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Brand Name :
Apthera
Synonyms :
amlexanox
Class :
Immunomodulators
Brand Name :
Apthera
Synonyms :
amlexanox
Class :
Immunomodulators
Dosage Forms & Strengths
Oral paste
5%
Mucoadhesive Patch
2%
Paste: After performing dental hygiene before sleep, apply approximately 0.5 cm of oral paste topically to each ulcer four times daily.
Do not exceed more than 10 days.
Patch: Apply one patch to each ulcer four times daily and practice good dental hygiene after meals and before night. You can use up to three patches at once if you have several ulcers.
Do not exceed more than 10 days.
Dosage Forms & Strengths
Oral paste
5%
Mucoadhesive Patch
2%
< 12 years: Safety and efficacy not established
>12 years:
Paste: After performing dental hygiene before sleep, apply approximately 0.5 cm of oral paste topically to each ulcer four times daily.
Do not exceed more than 10 days.
Patch: Apply one patch to each ulcer four times daily and practice good dental hygiene after meals and before night. You can use up to three patches at once if you have several ulcers.
Do not exceed more than 10 days.
Refer adult dosing
Actions and Spectrum:
Spectrum of Activity:
amlexanox’s primary use is treating recurrent aphthous ulcers (canker sores) in the mouth. In this context, its spectrum of activity is primarily focused on reducing inflammation, pain, and discomfort associated with oral ulcers.
Frequency not defined
Stinging
Irritation
Nausea
Diarrhea
Transient pain
Burning
Contact mucositis
Black box warning:
None
Contraindications/caution:
Contraindications:
Caution:
Pregnancy consideration: There was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
Pregnancy category: </b>B
Lactation: Excretion of the drug in human breast milk is unknown
Pregnancy category:
Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category
Pharmacology:
The pharmacology of amlexanox:
Pharmacokinetics:
Absorption
amlexanox is typically administered topically as an oral paste with mucoadhesive properties. When applied to the affected area in the mouth, the drug is absorbed through the oral mucosa. Systemic absorption is limited due to the localized nature of its application.
Distribution
Because amlexanox is primarily used topically, its distribution is confined to the application site in the oral mucosa. Systemic distribution to other body tissues is minimal.
Metabolism
amlexanox is metabolized within the body, but detailed information about its metabolic pathways is not extensively available. It is known to undergo various metabolic processes, which may include the formation of metabolites.
Elimination and Excretion
Any systemic amlexanox and its metabolites are likely eliminated primarily through urine, but specific proportions and pathways are not well-documented.
Administration:
Topical administration
amlexanox is applied directly to the affected area of the mouth where the aphthous ulcer is present. It is designed to adhere to the mucous membrane and provide local treatment.
Patient information leaflet
Generic Name: amlexanox
Why do we use amlexanox?
amlexanox is primarily used to treat recurrent aphthous ulcers (canker sores) in the mouth. It is administered as a topical mucoadhesive oral paste and is applied directly to the affected area. The primary use of amlexanox is to alleviate the symptoms associated with aphthous ulcers, which include pain, discomfort, and inflammation. Here are the primary uses of amlexanox:
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