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Pronunciation:

(am LEKS an oks)

U.S. Brand Names:

Aphthasol®

Generic Available:

Use:

Treatment of aphthous ulcers (ie, canker sores)

Use - Unlabeled/Investigational:

Allergic disorders

Pregnancy Risk Factor:

Pregnancy Implications:

Due to lack of data, avoid use in pregnancy, if possible.

Lactation:

Excretion in breast milk unknown/use caution

Contraindications:

Hypersensitivity to amlexanox or any component of the formulation

Warnings/Precautions:

Discontinue therapy if rash or contact mucositis develops.

Adverse Reactions:

1% to 2%:

Dermatologic: Allergic contact dermatitis

Gastrointestinal: Oral irritation

<1%: Contact mucositis

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)

Dosage:

Administer (0.5 cm - ¹/4") directly on ulcers 4 times/day following oral hygiene, after meals, and at bedtime

Patient Education:

This medication is only for treatment of mouth ulcers; do not apply to ulcers of the eye or any other part of the body. Use as directed. Apply after eating. Wash hands before and after use. Brush teeth and rinse mouth before applying directly to ulcers. Squeeze a small amount of paste on your clean finger tip and dab paste onto each ulcer in the mouth, using gentle pressure. Wash eyes immediately if any paste should come into contact with eyes. Notify prescriber or dentist if rash or irritation occurs, or if condition does not improve after 10 days use. Breast-feeding precaution: Consult prescriber if breast-feeding.

Dental Health: Effects on Dental Treatment:

Key adverse event(s) related to dental treatment: Allergic contact dermatitis and oral irritation. Discontinue therapy if rash or contact mucositis develops.

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Dental Comment:

Treatment of canker sores with amlexanox showed a 76% median reduction in ulcer size compared to a 40% reduction with placebo. Greer, et al, reported an overall mean reduction in ulcer size of 1.82 mm² for patients treated with 5% amlexanox versus an average reduction of 0.52 mm² for the control group. Recent studies in over thousands of patients have confirmed that amlexanox accelerates the resolution of pain and healing of aphthous ulcers more significantly than vehicle and no treatment.

Mental Health: Effects on Mental Status:

None reported

Mental Health: Effects on Psychiatric Treatment:

None reported

Dosage Forms:

Paste: 5% (5 g) [contains benzyl alcohol]

International Brand Names:

Elics® (JP); Solfa® (JP)

References

Greer RO Jr, Lindenmuth JE, Juarez T, et al, "A Double-Blind Study of Topically Applied 5% Amlexanox in the Treatment of Aphthous Ulcers,"J Oral Maxillofac Surg, 1993, 51(3):243-8.

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