Amlexanox Treatment Regimen for Aphthous Ulcers
Apply 5% amlexanox oral paste directly to the aphthous ulcer four times daily until the ulcer heals, typically for 5-6 days. 1, 2
Application Protocol
- Apply as a thin layer directly to the affected ulcer four times per day 1, 3
- Continue treatment for 5-6 days or until complete healing occurs 2, 3
- Begin application as soon as the ulcer appears for maximum benefit 4
- For adults and children 12 years and older, this regimen is appropriate 1
Expected Clinical Outcomes
Amlexanox significantly accelerates healing compared to placebo or no treatment:
- 21% of patients achieve complete healing by day 3 compared to only 8% with no treatment 4
- 44% experience complete pain resolution by day 3 versus 20% without treatment 4
- Median healing time is significantly reduced with statistically significant reductions in ulcer size, pain, erythema, and exudation by days 4-6 2, 3
Pain Management Context
For moderate pain from stomatitis in cancer patients receiving targeted therapy, amlexanox 5% oral paste may be considered as a topical NSAID option when standard analgesics are insufficient 5. This represents expert consensus for oncology-related oral lesions, though the primary evidence base for amlexanox remains in recurrent aphthous stomatitis.
Safety Considerations
- Test on a small area inside the elbow overnight before use if skin is sensitive 1
- Stop use and consult a physician if gradual blue-black darkening of the skin occurs, irritation becomes severe, or no improvement is seen after 3 months 1
- Minimal adverse effects were observed in 991 subjects exposed to amlexanox paste, with no significant irritation or sensitization 6
- Systemic absorption is minimal, with peak serum levels of only 120 ng/ml occurring 2.4 hours after a 100 mg dose, and a half-life of 3.5 hours with no accumulation 6
Common Pitfalls to Avoid
- Do not delay treatment—application should begin immediately when an ulcer appears, as early treatment provides maximum benefit 4
- Do not apply less frequently than four times daily, as this is the evidence-based regimen that demonstrated efficacy 1, 3
- Do not confuse amlexanox with topical corticosteroids—while corticosteroids are first-line for isolated oral ulcers in Behçet disease 5, amlexanox is specifically indicated for recurrent aphthous stomatitis
- Children under 12 years should not use amlexanox without consulting a physician first 1