Urso Suspension (120 mL) – Ursodeoxycholic Acid (250 mg/5 mL)

Composition:

• Active Ingredient: Ursodeoxycholic acid 250 mg per 5 mL of suspension

Indications:

• Used for the treatment of:
  • Primary biliary cholangitis (PBC)
  • Cholesterol gallstones in patients who are not surgical candidates
  • Liver disorders associated with biliary dysfunction

Mechanism of Action:

• Ursodeoxycholic acid is a bile acid that helps to reduce cholesterol levels in bile, facilitating the dissolution of cholesterol gallstones. It also has cytoprotective effects on liver cells and can improve liver function by promoting bile flow.

Dosage:

• The usual dosage may vary based on the condition being treated:
  • For adults with PBC, the typical starting dose is 13-15 mg/kg/day, which may be adjusted by a healthcare provider.
  • For gallstone dissolution, dosing usually involves 8-10 mg/kg/day.
• The suspension should be taken with food to enhance absorption.

Side Effects:

• Common Side Effects: Diarrhea, abdominal pain, nausea, and flatulence.
• Serious Side Effects: Allergic reactions, liver enzyme elevation, and gastrointestinal bleeding (rare).

Contraindications:

• Not recommended for individuals with:
  • Known hypersensitivity to ursodeoxycholic acid or any components of the formulation.
  • Severe liver dysfunction or biliary obstruction.

Storage:

• Store at room temperature, away from moisture and direct sunlight. Once opened, follow specific storage instructions as per the packaging.

Precautions:

• Use with caution in patients with liver disease or those on medications that may affect liver function.
• Regular monitoring of liver function tests may be necessary during treatment.

Patient Counseling:

• Advise patients to take the suspension as directed and to shake well before use to ensure proper dosing.
• Discuss potential side effects, particularly gastrointestinal symptoms, and the importance of reporting any severe reactions.
• Encourage adherence to the treatment regimen and maintaining follow-up appointments for monitoring liver health.

For personalized advice and specific recommendations, always consult with a healthcare professional or refer to the product packaging.