Adult Dosing
Gallstone dissolution
- 8-10 mg/kg/day PO divided bid-tid
Gallstone prevention in obese patients undergoing rapid weight loss
- 300 mg PO bid. Max: 600 mg/day
Primary Biliary Cirrhosis
- 13-15 mg/kg/day PO divided bid-qid given with food
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
See Supplemental Patient Information
- Gallbladder stone dissolution requires months of therapy. Complete dissolution does not occur in all patients
- Gall stones may recur within 2 yrs in 30% of patients and within 5 yr in 50% of patients
- Patients with hepatic encephalopathy, variceal bleeding, ascites or in need of an urgent liver transplant should receive appropriate specific treatment
- Calcified cholesterol stones, radiopaque stones, or radiolucent bile pigment stones do not dissolve with ursodiol therapy
- Patients with acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary gastrointestinal fistula should not be considered for ursodiol therapy
- Gallbladder nonvisualization developing during therapy predicts failure of complete stone dissolution. Treatment should be discontinued in such cases
- Bile acid sequestering agents and aluminum-based antacids may interfere with the action of ursodiol by reducing its absorption
- Safety beyond 24 months of treatment is not established
- Liver function tests (gamma-GT, alkaline phosphatase, AST, ALT) and bilirubin levels should be monitored every month for three months after initiation of therapy, and then after every 6 months
- Perform gallbladder ultrasound at 6-month intervals for first year of therapy to monitor gallstone response
Cautions: Use cautiously in
Supplemental Patient Information
- Should be taken with food
Pregnancy Category:B
Breastfeeding: Due to the low levels of ursodiol in breastmilk, amounts ingested by the infant would be small and would not be expected to cause any adverse effects in breastfed infants. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 20 July 2010). Manufacturer advises caution.
US Trade Name(s)
- Actigall
- Urso 250
- Urso Forte
US Availability
ursodiol (generic)
- TABS: 250, 500 mg
- CAPS: 300 mg
Actigall
Urso 250
Urso Forte
Canadian Trade Name(s)
Canadian Availability
ursodiol (generic)
Urso
Urso DS
UK Trade Name(s)
- Destolit
- Urdox
- Ursofalk
- Ursogal
UK Availability
ursodeoxycholic acid (generic)
Destolit
Urdox
Ursofalk
- CAPS: 250 mg
- SUSP: 250 mg/5 mL (250 mL)
Ursogal
Australian Trade Name(s)
Australian Availability
Ursofalk
- CAPS: 250 mg
- SUSP: 50 mg/mL (250 mL)
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- Ursodiol 250 MG TABS [Bottle] (TEVA PHARMACEUTICALS USA)
100 mg = $214
300 mg = $541.98 - Ursodiol 300 MG CAPS [Bottle] (TEVA PHARMACEUTICALS USA)
30 mg = $71.99
90 mg = $201.98 - Actigall 300 MG CAPS [Bottle] (WATSON LABS)
30 mg = $198.98
90 mg = $551 - Ursodiol 500 MG TABS [Bottle] (TEVA PHARMACEUTICALS USA)
100 mg = $404.99
300 mg = $1114.01 - Urso Forte 500 MG TABS [Bottle] (AXCAN PHARMA US)
30 mg = $185.99
90 mg = $526 - Urso 250 250 MG TABS [Bottle] (AXCAN PHARMA US)
30 mg = $106.46
90 mg = $297.01
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.