SQUARE PHARMACEUTICALS LTD.
Amlexanox is indicated for the treatment of aphthous ulcers in people with normal immune system.
Drugs for Aphthous ulcer
The mechanism of action by which Amlexanox accelerates healing of aphthous ulcers is unknown. In vitro studies have demonstrated Amlexanox to be a potent inhibitor of the formation and release of inflammatory mediators (histamine and leukotrienes) from mast cells, neutrophils and mononuclear cells. Given orally to animals, Amlexanox has demonstrated anti-allergic and anti-inflammatory activities and has been shown to suppress both immediate and delayed type hypersensitivity reactions. The relevance of these activities of Amlexanox to its effects on aphthous ulcers has not been established.
Adults (over 18 years of age): 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 8 inch (0.5 cm) on to the finger tip. Gently dab the paste on to each ulcer. Repeat the process if more than one ulcer are present. Wash hands after application. 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 is contraindicated in patients with known hypersensitivity to Amlexanox or other ingredients in the formulation.
The most common side effects are transient pain, stinging and/or burning at the site of application. The less frequent side effects are contact mucositis, nausea, and diarrhea.
Pregnancy category B. No adverse fetal effects were observed during teratological studies on animals, but there are no adequate and well-controlled studies in pregnant women. So this drug should be used during pregnancy only if clearly needed. Lactation: Amlexanox was found in the milk of lactating rats; therefore, caution should be exercised when administering Amlexanox oral paste to a nursing woman.
Ingestion of a full tube would result in systemic exposure below the maximum nontoxic dose of Amlexanox in animals. Gastrointestinal upset such as diarrhea and vomiting could result from an overdose.
Wash hands immediately after applying Amlexanox oral paste directly to ulcers with thefinger tips. Wash eyes promptly if they should come in contact with the paste. In the event that a rash or contact mucositis occurs, discontinue use.
Store in a cool & dry place. Protect from light. Keep out of reach of the children