Generic Name: Amlexanox
Class: EENT Drugs, Miscellaneous
VA Class: OR900
Chemical Name: 2-amino-7-isopropyl-5-oxo-5H-benzopyrano[2,3-b] pyridine-3-carboxylic acid
Molecular Formula: C16H14N2O4
CAS Number: 68302-57-8
Aphthous ulcer healing agent.1
Uses for Aphthasol
Treatment of aphthous ulcers in patients with normal immune systems.1
Safety and efficacy not established in immunocompromised patients.1
Aphthasol Dosage and Administration
Oral, Topical Use Only
Wash hands when application is finished.1
Oral, Topical Use Only
Apply approximately 0.5 cm (¼ inch) onto each ulcer 4 times daily.1
Select dosage with caution, usually starting at the low end of the dosage range, because of possible age-related decreases in hepatic, renal, or cardiac function and of concomitant disease or other drug therapy.1
Cautions for Aphthasol
Known hypersensitivity to amlexanox or any ingredient in the formulation.1
Discontinue use if rash or contact mucositis occurs.1
Safety and efficacy not established.1
Insufficient experience in patients ≥65 years of age to determine whether they respond differently than younger adults.1 Other clinical experience has not identified differences in responses between geriatric and younger patients.1 Select dosage with caution.1 (See Geriatric Patients under Dosage and Administration.)
Common Adverse Effects
Interactions for Aphthasol
No formal drug interaction studies to date.1
Distributed into milk in rats.1
Oral, Topical Use Only
Advice to Patients
Importance of learning and adhering to proper administration techniques.1
Importance of initiating treatment as soon as possible after noticing symptoms of an aphthous ulcer.1
Importance of using until the ulcer heals or consulting a clinician if substantial healing or pain relief has not occurred in 10 days.1
Importance of discontinuing treatment if rash or contact mucositis occurs.1
Importance of avoiding contact with eyes; if ocular contact occurs, rinse eye(s) promptly.1
Keep out of reach of children.1
Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as concomitant illnesses.1
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
Importance of informing patients of other important precautionary information.1 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Oral (Topical Use Only)
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2013. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Aphthasol 5% Paste (DISCUS DENTAL): 3/$29.99 or 9/$69.97
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2013, Selected Revisions April 1, 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
1. Access Pharmaceuticals, Inc. Aphthasol (amlexanox) oral paste 5% prescribing information. Dallas, TX; 2004 Mar.
2. Khandwala A, Van Inwegen RG, Alfano MC. 5% amlexanox oral paste, a new treatment for recurrent minor aphthous ulcers: I. Clinical demonstration of acceleration of healing and resolution of pain. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1997; 83:222-30. [PubMed 9117754]
3. Khandwala A, Van Inwegen RG, Charney MR et al. 5% amlexanox oral paste, a new treatment for recurrent minor aphthous ulcers: II. Pharmacokinetics and demonstration of clinical safety. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1997; 83:231-8. [PubMed 9117755]
4. Saijo T, Kuriki H, Ashida Y et al. Mechanism of the action of amoxanox (AA-673), an orally active antiallergic agent. Int Arch Allergy Appl Immunol. 1985; 78:43-50. [PubMed 2411669]
5. Makino H, Saijo T, Ashida Y et al. Mechanism of action of an antiallergic agent, amlexanox (AA-673), in inhibiting histamine release from mast cells. Int Arch Allergy Appl Immunol. 1987; 82:66-71. [PubMed 2433225]
6. Discus Dental, Culver City, CA: Personal communication.