Amlexanox is indicated for the treatment of aphthous ulcers (mouth ulcers).

The exact mechanism by which Amlexanox promotes healing of aphthous ulcers is not fully known. However, laboratory studies have shown that it effectively inhibits the formation and release of inflammatory mediators such as histamine and leukotrienes from mast cells, neutrophils, and mononuclear cells. Animal studies indicate that Amlexanox possesses both anti-inflammatory and anti-allergic properties, and it can suppress immediate as well as delayed hypersensitivity reactions. However, how these actions directly relate to its effect on aphthous ulcers is not completely established. After a single oral application of 100 mg paste (containing 5 mg Amlexanox), peak blood levels are reached approximately 2.4 hours later. Most of the drug is absorbed through the gastrointestinal tract, while only a small portion is absorbed directly from the ulcer site. The elimination half-life is approximately 3.5 ± 1.1 hours in healthy individuals.

• Apply the paste as soon as possible after noticing the symptoms of an aphthous ulcer. Continue to use the paste four times daily, preferably following oral hygiene after breakfast, lunch, dinner, and at bedtime.
• Dry the ulcer(s) by gently patting it with a soft, clean cloth.
• Wash hands before applying.
• Moisten the tip of the index finger.
• Squeeze a dab of paste approximately ¼ inch (0.5 cm) onto a fingertip.
• Gently dab the paste onto the ulcer. Repeat the process if more than one ulcer are present.
• Wash hands after application.
• Wash eyes promptly if they should come in contact with the paste.
• Use the paste until the ulcer heals. If significant healing or pain relief has not occurred in 10 days, consultation with the physician is required.

Amlexanox oral paste should not be used in patients who are hypersensitive to Amlexanox or any of the components of the formulation.

About 1–2% of patients may experience temporary pain, stinging, or a burning sensation at the site of application. Less commonly (<1%), adverse effects such as contact mucositis, nausea, and diarrhea have been reported.

US FDA pregnancy category B. Animal studies conducted at doses up to 200–600 times the recommended human dose did not show any harmful effects on the fetus. However, adequate and well-controlled studies in pregnant women are lacking. Therefore, this drug should be used during pregnancy only if clearly necessary. Amlexanox has been detected in the milk of lactating animals; therefore, caution should be exercised when used in breastfeeding women.

Hands should be washed immediately after applying Amlexanox oral paste directly to the ulcer using fingertips. If rash or contact mucositis develops, the medication should be discontinued.

Pediatric Use: The safety and effectiveness of Amlexanox oral paste in children have not yet been established.

Accidental ingestion of an entire 5 g tube of the paste is expected to produce systemic exposure much lower than the maximum non-toxic dose observed in animals. However, overdose may lead to gastrointestinal disturbances such as diarrhea and vomiting.

Store in a cool and dry place. Protect from light. Keep out of reach of children.