U.S. BRAND NAMES — Aphthasol®
Anti-inflammatory, Locally Applied
DOSING: ADULTS — Aphthous ulcers: Topical: Administer ~1/4 inch (0.5 cm) directly on ulcers 4 times/day following oral hygiene, after meals, and at bedtime.
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Aphthasol®: 5% (3 g) [contains benzyl alcohol]
DOSAGE FORMS: CONCISE
Aphthasol®: 5% (3 g)
GENERIC EQUIVALENT AVAILABLE — No
USE — Treatment of aphthous ulcers (ie, canker sores)
USE – UNLABELED / INVESTIGATIONAL — Allergic disorders
ADVERSE REACTIONS SIGNIFICANT
1% to 2%:
Dermatologic: Allergic contact dermatitis
Gastrointestinal: Oral irritation
<1% (Limited to important or life-threatening): Contact mucositis
CONTRAINDICATIONS — Hypersensitivity to amlexanox or any component of the formulation
WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Mucositis: Discontinue therapy if contact mucositis develops. Rash: Discontinue therapy if rash develops.
Special populations: Pediatrics: Safety and efficacy have not been established in children.
DRUG INTERACTIONS — There are no known significant interactions.
PREGNANCY RISK FACTOR — B (show table)
PREGNANCY IMPLICATIONS — Due to lack of data, avoid use in pregnancy, if possible.
LACTATION — Excretion in breast milk unknown/use caution
PRICING — (data from drugstore.com)
5% (3): $29.99
INTERNATIONAL BRAND NAMES — Elics (JP); Solfa (JP)
MECHANISM OF ACTION — As a benzopyrano-bipyridine carboxylic acid derivative, amlexanox has anti-inflammatory and antiallergic properties; it inhibits chemical mediatory release of the slow-reacting substance of anaphylaxis (SRS-A) and may have antagonistic effects on interleukin-3
PHARMACODYNAMICS / KINETICS
Absorption: Some from swallowed paste
Metabolism: Hydroxylated and conjugated metabolites
Half-life elimination: 3.5 hours
Time to peak, serum: 2 hours
Excretion: Urine (17% as unchanged drug)