Rebamipide Dosing for Aphthous Ulcers
For recurrent aphthous ulcers, rebamipide should be administered at 100 mg three times daily (total 300 mg/day) for a minimum of 12 weeks, with optimal results seen when continued for 24 weeks. 1
Evidence-Based Dosing Regimen
Standard Dose
- 100 mg three times daily (300 mg/day total) is the established dose for treating recurrent oral aphthous ulcers 1, 2
- Treatment duration should be 12-24 weeks for optimal efficacy 1
- This dose was validated in a randomized, double-blind, placebo-controlled trial specifically for aphthous ulcers in Behçet's disease patients 1
Formulation Options
- Tablets (100 mg) are the standard formulation 1, 3
- Granules (20%/0.5g) are bioequivalent to tablets and may be preferred for patients with difficulty swallowing 3
- Both formulations achieve similar pharmacokinetics: AUC₂₄ₕ of ~900 μg/L·h, Cₘₐₓ of ~220-240 μg/L, and tₘₐₓ of 2.4-2.5 hours 3
Clinical Efficacy Timeline
Expected Response Pattern
- Months 1-3: Initial improvement in aphthae count and pain scores begins 1
- Months 4-6: Continued reduction in ulcer frequency and pain, with peak benefit observed 1
- In patients with severe symptoms (monthly aphthae pain score >28), rebamipide produces progressive improvement throughout 6 months, while placebo shows worsening after month 3 (p < 0.01) 1
Comparative Effectiveness
- 65% of patients (11 of 17) achieved moderate or marked improvement with rebamipide versus 36% (5 of 14) with placebo 1
- When combined with 5% amlexanox oral paste, rebamipide accelerates healing compared to Dologel CT alone 2
Practical Implementation
Administration Guidelines
- Take 100 mg three times daily with meals to optimize absorption 1, 3
- Continue treatment for at least 12 weeks; extend to 24 weeks for patients with frequent recurrences 1
- No dose tapering required when discontinuing (unlike corticosteroids) 1
Advantages Over Topical Corticosteroids
- Non-cumbersome administration without the discomfort associated with corticosteroid ointments 1
- No specific adverse drug reactions reported in clinical trials 1
- Suitable for long-term use without the systemic effects of corticosteroids 1
Common Pitfalls to Avoid
- Insufficient treatment duration: Stopping before 12 weeks may result in incomplete response, as peak benefit occurs in months 4-6 1
- Underdosing: The validated dose is 300 mg/day (100 mg TID); lower doses have not been studied for aphthous ulcers 1
- Premature discontinuation: Patients may experience initial improvement but require continued therapy to prevent recurrence 1