| U.S. Brand Names |
| Aphthasol™ |
 |
| Generic Available |
|
No |
|
| Pharmacological Index |
|
Anti-inflammatory, Locally Applied |
|
| Use |
|
Treatment of aphthous ulcers (ie, canker sores); has been investigated in many allergic disorders |
|
| Pregnancy Risk Factor |
|
B |
|
| Pregnancy/Breast-Feeding Implications |
|
Due to lack of data, avoid use in pregnancy or lactation, if possible |
|
| Contraindications |
|
Hypersensitivity to amlexanox or components |
|
| 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 effect son interleukin-3 |
|
| Pharmacodynamics/Kinetics |
|
Absorption: Systemic absorption with swallowing of topical application of oral paste Metabolism: Metabolized to hydroxylated and conjugated product Half-life: 3.5 hours Time to peak serum concentration: 2 hours Elimination: 17% excreted unchanged |
|
| Usual Dosage |
|
Administer (0.5 cm - 1/4 ") directly on ulcers 4 times/day following oral hygiene, after meals, and at bedtime |
|
| Mental Health: Effects on Mental Status |
|
None reported |
|
| Mental Health: Effects on Psychiatric Treatment |
|
None reported |
|
| Dental Health: Local Anesthetic/Vasoconstrictor Precautions |
|
No information available to require special precautions |
|
| Dental Health: Effects on Dental Treatment |
|
Discontinue therapy if rash or contact mucositis develops |
|
| Patient Information |
|
Apply as soon as possible and continue 4 times/day (after meals and at bedtime); wash hands after use; contact physician if no reduction in pain occurs within 10 days |
|
| Dosage Forms |
|
Paste: 5% (5 g) |
|
| 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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