What is the recommended treatment for a patient with aphthous ulcers using Amlexanox (Aphthasol) Powder?

Amlexanox Powder for Aphthous Ulcers

For patients with aphthous ulcers, apply amlexanox 5% oral paste directly to ulcers four times daily until healed, as this accelerates healing and reduces pain more effectively than vehicle or no treatment. 1, 2

Application Protocol

• Apply amlexanox 5% paste directly to the ulcer four times daily starting as soon as possible after ulcer onset (ideally within 48 hours) and continue until complete healing occurs 2, 3
• Each application should involve placing a small amount (approximately 0.5 cm ribbon) directly onto the dried ulcer surface after gently patting the area dry 4, 5
• The paste should remain in contact with the ulcer; avoid eating or drinking for at least 30 minutes after application to maximize contact time 5

Expected Treatment Outcomes

• Complete ulcer healing occurs in 21% of patients by day 3 with amlexanox compared to only 8% with no treatment 3
• Complete pain resolution occurs in 44% of patients by day 3 with amlexanox compared to 20% with no treatment 3
• Amlexanox significantly reduces ulcer size (P=0.017 at day 4) and alleviates pain (P=0.021 at day 4) compared to placebo 5
• The median time to both ulcer healing and complete pain resolution is significantly reduced with amlexanox treatment 2, 3

Integration into Treatment Algorithm

Mild Aphthous Stomatitis

• Start with sodium bicarbonate rinses 4-6 times daily as foundational care 1
• Add amlexanox 5% paste four times daily for moderate symptoms or when topical anesthetics alone are insufficient 1
• Consider viscous lidocaine 2% before meals for additional pain control 1

Moderate Aphthous Stomatitis

• Amlexanox 5% paste is recommended as a topical NSAID option alongside or before escalating to topical corticosteroids 1
• If amlexanox alone is insufficient after 3-5 days, add topical high-potency corticosteroids such as betamethasone sodium phosphate 0.5 mg in 10 mL water as rinse-and-spit 1-4 times daily 1

Severe or Recalcitrant Cases

• Amlexanox may be used as adjunctive therapy but systemic corticosteroids (prednisone 30-60 mg daily for 1 week, then taper) become necessary for persistent severe cases 1

Safety Profile and Monitoring

• Amlexanox demonstrates minimal adverse effects with only limited systemic absorption (maximum serum concentration 120 ng/mL occurring 2.4 hours after 100 mg dose) 6
• The elimination half-life is 3.5 hours with no evidence of accumulation with multiple applications 6
• No significant irritation or sensitization was observed in 991 subjects exposed to amlexanox 5% paste 6
• Systemic absorption occurs primarily through gastrointestinal absorption rather than direct absorption through the ulcer 6

Critical Safety Warnings

• Stop use and consult a physician if gradual blue-black darkening of the skin occurs 7
• Discontinue if irritation becomes severe 7
• Reassess treatment if no improvement is seen after 3 months of use 7

Important Clinical Distinction

• Never confuse aphthous ulcers with oral herpes (HSV), as these require opposite treatments 1
• Oral herpes presents with vesicles that rupture into ulcers with prodromal tingling, while aphthous ulcers present as recurrent painful ulcers without vesicles 1
• Corticosteroids potentiate HSV infection and should be avoided in herpes, while antivirals are ineffective for aphthous ulcers 1

Formulation Considerations

• Amlexanox oral adhesive pellicles are as effective as tablets but may be more comfortable for patients to use 5
• Both formulations demonstrate equivalent efficacy in reducing ulcer size and pain 5