GNH USA

Europe — EMA

Gynofort

Gynofort is a 2% butoconazole nitrate vaginal cream for treating vulvovaginal candidiasis. Learn uses, side effects, precautions and interactions.

Butoconazole Nitrate

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What is Butoconazole Nitrate?

Gynofort is a prescription vaginal cream containing 2 % butoconazole nitrate, an azole antifungal agent. It is formulated for intravaginal use to treat fungal infections of the female genital tract. The product is marketed in the European Union and is classified as a prescription‑only medication. Its mechanism of action involves inhibition of ergosterol synthesis, which disrupts fungal cell membranes and helps restore normal vaginal flora.

What is Butoconazole Nitrate used for?

Gynofort is indicated for the treatment of vaginal yeast infections caused by susceptible Candida species.

- Acute vulvovaginal candidiasis (yeast infection of the vagina). - Symptomatic relief of itching, burning, and discharge associated with candidal infection. - Treatment of recurrent vulvovaginal candidiasis when prescribed by a healthcare professional. - Use as part of a comprehensive management plan for fungal vaginitis in adult women. - Adjunct therapy for mixed infections where a fungal component is confirmed.

What are the side effects of Butoconazole Nitrate?

Possible adverse reactions to Gynofort may occur locally in the vagina or systemically, although systemic effects are rare.

Common: - Mild irritation or burning at the application site. - Vaginal itching or redness. - Slight increase in vaginal discharge that is watery or white. - Unpleasant odor from the cream.

Serious: - Severe allergic reaction such as rash, hives, or swelling of the face, lips, or tongue. - Persistent or worsening vaginal irritation. - Signs of secondary bacterial infection (e.g., fever, foul‑smelling discharge).

What precautions apply to Butoconazole Nitrate?

Before using Gynofort, certain precautions should be considered to ensure safe and effective treatment.

- Confirm diagnosis of Candida infection; avoid use for bacterial or viral vaginitis. - Do not use if you are allergic to butoconazole nitrate or any azole antifungal. - Discuss pregnancy or breastfeeding status with a healthcare provider, as safety data are limited. - Avoid using other intravaginal products (e.g., douches, spermicides) during treatment. - If symptoms persist beyond the recommended course, seek medical advice. - Keep the cream out of reach of children and store at room temperature.

What does Butoconazole Nitrate interact with?

Gynofort may interact with other medications or products applied to the vagina, potentially affecting efficacy or safety.

Avoid: - Concurrent use of other intravaginal antifungal agents, which may increase local irritation. - Use with vaginal contraceptives containing spermicidal agents, as they can reduce the effectiveness of the cream.

Use with caution: - Systemic azole antifungals (e.g., fluconazole) because combined antifungal activity may increase risk of adverse effects. - Hormonal contraceptives, although no direct interaction, monitor for any changes in menstrual symptoms. - Topical corticosteroids applied vaginally, which could mask irritation signs.

Frequently asked questions

What is the active ingredient in Gynofort and how does it work?+
Gynofort contains butoconazole nitrate, an azole antifungal that blocks the fungal enzyme lanosterol 14α‑demethylase, preventing ergosterol synthesis and disrupting the cell membrane of Candida species.
How is Gynofort applied for vulvovaginal candidiasis?+
The cream is inserted into the vagina using an applicator, typically once daily for the duration prescribed by a healthcare professional. Exact dosing instructions should be followed on the label or as directed by a clinician.
Can Gynofort be used during pregnancy?+
Safety data for Gynofort in pregnancy are limited, and the pregnancy category is listed as unknown. Women who are pregnant or planning pregnancy should discuss potential risks and benefits with their healthcare provider before using the product.
Is Gynofort available over the counter?+
No. Gynofort is a prescription‑only medication in the European Union and must be prescribed by a qualified healthcare professional.
What are common side effects of Gynofort?+
Common local side effects include mild irritation or burning at the application site, vaginal itching, redness, a slight increase in watery or white discharge, and an unpleasant odor from the cream.
When should I seek medical attention while using Gynofort?+
If you experience signs of a severe allergic reaction such as rash, hives, swelling of the face, lips or tongue, or if vaginal irritation worsens or is accompanied by fever or foul‑smelling discharge, contact a healthcare professional promptly.
Can I use other vaginal products while treating with Gynofort?+
It is recommended to avoid other intravaginal products, such as douches, spermicides, or additional antifungal creams, during treatment unless specifically directed by a clinician.
Does Gynofort interact with oral antifungal medications?+
When used together with systemic azole antifungals (e.g., fluconazole), there may be an increased risk of adverse effects, so concurrent use should be discussed with a healthcare provider.
How long does it take for symptoms to improve after starting Gynofort?+
Many women notice relief of itching and discharge within a few days, but the full course of therapy should be completed as prescribed to ensure eradication of the infection.
What should I do if my symptoms do not improve after treatment?+
If symptoms persist after completing the prescribed course, contact your healthcare provider for re‑evaluation, as the infection may be resistant or another condition may be present.
Is Gynofort safe for breastfeeding mothers?+
Safety during lactation has not been established. Breastfeeding women should consult their physician before using Gynofort.
How should Gynofort be stored?+
Store the cream at room temperature, away from excess heat and moisture, and keep it out of reach of children.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Butoconazole Nitrate
Route
Vaginal Use
Manufacturer
Gedeon Richter România S.A.
Origin
EU

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