Amlexanox

U.S. BRAND NAMES — Aphthasol®

PHARMACOLOGIC CATEGORY
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.

Paste, oral:
Aphthasol®: 5% (3 g) [contains benzyl alcohol]

DOSAGE FORMS: CONCISE
Paste, oral:
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)
Paste (Aphthasol)
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)