Amlexanox: Indication, Dosage, Side Effect, Precaution

This information is not country-specific. Please refer to the Indonesia prescribing information.

Generic Medicine Info

Indications and Dosage

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.

Pregnancy Category (US FDA)

Topical: B

Overdosage

Reports of ingestion overdose in human are not available. Amlexanox overdose may cause GI upset such as vomiting and diarrhoea.

Action

Description:
Mechanism of Action: 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).

MIMS Class

Preparations for Oral Ulceration & Inflammation

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