Amlexanox INN

Composition: Each gram oral paste contains Amlexanox INN 50 mg.

Indications: For the treatment of Aphthous ulcers.

Dosage & Administration: 1. 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, Moister the tip of the index finger. 2. Squeeze a dab of paste approximately 1 /4 inch (0.5 cm) on to a finger tip. 3. Gently dab the paste on to the ulcer. Repeat the process if more than one ulcer. 4. Wash hands when done applying. Wash eyes promptly if they should come in contact with the paste. 5. 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. Or, as directed by the registered physician.

Use in pregnancy and lactation: Pregnancy Category B. There are no adequate and well controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Amlexanox was found in the milk of lactating rats; therefore caution exercised when administering Amlexanox oral paste to a nursing woman.

Packing: Tube containing 5 gm oral paste.

Prescribing Description

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