1. Clinical Overview
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.
| Onset | Duration | Bioavailability |
|---|---|---|
| Pain relief typically begins within 1-3 days of application. | Local effect lasts for several hours post-application; treatment course is typically 3-10 days. | Minimal systemic absorption following topical oral application; precise percentage not well quantified but considered negligible. |
2. Mechanism of Action
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.
3. Indications & Uses
- Recurrent Aphthous Stomatitis (Minor and Major Aphthous Ulcers)
- Canker Sores
4. Dosage & Administration
Adult Dosage: 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.
Administration: 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.
5. Side Effects
Common side effects may include:
- Transient pain, stinging, or burning at the application site (usually mild and subsides quickly)
- Altered taste sensation (dysgeusia)
6. Drug Interactions
| Drug | Effect | Severity |
|---|---|---|
| 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 |
7. Patient Counselling
- DO wash hands before and after application.
- DO apply 4 times daily consistently for best results.
- DO dry the ulcer before application.
- DONT apply to large areas of intact mucosa.
- DONT use for ulcers on skin or genitalia.
- DONT stop using it if mild stinging occurs initially.
8. Toxicology & Storage
Overdose: Acute oral ingestion of the paste may lead to gastrointestinal upset (nausea, vomiting, diarrhea). Topical overdose is unlikely but could cause increased local irritation.
Storage: Store at room temperature (15-25°C), protected from light and moisture. Keep the tube tightly closed. Keep out of reach of children. Do not freeze.