What are the recommended adult dose, administration instructions, treatment duration, side effects, contraindications, and alternative therapies for Rebamipide tablets?

Rebamipide Tablet: Clinical Guidance

Recommended Adult Dosing

The standard adult dose of rebamipide is 100 mg three times daily for gastric ulcers and erosive gastritis, with treatment duration of 8 weeks for gastric ulcers and 2 weeks for erosive gastritis. 1, 2

• Standard regimen: Rebamipide 100 mg orally three times daily (total daily dose 300 mg) 1, 3, 4
• Alternative formulation: Rebamipide 150 mg twice daily has demonstrated non-inferiority to the standard regimen for erosive gastritis 2
• Treatment duration for gastric ulcers: 8 weeks 1, 4
• Treatment duration for erosive gastritis: 2 weeks 2
• Extended therapy for recurrent aphthous ulcers: 12-24 weeks for Behçet's disease-associated oral ulcers 3

Administration Instructions

• Rebamipide can be administered without regard to meals, though taking with food may improve gastrointestinal tolerability (based on general gastroprotective drug principles) 1
• The medication should be taken consistently at the same times each day to maintain therapeutic levels 1, 2

Mechanism and Clinical Efficacy

Rebamipide functions as a gastroprotective agent through multiple mechanisms:

• Mucosal protection: Stimulates prostaglandin and mucus glycoprotein synthesis 1
• Anti-inflammatory effects: Inhibits reactive oxygen species, inflammatory cytokines, and neutrophil activation 1
• Improved healing quality: Reduces inflammatory cell infiltration in ulcer scars, resulting in better quality healing 4

Evidence for Specific Conditions

For NSAID-induced gastric ulcers: Rebamipide demonstrates particular efficacy, with complete ulcer healing in most patients and significant improvement in gastric inflammation scores (2.38 vs. 1.75, p = 0.011) 1

For ulcer recurrence prevention: Rebamipide reduces gastric ulcer recurrence rates comparably to amoxicillin plus omeprazole, without affecting Helicobacter pylori status 4

For recurrent aphthous ulcers: In Behçet's disease patients, 65% achieved moderate or marked improvement compared to 36% with placebo, with sustained benefit during months 4-6 of treatment 3

Side Effects and Safety Profile

Rebamipide is well tolerated with minimal adverse effects across all studied populations. 1, 3, 2

• Common adverse events: Similar rates between rebamipide and placebo groups, with no serious adverse drug reactions reported 2
• Gastrointestinal tolerability: Few adverse effects noted, with high patient satisfaction 1
• Long-term safety: No specific adverse reactions identified during extended 12-24 week treatment courses 3
• Comparison to alternatives: Does not cause discomfort associated with topical corticosteroid ointments 3

Contraindications and Precautions

While the provided evidence does not specify absolute contraindications, clinical considerations include:

• Pregnancy and lactation: Safety data not established in the provided evidence; use caution
• Pediatric use: No pediatric dosing data available in the provided evidence
• Renal/hepatic impairment: Specific dosing adjustments not addressed in the provided evidence

Alternative Therapies

For Gastric Ulcers and Erosive Gastritis

Proton pump inhibitors (PPIs): Omeprazole 20 mg daily for 8 weeks demonstrates comparable healing rates to rebamipide but does not improve healing quality 4

H2-receptor antagonists: Effective for acid suppression but associated with tachyphylaxis within 6 weeks and less effective than PPIs for erosive esophagitis 5

Combination therapy: Omeprazole plus amoxicillin (1500 mg three times daily for 2 weeks) achieves 65% H. pylori eradication and reduces ulcer recurrence 4

For Recurrent Aphthous Ulcers

Topical corticosteroids: Traditional treatment but may cause discomfort during application 3

Systemic corticosteroids: Used for severe Behçet's disease manifestations but carry greater systemic side effect burden 3

Clinical Pearls

• NSAID users: Rebamipide is particularly effective for NSAID-induced gastric ulcers, promoting both symptom improvement and inflammation reduction 1
• H. pylori status: Rebamipide does not eradicate H. pylori but prevents ulcer recurrence through improved healing quality 4
• Long-term use: For recurrent aphthous ulcers, benefits become more apparent after 3 months of continuous therapy 3
• Compliance advantage: The new 150 mg twice-daily formulation may improve adherence compared to three-times-daily dosing 2