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Udison 300

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https://www.1mg.com/medicines/udisen-226838

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ursodeoxycholic acid UDCA clinical use

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Here is a complete profile of Udison 300 (Ursodeoxycholic Acid 300 mg):

Udison 300 - Ursodeoxycholic Acid (UDCA) 300 mg

What is it?

Udison 300 is a brand name tablet containing Ursodeoxycholic Acid (UDCA) 300 mg, also known as ursodiol. UDCA is a naturally occurring, hydrophilic bile acid formed by bacterial epimerization of chenodeoxycholic acid in the gut. It is a minor constituent of normal human bile (~5%) but has significant therapeutic effects when given in higher doses.

Mechanism of Action

UDCA works through several complementary pathways:
  1. Litholytic effect - Alters bile acid composition, decreases biliary lipid secretion, and reduces cholesterol content of bile, making it less lithogenic (less likely to form stones). It dissolves cholesterol crystals and decreases hepatic secretion of biliary cholesterol.
  2. Displacement of toxic bile acids - Replaces and displaces toxic, hydrophobic endogenous bile acids (e.g., chenodeoxycholic, lithocholic acid) that accumulate in cholestatic liver disease.
  3. Cytoprotective effects - Protects hepatocytes from injury caused by hydrophobic bile acids.
  4. Immunomodulatory effects - Has effects on the immune system that contribute to its benefit in autoimmune cholestatic diseases like primary biliary cholangitis.
(Goodman & Gilman's Pharmacological Basis of Therapeutics)

Approved Uses / Indications

IndicationDose
Gallstone dissolution (radiolucent, non-calcified, <20 mm)8-10 mg/kg/day in 2-3 divided doses
Gallstone prevention (e.g., post-bariatric surgery, rapid weight loss)300 mg twice daily
Primary Biliary Cholangitis (PBC)13-15 mg/kg/day in 2-4 divided doses with food
Cystic fibrosis-associated liver/biliary disease (children 6-18 yrs)As directed by physician
Prevention of parenteral nutrition-associated cholestasis (neonates)Under specialist guidance
Post-bariatric surgery note: After gastric bypass, the incidence of gallstone or sludge formation is ~30%. UDCA 300 mg twice daily for 6 months post-operatively reduces this to only 3%. (Sabiston Textbook of Surgery)

Pharmacokinetics (ADME)

  • Absorption: Majority absorbed by passive diffusion from the small intestine after oral administration
  • Distribution: Becomes a major biliary and plasma bile acid after administration
  • Metabolism: Conjugated with glycine or taurine in the liver; secreted into bile; undergoes enterohepatic circulation (95% reabsorbed)
  • Excretion: Primarily excreted in feces

Adverse Effects

Generally well tolerated at recommended doses. Common side effects include:
  • Headache
  • GI disturbances (nausea, vomiting, diarrhea, constipation, abdominal pain)
  • Hair loss (alopecia)
  • Pruritus (itching)
  • Back pain
At higher than recommended doses, serious adverse effects can occur. Drug hypersensitivity reactions (urticaria, angioedema) are rare but reported.

Important Contraindications & Precautions

  • Do not use in patients with obstruction of the liver or gallbladder (complete biliary obstruction)
  • Not suitable for calcified (radio-opaque) gallstones, pigment stones, or large stones >20 mm
  • Caution in patients with intestinal problems (Crohn's disease) or prior intestinal surgery - risk of intestinal blockage
  • Stones recur in >50% of patients at 5 years after discontinuation - treatment does not cure the underlying predisposition to stone formation (Mulholland & Greenfield's Surgery)
  • Monitor liver function (ALT, AST, ALP, bilirubin) every 4 weeks for first 3 months, then every 3 months in PBC patients

Drug Interactions

  • Avoid co-administration with cholestyramine, colestipol, or antacids containing aluminum - these bind UDCA in the gut and reduce its absorption
  • Oral contraceptives, estrogens, and clofibrate may increase biliary cholesterol secretion and counteract the effect of UDCA

Key Clinical Points

  • UDCA is the first-line treatment for primary biliary cholangitis (PBC) - it slows disease progression and improves liver biochemistry. Patients who don't respond adequately may be given obeticholic acid (a farnesoid X receptor agonist) as add-on therapy.
  • For gallstone dissolution, ultrasound monitoring every 6 months for the first year is recommended to assess response. If no partial dissolution after 12 months, treatment is unlikely to succeed.
  • A 2025 systematic review and meta-analysis (PMID: 39984850) found UDCA also has beneficial effects on cardiometabolic risk factors (blood pressure, metabolic syndrome markers), representing an emerging area of interest beyond its traditional hepatobiliary indications.
Udison 300 is a prescription medication. The dose and duration depend on the indication and should be supervised by a physician with appropriate monitoring.
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