Amlex Oral paste: Each gram of oral paste contains 50 mg of Amlexanox lNN.
Amlex ® is an oral paste preparation of Amlexanox that exhibits both anti-allergic & anti-inflammatory properties. 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. Upon oral administration Amlexanox 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 of approximately 120 ng/mlare observed at 2.4 hours. Most or 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. Approximately 17% of the dose is eliminated in the urine as unchanged Amlexanox, a hydroxylated metabolite and their conjugates. With multiple application four times daily steady state levels were reached within one week and no accumulation was observed with up to four weeks of usage.
Route: Topical oral paste
Adults (>18 years):
Apply ~0.5 cm dab onto each aphthous ulcer 4 times daily after meals and at bedtime until healed. Consult physician if unhealed after 10 days.
Pediatric:
Safety and effectiveness not established.
No specific clinical drug interactions reported with topical oral paste; avoid simultaneous application of other oral topical medications to affected mucosal lesions.
Amlexanox oral paste is contraindicated in patients with known hypersensitivity to Amlexanox or other ingredients in the formulation.
Common: Transient pain, stinging, burning at application site. Less Common: Contact mucositis, nausea, diarrhea.
Overdose
Ingestion of a full tube would result in systemic exposure below the maximum nontoxic dose of Amlexanox in animals. Gastrointestinal upset such as diarrhea and vomiting could result from an overdose.
Category B. No adequate and well-controlled studies in pregnant women; use during pregnancy only if clearly needed. Lactation: Excreted in animal milk; caution should be exercised when administered to a nursing woman.
Store below 30°C in a cool, dry place. Protect from light and moisture. Keep out of reach of children.