Vusion

THE SAFETY OF MICONAZOLE NITRATE, ZINC OXIDE, AND WHITE PETROLEUM (VUSION) DURING PREGNANCY OR BREASTFEEDING

The information provided below is for readers based in the United States of America. Readers outside of the United States of America should seek the information from local sources.

THIS MEDICATION MAY CAUSE HARM TO YOUR DEVELOPING BABY:

Limited information is available on the safety of miconazole exposure during pregnancy.

What is miconazole?

Miconazole is a topical antifungal medication.

What is miconazole used to treat?

Miconazole is an antifungal used to treat diaper rash caused by Candidasis in infants over 4 weeks old. Miconazole ointment is used along with frequent diaper changes and diaper area cleaning.

How does miconazole work?

Miconazole damages the fungal cell membrane. Zinc oxide and white petroleum are protective and help to heal the skin.

If I am using miconazole, can it harm my developing baby?

Limited information exists around exposure to miconazole ointment for treating infant diaper rash during pregnancy. Available information on topical miconazole focuses on different formulations used to treat vaginal fungal infections in women. These studies have found that evidence does not support an association between miconazole exposure during pregnancy and birth defects; however, one study suggested a link between miconazole use during the first trimester and spontaneous abortion. Because of the lack of consistent evidence around miconazole and spontaneous abortion risk, miconazole should be avoided during the first trimester of pregnancy and widespread use on the mother's body should be avoided throughout pregnancy.

If I am using miconazole and become pregnant, what should I do?

It is important to exercise caution if administering miconazole ointment while pregnant. Talk to your doctor about alternative treatments.

If I am using miconazole, can I safely breastfeed my baby?

Little information is available on the presence of miconazole in breast milk or the overall safety of breastfeeding while administering miconazole for diaper rash in infants. The risks versus benefits of miconazole exposure should be weighed before breastfeeding.

If I am using miconazole, will it be more difficult to get pregnant?

No information is available to determine what effect miconazole has on human fertility.

If I am using miconazole, what should I know?

It is important to speak with your doctor to discuss the safety of miconazole exposure during pregnancy or breastfeeding. Topical miconazole is not expected to be as widely absorbed as oral forms of the medication. Pregnant women and women of childbearing age should exercise caution when administering topical miconazole for infant diaper rash or vaginal fungal infection.

If I am taking any medication, what should I know?

This report provides a summary of available information about the use of topical antifungals during pregnancy and breastfeeding. Content is from the product label unless otherwise indicated.

You may find Pregistry's expert reports about infections here,  about Candida (yeast) infections here, and reports about the individual medications used to treat infections here.   Additional information can also be found in the resources below. 

For more information about miconazole during and after pregnancy, contact http://www.womenshealth.gov/ (800-994-9662 [TDD: 888-220-5446]) or check the following link:

U.S. Food and Drug Administration:  Vusion Prescribing Information

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General information

It is very common for women to worry about having a miscarriage or giving birth to a child with a birth defect while they are pregnant. Many decisions that women make about their health during pregnancy are made with these concerns in mind.

For many women these concerns are very real. As many as 1 in 5 pregnancies end in a miscarriage, and 1 in 33 babies are born with a birth defect. These rates are considered the background population risk, which means they do not take into consideration anything about the health of the mom, the medications she is taking, or the family history of the mom or the baby’s dad. A number of different things can increase these risks, including taking certain medications during pregnancy.

It is known that most medications, including over-the-counter medications, taken during pregnancy do get passed on to the baby. Fortunately, most medicines are not harmful to the baby and can be safely taken during pregnancy. But there are some that are known to be harmful to a baby’s normal development and growth, especially when they are taken during certain times of the pregnancy. Because of this, it is important to talk with your doctor or midwife about any medications you are taking, ideally before you even try to get pregnant.

If a doctor other than the one caring for your pregnancy recommends that you start a new medicine while you are pregnant, it is important that you let them know you are pregnant.

If you do need to take a new medication while pregnant, it is important to discuss the possible risks the medicine may pose on your pregnancy with your doctor or midwife. They can help you understand the benefits and the risks of taking the medicine.

Ultimately, the decision to start, stop, or change medications during pregnancy is up to you to make, along with input from your doctor or midwife. If you do take medications during pregnancy, be sure to keep track of all the medications you are taking.