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Amlexanox

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Indications

Apsol is used to treat mouth ulcers (aphthous ulcers).

⚠️ Always consult a registered physician before taking any medicine.

Pharmacology

The exact mechanism by which Amlexanox speeds the healing of aphthous ulcers is not known. In laboratory studies, it has proven to be a strong inhibitor of the formation and release of inflammatory substances, such as histamine and leukotrienes, from mast cells, neutrophils and mononuclear cells. When given orally to animals, Amlexanox has shown anti-allergic and anti-inflammatory activity and has been found to suppress both immediate and delayed-type hypersensitivity reactions. How these activities relate to its effect on aphthous ulcers has not been established. Following a single oral application of 100 mg of paste (containing 5 mg of Amlexanox), peak serum levels are reached at around 2.4 hours. Most systemic absorption of Amlexanox occurs through the gastrointestinal tract, with only a small portion of the applied dose absorbed directly through the active ulcer. In healthy individuals, the elimination half-life was 3.5 ± 1.1 hours.

Pregnancy & Breastfeeding

Amlexanox falls under US FDA pregnancy category B. Animal studies tested doses two hundred to six hundred times the projected human daily dose and found no adverse effects on the fetus. However, well-controlled studies in pregnant women are lacking, and since animal data don't always predict how humans will respond, this medicine should only be used during pregnancy if clearly necessary. Amlexanox has also been detected in the breast milk of nursing rats, so caution is advised when giving Amlexanox oral paste to a breastfeeding woman.

⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.

Dosage Reference

⚠️ Reference ranges from official sources only. Consult your doctor for personalized dosing.

Adults: 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) onto a fingertip. Gently dab the paste onto the ulcer. Repeat the process if more than one ulcer are present. Wash hands after application. Wash eyes promptly if they should come in contact with the paste. 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.