Apsol
Generic: Amlexanox
Application:
Course Duration:
Alternatives (3)Cheaper & Alternative Brands (5%)
Same active generic (Amlexanox), same form (Oral Paste), exact same strength (5%)
Clinical Prescribing Information
Medical monograph and safety information for healthcare professionals & patients.Indications & Clinical Uses
Amlex is indicated for the treatment of aphthous ulcers.
Dosage & Administration
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.
Contraindications
Amlexanox oral paste is contraindicated in patients with known hypersensitivity to Amlexanox or other ingredients in the formulation.
Side Effects & Adverse Reactions
Adverse reactions reported by 1-2% of patients were transient pain, stinging and/or burning at the site of application. Infrequent (<1%) adverse reactions in the clinical studies were contact mucositis, nausea, and diarrhea.
Warnings & Precautions
Wash hands immediately after applying Amlex oral paste directly to ulcers with the finger tips. In the event that a rash or contact mucositis occurs, discontinue use.
Pharmacology & Mechanism of Action
The mechanism of action by which Amlexanox accelerates healing of aphthous ulcers is unknown. In vitro studies have demonstrated Amlexanox 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, Amlexanox 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 Amlexanox to its effects on aphthous ulcers has not been established. After a single oral application of 100 mg of paste (5 mg Amlexanox), maximal serum levels are observed at 2.4 hours. Most of the systemic absorption of Amlexanox is via the gastrointestinal tract and the amount absorbed directly through the active ulcer is not a significant portion of the applied dose. The half-life for elimination was 3.5 +/- 1.1 hours in healthy individuals.