Uses of Amlex: - Mouth ulcers Adult: Topical As a 5% oral paste: Apply approx 0.5 cm of oral paste directly on to each ulcer 4 times/day; following oral hygiene after meals and at bedtime. Initiate treatment at earliest symptom of an aphthous ulcer. Continue treatment until mouth ulcer is healed, not exceeding 10 days. Child: Not to be used in children below age 12.

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.

How to use Amlexanox: This medicine is for external use only. Use it in the dose and duration as advised by your doctor. Check the label for directions before use. Adult Dose: For topical use on mouth ulcers only. Avoid contact with the eyes; rinse immediately if ocular contact occurs. Wash hands before and after every application. Discontinue treatment if rash or contact mucositis develops. Seek medical advice if mouth ulcers have not healed after 10 days of treatment. Effects have not been evaluated in immune-compromised patients. Use lower initial dose for elderly patients. Not recommended for use in children below <12 yr. Pregnancy and lactation. Lactation: excretion in milk unknown; use with caution Renal Dose: Amlexanox accelerates healing of aphthous ulcers. The exact mechanism of action is not known. In vitro studies have shown that Amlexanox is a potent inhibitor of the formation and/or release of inflammatory mediators (histamine and leukotrienes) from mast cells, neutrophils, and mononuclear cells.

Known hypersensitivity to any of the ingredients.

Child: Not to be used in children below age 12.

Common - Application site pain - Stinging sensation - Burning sensation

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.

Precaution: Aphthous ulcer

Ingestion of a full tube of 5 grams of paste would result in systemic exposure well below the maximum nontoxic dose of Amlexanox in animals. Gastrointestinal upset such as diarrhea and vomiting could result from an overdose.

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

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. After a single oral application of 100 mg of paste (5 mg Amlexanox), maximal serum levels are observed at 2.4 hours. Most of the systemic absorption of Amlexanox is via the gastrointestinal tract and the amount absorbed directly through the active ulcer is not a significant portion of the applied dose. The half-life for elimination was 3.5 +/- 1.1 hours in healthy individuals.

1-10% Contact mucositis (1-2%),Local stinging (1-2%)