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 Aphthasol

Aphthasol (5% amlexanox in an adhesive oral paste) is the only FDA approved prescription medication used for relief and the healing of canker sores. Aphthasol is the first FDA-approved prescription paste for treating canker sores in patients with normal immune systems. Aphthasol is believed to work by inhibiting the formation and/or release of inflammatory mediators and it has the effect of limiting the extent of the progression of the ulceration of the canker sore.



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APHTHASOL DRUG INFO

ACTIVE INGREDIENT:

Amlexanox ( am-LEX-an-ox)


COMMON BRAND NAME(S):

Aphthasol


USES:

Aphthasol (amlexanox) is a topical paste that is applied to an aphthous ulcer, also known as a canker sore. aphthasol 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 aphthasol oral paste is not available.


HOW TO USE:

Aphthasol is applied to aphthous ulcers (canker sores) 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 aphthasol paste. Begin appling the paste as soon as possible after noticing the symptoms of an aphthous ulcer. Follow the directions on the prescription label. Squeeze a dab of paste approximately 1/4 inch (1/2 cm) onto a finger tip. Dab the paste onto each ulcer in the mouth using gentle pressure. Brush your teeth and then apply aphthasol, usually after breakfast, lunch, dinner and at bedtime. Wash hands before and immediately after applying aphthasol oral paste. Use the paste until the ulcer heals or as directed.


SIDE EFFECTS:

Side effects that you should report to your prescriber or health care professional as soon as possible: ;diarrhea ;nausea ;new or inflamed areas of mouth ;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


PRECAUTIONS:

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. Tell your doctor 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 aphthasol, benzyl alcohol, other medicines, foods, dyes, or preservatives ;pregnant or trying to get pregnant ;breast-feeding.


DRUG INTERACTIONS:

There are no reports of medicines that interact with aphthasol. 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.


OVERDOSE:

There are no reports of human ingestion overdosage. Ingestion of a full tube of 5 grams of paste would result in systemic exposure well below the maximum nontoxic dose of aphthasol in animals. Gastrointestinal upset such as diarrhea and vomiting could result from an overdose.


NOTES:

Keep all appointments with your doctor or dentist. aphthasol is for external use only. Do not let aphthasol 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.


MISSED 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.


STORAGE:

Store aphthasol paste in the original tube at room temperature. Do not use paste and throw tube and contents away after expiration date. Keep out of the reach of children. Store away from heat and direct light. Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down. Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.


IMPORTANT NOTE:

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

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