Schedule H

Oral

• Tablets: 150 mg, 300 mg

• Capsules: 150 mg, 300 mg

• Oral suspension: 250 mg/5 mL

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India):

1. Primary Biliary Cholangitis (PBC) / Primary Biliary Cirrhosis

Parameter Dose Clinical Notes

Starting dose 13–15 mg/kg/day in 2–3 divided doses Take with food to improve absorption

Titration Not typically required May start lower (10 mg/kg/day) if GI intolerance anticipated

Usual maintenance dose 13–15 mg/kg/day in 2–3 divided doses Long-term therapy; lifelong in most cases

Maximum dose 20 mg/kg/day Higher doses rarely needed

Clinical Note: Improves liver biochemistry (ALP, GGT, bilirubin) and delays histological progression. Response assessment at 1 year (Paris criteria, Barcelona criteria); non-responders may need second-line agents (obeticholic acid, fibrates) under specialist care.

Example dosing (70 kg adult): 900–1050 mg/day = 300 mg three times daily with meals

1. Dissolution of Radiolucent Cholesterol Gallstones

Parameter Dose Clinical Notes

Starting dose 8–12 mg/kg/day in 2 divided doses Take with meals

Titration Not applicable Fixed dosing

Usual maintenance dose 8–12 mg/kg/day in 2 divided doses Evening/bedtime dose may be larger

Maximum dose 15 mg/kg/day

Patient selection criteria:

• Radiolucent (cholesterol) stones only — confirm on imaging

• Stone size <15–20 mm diameter

• Functioning gallbladder (demonstrated by oral cholecystography or HIDA scan)

• Patient unsuitable for or refusing surgery

Duration: Minimum 6–12 months; continue for 3 months after complete dissolution confirmed on ultrasound. Reassess with USG every 6 months.

Note: Dissolution rate ~30–50% for selected patients; recurrence common after stopping therapy.

1. Intrahepatic Cholestasis of Pregnancy (ICP)

Parameter Dose Clinical Notes

Starting dose 10 mg/kg/day in 2–3 divided doses Initiate under obstetrician/gastroenterologist supervision

Titration May increase to 15 mg/kg/day if inadequate response after 1–2 weeks Based on symptom relief and bile acid levels

Usual maintenance dose 10–15 mg/kg/day in 2–3 divided doses Continue until delivery

Maximum dose 20–25 mg/kg/day In refractory cases; specialist decision

Clinical Note: First-line therapy for ICP. Improves pruritus and maternal liver biochemistry; may reduce adverse fetal outcomes. Delivery timing based on fetal monitoring and bile acid levels, not solely on UDCA response.

1. Prevention of Gallstone Formation During Rapid Weight Loss

Parameter Dose Clinical Notes

Starting dose 300 mg twice daily (or 8–10 mg/kg/day) Start when weight loss program initiated

Titration Not applicable

Usual maintenance dose 300 mg twice daily

Maximum dose 600 mg/day

Duration Continue throughout weight loss period and for 1–2 months after weight stabilisation

Indicated for patients undergoing very low-calorie diets or bariatric surgery.

Secondary Indications — Adults (Off-label, if any)

1. Non-Alcoholic Fatty Liver Disease (NAFLD) / NASH — OFF-LABEL

Parameter Details

Indication NAFLD/NASH with elevated liver enzymes unresponsive to lifestyle modifications

Dose 13–15 mg/kg/day in 2–3 divided doses

Duration 6–12 months trial; reassess response

Specialist only Yes — Hepatology/Gastroenterology

Evidence basis Limited efficacy data; may improve LFTs but no proven benefit on fibrosis or histology; used in Indian hepatology practice selectively

1. Primary Sclerosing Cholangitis (PSC) — OFF-LABEL

Parameter Details

Indication PSC with cholestasis; controversial use

Dose 13–15 mg/kg/day (standard dose); avoid high doses >20 mg/kg/day

Duration Long-term if beneficial; reassess annually

Specialist only Yes — Hepatology

Evidence basis May improve biochemistry but no proven survival benefit; high doses (>28 mg/kg/day) associated with increased adverse outcomes in trials. Used cautiously in Indian tertiary centres.

Caution: High-dose UDCA in PSC is NOT recommended per international evidence.

1. Drug-Induced Cholestatic Liver Injury — OFF-LABEL

Parameter Details

Indication Cholestatic pattern of drug-induced liver injury with persistent cholestasis

PAEDIATRIC DOSING (Specialist Only)

Primary Indications:

1. Biliary Atresia (Post-Kasai Portoenterostomy)

Parameter Dose Comments

Starting dose 10–15 mg/kg/day in 2–3 divided doses Initiate post-operatively

Titration May increase to 20 mg/kg/day based on response

Usual maintenance dose 15–20 mg/kg/day in 2–3 divided doses

Maximum dose 20 mg/kg/day

Duration Long-term; continue until liver transplantation or indefinitely if stable

Monitoring: LFTs, GGT, bilirubin, fat-soluble vitamin levels, growth parameters.

