Gynazole

DRUG DESCRIPTION

GYNAZOLE•1® (butoconazole nitrate) vaginal cream, 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:

GYNAZOLE.1(butoconazole nitrate) structural formula illustration

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® 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.

What are the possible side effects of butoconazole vaginal (Gynazole 1)?

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

Other less serious side effects are more likely to occur, such as:

  • burning;
  • itching;
  • pelvic pain or cramps;
  • itching;
  • soreness and swelling; or
  • increased urination.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side...

Read All Potential Side Effects and See Pictures of Gynazole »

What are the precautions when taking butoconazole (Gynazole)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungal agents (such as clotrimazole, fluconazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, immune system problems (such as HIV-AIDs), frequent vaginal yeast infections (more than 4 per year).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Ask your doctor whether you can have sexual intercourse while using...

Read All Potential Precautions of Gynazole »


Gynazole Consumer (continued)

SIDE EFFECTS: Increased vaginal/urethral burning/itching/pain, or mild abdominal cramps may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A different type of infection (bacterial vaginosis) or a more serious condition (Pelvic Inflammatory Disease-PID) may require different treatment. Tell your doctor immediately if you have any of the following symptoms: flu-like symptoms (including fever/chills), foul-smelling discharge from the vagina, stomach/abdominal pain.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other azole antifungal agents (such as clotrimazole, fluconazole); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, immune system problems (such as HIV-AIDs), frequent vaginal yeast infections (more than 4 per year).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Ask your doctor whether you can have sexual intercourse while using this product. This product may weaken rubber products (such as latex condoms, diaphragms, cervical caps) and lead to failure. This can result in pregnancy. Therefore, do not use these products during treatment with this medication and for 3 days after treatment is over. Consult your doctor about other forms of barrier protection/birth control (such as polyurethane condoms) during this time.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Pregnant women should use extra care when using the vaginal applicator. Follow your doctor's instructions closely on how to insert the medication using the applicator.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Gynazole Patient Information Including Side Effects

Brand Names: Gynazole 1

Generic Name: butoconazole vaginal (Pronunciation: byoo toe CON a zole)

  • What is butoconazole vaginal (Gynazole)?
  • What are the possible side effects of butoconazole vaginal (Gynazole)?
  • What is the most important information I should know about butoconazole vaginal (Gynazole)?
  • What should I discuss with my doctor before using butoconazole vaginal (Gynazole)?
  • How should I use butoconazole vaginal (Gynazole)?
  • What happens if I miss a dose (Gynazole)?
  • What happens if I overdose (Gynazole)?
  • What should I avoid while using butoconazole vaginal (Gynazole)?
  • What other drugs will affect butoconazole vaginal (Gynazole)?
  • Where can I get more information?

What is butoconazole vaginal (Gynazole)?

Butoconazole is an antifungal medication. It prevents fungus from growing.

Butoconazole vaginal is used to treat vaginal candida (yeast) infections.

Butoconazole vaginal may also be used for other purposes not listed in this medication guide.

What are the possible side effects of butoconazole vaginal (Gynazole)?

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

Other less serious side effects are more likely to occur, such as:

  • burning;
  • itching;
  • pelvic pain or cramps;
  • itching;
  • soreness and swelling; or
  • increased urination.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about butoconazole vaginal (Gynazole)?

Use this medication for the entire length of time prescribed by your doctor, even during your menstrual period. Your symptoms may get better before the infection is completely treated.

Butoconazole contains mineral oil, which can weaken the latex rubber that condoms and diaphragms are made of. If you use either of these forms of birth control, they may not be as effective during your treatment with butoconazole. Use another form of birth control while you are using butoconazole and for at least 3 full days after your treatment has ended.

Avoid wearing tight-fitting, synthetic clothing such as nylon underwear or panty hose that does not allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until your infection is healed.

Avoid using other vaginal creams or douches at the same time as butoconazole vaginal unless your doctor approves.

If the infection does not clear up after you have finished one course of therapy, or if your symptoms get worse, see your doctor. You may have another type of infection that butoconazole will not treat.

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