Most people suffer with a mouth ulcer every now and then. They're extremely common and usually painful, appearing as little craters in the lining of the mouth. Mouth plays a significant role in moment-to-moment living. And even a minor oral problem can cause significant eating, drinking or communicating health consequences. Imagine, if mouth is constantly taking in potentially mouth harming substances by way of the air you breath, the food that’s munched down on, those teeth picking fingers or bacterial and virus infection causing material allowed to pass through lips. However, not all oral infections, pain or sores originate externally. Some diseases and disorders can be the genesis for trouble. Mouth problems are a universal experience. In this regards, finally we find that the Amlexanox is effective in reducing aphthous ulcer, pain and lesional size.

1. A Presentation On
Amlexanox in the management of
oral Aphthous ulcers
By: Mr. Harikesh Maurya
Sr. Clinical Research Associate
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2. ORAL APHTHOUS ULCERS
Canker Sores
Minor Aphthous Ulcer
Major Aphthous Ulcer
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3. Pathology of Aphthous ulcer
1. Aphthous ulcers are among the common oral lesions in
the general population.
2. Frequency is as high as 50%.
3. Recurrent Aphthous ulceration can occur in 15-20% of
the population.
4. Aphthous ulcers are often quite painful
5. Most Aphthae heal within 7-10 days.
6. Aphthous ulcer are round or oval with grayish yellow
base surrounded by inflamed mucosa.
7. Usually occurs on lips, floor of mouth, ventral surface
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of tongue, gums.

4. Etiology of Aphthous ulcer
Trauma and Stress
Systemic disease and nutritional deficiencies
Genetic predisposition
Immune disorders
Drug Induction
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5. Treatment of Aphthous ulcer
1. Antimicrobial mouth washes : Used to control
microbial contamination and secondary infections
Antibiotics
(Tetracycline)
and
Anti-septic
(Chlorhexidine)
2.
Topical Corticosteriods eg. Betamethasone and
Beclomethasone.
3. Levamisole
4. Local Anesthetics eg. Lignocaine.
5. AMX-07 (5% oral paste)
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6. Amlexanox
Description
Amlexanox is used for local application for oral
cavity for the treatment of Aphthous ulcers
Composition
Each gm of oral paste contains
Amlexanox……………..50mg
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7. Amlexanox
2-Amino-7-(1-methyl-ethyl)-5-oxo-5H-[1] benzopyranol [2,3-b]
pyridine-3-carboxylic acid
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8. Mechanism of Action
1.
Amlexanox has anti-inflammatory and anti-allergic properties.
2.
It inhibits Slow Reacting substance of Anaphylaxis (SRS-A)
3.
It has antagonistic activity of Interleukin –3
4.
Inhibition of TNF-α
5.
It decreases the time ulcers take to heal
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9. Pharmacokinetics
 After single oral application of 100mg of paste (5%
Amlexanox), Cmax of approx. 120ng/ml at approx. 2-2.5
hrs.
 Most of the systemic absorption of Amlexanox is via
the gastrointestinal tract and amount absorbed from
active ulcer is not significant.
 Elimination half-life is 3.5hrs
 No accumulation was observed with-up to four weeks
of usage
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10. Amlexanox
Indications
Treatment of Aphthous ulcers
Dosage and Administration
1. Dry the ulcer by gently patting with soft clean cloth
2. Place small amount (approx. 1/4th inch) of Amlexanox
on to the ulcer 3-4 times daily
3. Product should be preferably applied following oral
hygiene after breakfast, lunch and at bedtime.
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11. Amlexanox
Contraindication
Amlexanox oral paste 5% is contraindicated in patients with
known hypersensitivity to Amlexanox or other ingredients in the
formulation
Pregnancy Category B
At doses up to 200 and 600 times the human doses, No adverse
fetal effects were observed. Drug should be used in Pregnancy
only if clearly needed
Lactation
Amlexanox was found in the milk of lactating rats; therefore
caution should be exercised.
Pediatric Use
Safety in children has not been established
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12. Amlexanox
Adverse Reactions
Transient pain, Stingling and/or burning at the site of
application in 1-2 % of patients.
Over dosage
No reports of human ingestion over dosage. Ingestion of
a full tube of 5gms of paste would result in systemic
exposure well below the non toxic dose of Amlexanox
in animals. Diarrhea and vomiting could occur.
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13. Advantages of Amlexanox over standard therapy
 Most treatments are palliative, addressing only the pain
associated with aphthous ulcers through topical treatment with
formulations of anaesthetics, such as benzocaine and lidocaine.
 There is only one active ingredient (Amlexanox) which is
clinically-proven to accelerate the healing of aphthous ulcers.
 Pain relief occurred in conjunction with healing of the ulcers.
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14. CONCLUSIONS
From the my opinion of view it is observed that 5%
Amlexanox Oral Paste is more effective and safe in
patients suffering from oral aphthous ulcers.
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