Gynazole (Butoconazole)
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Gynazole (Butoconazole)

GYNAZOLE•1®
(butoconazole nitrate) Vaginal cream, 2%

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 effect. You may report side effects to FDA at...

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 »

Last reviewed on RxList: 7/17/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

GYNAZOLE•1® (butoconazole nitrate) vaginal cream, 2% is indicated for the local treatment of vulvovaginal candidiasis (infections caused by Candida). The diagnosis should be confirmed by KOH smears and/or cultures (see Clinical Studies).

Note: GYNAZOLE•1® (butoconazole) is safe and effective in non-pregnant women; however, the safety and effectiveness of this product in pregnant women has not been established. (See PRECAUTIONS: Pregnancy.)

DOSAGE AND ADMINISTRATION

The recommended dose of GYNAZOLE (butoconazole) •1® is one applicatorful of cream (approximately 5 grams of the cream) intravaginally. This amount of cream contains approximately 100 mg of butoconazole nitrate.

HOW SUPPLIED

GYNAZOLE•1® (butoconazole nitrate) vaginal cream, 2% is available in cartons containing one single-dose prefilled disposable applicator (NDC 64011-001-08).

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). (See USP Controlled Room Temperature). Avoid heat above 30°C (86°F).

Manufactured for Ther-Rx Corporation by KV Pharmaceutical Co. St. Louis, MO 63044. 08/03. FDA Rev date: 7/24/2003

Last reviewed on RxList: 7/17/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Of the 314 patients treated with GYNAZOLE (butoconazole) •1® for 1 day in controlled clinical trials, 18 patients (5.7%) reported complaints such as vulvar/vaginal burning, itching, soreness and swelling, pelvic or abdominal pain or cramping, or a combination of two or more of these symptoms. In 3 patients (1%) these complaints were considered treatment-related. Five of the 18 patients reporting adverse events discontinued the study because of them.

Read the Gynazole (butoconazole) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 7/17/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

This cream contains mineral oil. Mineral oil may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms; therefore, use of such products within 72 hours following treatment with GYNAZOLE•1® (butoconazole) is not recommended.

Recurrent vaginal yeast infections, especially those that are difficult to eradicate, can be an early sign of infection with the human immunodeficiency virus (HIV) in women who are considered at risk for HIV infection.

PRECAUTIONS

General: If clinical symptoms persist, tests should be repeated to rule out other pathogens, to confirm the original diagnosis, and to rule out other conditions that may predispose a patient to recurrent vaginal fungal infections.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis:Long term studies in animals have not been performed to evaluate the carcinogenic potential of this drug.

Mutagenicity: Butoconazole nitrate was not mutagenic when tested in the Ames bacterial test, yeast, chromosomal aberration assay in CHO cells, CHO/HGPRT point mutation assay, mouse micronucleus, and rat dominant lethal assays.

Impairment of Fertility: No impairment of fertility was seen in rabbits or rats administered butoconazole nitrate in oral doses up to 30 mg/kg/day (5 times the human dose based on mg/M2) or 100 mg/kg/day (10 times the human dose based on mg/M2), respectively.

Pregnancy

Pregnancy Category C

In pregnant rats administered 6 mg/kg/day of butoconazole nitrate intravaginally during the period of organogenesis, there was an increase in resorption rate and decrease in litter size; however, no teratogenicity was noted. This dose represents a 130- to 353-fold margin of safety based on serum levels achieved in rats following intravaginal administration compared to the serum levels achieved in humans following intravaginal administration of the recommended therapeutic dose of butoconazole nitrate.

Butoconazole nitrate has no apparent adverse effect when administered orally to pregnant rats throughout organogenesis at dose levels up to 50 mg/kg/day (5 times the human dose based on mg/M2). Daily oral doses of 100, 300 or 750 mg/kg/day (10, 30 or 75 times the human dose based on mg/M2 respectively) resulted in fetal malformations (abdominal wall defects, cleft palate), but maternal stress was also evident at these higher dose levels. There were, however, no adverse effects on litters of rabbits who received butoconazole nitrate orally, even at maternally stressful dose levels (e.g., 150 mg/kg, 24 times the human dose based on mg/M2). Butoconazole nitrate, like other azole anti-fungal agents, causes dystocia in rats when treatment is extended through parturition. However, this effect was not apparent in rabbits treated with as much as 100 mg/kg/day orally (16 times the human dose based on mg/M2).

There are, however, no adequate and well-controlled studies in pregnant women. GYNAZOLE (butoconazole) •1® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when butoconazole nitrate is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in children have not been established.

Last reviewed on RxList: 7/17/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No information provided.

CONTRAINDICATIONS

GYNAZOLE•1® (butoconazole) is contraindicated in patients with a history of hypersensitivity to any of the components of the product.

Last reviewed on RxList: 7/17/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Following vaginal administration of butoconazole nitrate vaginal cream, 2% to 3 women, 1.7% (range 1.3 - 2.2%) of the dose was absorbed on average. Peak plasma levels (13.6 - 18.6 ng radioequivalents/mL of plasma) of the drug and its metabolites are attained between 12 and 24 hours after vaginal administration.

Microbiology

The exact mechanism of the antifungal action of butoconazole nitrate is unknown; however, it is presumed to function as other imidazole derivatives via inhibition of steroid synthesis. lmidazoles generally inhibit the conversion of lanosterol to ergosterol, resulting in a change in fungal cell membrane lipid composition. This structural change alters cell permeability and, ultimately, results in the osmotic disruption or growth inhibition of the fungal cell.

