Miconazole Buccal

WHY is this medicine prescribed?

Buccal miconazole is used to treat yeast infections of the mouth and throat in adults and children 16 years of age and older. Miconazole buccal is in a class of medications called imidazoles. It works by stopping the growth of fungi that cause infection.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Buccal miconazole comes as a tablet to apply to the upper gum of the mouth. It is usually applied once a day in the morning, after you brush your teeth, for 14 days. Use buccal miconazole at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use miconazole exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Do not swallow, chew, or crush the tablet.

You may eat and drink while the tablet is in place.

To use buccal miconazole, follow these steps:

1. Find the area on the upper gum above your left and right incisor teeth (the teeth just to the left and right of your two front teeth). Alternate placement between the right and left side of the mouth, each time a tablet is used.
2. With dry hands, remove one tablet from the bottle.
3. Gently apply the rounded side of the tablet to the upper gum area as high as it will go on your gum above one of your incisor teeth.
4. Hold the tablet in place for 30 seconds by gently pressing on the outside of the upper lip over the tablet.
5. If the tablet does not stick to your gum or it sticks to your cheek or the inside of your lip, reposition it to stick to your gum.
6. Leave the tablet in place until it dissolves.
7. Clear away any remaining tablet material before applying your next tablet.

Do not interfere with the placement of the tablet. Check to see if the tablet is still in place after eating, drinking, rinsing your mouth, or brushing your teeth. Avoid the following while you are using miconazole buccal.

• Do not touch or press on the tablet once it has been applied.
• Do not wear upper dentures.
• Do not vigorously rinse your mouth.
• Do not hit the tablet when brushing your teeth.
• Do not chew gum when the tablet is in place.

If the tablet comes off within the first 6 hours of application, reapply the same tablet. If it still will not stick, then apply a new tablet. If you accidentally swallow the tablet within the first 6 hours of application, drink a glass of water and place a new tablet on your gum. If the tablet falls off or is swallowed 6 or more hours after application, do not apply a new tablet until your next regular time.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using buccal miconazole,

• tell your doctor and pharmacist if you are allergic to miconazole, milk protein concentrate, any other medications, or any of the ingredients in buccal miconazole. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: ergot medications such as dihydroergotamine (D.H.E. 45, Migranal), ergoloid mesylates (Hydergine), ergonovine (Ergotrate), ergotamine (Ergomar, in Cafergot, in Migergot, others), and methylergonovine (Methergine); oral medications for diabetes; phenytoin (Dilantin, Phenytek); and warfarin (Coumadin, Jantoven). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with miconazole, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor if you have or have ever had liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using buccal miconazole, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Use 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 use a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Miconazole may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• headache
• nausea
• vomiting
• upper stomach pain
• change in or loss of taste
• dry mouth
• toothache
• cough

Some side effects can be serious. If you experience any of these symptoms, stop using miconazole and call your doctor immediately or get emergency medical treatment:

• hives
• rash
• itching
• difficulty breathing or swallowing
• swelling of the face, throat, tongue, lips, or eyes
• swelling or pain where medication was applied

Miconazole buccal may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

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).

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

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.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else use your medication. Your prescription is probably not refillable. If you still have symptoms of infection after you finish the buccal miconazole, call your doctor.

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.