1. Progressive Familial Intrahepatic Cholestasis (PFIC) Types 1, 2, 3

Parameter Dose Comments

Starting dose 10–15 mg/kg/day in 2–3 divided doses

Titration Increase up to 20–30 mg/kg/day based on response

Usual maintenance dose 15–20 mg/kg/day PFIC3 may respond better than PFIC1/2

Maximum dose 30 mg/kg/day

Duration Long-term

Note: Variable response; PFIC3 (MDR3 deficiency) often responds well; PFIC1 and PFIC2 have limited response.

1. Cystic Fibrosis-Associated Liver Disease (CFLD)

Parameter Dose Comments

Starting dose 20 mg/kg/day in 2–3 divided doses

Titration Not applicable Fixed dosing

Usual maintenance dose 20–30 mg/kg/day in 2–3 divided doses

Maximum dose 30 mg/kg/day

Duration Long-term

Monitoring: LFTs every 3–6 months; fat-soluble vitamin levels (A, D, E, K); growth velocity; nutritional status.

1. Alagille Syndrome

Parameter Dose Comments

Starting dose 10–15 mg/kg/day in 2–3 divided doses

Titration Increase up to 20 mg/kg/day based on response

Usual maintenance dose 15–20 mg/kg/day

Maximum dose 20 mg/kg/day

Limited efficacy for pruritus; may improve biochemistry in some patients.

Secondary Indications — Paediatrics (Off-label, if any)

Total Parenteral Nutrition (TPN)-Associated Cholestasis — OFF-LABEL

Parameter Details

Indication Cholestasis in neonates/infants on prolonged TPN

Dose 10–30 mg/kg/day in 2–3 divided doses

Duration Until TPN discontinued and cholestasis resolved

Specialist only Yes — Paediatric gastroenterology/Neonatology

Evidence basis Limited data; used in Indian paediatric practice

Not recommended below 1 month of age except under paediatric hepatology/gastroenterology specialist supervision with careful monitoring.

No dose adjustment required.

UDCA is primarily eliminated via biliary excretion; renal impairment does not significantly affect pharmacokinetics. Safe in all stages of CKD.

UDCA is commonly used to treat liver disease; however, in advanced decompensated cirrhosis, efficacy is limited and close monitoring is essential.

• Known hypersensitivity to ursodeoxycholic acid or other bile acids

• Radiopaque (calcified) gallstones — UDCA only dissolves cholesterol (radiolucent) stones

• Non-functioning gallbladder (non-visualisation on oral cholecystography)

• Complete biliary obstruction

• Acute cholecystitis or acute cholangitis

• Frequent biliary colic requiring surgical intervention

• Inflammatory bowel disease affecting the ileum (impairs enterohepatic circulation)

• Gallstone patients — confirm radiolucent stones on imaging before initiating therapy; ultrasonography cannot reliably distinguish stone composition

• Chronic liver disease — monitor for clinical deterioration

• Patients with portal hypertension — may have altered enterohepatic circulation

• Diarrhoea with high doses — dose-limiting adverse effect

• Concurrent use of drugs affecting bile acid absorption (cholestyramine, colestipol, antacids)

• Pregnancy — use only under specialist supervision (see Pregnancy section)

Aspect Recommendation

Risk category Generally considered safe; no confirmed teratogenicity in human data

First trimester Limited data; use if clearly indicated under specialist supervision

Second/Third trimester Safe; first-line treatment for intrahepatic cholestasis of pregnancy (ICP)

Use in pregnancy Drug of choice for ICP; used to relieve pruritus and improve biochemistry

Preferred alternatives None for ICP; UDCA is first-line

Monitoring Maternal LFTs, serum bile acids; fetal wellbeing assessment; timing of delivery

Aspect Recommendation

Compatibility Compatible with breastfeeding

Drug levels in milk Low; minimal infant exposure expected

Preferred alternatives None required

Recommendations May breastfeed while on UDCA therapy

Infant monitoring Routine monitoring; observe for loose stools (rare)

Aspect Recommendation

Starting dose Same as adult weight-based dosing

Titration Slower titration if GI intolerance anticipated

Special considerations Age alone does not require dose modification

Extra risks GI adverse effects (diarrhoea) may be less tolerated; ensure adequate hydration; polypharmacy — check for drug interactions

Monitoring Standard LFT monitoring

Drug Interaction Management

Cholestyramine / Colestipol / Colesevelam Bile acid sequestrants bind UDCA in GI tract → markedly reduced UDCA absorption and efficacy Separate dosing by ≥4–5 hours (give UDCA 1 hour before or 4–5 hours after bile acid sequestrant)

Aluminium-containing antacids Bind UDCA → reduced absorption Avoid concurrent use or separate by 2 hours

