Amlexanox


Concise Prescribing Info
Indications/Uses
Aphthous ulcer in patients w/ normal immune systems
Dosage/Direction for Use
Adult : Topical As a 5% oral paste: Apply approx 0.5 cm of oral paste directly on to each ulcer 4 times/day; following oral hygiene after meals and at bedtime. Initiate treatment at earliest symptom of an aphthous ulcer. Continue treatment until mouth ulcer is healed, not exceeding 10 days. As a 2% mucoadhesive patch: Apply one patch to each ulcer 4 times/day; following oral hygiene after meals and before bedtime. If multiple ulcers present, up to 3 patches may be used at one time. Continue treatment until mouth ulcer is healed, not exceeding 10 days.
Dosage Details
Topical/Cutaneous
Aphthous ulcer
Adult: For use in patients with normal immune systems: As a 5% oral paste: Apply approx 0.5 cm of oral paste directly on to each ulcer 4 times daily; following oral hygiene after meals and at bedtime. Initiate treatment at earliest symptom of an aphthous ulcer. Continue treatment until mouth ulcer is healed, not exceeding 10 days. As a 2% mucoadhesive patch: Apply one patch to each ulcer 4 times daily; following oral hygiene after meals and before bedtime. If multiple ulcers present, up to 3 patches may be used at one time. Continue treatment until mouth ulcer is healed, not exceeding 10 days.
Child: Not to be used in children below age 12.
Special Precautions
For topical use on mouth ulcers only. Avoid contact with the eyes; rinse immediately if ocular contact occurs. Wash hands before and after every application. Discontinue treatment if rash or contact mucositis develops. Seek medical advice if mouth ulcers have not healed after 10 days of treatment. Effects have not been evaluated in immune-compromised patients. Use lower initial dose for elderly patients. Not recommended for use in children below <12 yr. Pregnancy and lactation.
Adverse Reactions
Application site reactions e.g. transient pain, stinging, burning, irritation, contact mucositis, nausea and diarrhoea.
Overdosage
Reports of ingestion overdose in human are not available. Amlexanox overdose may cause GI upset such as vomiting and diarrhoea.
Action
Description: Amlexanox accelerates healing of aphthous ulcers. The exact mechanism of action is not known. In vitro studies have shown that Amlexanox is a potent inhibitor of the formation and/or release of inflammatory mediators (histamine and leukotrienes) from mast cells, neutrophils, and mononuclear cells.
Pharmacokinetics:
Absorption: Systemic absorption occurs mostly via GI tract; absorption directly through the active ulcer is not significant. Cmax: Approx 120 ng/mL. Tmax: About 2.4 hr (following single application of 100 mg of 5% cream). Steady-state concentrations reached within 1 wk with multiple applications 4 times daily.
Metabolism: Metabolised to hydroxylated and conjugated metabolites.
Excretion: Excreted in urine (about 17% as unchanged drug, 6.2% as amlexanox hydroxylated metabolite, and 3% as conjugates of M1). Elimination half-life: About 3.5 hr.
Storage
Store at room temperature 15-30°C (59-86°F).
Disclaimer: This information is independently developed by MIMS based on Amlexanox from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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