An He

Amlexanox oral paste, 5%, is indicated for the treatment of aphthous ulcers in people with normal immune systems.

The paste should be applied as soon as possible after noticing the symptoms of an aphthous ulcer and should be used four times daily, preferably following oral hygiene after breakfast, lunch, dinner, and at bedtime. Squeeze a dab of paste approximately ¼ inch (0.5 cm) onto a finger tip. With gentle pressure, dab the paste onto each ulcer in the mouth. Use of the medication should be continued until the ulcer heals. If significant healing or pain reduction has not occurred in 10 days, consult your dentist or physician.

Amlexanox oral paste, 5%, is contraindicated in patients with known hypersensitivity to amlexanox or other ingredients in the formulation.

WARNINGS

No information provided.

PRECAUTIONS

General

Wash hands immediately after applying amlexanox oral paste, 5%, directly to ulcers with the finger tips. In the event that a rash or contact mucositis occurs, discontinue use.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Amlexanox was not carcinogenic when administered orally to rats for two years and to mice for 18 months. In vitro (Ames) and in vivo (mouse micronucleus) mutagenicity tests of amlexanox were negative. Amlexanox at doses up to two hundred times the projected human daily dose, on a mg/m² basis, did not significantly affect fertility or general reproductive performance in rats.

Pregnancy Category B

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/m² basis. No adverse fetal effects were observed. At doses up to two hundred times the projected human daily dose, on a mg/m² 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.

Nursing Mothers

Amlexanox was found in the milk of lactating rats; therefore, caution should be exercised when administering amlexanox oral paste, 5%, to a nursing woman.

Pediatric Use

Safety and effectiveness of amlexanox oral paste, 5%, in pediatric patients have not been established.

Geriatric Use

Clinical studies of An He (amlexanox) did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Adverse reactions considered related or possibly related to amlexanox oral paste, 5%, were not reported by more than 5% of patients. Adverse reactions reported by 1-2% of patients were transient pain, stinging and/or burning at the site of application. Infrequent ( < 1%) adverse reactions in the clinical studies were contact mucositis, nausea, and diarrhea.

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.