Gynazole-1

What is Gynazole-1?

This is a prescription medicine that is medicine is used to treat vaginal yeast infections.

Description

GYNAZOLE • 1® Butoconazole Nitrate Vaginal Cream USP, 2% contains butoconazole nitrate 2%, an imidazole derivative with antifungal activity. Its chemical name is (±)-1-[4-(p-chlorophenyl)-2- [(2,6-dichlorophenyl) thio]butyl] imidazole mononitrate, and it has the following chemical structure:

Butoconazole nitrate is a white to off-white crystalline powder with a molecular weight of 474.79. It is sparingly soluble in methanol; slightly soluble in chloroform, methylene chloride, acetone, and ethanol; very slightly soluble in ethyl acetate; and practically insoluble in water. It melts at about 159°C with decomposition.

GYNAZOLE • 1® Butoconazole Nitrate Vaginal Cream USP, 2% contains 2% butoconazole nitrate in a cream of edetate disodium, glyceryl monoisostearate, methylparaben, mineral oil, polyglyceryl-3 oleate, propylene glycol, propylparaben, colloidal silicon dioxide, sorbitol solution, purified water, and microcrystalline wax.

Before taking Gynazole-1, tell your doctor:

• If you are allergic to Gynazole-1; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Gynazole-1 with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Gynazole-1?

• 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.
• Do not use Gynazole-1 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 Gynazole-1 and for 72 hours after the last dose.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Gynazole-1 best taken?

Use Gynazole-1 as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Do not take Gynazole-1 by mouth. For vaginal use only. Keep out of your mouth, nose, and eyes (may burn).
• Wash your hands before and after use.

What do I do if I miss a dose?

• Only 1 dose of Gynazole-1 is needed. If you miss your dose, take it as soon as you think about it.

What are the side effects of Gynazole-1 that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

What are some other side effects of Gynazole-1?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Vaginal irritation.
• Burning.
• Stomach pain.
• Pelvic pain.
• Stomach cramps.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

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.

How do I store and/or throw out Gynazole-1?

• Store at room temperature.
• Protect from heat.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

• Rx Only
• NDC 45802-396-01
• GYNAZOLE•1®
• Butoconazole Nitrate Vaginal Cream USP, 2%
• The applicator delivers approximately 5 g cream, containing 100 mg butoconazole nitrate.
• IN ONE PREFILLED DISPOSABLE APPLICATOR
• For Vaginal Use Only.
• NET WT 5.8 g

 

SRC: NLM .