Aphthasol

DRUG DESCRIPTION

Aphthasol contains 5% amlexanox in an adhesive oral paste. Chemically, amlexanox is 2-amino-7-isopropyl-5-oxo-5H-[1]benzopyrano[2,3-b] pyridine-3-carboxylic acid. It has a molecular formula of C16H14N2O4 and has a molecular weight of 298.30. Amlexanox is odorless, white to yellowish-white crystalline powder. The structural formula is:

 Aphthasol® (amlexanox) Structural Formula Illustration

Each gram of beige colored oral paste contains 50 mg of amlexanox in an adhesive oral paste base consisting of benzyl alcohol, gelatin, glyceryl monostearate, mineral oil, pectin, petrolatum, and sodium carboxymethylcellulose.

What are the possible side effects of amlexanox (Aphthasol)?

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.

Stop using amlexanox and call your doctor if you have any of these serious side effects:

  • skin rash;
  • new mouth ulcers; or
  • white patches or sores inside your mouth or on your lips.

Less serious side effects may include may a slight stinging or burning when you first apply the medication.

This is not a complete list of side...

Read All Potential Side Effects and See Pictures of Aphthasol »

What are the precautions when taking amlexanox (Aphthasol)?

Before using amlexanox, tell your doctor/dentist or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor/dentist or pharmacist your medical history, especially of: immune system problems.

Avoid alcohol and nicotine because these products can irritate the sores.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before...

Read All Potential Precautions of Aphthasol »


Aphthasol Consumer (continued)

SIDE EFFECTS: Temporary pain, stinging, or burning at the application site may occur. If any of these effects persist or worsen, tell your doctor/dentist or pharmacist promptly.

Remember that your doctor/dentist has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor/dentist immediately if any of these unlikely but serious side effects occur: increased mouth sores, nausea, diarrhea.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using amlexanox, tell your doctor/dentist or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor/dentist or pharmacist your medical history, especially of: immune system problems.

Avoid alcohol and nicotine because these products can irritate the sores.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Aphthasol Patient Information Including Side Effects

Brand Names: Aphthasol

Generic Name: amlexanox (topical) (Pronunciation: am LEX a nox)

  • What is amlexanox (Aphthasol)?
  • What are the possible side effects of amlexanox (Aphthasol)?
  • What is the most important information I should know about amlexanox (Aphthasol)?
  • What should I discuss with my health care provider before using amlexanox (Aphthasol)?
  • How should I use amlexanox (Aphthasol)?
  • What happens if I miss a dose (Aphthasol)?
  • What happens if I overdose (Aphthasol)?
  • What should I avoid while using amlexanox (Aphthasol)?
  • What other drugs will affect amlexanox (Aphthasol)?
  • Where can I get more information?

What is amlexanox (Aphthasol)?

Amlexanox is an oral paste that is used to treat canker sores, also called aphthous (AFF-thus) ulcers, in the mouth.

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

What are the possible side effects of amlexanox (Aphthasol)?

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.

Stop using amlexanox and call your doctor if you have any of these serious side effects:

  • skin rash;
  • new mouth ulcers; or
  • white patches or sores inside your mouth or on your lips.

Less serious side effects may include may a slight stinging or burning when you first apply the medication.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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

Use this medication 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 amlexanox oral paste. Talk to your doctor about any unusual or bothersome side effects.

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