Miconazole (Buccal mucosa)

Miconazole (Buccal mucosa) treats fungal (yeast) infections in the mouth and throat (oral thrush). It is part of a group of medicines called antifungals and works by killing or stopping the growth of the fungus or yeast.

This medicine is available only with your doctor's prescription.

It is very important for your doctor to check your progress during regular visits. This will help your doctor ensure that the medicine is working properly and to monitor for any side effects that may occur from the medicine.

This medicine may cause a serious allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and needs immediate medical help. Call your doctor right away if you experience a rash; itching; hoarseness; difficulty breathing; difficulty swallowing; or any swelling of your hands, face, or mouth while using this medicine.

If your symptoms do not get better, or if they get worse, consult your doctor.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it may provide. Here are some important points to think about for this medicine:

Allergies

Tell your doctor if you have ever had an unusual or allergic reaction to this medicine or any other medicines. Also inform your healthcare professional if you have other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on how buccal miconazole affects children younger than 16 years of age. Safety and effectiveness have not been established.

Geriatric

There is no information available on how buccal miconazole affects elderly patients.

Breast Feeding

There are no adequate studies on the risk to infants when this medication is used during breastfeeding. Carefully weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there might be an interaction. In these situations, your doctor may need to adjust the dose or take other precautions. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below when using this medicine. The following interactions are significant but may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change your other medicines.

• Pimozide

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency for one or both medicines.

• Amiodarone
• Carvedilol
• Cilostazol
• Domperidone
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Escitalopram
• Fosphenytoin
• Ifosfamide
• Naloxegol
• Olaparib
• Phenobarbital
• Phenytoin
• Piperaquine
• Primidone
• Simeprevir
• Warfarin

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may still be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or frequency for one or both.

• Anisindione
• Dicumarol
• Phenprocoumon
• Tolterodine
• Trimetrexate

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to potential interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional how to take your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Be sure to inform your doctor if you have any other medical conditions, especially:

• Liver disease—Use with caution. The effects may be stronger because the medicine is removed from the body more slowly.

• Milk protein allergy, history of—Should not be used in patients with this condition.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Body aches or pain
• cough
• difficulty with breathing
• ear congestion
• fever or chills
• headache
• loss of voice
• lower back or side pain
• nasal congestion
• painful or difficult urination
• pale skin
• runny nose
• sneezing
• sore throat
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual tiredness or weakness

Rare

• Black, tarry stools
• pale skin
• shortness of breath
• ulcers, sores, or white spots in the mouth

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Change in taste
• diarrhea
• dry mouth
• headache
• itching skin
• loss of taste
• nausea
• pain, redness, and swelling of the gums
• sores on the tongue
• toothache

Less common

• Abdominal or stomach pain
• loss of appetite
• pain
• upper abdominal or stomach pain
• weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Oravig

Available Dosage Forms:

• Tablet

Therapeutic Class: Antifungal

Chemical Class: Imidazole

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon.

To use the buccal tablet:

• Apply the tablet in the morning, after brushing your teeth.
• With dry hands, place the rounded side of one tablet on your upper gum above the incisor tooth. You have a right and left incisor tooth. They are just to the right and left of your 2 front teeth.
• Hold the tablet in place by placing your fingertip over the upper lip for 30 seconds. This will make the tablet stick to your gum.
• Allow the tablet to dissolve. Do not crush, chew, or swallow the tablet.
• It is not a problem if the tablet sticks to the cheek or the inside of the lip.
• If the tablet does not stick or falls off within the first 6 hours, use the same tablet and put it on again. If it still does not stick, use a new tablet.
• If you swallow the tablet within the first 6 hours, drink a glass of water and place a new tablet on your gum.
• If the tablet falls off after 6 hours or longer, do not apply a new tablet. Wait for your next dose.
• You may eat or drink normally when the tablet is in place, but chewing gum should be avoided.

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 buccal dosage form (tablets):For fungus infection in the mouth and throat: Adults and teenagers 16 years of age and older—One tablet placed on the upper gum once a day for 14 days. Teenagers and children younger than 16 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take 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. Do not double doses.

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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