Ciclosporin (Cyclosporine) UDCA may increase ciclosporin absorption and bioavailability Monitor ciclosporin levels; may need ciclosporin dose reduction

Drug Interaction Management

Oestrogen-containing oral contraceptives Oestrogens increase biliary cholesterol secretion → may reduce efficacy of UDCA for gallstone dissolution Consider alternative contraception during gallstone dissolution therapy; or accept reduced efficacy

Clofibrate and other fibrates Increase biliary cholesterol saturation → may counteract gallstone dissolution Avoid if using UDCA for gallstone dissolution

Statins No contraindication; UDCA may improve LFTs making concurrent statin use safer Monitor LFTs

Antidiabetic drugs No direct interaction; improved liver function may affect glycaemic control Monitor blood glucose

Nitrendipine May increase nitrendipine bioavailability Monitor blood pressure

• Diarrhoea (dose-dependent; most common)

• Abdominal discomfort and cramping

• Nausea

• Dyspepsia

• Flatulence

• Pruritus (paradoxical worsening — rare)

• Headache

• Dizziness

Note: Most GI adverse effects are dose-dependent and can be managed by dividing doses or temporary dose reduction.

Adverse Effect Clinical Notes

Gallstone calcification Radiolucent stones may calcify during therapy → discontinue if stones become radiopaque

Acute cholecystitis / Biliary colic May occur if stone migration; right upper quadrant pain requires evaluation; discontinue UDCA

Hepatotoxicity Rare; paradoxical worsening of LFTs — discontinue and evaluate

Decompensation in advanced cirrhosis Use with caution; may worsen in some patients

Hypersensitivity reactions Rare; discontinue if occurs

Action: Discontinue UDCA if acute biliary symptoms develop, significant LFT deterioration occurs, or hypersensitivity is suspected.

After initiation LFTs at 1 month, then every 3 months for first year

PBC-specific Assess treatment response at 12 months using Paris criteria or similar (ALP <3× ULN, AST <2× ULN, bilirubin ≤1 mg/dL)

Gallstone dissolution Ultrasound every 6 months to assess stone dissolution; continue 3 months after complete dissolution

Long-term (PBC, cholestatic disorders) LFTs every 6 months; annual clinical reassessment; ultrasound for hepatocellular carcinoma surveillance if cirrhotic

Paediatric Fat-soluble vitamin levels (A, D, E, K) every 6–12 months; growth parameters; nutritional assessment

• Udiliv (Abbott) — widely used

• Ursocol (Sun Pharma)

• Udicol (Macleods)

• Udihep (Zydus)

• Urdox (Intas)

• Ursofalk (Dr. Falk Pharma)

• Ursokem (Alkem)

• Actibile (Mankind)

• Sorbidiol (Torrent)

• Multiple generic manufacturers

Note: No significant FDCs available; all formulations are single-agent UDCA.

• Not listed in NLEM 2022

• Not under NPPA price control

• Price variation significant across brands

1. Confirm stone type before prescribing for gallstones — UDCA only dissolves cholesterol (radiolucent) stones; calcified stones will not respond. Obtain oral cholecystography or HIDA if ultrasound is inconclusive about stone composition and gallbladder function.

1. Diarrhoea is dose-limiting — if diarrhoea occurs, divide daily dose into more frequent smaller doses or temporarily reduce total daily dose; usually improves with continued use.

1. Take with food — food enhances UDCA absorption; advise patients to take tablets/capsules with meals. Larger portion of dose at dinner may improve tolerability.

1. Response assessment in PBC — evaluate biochemical response at 12 months; non-responders (ALP >3× ULN or bilirubin >1 mg/dL) may benefit from addition of fibrates or obeticholic acid (specialist decision).

1. Avoid high doses in PSC — standard doses (13–15 mg/kg/day) may be used; high doses (>20–28 mg/kg/day) are associated with worse outcomes and should be avoided.

1. Long-term therapy in PBC — UDCA is lifelong in PBC; improves transplant-free survival in responders; do not discontinue without hepatology input.

1. Gallstone dissolution requires patience — complete dissolution takes 6–24 months; recurrence is common (30–50%) after stopping therapy; indefinite maintenance therapy may be needed in some patients.

ursodeoxycholic acid; UDCA; ursodiol; bile acid; cholestasis; primary biliary cholangitis; PBC; gallstones; intrahepatic cholestasis of pregnancy; ICP; hepatology; pregnancy-safe; Schedule H

RxIndia v1.0 — 29 May 2025

• CDSCO approved prescribing information

• Indian Pharmacopoeia

• National Formulary of India (NFI)

• API Textbook of Medicine

• AIIMS Hepatology Protocols

• ICMR NAFLD Guidelines

• IAP Guidelines (paediatric liver disease)

• Goodman & Gilman's The Pharmacological Basis of Therapeutics (supportive)

• EASL Clinical Practice Guidelines on PBC (supportive for response criteria)