Butoconazole Nitrate
PrescriptionNombres comerciales: gynazole 1
About This Medication
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. Chemical Structure.jpg
Principios Activos
| Ingrediente | Concentración |
|---|---|
| Butoconazole Nitrate | - |
Indicaciones y Uso
Dosificación y Administración
Side Effects Overview
Advertencias y Precauciones
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 Nitrate Vaginal Cream USP, 2% 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.
Contraindicaciones
CONTRAINDICATIONS GYNAZOLE • 1 ® Butoconazole Nitrate Vaginal Cream USP, 2% is contraindicated in patients with a history of hypersensitivity to any of the components of the product.
Frequently Asked Questions
INDICATIONS AND USAGE GYNAZOLE • 1 ® Butoconazole Nitrate Vaginal Cream USP, 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 Nitrate Vaginal Cream USP, 2% 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 • 1 ® 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.
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 Nitrate Vaginal Cream USP, 2% 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.
CONTRAINDICATIONS GYNAZOLE • 1 ® Butoconazole Nitrate Vaginal Cream USP, 2% is contraindicated in patients with a history of hypersensitivity to any of the components of the product.
Butoconazole Nitrate is a prescription medication. You will need a valid prescription from a licensed healthcare provider.
Similar Other Products
Browse all Other products →References & Data Sources
- • DailyMed — Butoconazole Nitrate drug label (National Library of Medicine)
- • openFDA — Butoconazole Nitrate label data (U.S. Food & Drug Administration)
- • RxNorm — RXCUI 890785 (NLM Normalized Drug Names)
- • NDC Directory — Butoconazole Nitrate (FDA National Drug Code)
Aviso Médico
La información en esta página tiene fines exclusivamente educativos y no debe utilizarse como sustituto del consejo médico profesional, diagnóstico o tratamiento.
Siempre consulte a su médico u otro proveedor de salud calificado ante cualquier pregunta que pueda tener sobre una condición médica o medicamento.
Fuentes de datos: DailyMed (NLM), openFDA, MFDS