Butoconazole nitrate is an imidazole derivative that has fungicidal activity in vitro against Candida spp. and has been demonstrated to be clinically effective against vaginal infections due to Candida albicans. Candida albicans has been identified as the predominant species responsible for vulvovaginal candidiasis.

Clinical Studies

Vulvovaginal Candidiasis: Two studies were conducted that compared 2% butoconazole nitrate cream with clotrimazole tablets. There were 322 enrolled patients, 161 received 2.0% butoconazole vaginal cream and 161 patients inserted the 500-mg clotrimazole vaginal tablet. At the second follow-up visit (30 days post-therapy), 118 patients in the butoconazole group and 116 in the clotrimazole group were evaluable for efficacy analysis, respectively. All of these patients had infection caused by Candida albicans.

The efficacy of the study drugs was assessed by evaluating clinical, mycologic and therapeutic cure rates, which are summarized in Table 1. The therapeutic cure is defined by a complete resolution of signs and symptoms of vaginal candidiasis (clinical cure) along with a negative KOH examination and negative culture for Candida spp. (microbiologic eradication) at the long term follow-up. The therapeutic cure rate was 67% in the butoconazole group and 61% in the clotrimazole group.

Table 1

  2% butoconazole nitrate cream 500-mg clotrimazole vaginal tablet
Enrolled 161 161
Evaluable at Late Follow-up 118 116
Clinical Cure 95/118 (81%) 93/116 (80%)
Mycologic Eradication* 87/118 (74%) 77/116 (66%)
Therapeutic Cure 79/118 (67%) 71/116 (61%)
*=C. albicans in the vaginal culture was proven at admission in all of these patients.

Last reviewed on RxList: 7/17/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 7/17/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 7/17/2008
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Gynazole Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

BUTOCONAZOLE NITRATE CREAM - VAGINAL

(BUE-toe-KON-a-zole NYE-trate)

COMMON BRAND NAME(S): Gynazole-1, Mycelex

USES: This medication is used to treat vaginal yeast infections. Butoconazole reduces vaginal burning, itching, and discharge that may occur with this condition. This medication is an azole antifungal. It works by stopping the growth of yeast (fungus) that causes the infection.

HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using butoconazole, and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.

This product is for vaginal use only. Wash your hands before and after use. Avoid contact of this cream with your eyes. If it gets into your eyes, wash them immediately with plenty of water. Call your doctor if eye irritation persists.

This product is given as a single dose, usually at bedtime or as directed by your doctor. Learn all preparation and usage instructions in the product package. Lie on your back with your knees toward your chest. Insert the applicator filled with medication into the vagina as far as it will comfortably go. Slowly press the plunger of the applicator in to apply the full dose of the cream.

Do not use tampons or douches while using this medication. Unscented sanitary napkins may be used for your menstrual period or to protect your clothing from leakage of the medication.

Tell your doctor if your condition does not improve or if it returns within 2 months. You may need a different or additional medication to treat your condition.

Disclaimer

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.

Read the Gynazole (butoconazole) Side Effects Center for a complete guide to possible side effects »

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.

Disclaimer

Gynazole Consumer (continued)

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may increase the risk of vaginal yeast infections include antibiotics, corticosteroids (such as prednisone), and drugs that suppress the immune system (such as cyclosporine, methotrexate).

Keep a list of all the products you use. Share the list with your doctor and pharmacist to reduce your risk for serious medication problems.

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

To help prevent vaginal yeast infections, dry the genital area thoroughly after showering, bathing, or swimming. Avoid wearing tight jeans, nylon underwear, pantyhose, a wet bathing suit, or damp/sweaty exercise clothes for long periods. Wear cotton underwear, and change your underwear daily.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in that case.

If your sexual partner experiences symptoms, they should contact their doctor immediately.

MISSED DOSE: Not applicable. This medication is usually given as one dose only.

STORAGE: Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised May 2010. Copyright(c) 2010 First Databank, Inc.

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)?

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.

Read the Gynazole (butoconazole) Side Effects Center for a complete guide to possible side effects »

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.

Side Effects Centers

Gynazole Patient Information including How Should I Take

What should I discuss with my doctor before using butoconazole vaginal (Gynazole)?

Do not use butoconazole vaginal if you have ever had an allergic reaction to it.

You should not use butoconazole vaginal if you have a fever, abdominal pain, foul-smelling vaginal discharge, diabetes, HIV, or AIDS.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

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.

It is not known whether butoconazole passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use butoconazole vaginal (Gynazole)?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor.

Wash your hands before and after using this medication.

Insert the cream into your vagina using the applicator as directed.

Avoid getting this medication in your eyes, nose, or mouth.

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.

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.

You may use a sanitary napkin to prevent the medication from staining your clothing but do not use a tampon.

Store butoconazole vaginal at room temperature away from moisture and heat.

Side Effects Centers

Gynazole Patient Information including If I Miss a Dose

What happens if I miss a dose (Gynazole)?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Gynazole)?

Seek emergency medical attention if you think you have used too much of this medicine, or if anyone has accidentally swallowed it.

An overdose of butoconazole applied in the vagina is not expected to produce life-threatening symptoms.

What should I avoid while using butoconazole vaginal (Gynazole)?

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.

What other drugs will affect butoconazole vaginal (Gynazole)?

There may be other drugs that can affect butoconazole vaginal. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about butoconazole vaginal.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.07. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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Side Effects Centers

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