Aphthasol (Amlexanox) is an anti-inflammatory used to treat ulcers of the mouth called aphthous ulcers or canker sores. Aphthasol decreases the time ulcers take to heal. Because Aphthasol decreases the healing time, it also decreases the pain you feel. Aphthasol comes as a beige-colored paste and is usually applied four times a day.
What is the most important information I should know about Aphthasol?
Never take more of this medication than is directed by your doctor. If your symptoms are not being adequately treated, talk to your doctor.
What is Aphthasol?
Aphthasol is the only FDA-approved TOPICAL prescription medication for the treatment CANKER SORE mouth ulcerations in healthy immunocompetent individuals.
Aphthasol helps decrease the progression of the ulcerations and therefore decreases the duration of the pain.
Aphthasol is indicated in HEALTHY individuals with NORMAL immune systems who suffer from canker sores.
What should I discuss with my healthcare provider before taking Aphthasol?
Do not use Aphthasol if you are pregnant, attempting to become pregnant, or at a high risk of becoming pregnant. Aphthasol ( amlexanox oral paste 5%) is a Pregnancy Category B which means that animal studies did not indicate any significant fetal malformations, but there are NO adequate studies of topically applied ciclopirox in pregnant women and therefore may pose potential risk to the fetus.
Do NOT use Aphthasol if you are breast feeding.
Do NOT use Aphthasol if you are allergic or sensitive to any of the ingredients: amlexanox in a solution base containing benzyl alcohol, gelatin, glyceryl monostearate, mineral oil, pectin, petrolatum, and sodium carboxymethylcellulose.
Aphthasol is contraindicated if you have a history of immunosuppression or immune system disease, if you are HIV-positive, if you are on cancer chemotherapy treatment.
Aphthasol is NOT approved for pediatric use, and we do NOT prescribe Aphthasol to anyone under the age of 18.
How should I take Aphthasol?
Aphthasol paste should be applied as soon as possible after noticing the symptoms of a canker sore.
Aphthasol should be applied four times daily, preferably following oral hygiene after breakfast, lunch, dinner and at bedtime. Before applying wash your hands. Dry the ulcer or ulcers by gently patting it with a soft, clean cloth. Moisten the tip of your index finger. Squeeze a dab of paste approximately 1/4 inch (0.5 cm) onto your finger tip.
Gently dap the Aphthasol onto each ulcer in the mouth. Wash your hands when you are done applying Aphthasol.
Do not eat or drink for 30 minutes after apply Aphthasol as the medication would be washed away. Use this medication 4 times/ day until the ulcer heals.
Aphthasol oral paste is for TOPICAL USE ONLY on canker sores inside the mouth area. Avoid getting Aphthasol in your eyes, nose or mouth. Flush with water and seek immediate medical attention!
If significant healing or pain relief has not occurred in 10 days, seek immediate medical attention from your regular physician.
Aphthasol is only indicated for people with normal immune systems.
Keep away from children.
What are the possible side effects of Aphthasol?
The majority of patients using Aphthasol experience no side effects. The adverse reactions reported by 1 - 2% of patients using Aphthasol are transient pain, stinging and/or burning at the site of application. In less than 1% contact mucositis, nausea and diarrhea were reported. If you experience increasing redness, progressive ulceration and increasing pain after 10 days of using Aphthasol, contact your doctor immediately!
If you get the medication in your eyes, rinse immediately with water and contact your regular physician!
There are NO systemic effects when used appropriately.
Where can I get more information?
Your pharmacist has more information about Aphthasol written for health professionals that you may read.
