What are the indications and usage of Udiliv (Ursodeoxycholic acid) Tablet?

Indications and Usage of Udiliv (Ursodeoxycholic Acid) Tablet

Udiliv (Ursodeoxycholic acid) is primarily indicated for the treatment of primary biliary cirrhosis (PBC), dissolution of small radiolucent gallstones, and prevention of gallstone formation in obese patients experiencing rapid weight loss.

Primary Indications

1. Primary Biliary Cirrhosis (PBC)

• Dosage: 13-15 mg/kg/day 1, 2
• Efficacy: Improves liver function tests and prolongs survival in PBC patients 3
• Mechanism: Works through multiple mechanisms including:
  • Stimulation of hepatobiliary secretion
  • Stabilization of biliary bicarbonate umbrella
  • Inhibition of hepatocyte and cholangiocyte apoptosis
  • Reduction of endoplasmic reticulum stress induced by toxic endogenous bile acids 3

2. Gallstone Management

• Indication: For patients with radiolucent, noncalcified gallstones < 20 mm in greatest diameter 4
• Patient selection: Appropriate for patients with increased surgical risk due to:
  • Systemic disease
  • Advanced age
  • Idiosyncratic reaction to general anesthesia
  • Patients who refuse surgery 4
• Dosage: Approximately 10-12 mg/kg/day 5
• Safety note: Treatment beyond 24 months is not established 4

3. Prevention of Gallstone Formation

• Indicated for obese patients experiencing rapid weight loss 4

Secondary Uses (Off-label)

1. Primary Sclerosing Cholangitis (PSC)

• Important caution: Current guidelines recommend against routine use of UDCA in adult patients with PSC 1
• Exception: May be considered in PSC patients with overlap syndrome (PSC with autoimmune hepatitis features) in combination with immunosuppressive agents 1, 6
• Dosing considerations:
  • Low doses (10-15 mg/kg/day) may improve biochemical parameters but not disease progression 1
  • High doses (28-30 mg/kg/day) may be harmful in late-stage disease 1, 7

2. Intrahepatic Cholestasis of Pregnancy

• Dosage: 10-15 mg/kg/day in divided doses, can be increased to 25 mg/kg/day for refractory symptoms 6
• Benefits: Improves maternal pruritus and liver test abnormalities 6

Dosing Considerations

• Optimal dose for PBC: 13.5 mg/kg/day (approximately 900 mg/day for average adult) 2
• Maximum bile acid enrichment: Achieved at approximately 900 mg/day 2
• Pediatric dosing: Weight-based, typically 10-15 mg/kg/day 6
• Caution: Very narrow therapeutic window between recommended dose (13 mg/kg/day) and toxic dose (28 mg/kg/day) 7

Safety Profile and Adverse Effects

• Common side effects: Generally well-tolerated; may cause mild gastrointestinal symptoms
• Serious adverse effects (rare but reported):
  • Hepatitis
  • Pruritus
  • Cholangitis
  • Ascites
  • Severe watery diarrhea 7
• Long-term concerns:
  • Potential increase in hepatocellular carcinoma in PBC when biochemical response is not achieved 7
  • Transformation into lithocholic acid that may induce DNA strand breakage 7

Monitoring Recommendations

• Regular assessment of liver function tests
• Monitoring for development of overlap syndromes in cholestatic conditions
• In pregnant women, monitoring of bile acid levels and vitamin K status 6

Clinical Pearls

• UDCA reaches maximum biliary concentration of 50-60% of total bile acids at doses of 10-12 mg/kg/day 5
• Efficacy in gallstone dissolution is affected by stone size and number (larger stones and increased number hinder dissolution) 5
• Most biliary symptoms tend to improve within 3 months of starting therapy 5
• For PBC, UDCA should be continued long-term as it improves survival 3