Aphthasol, OraDisc A
Classifications: antiinflammatory agent; Therapeutic: antiinflammatory
Pregnancy Category: B
5% paste; 2 mg mucoadhesive disc
Amlexanox is a potent inhibitor of inflammatory mediators (e.g., leukotrienes, IgE, IgG). Its mechanism of healing is unknown.
Amlexanox reduces healing time and pain related to aphthous ulcers or canker sores.
Treatment of aphthous ulcers in patients with normal immune systems.
Sensitivity to amlexanox or benzyl alcohol.
Immunosuppressed patients; pregnancy (category B), lactation. Safety and efficacy in children are not established.
Route & Dosage
Adult: Topical Apply 1/4 in. (0.5 cm) to finger and dab onto each mouth ulcer q.i.d. (after oral hygiene p.c. and h.s.) for 10 d cycle; apply disc to each mouth ulcer and allow to dissolve
- Apply after oral hygiene following each meal and before bedtime.
- Avoid prolonged contact with skin and wash off skin if contact occurs.
- Store at 15°30° C (59°86° F) away from heat and moisture. Do not freeze.
Adverse Effects (≥1%)Body as a Whole:
Transient pain, stinging, or burning at application site.
Minimally absorbed through ulcer. Onset:
Approximately 3 d. Elimination:
17% in urine. Half-Life:
Assessment & Drug Effects
- Discontinue use if rash or inflamed membranes develop.
Patient & Family Education
- Use at first sign of canker sore. Wash hands before and immediately after application.
- Flush eyes immediately with large amount of cold water if paste accidentally comes in contact with eyes or eye area.
- Contact physician if healing does not result after 10 d of therapy.