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Urso 250(trade name),
Urso DS(trade name),
Urso Forte(trade name)
Pregnancy Category: B
ClassificationTherapeutic: gallstone dissolution agents
Gallbladder stone dissolution and prevention.Primary biliary cirrhosis.Biliary atresia.TPN-induced cholestasis.
↓ cholesterol content of bile and bile stones by suppressing cholesterol synthesis and secretion from the liver and inhibits intestinal absorption of cholesterol.
Gallstone dissolution and reduction in gallstone formation.
↓ progression of liver disease and improvement in liver function tests.
Distribution: Only small quantities are found in the systemic circulation; sites of action include the liver, bile, and gut lumen.
Protein Binding: 70%.
Metabolism and Excretion: Undergoes extensive enterohepatic recycling; excreted in feces via bile.
Half-life: 100 hr.
Contraindicated in: Patients requiring cholecystectomy; Calcified cholesterol stones, radiopaque stones, bile pigment stones, or stones >20 mm;Complete biliary obstruction.
Use Cautiously in: Chronic liver disease.
Adverse Reactions/Side Effects
Central nervous system
- sleep disorder
- hair thinning
- abdominal/biliary pain
- ↑ liver enzymes
Drug-Drug interactionCholestyramine, colestipol, and aluminum-containing antacids may ↓ absorption.Estrogens may ↓ its effectiveness.
Oral (Adults) Gallstone dissolution—Initial 8–10 mg/kg/day in 2–3 divided doses; maintenance: 250 mg/day at bedtime for 6 mo–1 yr; Gallstone prevention—300 mg twice daily; Primary biliary cirrhosis—13–15 mg/kg/day in 2–4 divided doses.
Oral (Children and Infants) TPN-induced cholestasis—30 mg/kg/day in 2–3 divided doses.
Oral (Infants) Biliary atresia—10–15 mg/kg/day.
Availability (generic available)
Capsules: 300 mg
Tablets: 250 mg, 500 mg
- Monitor abdominal pain prior to and periodically during therapy.
- Monitor ultrasonograms at 6 mo intervals during the first year of therapy.
- Lab Test Considerations: Monitor liver function tests (GGT, alkaline phosphatase, AST, ALT) and bilirubin levels every mo for three mo and every six mo thereafter. If increase to clinically significant levels, consider discontinuation of therapy.
Potential Nursing DiagnosesAcute pain (Indications)
- Administer with food. Tablets may be broken in half and swallowed with water. To minimize the bitter taste, advise patient to swallow the half-tablet quickly without chewing. Half-tablets should be stored separately for up to 28 days.
- Instruct patient to take ursodiol as directed.
- Advise patient to avoid aluminum-containing antacids during therapy; may impair absorption.
- Dissolution and reduction in formation of gallstones. May take several mo of therapy and complete dissolution may not occur. Stone recurrence may occur after dissolution.
- ↓ progression of liver disease and improvement in liver function tests.
Actigall®A drug used to dissolve gallstones as an alternative to cholecystectomy in patients with radiolucent, noncalcified gallstones ≤ 20 mm in diameter, and to prevent gallstone development in patients undergoing rapid weight loss.
Contraindications Actigall does not dissolve calcified cholesterol stones, radiopaque stones, or radiolucent bile pigment stones. It is useless for acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula.