     EYWA PHARMA
  • INGREDIENTS AND APPEARANCE
    Product Information