
Apsol5%
Square Pharmaceuticals PLC.
Amlexanox (as a 5% oromucosal paste) is an FDA-approved, evidence-based topical treatment with the following indications: Established/FDA-approved use Recurrent aphthous ulcers (canker sores):…
Amlexanox (as a 5% oromucosal paste) is an FDA-approved, evidence-based topical treatment with the following indications:
Amlexanox paste is not intended for ulcers caused by other conditions (e.g., herpes, trauma, systemic disease); a physician should evaluate ulcers that are unusually large, persistent, or recurrent.
| Indication | Population | Recommended Dose |
|---|---|---|
| Aphthous ulcers (canker sores) | Adults and adolescents (established use) | Apply approximately a 1/4-inch (0.6 cm) strip of 5% Amlexanox paste directly onto each ulcer 4 times daily, after oral hygiene (e.g., after breakfast, lunch, dinner, and at bedtime), starting as soon as symptoms/lesions are noticed. |
| Aphthous ulcers (canker sores) | Children under 6 years | Safety and efficacy not established (see Use in Special Populations). |
No specific dose adjustment is established for topical Amlexanox given its minimal systemic absorption; formal studies in renal or hepatic impairment have not been conducted.
Continue application until the ulcer heals. If healing has not occurred within 10 days of starting Amlexanox, discontinue use and consult a physician or dentist.
Local application-site reactions are the most common side effects of Amlexanox and are generally mild and transient.
Recurrent, unusually severe, or persistent mouth ulcers that do not respond to Amlexanox within 10 days should be evaluated by a physician or dentist to exclude other underlying causes.
Amlexanox oral paste is contraindicated in patients with known hypersensitivity to Amlexanox or to any other component of the paste formulation.
Disclaimer
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