Gynazole 1

Gynazole-1 is a prescription medication used to treat yeast infections of the vagina. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Since butoconazole vaginal is used as a single dose from a prefilled applicator, an overdose is unlikely to occur.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have new or worsening vaginal symptoms.

Common side effects may include:

• pelvic pain or cramps;

• vaginal burning or itching;

• vaginal pain and swelling; or

• mild vaginal irritation after use.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

• Tell all of your health care providers that you take Gynazole-1. This includes your doctors, nurses, pharmacists, and dentists.
• If vaginal yeast infections happen often, talk with the doctor.
• Protect clothing and fabrics from staining.
• Do not use this medicine for itching caused by a health problem other than a vaginal yeast infection. Talk with the doctor.
• Do not use Gynazole-1 if you have belly pain, fever, or bad-smelling vaginal discharge. Talk with your doctor.
• Condoms or diaphragms may not work to prevent pregnancy. Use some other kind of birth control while taking this medicine and for 72 hours after care ends.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Gynazole-1 while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Gynazole-1, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Gynazole-1. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Gynazole-1 (butoconazole).

Review Date: October 4, 2017

GYNAZOLE • 1® Butoconazole Nitrate Vaginal Cream USP, 2% is contraindicated in patients with a history of hypersensitivity to any of the components of the product.

The recommended dose of GYNAZOLE • 1® Butoconazole Nitrate Vaginal Cream USP, 2% is one applicatorful of cream (approximately 5 grams of the cream) intravaginally. This amount of cream contains approximately 100 mg of butoconazole nitrate.

Applies to butoconazole topical: intravaginal cream

Side effects include:

Vulvar/vaginal burning, itching, soreness and swelling, pelvic or abdominal pain or cramping.