ursodiol
ursodiol is listed in the FDA National Drug Code directory with 7 NDC codes, marketed under brand names including URSODIOL, URSOLIGN. Available dosage forms: powder, capsule, tablet.
Drug Details
- Generic Name
- ursodiol
- Brand Names
- URSODIOL, URSOLIGN
- Application Number
- ANDA210344
- Sponsor
- Arch Pharmalabs Limited
- NDC Codes
- 7
- Dosage Forms
- POWDER, CAPSULE, TABLET
- Routes
- ORAL
- Active Ingredients
- URSODIOL
Indications and Usage
INDICATIONS AND USAGE Ursodiol is indicated for patients with radiolucent, noncalcified gallbladder stones < 20 mm in greatest diameter in whom elective cholecystectomy would be undertaken except for the presence of increased surgical risk due to systemic disease, advanced age, idiosyncratic reaction to general anesthesia, or for those patients who refuse surgery. Safety of use of Ursodiol beyond 24 months is not established. Ursodiol is indicated for the prevention of gallstone formation in obese patients experiencing rapid weight loss.
Warnings
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 obstructive symptoms that required surgical intervention. These patients had medical conditions that predisposed them to intestinal stenosis or stasis (e.g., surgical enteroanastomoses, Crohn's disease). If a patient presents with obstructive gastrointestinal symptoms, hold Ursodiol until a clinical evaluation has been conducted.