Aphthasol (Amlexanox)

Aphthasol Review

Aphthasol is used as a paste in the mouth to treat aphthous ulcers (canker sores).

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Aphthasol Drug Class and Mechanism

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/or 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.

Aphthasol Uses

Aphthasol comes as a beige-colored paste. Aphthasol should be used as soon as possible after noticing symptoms of an ulcer. Aphthasol is usually applied four times a day, following brushing and flossing after breakfast, lunch, dinner, and at bedtime. Squeeze 1/4 inch of the paste on your finger. With gentle pressure, dab amlexanox onto each ulcer in the mouth. Wash hands immediately after using amlexanox. Aphthasol is only used until the ulcer has healed, usually within 10 days. Contact your physician or dentist if significant healing has not occurred within 10 days.

Aphthasol Side Effects

Although side effects from amlexanox are not common, they can occur. Tell your doctor or dentist if any of these symptoms are severe or do not go away: slight pain, stinging, or burning of the skin that comes and goes nausea diarrhea If you experience the following symptom, call your doctor or dentist immediately: rash

Aphthasol Pregnancy

Teratology studies were performed with rats and rabbits at doses up to two hundred and six hundred times, respectively, the projected human daily dose, on a mg/m 2 basis. No adverse fetal effects were observed. At doses up to two hundred times the projected human daily dose, on a mg/m 2 basis, amlexanox did not have significant effect on peri- and postnatal development of rat fetuses. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Aphthasol Overdose

There are no reports of human ingestion overdosage. 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.

Aphthasol More Information

This medicine is available only with your doctor's prescription.