(am lex' an ox)

Brand Name(s): Aphthasol^®

IMPORTANT NOTICE:

Amlexanox is no longer available in the US. If you are currently using amlexanox, you should call your doctor to discuss switching to another treatment.

WHY is this medicine prescribed?

Amlexanox is used to treat ulcers of the mouth called aphthous ulcers or canker sores. It decreases the time ulcers take to heal. Because amlexanox decreases the healing time, it also decreases the pain you feel.

This medication is sometimes prescribed for other uses; ask your doctor, dentist, or pharmacist for more information.

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 SPECIAL PRECAUTIONS should I follow?

Before using amlexanox,

• tell your doctor or dentist and pharmacist if you are allergic to amlexanox or any other drugs.

• Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while using amlexanox. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor or dentist if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using amlexanox, call your doctor or dentist.

What should I do IF I FORGET to take 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 medicine 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).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

What OTHER INFORMATION should I know?

Keep all appointments with your doctor or dentist. Amlexanox is for external use only. Do not let amlexanox get into your eyes. If it does get into your eyes, rinse them promptly.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription. Tell your doctor or dentist if your ulcers get worse or do not get better within 10 days.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: October 15, 2023.