Butoconazole Vaginal Cream (patient information)

Why this medication is prescribed

Butoconazole is used to treat yeast infections of the vagina.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

How this medication should be used

Butoconazole comes as a cream to insert into the vagina. It is usually used daily at bedtime for either 1 or 6 days. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use butoconazole exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

To use the vaginal cream, read the instructions provided with the medication and follow these steps:

1. Fill the special applicator that comes with the cream to the level indicated.
2. Lie on your back with your knees drawn upward and spread apart.
3. Insert the applicator high into your vagina (unless you are pregnant), and then push the plunger to release the medication. If you are pregnant, insert the applicator gently. If you feel resistance (hard to insert), do not try to insert it further; call your doctor.
4. Withdraw the applicator and discard.
5. Wash your hands promptly to avoid spreading the infection.

The dose should be applied when you lie down to go to bed. The drug works best if you do not get up again after applying it except to wash your hands. You may wish to wear a sanitary napkin to protect your clothing against stains. Do not use a tampon because it will absorb the drug. Do not douche unless your doctor tells you to do so.

Continue to use butoconazole even if you feel well. Do not stop using butoconazole without talking to your doctor. Continue using this medication during your menstrual period.

Special precautions

Before taking butoconazole:

• tell your doctor and pharmacist if you are allergic to butoconazole or any other drugs.
• tell your doctor and pharmacist what prescription and nonprescription drugs you are taking, especially antibiotic medications and vitamins.
• tell your doctor if you have or have ever had diabetes, problems with your immune system, human immunodeficiency virus infection (HIV), or acquired immunodeficiency syndrome (AIDS).
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using butoconazole, call your doctor.

What to do if you forget a dose

Insert 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 insert a double dose to make up for a missed one.

Side Effects

Butoconazole may cause side effects. If you experience any of the following symptoms, call your doctor immediately:

• burning in vagina when cream is inserted
• irritation in vagina when cream is inserted
• stomach pain
• fever
• foul-smelling discharge

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 [at http://www.fda.gov/MedWatch/report.htm] or by phone [1-800-332-1088].

Storage conditions needed for 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). Do not freeze. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

Other information

Keep all appointments with your doctor. Butoconazole is for external use only. Do not let cream get into your eyes or mouth, and do not swallow it.

Refrain from sexual intercourse. An ingredient in the cream may weaken certain latex products like condoms or diaphragms; do not use such products within 72 hours of using this medication. Wear clean cotton panties (or panties with cotton crotches), not panties made of nylon, rayon, or other synthetic fabrics.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription. If you still have symptoms of infection after you finish the butoconazole, call your doctor.

Brand names

• Gynazole-1®