Butoconazole

What is Butoconazole?

• Butoconazole (Femstat 3; Gynazole-1) is an imidazole derivative with antifungal activity used in gynecology. It is administered as a vaginal cream.

Butoconazole structure

Butoconazole

What are the uses of this medicine?

• Butoconazole (Femstat 3; Gynazole-1) is used to treat yeast infections of the vagina.
• Butoconazole Nitrate Vaginal Cream USP, 2% is indicated for the local treatment of vulvovaginal candidiasis (infections caused by Candida).

How does this medicine work?

• The nitrate salt form of butaconazole, a synthetic imidazole derivative with fungistatic properties.
• Butoconazole nitrate interferes with steroid biosynthesis by inhibiting the conversion of lanosterol to ergosterol, thereby changing the fungal cell membrane lipid composition.
• This alters cell permeability and leads to growth inhibition.
• Butaconazole nitrate is active against many dermatophytes and yeasts.
• It also contains antibacterial effects against some gram-positive organisms.
• 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.

Who Should Not Use this medicine ?

This medicine cannot be used in patients with:

• a history of hypersensitivity to any of the components of the product.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention any of the following:

• antibiotic medications

Is this medicine FDA approved?

• Yes, it is FDA approved.

How should this medicine be used?

Recommended dosage:

• The recommended dose of 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.

Administration:

• Butoconazole comes as a cream to insert into the vagina. It is usually used daily at bedtime.
• The dose should be applied when you lie down to go to bed. T
• he drug works best if you do not get up again after applying it except to wash your hands.
• You may wish to wear a sanitary napkin to protect your clothing against stains.
• Do not use a tampon because it will absorb the drug.
• Do not douche unless your doctor tells you to do so.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Butoconazole Nitrate Vaginal Cream USP, 2%

This medicine is available in fallowing brand namesː

• Femstat 3; Gynazole-1

What side effects can this medication cause?

The most common side effects of this medicine include:

• vulvar/vaginal burning
• itching, soreness and swelling
• pelvic or abdominal pain or cramping
• fever
• foul-smelling discharge

What special precautions should I follow?

• 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 Butoconazole Nitrate Vaginal Cream USP, 2% is not recommended.
• 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.
• Tell your doctor if you have or have ever had diabetes, problems with your immune system, human immunodeficiency virus infection (HIV), or acquired immunodeficiency syndrome (AIDS).
• There are no adequate and well-controlled studies in pregnant women. Butoconazole Nitrate Vaginal Cream USP, 2% should be used during pregnancy only under the supervision of a physician.
• 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.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Pregnancy Category C.
• There are, however, no adequate and well-controlled studies in pregnant women.
• Butoconazole Nitrate Vaginal Cream USP, 2% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• Safety and effectiveness in children have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• BUTOCONAZOLE NITRATE

Inactive ingredients:

• EDETATE DISODIUM
• GLYCERYL ISOSTEARATE
• METHYLPARABEN
• MINERAL OIL
• POLYGLYCERYL-3 OLEATE
• PROPYLENE GLYCOL
• PROPYLPARABEN
• SILICON DIOXIDE
• SORBITOL
• WATER
• MICROCRYSTALLINE WAX

Who manufactures and distributes this medicine?

• Made in Israel

Manufactured By:

• Perrigo
• Yeruham , Israel

Distributed By:

• Perrigo®
• Allegan, MI

What should I know about storage and disposal of this medication?

• Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).
• Avoid heat above 30°C (86°F).

• Dailymed label info on Butoconazole
• FDA Butoconazole

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