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Amlexanox is indicated for the treatment of aphthous ulcers in people with normal immune system.
Dosage & Administration
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 ¼ 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.
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 & Lactation
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.
Precautions & Warnings
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.
Use in Special Populations
Safety and effectiveness of Amlexanox oral paste in pediatric patients have not been established.
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.
Store in a cool & dry place. Protect from light. Keep out of reach of the children