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MEDICINE MONOGRAPH CODE: [5.20] ID: TIP-MED-000088

Ursodeoxycholic Acid (UDCA)

Active Ingredient / Scientific Identity: Ursodeoxycholic Acid • Class: Hydrophilic Cytoprotective & Choleretic Bile Acid (Schedule H)

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THE INDIAN PHARMACIST — Educational Reference Sheet
Profile: Ursodeoxycholic Acid (UDCA) ([5.20] | ID: TIP-MED-000088) • Last Reviewed: 2026-11-10
Source URL: https://theindianpharmacist.com/medicine/5-20-ursodeoxycholic-acid-udca/
Generic / Entity NameUrsodeoxycholic Acid (UDCA) ([5.20])
Verified Indian Brands / RefGeneric Compendial Entry (No Commercial Brand Claimed)
Pharmacological ClassHydrophilic Cytoprotective & Choleretic Bile Acid (Schedule H)
Available Dosage FormsTablets / Capsules: 150 mg, 300 mg, 450 mg SR, 600 mg
Regulatory ClassificationNon-Schedule / OTC or Schedule K Permitted Preparation (Medical Supervision Recommend
Key Warning & Review DateRenal: No adjustment needed (hepatobiliary clearance). Hepatic: Therapeutic in cholestatic liver disease; monitor LFTs
Reviewed: 2026-11-10
Safety Matrix:⚖️ Legal Status: Non-Schedule / OTC or Schedule K Permitted Preparati✔️ Standard Clinical Dispensing Precautions

1. Clinical & Scientific Overview

Ursodeoxycholic Acid (UDCA) (TIP-MED-000088, Reference Code [5.20]) is classified under Gastrointestinal & Hepatobiliary Medicines (Ch 05) as a Hydrophilic Cytoprotective & Choleretic Bile Acid (Schedule H). Within the Indian regulatory and compendial framework, it is governed under Non-Schedule / OTC or Schedule K Permitted Preparation (Medical Supervision Recommended for High-Dose/Therapeutic Regimens).

Verified Indian Market Examples / Compendial Status:
Representative Indian Market Examples (Edition 2.7 Ch 05 [5.20], p. 69): Udiliv (Abbott), Ursocol / Ursocol SR (Sun), Actibile (Zydus) — Strengths & Dosage Forms: Tablets / Capsules: 150 mg, 300 mg, 450 mg SR, 600 mg
Representative Indian Market Examples (Edition 2.7 Ch 05 [5.20], p. 69): Udiliv (Abbott), Ursocol / Ursocol SR (Sun), Actibile (Zydus) — Strengths & Dosage Forms: Tablets / Capsules: 150 mg, 300 mg, 450 mg SR, 600 mg
Dosage Forms & Available Strengths:
Tablets / Capsules: 150 mg, 300 mg, 450 mg SR, 600 mg
Routes: Oral / Parenteral / Topical as specified by formulation

3. Mechanism of Action & Pharmacodynamics

Hydrophilic Cytoprotective & Choleretic Bile Acid (Schedule H) acting on target receptor/enzyme pathways in Gastrointestinal & Hepatobiliary Medicines (Ch 05): clinical efficacy is mediated via Hydrophilic Cytoprotective & Choleretic Bile Acid (Schedule H) for Intrahepatic Cholestasis of Pregnancy (ICP — relieves maternal pruritus & protects foetus), Primary Biliary Cholangitis (PBC), dissolution of radiolucent cholesterol gallstones, drug-induced cholestatic liver injury, and NASH/MAFLD.

4. Therapeutic Indications & Evidence-Supported Uses

  • Intrahepatic Cholestasis of Pregnancy (ICP — relieves maternal pruritus & protects foetus), Primary Biliary Cholangitis (PBC), dissolution of radiolucent cholesterol gallstones, drug-induced cholestatic liver injury, and NASH/MAFLD

🇮🇳 Jurisdiction & Indication Note: Indications and schedules reflect Indian compendial and regulatory records (CDSCO / Indian Pharmacopoeia & NFI / NLEM 2022). Where international reference labels (US FDA DailyMed / NCBI StatPearls) are cited for pharmacokinetic or mechanistic parameters, international approvals do not automatically imply CDSCO approval in India.

