Urso Forte

Generic name: Ursodiol

Drug class: Gallstone solubilizing agents

Dosage form: 500 mg scored tablet

Route of administration: Oral

Dose: 13–15 mg/kg/day, administered in two to four divided doses with food

Mechanism of action: Ursodiol reduces the cholesterol content of bile by inhibiting hepatic cholesterol secretion and increasing bile acid secretion, leading to the gradual dissolution of cholesterol gallstones. It also has cytoprotective effects on bile duct epithelial cells and inhibits apoptosis of hepatocytes.

Drug usage cases:

• Treatment of primary biliary cholangitis (PBC)
• Dissolution of small cholesterol gallstones in patients who are not candidates for surgery
• Prevention of gallstone formation in obese patients undergoing rapid weight loss

Drug contraindications:

• Complete biliary obstruction
• Known hypersensitivity or intolerance to ursodiol or any component of the formulation

Side effects:

• Abdominal discomfort or pain
• Alopecia (hair loss)
• Diarrhea
• Nausea
• Pruritus (itching)
• Rash
• Leukopenia (low white blood cell count)
• Elevated creatinine or blood glucose levels
• Thrombocytopenia (low platelet count)

Warnings:

• Liver function tests (γ-GT, alkaline phosphatase, AST, ALT) and bilirubin levels should be monitored monthly for the first three months of therapy, and every six months thereafter. Treatment discontinuation should be considered if these parameters increase to a level considered clinically significant in patients with stable historical liver function test levels.
• Caution should be exercised to maintain bile flow in patients taking ursodiol.
• Rare cases of enteroliths (bezoars) have been reported in patients with risk factors for intestinal stenosis or stasis. If a patient presents with obstructive gastrointestinal symptoms, hold ursodiol until a clinical evaluation has been conducted.

Use during pregnancy or breastfeeding: The safety of ursodiol during pregnancy and breastfeeding has not been established. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when administering ursodiol to a nursing woman, as it is not known whether ursodiol is excreted in human milk.