Introduction
Amlex Oral Paste 5% is an antiallergic drug, clinically effective for atopic diseases, especially allergic asthma and rhinitis. Amlex Oral Paste 5% as a topical paste is a well tolerated treatment of recurrent aphthous ulcers. Recurrent aphthous ulcer (RAU) is the most prevalent oral mucosal disease in humans, estimated to affect between 5% and 50% of the general population.
Uses
Used as a paste in the mouth to treat aphthous ulcers (canker sores).
Pharmacodynamics
Amlex Oral Paste 5% is a mucoadhesive oral paste which has been clinically proven to abort the onset, accelerate healing and resolve the pain of aphthous ulcers (canker sores). It decreases the time ulcers take to heal. Because amlexanox decreases the healing time, it also decreases the pain you feel. Recent studies have also shown that the majority of ulcers can be prevented by application of the paste during the prodromal (pre-ulcerative) phase of the disease. Recurrent Aphthous Ulcers (RAU) also known as Recurrent Aphthous Stomatitis (RAS) is recognized as the most common oral mucosal disease known to man. Estimates suggest that 20% - 25% of the general population suffer at least one incidence of aphthous ulcers each year. Amlex Oral Paste 5% is also being investigated for its anti-allergenic and anti-inflammatory properties.
Mechanism of Action
As a benzopyrano-bipyridine carboxylic acid derivative, amlexanox has anti-inflammatory and antiallergic properties. It inhibits chemical mediatory release of the slow-reacting substance of anaphylaxis (SRS-A) and may have antagonistic effects on interleukin-3. When cells are under stress, they release an inactive form of human fibroblast growth factor 1 (FGF-1), a potent mitogen (entity that causes mitosis). Amlex Oral Paste 5% binds to FGF1, increasing its conformational stability, sterically blocking Cu(2+) induced oxidation which normally leads to activation of FGF-1.
Absorption
No significant absorption directly through the active ulcer. Most of the systemic absorption is via the gastrointestinal tract.
Half Life
Elimination half-life is 3.5 ± 1.1 hours.
Dosage
- 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.
