Ursodiol
Ursodiol is a naturally occurring bile acid used to dissolve gallstones and treat certain liver diseases. It works by reducing the amount of cholesterol released by your liver and by slowly dissolving the cholesterol that has formed into stones.
Dosage by Body Weight
Adult dosing for gallstone dissolution is typically 8-10 mg/kg/day in 2 to 3 divided doses. For PBC, the dose is 13-15 mg/kg/day in 2 to 4 divided doses. Pediatric dosing for cholestasis is typically 15-30 mg/kg/day divided into 2 to 3 doses. Requires liquid compounding for low body weight patients.
- Body Weight
- Below 5 kg
- Dose
- 25 mg to 50 mg daily
- Frequency
- Divided into 2 doses daily
- Tracking Notes
- Requires a custom compounded oral liquid suspension. Use only under strict pediatric specialist supervision.
- Body Weight
- 5-7 kg
- Dose
- 50 mg to 75 mg daily
- Frequency
- Divided into 2 doses daily
- Tracking Notes
- To be administered as a compounded liquid formulation. Monitor liver function regularly.
- Body Weight
- 8-10 kg
- Dose
- 80 mg to 100 mg daily
- Frequency
- Divided into 2 doses daily
- Tracking Notes
- Doses are calculated based on approximately 10-15 mg/kg/dose.
- Body Weight
- 11-15 kg
- Dose
- 110 mg to 150 mg daily
- Frequency
- Divided into 2 doses daily
- Tracking Notes
- Adjustments should be made by a physician based on clinical response and tolerability.
- Body Weight
- 16-20 kg
- Dose
- 160 mg to 200 mg daily
- Frequency
- Divided into 2 doses daily
- Tracking Notes
- If tablets or capsules are used, they must be safely split or prepared by a pharmacist if the child cannot swallow them whole.
| Body Weight | Dose | Frequency | Tracking Notes |
|---|---|---|---|
| Below 5 kg | 25 mg to 50 mg daily | Divided into 2 doses daily | Requires a custom compounded oral liquid suspension. Use only under strict pediatric specialist supervision. |
| 5-7 kg | 50 mg to 75 mg daily | Divided into 2 doses daily | To be administered as a compounded liquid formulation. Monitor liver function regularly. |
| 8-10 kg | 80 mg to 100 mg daily | Divided into 2 doses daily | Doses are calculated based on approximately 10-15 mg/kg/dose. |
| 11-15 kg | 110 mg to 150 mg daily | Divided into 2 doses daily | Adjustments should be made by a physician based on clinical response and tolerability. |
| 16-20 kg | 160 mg to 200 mg daily | Divided into 2 doses daily | If tablets or capsules are used, they must be safely split or prepared by a pharmacist if the child cannot swallow them whole. |
Formulation
Purpose
Used to dissolve cholesterol gallstones, prevent gallstone formation in obese patients undergoing rapid weight loss, and treat primary biliary cholangitis (PBC).
Generic Name
UrsodiolBranded Drug Names
Ursodiol is listed as a generic drug name. Common branded medicines that may contain the same active ingredient include:
Scheduled Drug
No. This medicine is generally not treated as a scheduled/prescription-only drug in common consumer references, but local rules may vary.