you're taking Aphthasol Generic Name: Amlexanox Class: EENT Drugs, Miscellaneous VA Class: OR900 Chemical Name: 2-amino-7-isopropyl-5-oxo-5H-[1]benzopyrano[2,3-b] pyridine-3-carboxylic acid Molecular Formula: C 16 H 14 N 2 O 4 CAS Number: 68302-57-8 Overview Side Effects Professional Pregnancy Reviews More Support Group Q & A Introduction Aphthous ulcer healing agent. 1 Uses for Aphthasol Aphthous Ulcers Treatment of aphthous ulcers in patients with normal immune systems. 1 Safety and efficacy not established in immunocompromised patients. 1 Slideshow Diabetic Nerve Pain: Symptoms And Treatment Aphthasol Dosage and Administration Administration Oral, Topical Use Only Apply topically to oral cavity as a paste. 1 Not for ophthalmic use. 1 Apply paste as soon as possible after noticing aphthous ulcer symptoms. 1 Apply 4 times daily, preferably following oral hygiene after breakfast, lunch, dinner, and at bedtime. 1 Before application, dry ulcer(s) by gently patting with a soft, clean cloth. 1 Wash hands and apply paste onto moistened index finger tip; dab paste with gentle pressure onto each ulcer in the mouth. 1 Wash hands when application is finished. 1 Dosage Adults Aphthous Ulcers Oral, Topical Use Only Apply approximately 0.5 cm ( inch) onto each ulcer 4 times daily. 1 Continue treatment until ulcer heals. 1 If substantial healing or pain reduction has not occurred in 10 days, consult dentist or physician. 1 Special Populations Geriatric Patients 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 Contraindications Known hypersensitivity to amlexanox or any ingredient in the formulation. 1 Warnings/Precautions Sensitivity Reactions Hypersensitivity Reactions Discontinue use if rash or contact mucositis occurs. 1 Specific Populations Pregnancy Category B. 1 Lactation Distributed into milk in rats. 1 Caution if used in nursing women. 1 Pediatric Use Safety and efficacy not established. 1 Geriatric Use 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 Transient pain, stinging, and/or burning at application site. 1 3 Interactions for Aphthasol No formal drug interaction studies to date. 1 Aphthasol Pharmacokinetics Absorption Bioavailability Not substantially absorbed through the active ulcer; 1 systemic absorption occurs mostly via the GI tract. 1 3 Peak serum concentrations attained 2.4 hours after a single oral application of 100 mg of paste (5 mg amlexanox). 1 3 Steady-state concentrations reached within 1 week after multiple applications 4 times daily; no accumulation observed with 4 weeks of use. 1 3 Distribution Extent Distributed into milk in rats. 1 Elimination Elimination Route Approximately 17% of dose is excreted in urine as unchanged drug, hydroxylated metabolite, and conjugates. 1 3 Half-life Approximately 3.5 hours (range: 2.4 4.6 hours). 1 3 Stability Storage Oral, Topical Use Only Paste 15 30 C. 1 Actions Accelerates healing of aphthous ulcers; precise mechanism of such effect unknown. 1 2 3 Potent in vitro inhibitor of formation and/or release of inflammatory mediators (histamine and leukotrienes) from mast cells, neutrophils, and mononuclear cells. 1 4 5 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.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Amlexanox Routes Dosage Forms Strengths Brand Names Manufacturer Oral (Topical Use Only) Paste 5% Aphthasol Uluru AHFS DI Essentials. Copyright 2017, Selected Revisions April 1, 2008. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. References 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. Next Pregnancy Warnings Print this page Add to My Med List More about Aphthasol (amlexanox topical) Side Effects During Pregnancy Support Group 0 Reviews Add your own review/rating Drug class: mouth and throat products Consumer resources Aphthasol Aphthasol (Advanced Reading) Professional resources Amlexanox (AHFS Monograph) Related treatment guides Aphthous Stomatitis, Recurrent Aphthous Ulcer FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Availability Discontinued B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Mouth and throat products Related Drugs Aphthous Stomatitis, Recurrent hydrocortisone topical , amlexanox topical , OraDisc A , More... 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