Generic
Amlexanox
3 brands available in the market
At a glance
Amlexanox is an anti-aphthous ulcer medication used for the treatment of mouth ulcers. It reduces inflammation, relieves pain and promotes faster healing. It forms a protective film over the ulcer surface.
Description
Amlexanox is an anti-aphthous ulcer medication that reduces inflammation, redness and pain of mouth ulcers. It works by inhibiting the formation and release of inflammatory mediators like histamine and leukotrienes from mast cells, neutrophils and mononuclear cells. It adheres to the wet surfaces of the mouth and forms a protective film over the ulcer, which accelerates healing. It is usually applied after meals and at bedtime.
Indications
Mouth ulcers (aphthous ulcers/canker sores).
Therapeutic class
Anti-aphthous Ulcer Medication
Pharmacological class
Anti-inflammatory & Anti-allergic Agent
Pharmacology
Amlexanox accelerates the healing of aphthous ulcers. Although the exact mechanism is not fully known, in vitro studies have shown that Amlexanox is a potent inhibitor of the formation and/or release of inflammatory mediators (histamine and leukotrienes) from mast cells, neutrophils, and mononuclear cells. It adheres to the wet surfaces of the mouth and forms a protective film over the ulcer, speeding up the healing process.
Mechanism of action
Amlexanox reduces inflammation and pain by inhibiting the formation and release of inflammatory mediators like histamine and leukotrienes from mast cells, neutrophils and mononuclear cells. It also forms a protective film over the ulcer, accelerating healing.
Dosage
Adults: Apply directly to the ulcer 4 times daily (after breakfast, lunch, dinner and at bedtime after brushing teeth). Continue use until the ulcer heals completely or as directed by the physician.
Administration
For topical use on mouth ulcers only. Wash hands before and after application. Avoid contact with the eyes. Refrain from eating or drinking for at least 30 minutes after application.
Missed dose
If you miss a dose, apply it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule.
Side effects
Common side effects: Mild pain, stinging or burning sensation at the application site, taste alteration.
Rare: Nausea, diarrhea, contact mucositis, skin rash.
Precautions & warnings
- Wash hands before and after application
- Avoid contact with eyes (rinse with plenty of water if contact occurs)
- Consult a doctor if no significant improvement occurs within 10 days
- Discontinue use if skin rash, new mouth ulcers or white patches appear
- Efficacy has not been evaluated in immunocompromised patients
- Use lower initial doses in elderly patients
Contraindications
- Hypersensitivity to amlexanox or any component
- Children under 12 years of age
Drug interactions
No known drug interactions have been identified.
Food interactions
No food interactions (topical application).
Use in pregnancy
Pregnancy Category: B. Animal studies have shown low or no adverse effects on the fetus; human studies are limited. Use only if clearly needed with medical advice.
Pregnancy Category: B — always consult a doctor before taking during pregnancy.
Use in lactation
Limited information is available on the use of amlexanox during breastfeeding; consult your doctor.
Pediatric use
Safety and efficacy have not been established in children under 12 years of age.
Geriatric use
Lower initial doses are recommended for elderly patients.
Renal / hepatic impairment
No dose adjustment needed for renal or hepatic impairment with topical use.
Overdose effects
Topical overdose is unlikely; excessive application may cause local irritation.
Storage conditions
Store in a cool and dry place, protected from light. Keep out of reach of children.
Chemical structure
C16H14N2O4 (Molecular weight: 298.29 g/mol)