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Pronunciation
(am LEKS an oks)
Generic Available
No
U.S. Brand Names
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Treatment of aphthous ulcers (ie, canker sores)
Use: Dental
Treatment of aphthous ulcers (ie, canker sores)
Use: Unlabeled/Investigational
Allergic disorders
Pregnancy Risk Factor
B
Pregnancy Considerations
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
Topical: 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 (see Dental Comment).
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
Nursing: Physical Assessment/Monitoring
Assess knowledge/teach patient appropriate application and use, adverse effects to report, and interventions for side effects.
Dosage Forms
Paste: 5% (5 g) [contains benzyl alcohol]
Pricing: U.S. (www.drugstore.com)
Paste (Aphthasol)
5% (5): $21.99
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.
Lexi-Comp.com
Last full review/revision May 2006
Content last modified May 2006
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