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All about: Gynazole-1 Cream

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Generic Name: Butoconazole One-Dose Vaginal Cream (byoo-toe-KOE-na-zole)
Brand Name: Gynazole-1

Gynazole-1 Cream is used for:

Treating vaginal yeast infections.

Gynazole-1 Cream is an antifungal agent. It works by weakening the cell wall of sensitive fungi, causing the cell contents to leak. This kills the fungi.

Do NOT use Gynazole-1 Cream if:

  • you are allergic to any ingredient in Gynazole-1 Cream

Contact your doctor or health care provider right away if any of these apply to you.

Before using Gynazole-1 Cream:

Some medical conditions may interact with Gynazole-1 Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Gynazole-1 Cream. However, no specific interactions with Gynazole-1 Cream are known at this time.

Ask your health care provider if Gynazole-1 Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Gynazole-1 Cream:

Use Gynazole-1 Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Gynazole-1 Cream is for vaginal use only. Do not use in the eyes or take by mouth.
  • Wash your hands before and after using Gynazole-1 Cream. Insert 1 applicator-full of cream into the vagina. Throw the applicator away after using it.
  • Only one dose of Gynazole-1 Cream is required. If you forget to use Gynazole-1 Cream, use it as soon as you remember.

Ask your health care provider any questions you may have about how to use Gynazole-1 Cream.

Important safety information:

  • If your symptoms do not get better within a few days or if they get worse, check with your doctor.
  • If your infection clears up and occurs again in a few weeks, see your doctor. Recurrent vaginal infections, especially those that are difficult to cure, may be an early sign of HIV infection in women who are considered at risk for HIV infection.
  • Gynazole-1 Cream may be used during your period. Use a sanitary pad rather than a tampon to prevent staining of clothing.
  • Gynazole-1 Cream contains mineral oil, which may weaken latex or rubber products such as condoms and diaphragms. Do not use condoms or diaphragms within 72 hours of using Gynazole-1 Cream.
  • Gynazole-1 Cream should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Gynazole-1 Cream while you are pregnant. It is not known if Gynazole-1 Cream is found in breast milk. If you are or will be breast-feeding while you use Gynazole-1 Cream, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Gynazole-1 Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Burning, itching, soreness, or swelling in or around the vagina not present before using Gynazole-1 Cream.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); pain or cramping in the stomach or pelvic area.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Gynazole-1 Cream may be harmful if swallowed.

Proper storage of Gynazole-1 Cream:

Store Gynazole-1 Cream at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Gynazole-1 Cream out of the reach of children and away from pets.

General information:

  • If you have any questions about Gynazole-1 Cream, please talk with your doctor, pharmacist, or other health care provider.
  • Gynazole-1 Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Gynazole-1 Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: September 5, 2007
Database Edition 07.3.1.003
Copyright © 2007 Wolters Kluwer Health, Inc.

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