1. WHAT IS APHTHASOL?
 

Aphthasol is the FIRST FDA-APPROVED and ONLY AVAILABLE prescription drug specifically indicated for the treatment of Recurrent Aphthous Ulcers (RAU) in people with a normal immune system. It is a thick, light brown, mucoadhesive paste.
 
 

2. WHAT IS THE ACTIVE INGREDIENT FOR APHTHASOL?
 

In addition to the beneficial effects of the barrier created by the paste, the active ingredient for Aphthasol is Amlexanox 5%.
 
 

3. HOW WELL DOES APHTHASOL WORK?
 

Clinical trials have shown Aphthasol to promote 90% faster pain resolution and 72% faster healing than no treatment.
 

4. HOW DOES APHTHASOL WORK?
  

The thick mucoadhesive paste provides a barrier, which aids in healing. In addition, RAU's contain significant numbers of "activated" mast cells (these are the cells that make histamine in hay fever). Activated mast cells secrete histamines (known to cause allergy) and leukotrienes (known to cause inflammation). Amlexanox is known to inhibit histamine and leukotriene secretion by mast cells.
  5. WHEN SHOULD I START USING APHTHASOL?
 

The earlier in the cycle, the better. Best results are achieved when Aphthasol is applied as early in the PRODROMAL STAGE (onset) as possible.
  6. HOW OFTEN SHOULD I USE APHTHASOL?
   

Aphthasol should be applied to the affected area 4 times per day (Q.I.D.) for 7-10 days or until sufficient healing occurs. Patients may only need to use the product for 2-3 days to achieve significant results

Indications - Aphthasol is indicated for the treatment of aphthous ulcers in people with normal immune systems. It is indicated for individuals 18 years or older.

Pediatric Use - Safety and effectiveness of Aphthasol (amlexanox oral paste), 5% in pediatric patients have not been established

Geriatric Use - Clinical Studies of Aphthasol did not include sufficient numbers of subjects aged 54 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

Contraindications - Aphthasol (amlexanox oral paste), 5%, is contraindicated in patients with known hypersensivity to amlexanox or other ingredients in the formulation. Safety and effectiveness of amlexanox in immunocompromised patient have not been assessed!

Adverse Reactions - Adverse Reactions considered related or possibly related to amlexanox oral paste, 5%, were not reported by more than 5% of patients. Adverse reactions reported by 1-2% of the patients were transient pain stinging and/or burning at the site of application. Infrequent (<1%) adverse reactions in the clinical studies were contact mucositis, nausea, and diarrhea

Overdosage - There are no reports of human ingestion overdosage. Ingestion of a full tube of 5 grams of paste would result in systematic exposure well below the maximum nontoxic dose of amlexanox in animals. Gastrointestinal upset such as diarrhea and vomiting could result from an overdose.

Aphthasol is the first FDA-approved and only available prescription drug specifically for the treatment of recurrent aphthous ulcers, more commonly known as canker sores. Clinical trials have shown that Aphthasol promotes 90% faster pain resolution and 72% faster healing than no treatment.

The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient. This information is intended for residents of the United States.

Please see the complete prescription information for Aphthasol (Amlexanox Oral Paste), 5%
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