Butoconazole Vaginal Cream

What is this medication?

BUTOCONAZOLE (byoo toe KOE na zole) treats infections caused by too much yeast or fungus in the vagina. It belongs to a group of medications called antifungals. It will not treat infections caused by bacteria or viruses.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Gynazole-1

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• An unusual or allergic reaction to butoconazole, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is for use in the vagina. Do not take by mouth. Wash your hands before and after use. Use it as directed on the prescription label. Peel back the protective foil and remove the prefilled applicator. Do not remove tip. Pull the ring back fully to extend plunger. Gently insert the applicator into the vagina as far as it will comfortably go. Push the plunger to release the cream into the vagina. Gently remove the applicator and throw it away.

Talk to your care team about the use of this medication in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

This does not apply. This medication is not for regular use.

What may interact with this medication?

Interactions are not expected. Do not use any other vaginal products without talking to your care team.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

If you develop abdominal pain, a high fever, or foul-smelling vaginal discharge, contact your care team. Do not self-treat if you have these symptoms. These symptoms are signs of a more serious infection and you will need examined by a care team.

Do not have sex or use vaginal products, such as tampons or douches, while using this medication and for a time after use. Having sex or using vaginal products can make this medication not work as well. Talk with your care team about how long to not have sex or use vaginal products after the last dose.

This medication can damage and reduce the effect of latex-containing products, such as condoms and diaphragms. Avoid use of latex-containing products while taking this medication and for 3 days after the last dose. Get rid of any products that are exposed to this medication.

Your clothing may get soiled. To help prevent reinfection, wear freshly washed cotton, not synthetic, underwear.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Unusual vaginal discharge, itching, or odor

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Vaginal irritation at application site

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store between 15 and 30 degrees C (59 and 86 degrees F). Do not freeze. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.