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Basic Drug Info
Drug Name:Gynazole-1
Manufacturer:KV Pharmaceuticals
Other Info:

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.

Imidazoles 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 candidasis.



Clinical Trials:


Indications and Usage

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® 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).
Candidiasis, Vulvovaginal -- Infection of the VULVA and VAGINA with a fungus of the genus CANDIDA.

Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

Candidiasis -- Infection with a fungus of the genus CANDIDA. It is usually a superficial infection of the moist areas of the body and is generally caused by CANDIDA ALBICANS. (Dorland, 27th ed)

Contraindications
Gynazole-1® is contraindicated in patients with a history of hypersensitivity to any of the components of the product.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

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® 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.

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