Generic Name

Amlexanox

Precaution

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

Indication

Aphthous ulcer

Contra Indication

Known hypersensitivity to any of the ingredients.

Dose

N/A

Side Effect

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

Pregnancy Category

Mode of Action

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.

Interaction

N/A

Pregnancy Category Note

Pregnancy Category: B Lactation: excretion in milk unknown; use with caution

Adult Dose

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 Dose

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

Renal Dose

N/A

Administration

N/A