5. Educational Dosage Context, Formulations & Administration

Educational Dosing & Regimen Summary: ICP / Cholestasis: 10–15 mg/kg/day (typically 300 mg PO BD or TDS). PBC: 13–15 mg/kg/day in 2–3 divided doses. Gallstone Dissolution: 8–10 mg/kg/day in 2 doses

Administration & Meal Timing: Take WITH or immediately after meals (biliary contraction with food enhances intestinal mixing and cholelitholytic efficacy) | Morning & Evening with Meals (BD) or Bedtime

6. Pharmacokinetics, Metabolism & Renal/Hepatic Adjustment

Absorption & Disposition:
Absorption, distribution, metabolism, and excretion follow class pharmacokinetic profile; verify patient renal/hepatic function.
Metabolism & Biotransformation:
Renal: No adjustment needed (hepatobiliary clearance). Hepatic: Therapeutic in cholestatic liver disease; monitor LFTs
Elimination & Renal Adjustment:
Renal: No adjustment needed (hepatobiliary clearance). Hepatic: Therapeutic in cholestatic liver disease; monitor LFTs
Hepatic Impairment Considerations:
Renal: No adjustment needed (hepatobiliary clearance). Hepatic: Therapeutic in cholestatic liver disease; monitor LFTs

7. Contraindications, Precautions & High-Risk Warnings

Contraindications & Red-Flag Precautions:
  • Contraindicated in radio-opaque calcified gallstones, acute cholecystitis/cholangitis, complete biliary tract obstruction, and non-functioning gallbladder

Key Clinical Precautions: Renal: No adjustment needed (hepatobiliary clearance). Hepatic: Therapeutic in cholestatic liver disease; monitor LFTs

8. Adverse Effects Profile

Common & Mechanism-Related Adverse Effects:
  • Loose stools or mild pasty diarrhoea (dose-related in 2–5%), mild nausea, right upper quadrant discomfort
  • Rare decompensation in advanced Child–Pugh C cirrhosis if excessive high doses (>28 mg/kg/d) are used; gallstone calcification
Serious / Dose-Limiting Adverse Effects:
  • Monitor for severe hypersensitivity, organ toxicity, or dose-limiting adverse events.

9. Major Drug–Drug, Drug–Food & Drug–Herb Interactions

  • Aluminium-containing Antacids, Cholestyramine, Colestipol, and Charcoal bind UDCA in the gut and block its absorption — separate by >=2–4 hours! Increases Cyclosporine absorption

10. Clinical Monitoring, Patient Counselling & Storage

Clinical & Laboratory Monitoring: Monitor clinical response, baseline renal/hepatic parameters, and relevant serum biomarkers.

Pharmacist Patient Counselling Points:

  • Patient Counselling Checklist: Safe and essential in pregnancy for obstetric cholestasis (intense itching of palms and soles); take with meals and space at least 2 hours apart from antacids
  • Meal & Clock Timing Instruction: Take WITH or immediately after meals (biliary contraction with food enhances intestinal mixing and cholelitholytic efficacy) (Morning & Evening with Meals (BD) or Bedtime)
  • Missed Dose Protocol: Take with next meal if remembered; do not double dose
  • Geriatric Dispensing Pearl: Well tolerated in older adults; reduce dose if loose stools occur

Storage, Stability & Dispensing Safeguards: Store below 25°C–30°C in original moisture- and light-resistant packaging out of reach of children. Available forms: Tablets / Capsules: 150 mg, 300 mg, 450 mg SR, 600 mg

