Published on March 1, 2014
A Presentation On Amlexanox in the management of oral Aphthous ulcers By: Mr. Harikesh Maurya Sr. Clinical Research Associate 1
ORAL APHTHOUS ULCERS Canker Sores Minor Aphthous Ulcer Major Aphthous Ulcer 2
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 3 of tongue, gums.
Etiology of Aphthous ulcer Trauma and Stress Systemic disease and nutritional deficiencies Genetic predisposition Immune disorders Drug Induction 4
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) 5
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 6
Amlexanox 2-Amino-7-(1-methyl-ethyl)-5-oxo-5H- benzopyranol [2,3-b] pyridine-3-carboxylic acid 7
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 8
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 9
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. 10
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 11
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. 12
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. 13
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. 14
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Amlexanox Aphthous ulcers Recurrent oral ulcers Canker sores abstract Aphthous ulcers (Canker sores) are recurrent multiple ulcers occurring in oral mucosa
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