Vusion

Miconazole is a prescription medication used to treat fungal yeast infections of the mouth or the throat. Miconazole belongs to a group of drugs called azole antifungals which work by killing fungi by interfering with their cell membranes.

This medication comes in buccal tablet form which is a tablet that dissolves when held between the cheek and gum. Miconazole is taken once daily and should be applied between the cheek and upper gum.

Common side effects of miconazole include diarrhea, change in taste, and headache.

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Miconazole may affect the way other medicines work, and other medicines may affect how miconazole works.

Especially tell your doctor if you take:

• a diabetes medicine
• phenytoin (Dilantin, Phenytek)
• an ergot medicine. Ask your doctor or pharmacist if you are not sure if your medicine is an ergot medicine.
• the blood thinner medicine warfarin sodium (Coumadin, Jantoven)

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

Grapefruit and grapefruit juice may interact with miconazole and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if miconazole will harm your unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if miconazole passes into your breast milk. Talk to your doctor about the best way to feed your baby if you use miconazole.

For all patients taking Vusion (miconazole and zinc oxide):

• If you have an allergy to this medicine or any part of Vusion.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have a weak immune system.

Children:

• If your child is younger than 1 month of age. Do not give this medicine to an infant younger than 1 month of age.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Vusion with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Skin irritation.

Carcinogenesis, Mutagenesis, Impairment of Fertility

The carcinogenic potential of Vusion in animals has not been evaluated.

Miconazole nitrate was negative in a bacterial reverse mutation test, a chromosome aberration test in mice, and micronucleus assays in mice and rats.

Miconazole nitrate had no adverse effect on fertility in a study in rats at oral doses of up to 320 mg/kg/day, which is 89 times the maximum possible topical exposure of caregivers, assuming 100% absorption.

You should not use Vusion if you are allergic to miconazole, zinc, dimethicone, mineral oil, petroleum, or lanolin.

Do not use Vusion ointment on a child younger than 4 weeks old.

To make sure this medicine is safe for you, tell your doctor if you have:

• a weak immune system caused by disease or by using certain medicines.

It is not known whether Vusion ointment 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 and zinc oxide topical passes into breast milk or if it could harm a nursing baby. Do not use Vusion ointment without a doctor's advice if you are breast-feeding a baby.

Avoid covering treated skin areas with tight-fitting, synthetic clothing (such as nylon or polyester clothing, or plastic pants) that does not allow air to circulate to your skin. If you are treating your feet, wear clean cotton socks and sandals or shoes that allow for air circulation. Keep your feet as dry as possible.

Rinse with water if Vusion ointment gets in your eyes.

Avoid using scented or perfumed soaps or lotions to clean the diaper area.

Avoid getting this medication in the mouth or vagina.

It is not likely that other drugs you take orally or inject will have an effect on topically applied miconazole and zinc oxide. 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 / zinc oxide topical: external ointment