Not under Schedule H/X

Oral

• Tablets: 100 mg

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India):

1. Gastric Ulcer

Parameter Recommendation

Starting dose 100 mg orally three times daily

Titration Not applicable

Usual maintenance dose 100 mg orally TID

Maximum dose 300 mg/day (100 mg TID)

Duration 4–8 weeks or until endoscopic healing confirmed

Clinical notes:

• Mechanism involves stimulation of mucin secretion and enhancement of prostaglandin production

• Does not suppress gastric acid secretion

• Consider combining with PPI in high-risk patients

1. Erosive Gastritis / Chronic Gastritis

Parameter Recommendation

Starting dose 100 mg orally three times daily

Titration Not applicable

Usual maintenance dose 100 mg orally TID

Maximum dose 300 mg/day

Duration 2–4 weeks minimum; may be extended in atrophic gastritis

Clinical notes:

• Symptomatic improvement typically observed within 7–10 days

• Continue therapy until endoscopic resolution in erosive disease

1. NSAID-Induced Gastric Mucosal Injury (Prophylaxis and Symptom Relief)

Parameter Recommendation

Starting dose 100 mg orally two to three times daily

Titration Not applicable

Usual maintenance dose 100 mg orally BD–TID

Maximum dose 300 mg/day

Duration Continue throughout NSAID therapy

Clinical notes:

• Consider when PPI use is contraindicated or in patients with low bleeding risk

• Does not replace PPI in high-risk ulcer patients

• Suitable for functional symptoms associated with NSAID use

Secondary Indications – Adults Only (Off-label, if any):

Indication Dose Duration Evidence Basis Notes

Radiation-induced mucositis (OFF-LABEL) 100 mg orally TID Individualized based on radiotherapy course Small RCTs and Asian post-marketing studies Specialist only; used in select oncology centres in India

Functional Dyspepsia (OFF-LABEL) 100 mg orally TID 4–8 weeks Meta-analysis of small Asian trials; Indian GI specialist practice Specialist only

PAEDIATRIC DOSING (Specialist Only)

Primary Indications:

Not routinely recommended in children. Use is limited and lacks robust Indian data. Should only be considered under specialist supervision.

Below 12 years All indications Not recommended — Insufficient safety data

Secondary Indications – Paediatric Doses (Off-label, if any):

Adolescents (12–18 years) Gastric ulcer / Gastritis (OFF-LABEL) 100 mg orally 2–3 times daily 2–4 weeks Limited data; extrapolated from adult practice Specialist only; monitor for diarrhoea and headache

Safety Statement: Not recommended below 12 years due to lack of safety and efficacy data.

Severe impairment (eGFR <30) Use with caution; limited data available

Haemodialysis No specific data; use with caution

• Monitor renal function periodically if prolonged use anticipated

• Known hypersensitivity to rebamipide or any excipients

• Severe hepatic failure (lack of safety data)

• Known history of drug-induced hypersensitivity reactions

• Elderly patients — monitor for gastrointestinal adverse effects and CNS symptoms

• Renal dysfunction — exercise caution with prolonged use

• Patients on anticoagulant therapy — monitor closely

• Polypharmacy in elderly — assess for cumulative adverse effects

Parameter Information

Safety category Not well studied in humans; animal data suggest low teratogenic risk

Use recommendation May be used if benefit clearly outweighs risk; avoid in first trimester if possible

Preferred alternatives Sucralfate, PPIs (omeprazole/pantoprazole)

Monitoring Maternal GI symptoms; no specific fetal monitoring required

Parameter Information

Compatibility Likely compatible — minimal excretion into breast milk expected

Drug levels in milk Expected to be low

Preferred alternatives Sucralfate if symptoms persist

Infant monitoring GI symptoms, feeding pattern, general wellbeing

Parameter Recommendation

Starting dose 100 mg twice daily may be preferable initially

Titration Increase to TID if tolerated after 3–5 days

Extra risks Constipation, dizziness, headache, drowsiness

Monitoring Renal function; assess for polypharmacy interactions

Drug Interaction Management

Warfarin Theoretical potential for altered anticoagulant effect Monitor INR closely; adjust warfarin dose as needed

Drug Interaction Management

NSAIDs Co-use permitted; rebamipide provides gastric protection Safe combination; does not eliminate all NSAID-related GI risks in high-risk patients

PPIs Synergistic symptomatic benefit Safe co-use; rebamipide is not a replacement for ulcer healing with PPIs

Antacids (magnesium/aluminium) May decrease rebamipide absorption slightly Stagger dosing by at least 2 hours

Fluoroquinolones No direct interaction Monitor for exacerbation of GI upset

• Constipation

• Diarrhoea

• Nausea

• Abdominal discomfort

• Headache

• Dizziness

Adverse Effect Frequency Action

Peripheral blood eosinophilia Rare Monitor CBC; consider discontinuation

Liver enzyme elevation Uncommon Monitor LFTs; discontinue if significant elevation

Hypersensitivity rash Rare Discontinue immediately

Agranulocytosis / Pancytopenia Very rare Discontinue immediately; urgent haematology referral

Phase Parameters

Baseline LFTs (if prolonged use anticipated); RFTs in elderly or renal impairment

After initiation GI tolerance, headache, bowel habits — assess within 1–2 weeks

Long-term (>1 month) LFTs periodically; CBC every 2–3 months if on extended therapy

• Mucosta

• Rablet M

• Rebagen

• Rebanext

• Rebagen M (FDC with pantoprazole — not in NLEM)

• Not a PPI substitute: Best used in low-to-moderate risk patients or as adjunct therapy alongside PPI in appropriate cases

• Acid-independent mechanism: Does not alter gastric pH — safe when acid suppression is contraindicated

• NSAID co-prescription: Useful adjunct but does not fully protect high-risk patients from ulcer complications

• Constipation in elderly: Dose-limiting in some; consider starting at BID in frail patients

• Minimal systemic absorption: Fewer systemic adverse effects compared to misoprostol

• Symptom onset: Improvement typically begins within 7–10 days

Rebamipide; peptic ulcer; gastritis; gastroprotection; mucosal agent; NSAID ulcers; constipation-risk; elderly-safe; PPI alternative; gastroenterology

RxIndia v1.0 — 10 Jan 2025

• CDSCO product information

• Indian Pharmacopoeia (IP)

• AIIMS Drug Formulary

• API Textbook of Medicine

• Indian gastroenterologist practice protocols

• NLEM (checked for inclusion status — not currently included)