Applies to the following strengths: 300 mg; 250 mg; 500 mg
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Usual Adult Dose for:
Usual Pediatric Dose for:
Additional dosage information:
Usual Adult Dose for Biliary Cirrhosis
Tablets: 13 to 15 mg/kg/day orally in 2 to 4 divided doses with food
-Dose should be adjusted according to patient's need at physician's discretion.
Approved indication: For treatment of patients with primary biliary cirrhosis
Usual Adult Dose for Gallbladder Disease
Gallbladder stone dissolution: 8 to 10 mg/kg/day orally in 2 or 3 divided doses
Gallstone prevention: 300 mg orally twice a day
-Ultrasound images of gallbladder recommended at 6-month intervals for first year of therapy to monitor gallstone response. If gallstones appear to have dissolved, therapy should be continued and dissolution confirmed on a repeat ultrasound examination within 1 to 3 months.
-Most patients who eventually achieve complete stone dissolution show partial or complete dissolution at the first on-treatment reevaluation.
-If partial stone dissolution is not seen by 12 months of therapy, likelihood of success is greatly reduced.
-Safety of use beyond 24 months is not established.
-For dissolution of gallstones in patients with radiolucent, noncalcified gallbladder stones less than 20 mm in greatest diameter who are not candidates for cholecystectomy due to increased surgical risk (e.g., systemic disease, advanced age, idiosyncratic reaction to general anesthesia) or who refuse surgery
-For gallstone prevention in obese patients undergoing rapid weight loss
Usual Pediatric Dose for Gallbladder Disease
(Not approved by FDA)
Some experts recommend:
Parenteral nutrition-induced cholestasis in neonates:
Treatment: 30 mg/kg/day orally in 3 divided doses; some centers divide in 2 daily doses
With initiation of parenteral nutrition: 5 mg/kg/day orally in 4 divided doses beginning on day of life 3
With initiation of enteral feeding: Increase dose to 10 mg/kg/day orally in 4 divided doses.
When full enteral feedings reached: Increase dose to 20 mg/kg/day orally in 4 divided doses.
Infants: 10 to 15 mg/kg orally once a day
Treatment of TPN-induced cholestasis:
Infants and children: 30 mg/kg/day orally in 3 divided doses
Improvement in the hepatic metabolism of essential fatty acids in cystic fibrosis:
Children: 30 mg/kg/day orally in 2 divided doses
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
Consult WARNINGS section for dosing related precautions.
Data not available
-The 500 mg scored tablet may be broken in halves to provide recommended dose; segments should be swallowed unchewed with water due to bitter taste.
-Half-tablets (500 mg scored tablets broken in half): May be used for up to 28 days when stored in current packaging (bottles) at 20C to 25C (68F to 77F); should be stored separately from whole tablets.
-Hepatic: For capsules, monitor AST and ALT (start of therapy and thereafter as clinically indicated); for tablets, monitor bilirubin levels and liver function tests, including gamma-glutamyltransferase, alkaline phosphatase, AST, ALT (every month for 3 months after start of therapy then every 6 months thereafter)
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
More about ursodiol
- Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- Drug Images
- Drug Interactions
- Compare Alternatives
- Support Group
- Pricing & Coupons
- En Español
- 12 Reviews – Add your own review/rating
- Drug class: gallstone solubilizing agents