NuZole

Miconazole is a prescription antifungal medicine used in adults to treat fungal (yeast) infections of the mouth and the throat.

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

How to use Miconazole Tablet:

Before applying the tablet,

1.  Locate the area on the upper gum, just above either the left or the right incisor. The incisor tooth is the tooth just to the right or left of your two front teeth.

2.  Take one miconazole tablet out of the bottle. Miconazole is round on one side and flat on the other side. The tablet is marked with an “L” on the flat side.

Applying the miconazole tablet,

3.  Place the flat side of the miconazole tablet on your dry fingertip. Gently push the rounded side of the tablet against your upper gum. Push the miconazole tablet up as high as it will go on your gum. The flat side will be facing the inside of your lip.

4.  Hold the miconazole tablet in place by applying a slight pressure with your finger on the outside of your upper lip for 30 seconds. This will make the tablet stick to your gum.

5.  Leave the tablet in place until it dissolves.

6.  Before applying your next dose, be sure to clear away any remaining miconazole tablet material.

Miconazole Tablet:

• Always use miconazole exactly as your doctor tells you. Miconazole is usually applied in the morning after you brush your teeth.
• Miconazole is placed 1 time each day to your upper gum for 14 days.
• You may eat and drink while using miconazole.
• Do not crush, chew or swallow miconazole.
• You should change where you place miconazole, between the left and right side of your upper gum with each use.
• It is okay if miconazole sticks to your cheek, the inside of your lip or your gum. If miconazole does not stick or falls off of your gum within the first 6 hours, re-apply it. If it still does not stick, replace it with a new tablet.
• If you swallow miconazole within the first 6 hours of placing, drink a glass of water and place a new miconazole to your gum.
• If miconazole falls off or is swallowed after it was in place for 6 hours or more, do not apply a new miconazole. Just place your next dose at your regular time.
• Check to see if miconazole is still in place after you brush your teeth, rinse your mouth, eat, or drink.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use this medicine if you are allergic to miconazole.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have other medical conditions, especially:

• if you are using a blood thinner such as warfarin, Coumadin, Jantoven.

It is not known whether miconazole topical will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

It is not known whether miconazole topical passes into breast milk or if it could harm a nursing baby. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using miconazole topical and call your doctor at once if you have:

• severe blistering, redness, or irritation of treated skin.

Common side effects may include:

• itching, peeling, or dry skin.

Although the risk of serious side effects is low when miconazole topical is applied to the skin, side effects can occur if the medicine is absorbed into your bloodstream, including:

• dry mouth, sore tongue, tooth pain, red or swollen gums;

• altered sense of taste;

• nausea, diarrhea; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

It is not likely that other drugs you take orally or inject will have an effect on topically applied miconazole. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Applies to miconazole topical: topical cream, topical gel/jelly, topical kit, topical lotion, topical ointment, topical powder, topical spray, topical tablet effervescent, topical tincture

Along with its needed effects, miconazole topical (the active ingredient contained in NuZole) 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 as soon as possible if any of the following side effects occur while taking miconazole topical:

• Blistering, burning, redness, skin rash, or other sign of skin irritation not present before use of this medicine

Applies to miconazole topical: compounding powder, topical cream, topical gel, topical liquid, topical lotion, topical ointment, topical powder, topical spray, topical tincture, vaginal cream, vaginal cream with applicator, vaginal kit, vaginal suppository, vaginal tampon

Local

Local side effects have been reported frequently with topical miconazole therapy. When administered intravaginally or topically, itching, burning and rash have been reported. Contact dermatitis, confirmed by patch testing, has been reported.[Ref]

Nervous system

Nervous system side effects have rarely included headache.[Ref]

Genitourinary

Genitourinary side effects have included cramping, pain, and bleeding with the intravaginal use of miconazole.[Ref]

Some side effects of NuZole may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.