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Ursodiol Dosage

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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

Comments:
-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

Capsules:
Gallbladder stone dissolution: 8 to 10 mg/kg/day orally in 2 or 3 divided doses
Gallstone prevention: 300 mg orally twice a day

Comments:
-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.

Approved indications:
-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

Prevention:
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.

Biliary atresia:
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

Precautions

Consult WARNINGS section for dosing related precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-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.

Storage requirements:
-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.

Monitoring:
-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)

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