Pronunciation:

mye-KON-a-zole

Brand Names:

• Oravig

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antifungal

Chemical—

Imidazole

Uses of This Medicine:

Miconazole buccal treats fungus (yeast) infections in the mouth and throat (oral thrush). It belongs to the group of medicines called antifungals and works by killing or preventing growth of the fungus or yeast.

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of buccal miconazole in children younger than 16 years of age. Safety and efficacy have not been established.

Older adults—

No information is available on the relationship of age to the effects of buccal miconazole in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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 some of the other medicines you take.

• Deuruxolitinib
• Pimozide

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amiodarone
• Carvedilol
• Celecoxib
• Cilostazol
• Domperidone
• Erdafitinib
• Escitalopram
• Fosphenytoin
• Ifosfamide
• Methadone
• Naloxegol
• Olaparib
• Phenobarbital
• Phenytoin
• Piperaquine
• Primidone
• Simeprevir
• Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Anisindione
• Dicumarol
• Phenprocoumon
• Tolterodine
• Trimetrexate

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

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

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor to make sure the medicine is working properly and to check for any unwanted effects that may be caused by the medicine.

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

If your symptoms do not improve, or if they become worse, check with your doctor.

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

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur 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.