Rebamipide Schedule (India)

Not under Schedule H/X

Rebamipide Routes

Oral

Rebamipide Formulations

Tablets: 100 mg

Rebamipide Adult indications

INDICATIONS + DOSING — FOR CLINICIAN USE ONLY

Primary Indications (Approved / Standard in India):

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

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

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

Rebamipide Paediatric indications

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.

Age Group	Dose (mcg/kg/day)	Typical Total Daily Dose	Clinical Notes

Below 12 years All indications Not recommended — Insufficient safety data

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

Age Group	Dose (mcg/kg/day)	Typical Total Daily Dose	Clinical Notes

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.

Rebamipide Renal Adjustments

eGFR (ml/min/1.73m²)	Recommendation
eGFR (ml/min/1.73m²)	Recommendation
eGFR (ml/min/1.73m²)	Recommendation

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

Rebamipide Hepatic adjustment

Hepatic Impairment	Recommendation
Mild impairment (Child-Pugh A)	No adjustment needed
Moderate impairment (Child-Pugh B)	Caution advised; consider initiating at 100 mg twice daily
Severe impairment (Child-Pugh C)	Avoid use; limited metabolism data; specialist decision only

Rebamipide Contraindications

Known hypersensitivity to rebamipide or any excipients

Severe hepatic failure (lack of safety data)

Rebamipide Cautions

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

Rebamipide Pregnancy

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

Rebamipide Lactation

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

Rebamipide Elderly

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

Rebamipide Major drug interactions

Drug Interaction Management

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

Rebamipide Moderate drug interactions

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

Rebamipide Common Adverse effects

Constipation

Diarrhoea

Nausea

Abdominal discomfort

Headache

Dizziness

Rebamipide Serious Adverse effects

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

Rebamipide Monitoring requirements

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

Rebamipide Brands in India

Mucosta

Rablet M

Rebagen

Rebanext

Rebagen M (FDC with pantoprazole — not in NLEM)

Rebamipide Price range (INR)

Formulation	Approximate Price (per tablet)
100 mg tablet ₹7–₹20 per tablet Brand-dependent
FDCs with PPIs ₹15–₹30 per tablet Not under NPPA price control

Rebamipide Clinical pearls

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 Tags

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

Rebamipide Version

RxIndia v1.0 — 10 Jan 2025

Rebamipide Reference

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)

RxIndia

The Drug Registry

Rebamipide