Amlexanox is a topical anti-inflammatory and anti-allergic agent, chemically distinct from corticosteroids, NSAIDs, or antihistamines. It is specifically indicated for the treatment of recurrent aphthous stomatitis (canker sores) in India. It works by inhibiting the formation and release of inflammatory mediators like histamine and leukotrienes from mast cells, neutrophils, and mononuclear cells, thereby reducing pain, inflammation, and healing time of oral ulcers.
Adult: Apply a small amount (approx. 1/4 inch or 0.5 cm) of the 5% paste directly to each ulcer using a clean fingertip. Use 4 times daily: after breakfast, lunch, dinner, and at bedtime.
Note: 1. Wash hands before and after application. 2. Dry the ulcer area gently with a clean cloth/tissue. 3. Apply a small dab directly onto the ulcer and smooth it into a thin, even layer. 4. Do not rub vigorously. 5. Avoid eating or drinking for at least 1 hour after application. 6. Continue treatment until the ulcer is healed or as directed by the physician.
Amlexanox exerts its therapeutic effects through multiple anti-inflammatory pathways. It inhibits the formation and release of inflammatory mediators, including histamine and leukotrienes (LTB4, LTC4), from mast cells, neutrophils, and mononuclear cells. It also inhibits the release of tumor necrosis factor-alpha (TNF-α) and interleukin-1β (IL-1β). Furthermore, it may inhibit the antigen-IgE mediated release of histamine and peptide leukotrienes from mast cells and basophils.
Pregnancy: Category B (Indian/US FDA). Animal studies have shown no risk, but no adequate and well-controlled studies in pregnant women. Use only if clearly needed and under medical supervision.
Driving: No effect. The drug has no CNS activity.
| Other topical oral medications (e.g., corticosteroids, local anesthetics) | Potential for physical/chemical interaction at the site. Apply Amlexanox at least 30 minutes apart from other topical agents. | Moderate |
| None known for systemic interactions | Due to negligible absorption, systemic drug-drug interactions are not expected. | Low |