DRUGS AND SUPPLEMENTS

Amlexanox

March 21, 2017

Amlexanox oral paste

What is amlexanox paste?

AMLEXANOX (Aphthasol®) is a topical paste that is applied to an aphthous ulcer, also known as a canker sore. Amlexanox increases healing and decreases pain related to the ulcer. This medicine should only be used in patients who have no problems with their immune system. Use this medication for the treatment of aphthous ulcers of the mouth only. Do not use for ulcers of the eye or any other area of the body. Generic amlexanox oral paste is not available.

NOTE: This drug is discontinued in the United States.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • any condition that may decrease your immune status such as cancer or HIV

  • receiving chemotherapy or radiation therapy

  • an unusual or allergic reaction to amlexanox, benzyl alcohol, other medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should I take this medicine?

Amlexanox is applied to aphthous ulcers (canker sores) of the mouth only; do not apply to ulcers in eyes or other areas. Wash eyes promptly with clear running water if they should come into contact with the amlexanox paste. Begin applying the paste as soon as possible after noticing the symptoms of an aphthous ulcer. Brush your teeth and then apply amlexanox, usually after breakfast, lunch, dinner and at bedtime. Wash hands before and immediately after applying amlexanox oral paste. Follow the directions on the prescription label. Squeeze a dab of paste approximately 1/4 inch (1/2 cm) onto a clean, moistened finger tip. Dry the ulcer by patting gently with a dry, clean cloth. Dab the correct amount of paste onto each ulcer in the mouth using gentle pressure. Use the paste until the ulcer heals or as directed.

What if I miss a dose?

Apply the paste as soon as possible if you miss a dose, unless it is time for a routine application. Do not double up on doses. Do not apply more than 4 times per day.

What drug(s) may interact with amlexanox?

There are no reports of medicines that interact with amlexanox.

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking amlexanox?

Watch for new inflamed areas of the mouth or a rash. To prevent spreading the aphthous ulcers to new areas of the mouth, wash your hands after every application of paste. Discontinue use and contact your physician or dentist if inflammation of mouth or rash occur.

Watch for healing of ulcer and a decrease in pain. If these do not occur within 10 days of treatment, contact physician or dentist.

What side effects may I notice from receiving amlexanox?

Side effects that you should report to your prescriber or health care professional as soon as possible:

  • diarrhea

  • inflamed areas of mouth

  • nausea

  • rash

Side effects that usually do not require immediate attention (report to your prescriber or health care professional if they continue or become bothersome):

  • burning or stinging of ulcer when paste is applied

  • transient pain at site of ulcer

Where can I keep my medicine?

Keep this medicine out of the reach of children.

Store amlexanox paste in the original tube at 15—30 degrees C (59—86 degrees F). Throw away any unused medicine after the expiration date.

Amlexanox oral patch

What is Amlexanox oral patch?

AMLEXANOX (OraDisc A™) is a topical patch that is applied to an aphthous ulcer, also known as a canker sore. Amlexanox increases healing and decreases pain related to the ulcer. This medicine should only be used in patients who have no problems with their immune system. Use this medication for the treatment of aphthous ulcers of the mouth only. Do not use for ulcers of the eye or any other area of the body. A generic amlexanox oral patch is not available.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • any condition that may decrease your immune status such as cancer or HIV

  • receiving chemotherapy or radiation therapy

  • an unusual reaction to amlexanox, medicines, foods, dyes, or preservatives

  • pregnant or trying to get pregnant

  • breast-feeding

How should this medicine be used?

Amlexanox is applied to aphthous ulcers (canker sores) of the mouth only; do not apply to ulcers in eyes or other areas. Wash eyes promptly with clear running water if they should come into contact with the amlexanox patch. Wash hands before and immediately after applying amlexanox oral patch. Begin applying the patch as soon as possible after noticing the symptoms of an aphthous ulcer. Follow the directions on the prescription label. Brush your teeth and then apply amlexanox, usually after breakfast, lunch, dinner and at least 80 minutes before bedtime. Press one patch onto each ulcer in the mouth using gentle pressure. Only treat up to 3 ulcers at a time. Do not eat or drink for 1 hour after each patch application. Use the patch until the ulcer heals or up to 10 days.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

Apply the patch as soon as possible if you miss a dose, unless it is time for a routine application. Do not double up on doses. Do not apply more than 4 times per day.

What drug(s) may interact with Amlexanox?

There are no reports of medicines that interact with amlexanox.

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking Amlexanox?

The patch will slowly dissolve in your mouth over 20—80 minutes. You may feel small particles in your mouth as the patch melts. You may swallow the particles.

Watch for new inflamed areas of the mouth or a rash. To prevent spreading the aphthous ulcers to new areas of the mouth, wash your hands before and after every application of patch. Discontinue use and contact your physician or dentist if inflammation of mouth or rash occur.

Watch for healing of ulcer and a decrease in pain. If these do not occur within 10 days of treatment, contact physician or dentist.

What side effects may I notice from receiving Amlexanox?

Side effects that you should report to your prescriber or health care professional as soon as possible:

  • inflamed areas of mouth

  • nausea

  • rash

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):

  • burning or stinging of ulcer when paste is applied

  • transient pain at site of ulcer

Where can I keep my medicine?

Keep this medicine out of the reach of children.

Store amlexanox patch in the original container at room temperature at 25 degrees C (77 degrees F). Throw away any unused medicine after the expiration date.

Updated:  

March 21, 2017

Sources:  

U.S. FDA-approved Package Insert