Amlexanoxum

Amlexanoxum Uses, Dosage, Side Effects, Food Interaction and all others data.

The mechanism of action by which Amlexanoxum accelerates healing of aphthous ulcers is unknown. In vitro studies have demonstrated Amlexanoxum to be a potent inhibitor of the formation and release of inflammatory mediators (histamine and leukotrienes) from mast cells, neutrophils and mononuclear cells. Given orally to animals, Amlexanoxum has demonstrated anti-allergic and anti-inflammatory activities and has been shown to suppress both immediate and delayed type hypersensitivity reactions. The relevance of these activities of Amlexanoxum to its effects on aphthous ulcers has not been established.

Amlexanoxum 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. Amlexanoxum is also being investigated for its anti-allergenic and anti-inflammatory properties.

Amlexanoxum
Uses
Dosage
Side Effect
Precautions
Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
Food Interaction
Half Life
Volume of Distribution
Clearance
Interaction With other Medicine
Contradiction
Storage

Trade Name	Amlexanoxum
Generic	Amlexanox
Amlexanox Other Names	Amlexanox, Amlexanoxo, Amlexanoxum, Amoxanox
Type
Formula	C₁₆H₁₄N₂O₄
Weight	Average: 298.2934 Monoisotopic: 298.095356946
Groups	Approved, Investigational, Withdrawn
Therapeutic Class	Drugs for Aphthous ulcer
Manufacturer
Available Country
Last Updated:	September 19, 2023 at 7:00 am

Uses

Amlexanoxum is used for the treatment of aphthous ulcers in people with normal immune system.

How Amlexanoxum works

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). Amlexanoxum binds to FGF1, increasing its conformational stability, sterically blocking Cu(2+) induced oxidation which normally leads to activation of FGF-1.

Dosage

Amlexanoxum dosage

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.

Side Effects

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.

Precaution

Wash hands immediately after applying Amlexanoxum 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.

Elimination Route

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.

Pregnancy & Breastfeeding use

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

Contraindication

Amlexanoxum oral paste is contraindicated in patients with known hypersensitivity to Amlexanoxum or other ingredients in the formulation.

Special Warning

Safety and effectiveness of Amlexanoxum oral paste in pediatric patients have not been established.

Acute Overdose

Ingestion of a full tube would result in systemic exposure below the maximum nontoxic dose of Amlexanoxum in animals. Gastrointestinal upset such as diarrhea and vomiting could result from an overdose.