Aphthasol

Name: Aphthasol

Pharmacology

Mechanism of Action

Studies have suggested that it inhibits formation & release of proinflammatory substances; may have antigonistic effects on interleukin

Pharmacokinetics

Half-Life: 3.5 hr

Metabolism: Conjugated and hydroxylated metabolites

Excretion: Urine (17%)

Peak plasma time: 2 hr

Absorption: Minimal from swallowed paste

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Aphthasol Overview

Aphthasol is a brand name medication included in the following groups of medications: Other agents for local oral treatment, OTHER SYSTEMIC DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES. For more information about Aphthasol see its generic Amlexanox

Introduction

Aphthous ulcer healing agent.1

Actions

  • Accelerates healing of aphthous ulcers; precise mechanism of such effect unknown.1 2 3

  • Potent in vitro inhibitor of formation and/or release of inflammatory mediators (histamine and leukotrienes) from mast cells, neutrophils, and mononuclear cells.1 4 5

Uses For Aphthasol

Amlexanox is used as a paste in the mouth to treat aphthous ulcers (canker sores).

This medicine is available only with your doctor's prescription.

Before Using Aphthasol

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There is no specific information comparing use of amlexanox in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. There is no specific information comparing use of amlexanox in the elderly with use in other age groups.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Immune system problems—It is not known if this medicine will work properly in patients with these problems

What is Aphthasol?

Aphthasol contains amlexanox 5% in an adhesive oral paste.

Aphthasol is used to treat canker sores, also called aphthous ulcers, in the mouth in people with normal immune systems.

Aphthasol may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Aphthasol?

Use Aphthasol as directed on the label, or as your doctor has prescribed. Do not use the medication in larger amounts or for longer than recommended.

If you miss a dose, use it as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects are more likely, and you may have none at all. You may feel a slight burning or stinging when you first apply Aphthasol oral paste. Talk to your doctor about any unusual or bothersome side effects.

What should I avoid?

There are no restrictions on food, beverages, or activity while using Aphthasol unless your doctor has told you otherwise.

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