11. Visual Pharmacology & Mechanism Diagram (svg-v339-01-adme-12-step-journey)

THE 12-STEP ORAL DRUG JOURNEY THROUGH THE HUMAN BODY (LADME) Note: IV bolus enters Step 6 directly (F = 100%); Sublingual & Transdermal routes bypass Step 4–5 Portal First-Pass Metabolism 1. Oral Administration • Tablet / Capsule swallowed • Gastric emptying to duodenum pH 1.5–3.5 (Stomach) 2. Disintegration & Dissolution • Tablet breaks into granules • API dissolves in GI fluid Noyes-Whitney Dissolution Rate 3. GI Epithelial Absorption • Crosses intestinal villi • Passive / Active / P-gp efflux Small Intestine (Large Surface Area) 4. Portal Circulation • Mesenteric veins → Portal vein • Delivers blood to liver sinusoids Pre-systemic Venous Conduit 5. First-Pass Metabolism • Gut & hepatic CYP450 extraction • High: GTN, Propranolol, Morphine Determines Bioavailability (F = f_a × (1-E_H)) 6. Systemic Circulation • Hepatic vein → IVC → Heart • Unbound vs Albumin-bound drug Only FREE drug is active 7–8. Tissue Distribution (Vd) • Capillary permeation to organs • Blood-Brain & Placental barriers Vd = Dose / C_0 (L or L/kg) 9. Target Site of Action • Receptors (GPCR, Ion channel) • Enzymes & Carrier Transporters Pharmacodynamic Effect (E_max, EC50) 10. Hepatic Biotransformation • Phase I (CYP450 Oxidation/Hydrolysis) • Phase II (Glucuronidation/Sulfation) Converts lipophilic drug → hydrophilic metabolite 11. Renal & Biliary Elimination • Nephron: Filtration + Secretion − Reabsorption • Biliary excretion & Enterohepatic recycling Total Clearance CL_tot = CL_renal + CL_hepatic 12. Excretion from the Body • Urine (Primary polar metabolite route) • Bile/Faeces, Expired Air, Sweat, Milk Elimination Half-Life t1/2 = (0.693 × Vd) / CL
svg-v339-01-adme-12-step-journey — 8.1 Complete 12-Step Journey of an Orally Administered Drug (ADME): Figure 8.1: The 12-step physiological journey of a typical orally administered solid dosage form through Liberation, Absorption, Distribution, Metabolism, and Excretion (LADME). Note: Parenteral (IV), sublingual, and inhalational routes bypass gastrointestinal absorption and/or hepatic first-pass metabolism.

12. Authoritative References, Regulatory Sources & Editorial Disclaimer

Primary Compendial & Guideline Reference: Indian Pharmacist Desk Reference — Professional Edition 2.7 (2026–27) • Ch 05 [5.20] (p. 69)

Official Verification Portals: Indian Pharmacopoeia Commission (IPC) & National Formulary of India (NFI) • Central Drugs Standard Control Organization (CDSCO) • Ministry of Health & Family Welfare — NLEM 2022 • NCBI Bookshelf / StatPearls Pharmacology Reference • DailyMed (US FDA Official Prescribing Reference)

Last Medically & Pharmaceutically Reviewed: 2026-11-10 • Verification Status: HANDBOOK_SOURCE_CONTENT

Educational & Clinical Disclaimer: This reference profile is published solely for pharmacy education, academic study, and professional clinical reference. It does not substitute for patient-specific clinical judgement, qualified specialist oncology/medical supervision, or official CDSCO/IP prescribing information. Never self-medicate with prescription, Schedule H/H1/X, NDPS, or oncology medicines.

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Educational Reference Notice: This printout from THE INDIAN PHARMACIST (https://theindianpharmacist.com/medicine/5-20-ursodeoxycholic-acid-udca/, Last Reviewed: 2026-11-10) is an educational reference sheet for students and healthcare learners. It is NOT an official prescribing guideline or patient-specific treatment order.