Europe — EMA
Gynazol (Butoconazole Nitrate)
Learn about Gynazol butoconazole nitrate, a vaginal antifungal for treating candidiasis, its uses, side effects, precautions, and drug interactions.
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What is Butoconazole Nitrate?
Gynazol is a vaginal antifungal medication whose active ingredient is butoconazole nitrate; the product is supplied in a vaginal dosage form, with strength not specified in the available data. It belongs to the imidazole class of antifungal agents and is marketed in the European Union for the treatment of fungal infections of the vagina. It is intended for local application and is used under the guidance of a healthcare professional.
What is Butoconazole Nitrate used for?
Gynazol is indicated for the treatment of vaginal candidiasis caused by susceptible Candida species.
- Management of acute vulvovaginal yeast infections. - Adjunct therapy for recurrent Candida infections when prescribed by a clinician. - Treatment of symptomatic vaginal itching, burning, and discharge associated with candidiasis. - Use in adult women following confirmed diagnosis of fungal vaginitis. - Therapeutic option for patients who cannot tolerate oral antifungal agents. - Consideration for use in women preferring topical over systemic therapy.
What are the side effects of Butoconazole Nitrate?
Possible adverse reactions to Gynazol are generally mild, but serious events have been reported rarely.
Common: - Local irritation or burning at the application site. - Vaginal itching or mild discomfort. - Increased vaginal discharge with a watery or milky appearance. - Mild abdominal cramping.
Serious: - Allergic reaction presenting as rash, swelling, or hives. - Severe vaginal inflammation or ulceration. - Signs of systemic hypersensitivity such as difficulty breathing.
What precautions apply to Butoconazole Nitrate?
Before using Gynazol, certain precautions should be considered to ensure safe and effective treatment.
- Confirm diagnosis of vaginal candidiasis before initiating therapy. - Avoid use if you have a known hypersensitivity to butoconazole nitrate or other imidazole antifungals. - Do not use during active vaginal infections of bacterial or parasitic origin without medical advice. - Pregnancy and breastfeeding status should be discussed with a healthcare provider. - If symptoms persist beyond the recommended treatment period, seek further medical evaluation. - Do not insert the applicator beyond the recommended depth to prevent mucosal injury.
What does Butoconazole Nitrate interact with?
Gynazol may interact with other medications or substances applied vaginally; awareness of these interactions helps minimize risk.
Avoid: - Concurrent use of other vaginal antifungal or antiseptic products without professional guidance. - Co‑administration with intravaginal estrogen creams that may alter local absorption.
Use with caution: - Systemic azole antifungals (e.g., fluconazole) as they may increase overall azole exposure. - Topical corticosteroids applied to the vaginal area, which could mask irritation. - Chemotherapeutic agents that suppress immune function, potentially affecting treatment response.



