Aphthasol

Name: Aphthasol

How should this medicine be used?

Amlexanox comes as a beige-colored paste. Amlexanox should be used as soon as possible after noticing symptoms of an ulcer. Amlexanox is usually applied four times a day, following brushing and flossing after breakfast, lunch, dinner, and at bedtime. Squeeze 1/4 inch (0.6 centimeters) of the paste on your finger. With gentle pressure, dab amlexanox onto each ulcer in the mouth. Wash hands immediately after using amlexanox. Amlexanox is only used until the ulcer has healed, usually within 10 days. Contact your physician or dentist if significant healing has not occurred within 10 days.

Follow the directions on your prescription label carefully, and ask your doctor, dentist, or pharmacist to explain any part you do not understand. Use amlexanox exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor or dentist.

What should I do if I forget a dose?

Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply a double dose to make up for a missed one.

What side effects can this medication cause?

Amlexanox may cause side effects. Tell your doctor or dentist if any of these symptoms are severe or do not go away:

  • slight pain, stinging, or burning of the skin that comes and goes
  • nausea
  • diarrhea

If you experience the following symptom, call your doctor or dentist immediately:

  • rash

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Drug interactions

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Stability

Storage

Oral, Topical Use Only

Paste

15–30°C.1

Proper Use of Aphthasol

How to use this medicine:

  • Apply this medicine to the canker sore as soon as you notice it.
  • Squeeze a small amount of the paste (about 1/4 inch) onto your fingertip. Using gentle pressure, dab the paste onto each sore in your mouth.
  • Wash your hands immediately after using amlexanox paste.
  • Keep using the medicine until the sore is healed. However, if it is not healed after 10 days, check with your doctor.
  • Do not get any of the paste in your eyes. If any gets in your eyes, wash them out with water right away.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For mucosal-local dosage form (oral paste):
    • For treatment of canker sores:
      • Adults—Apply to each canker sore in the mouth four times a day, after you brush your teeth after breakfast, lunch, dinner, and at bedtime.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

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.

How should I use Aphthasol?

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

For best results, start using Aphthasol when you first notice symptoms of a canker sore.

Aphthasol oral paste is usually applied 4 times each day--usually after breakfast, lunch, and dinner, and at bedtime.

It is best to apply the paste after you have brushed and rinsed your teeth. Always dry the canker sore with a clean cloth before applying Aphthasol oral paste.

Wash your hands before applying the oral paste.

Dry the canker sore with a soft clean cloth before applying the paste.

To use the paste, moisten the tip of your finger with water and squeeze out a 1/4-inch dab of paste onto the wet tip of your finger.

Gently apply the Aphthasol paste to the canker sore. There is no need to rub in the medicine.

Wash your hands with soap and water to remove any remaining paste from your finger.

Talk with your doctor if your symptoms do not improve after 10 days of treatment.

Store Aphthasol oral paste at room temperature away from moisture and heat.

Aphthasol side effects

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 Aphthasol 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 Aphthasol 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.

For Healthcare Professionals

Applies to amlexanox topical: mucous membrane paste

Local

Local side effects have included transient stinging, pain or burning at the site of application in 1% to 2% of patients.[Ref]

Gastrointestinal

Gastrointestinal side effects have included contact mucositis, nausea, and diarrhea in less than 1% of patients.[Ref]

Some side effects of Aphthasol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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