GNH USA

Europe — EMA

Gynazol

Learn about Gynazol butoconazole nitrate, a prescription vaginal antifungal for vulvovaginal candidiasis, its uses, side effects, and safety information.

Butoconazole Nitrate

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What is Butoconazole Nitrate?

Gynazol is a prescription vaginal product that contains the antifungal agent butoconazole nitrate. The formulation is designed for local administration in the vagina, though the specific dosage form and strength are not disclosed in the available data. Classified as an imidazole antifungal (ATC code D01AC13), Gynazol works by inhibiting fungal ergosterol synthesis, making it suitable for treating certain yeast infections in adult patients and improving symptoms.

What is Butoconazole Nitrate used for?

Gynazol is indicated for the treatment of vulvovaginal candidiasis, a common yeast infection of the vaginal and vulvar tissues.

- Treatment of acute vulvovaginal candidiasis caused by Candida species. - Management of recurrent vulvovaginal yeast infections when prescribed by a healthcare professional. - Use as part of a therapeutic regimen for patients with confirmed fungal infection of the vagina. - Adjunct to hygiene measures to reduce symptoms such as itching, burning, and discharge. - Option for patients who require a locally acting antifungal with a different mechanism than azoles like fluconazole.

What are the side effects of Butoconazole Nitrate?

The safety profile of Gynazol reflects the typical adverse events associated with topical imidazole antifungals.

Common: - Mild vaginal irritation or burning at the application site. - Itching or redness of the surrounding skin. - Unusual vaginal discharge that is watery or slightly cloudy. - Temporary increase in vaginal discomfort during the first 24–48 hours.

Serious: - Severe allergic reaction such as swelling of the lips, tongue, or throat. - Persistent or worsening vaginal irritation that does not improve after several days. - Development of a new rash or hives elsewhere on the body.

What precautions apply to Butoconazole Nitrate?

Before using Gynazol, patients should consider several precautionary measures to ensure safe and effective treatment.

- Confirm diagnosis of vulvovaginal candidiasis with a healthcare provider before starting therapy. - Avoid use if you have a known hypersensitivity to butoconazole nitrate or any imidazole compounds. - Do not apply the product on inflamed, ulcerated, or broken skin in the vaginal area. - Discuss pregnancy, planned pregnancy, or breastfeeding with a clinician, as safety data are limited. - Inform your doctor of any concurrent vaginal medications, including douches, spermicides, or hormonal creams. - Keep the product out of reach of children and store it according to label instructions.

What does Butoconazole Nitrate interact with?

Gynazol may interact with other vaginal products or systemic medications that affect fungal growth or hormone balance.

Avoid: - Concurrent use of other topical antifungal agents (e.g., clotrimazole, miconazole) without medical advice. - Simultaneous application of vaginal contraceptives or spermicidal gels that could alter drug absorption. - Use with systemic azole antifungals (e.g., fluconazole) unless directed by a prescriber, due to overlapping mechanisms.

Use with caution: - Hormonal vaginal therapies (e.g., estrogen creams) that may change vaginal pH. - Antibiotics that disrupt normal vaginal flora, potentially affecting treatment outcome. - Herbal or over-the-counter products that claim antifungal activity; discuss with a clinician.

Frequently asked questions

What type of medication is Gynazol and what does it contain?+
Gynazol is a prescription vaginal medication that contains the antifungal active ingredient butoconazole nitrate.
Which condition is Gynazol primarily prescribed for?+
It is primarily prescribed for the treatment of vulvovaginal candidiasis, a yeast infection of the vagina and vulva.
How does butoconazole nitrate work to treat fungal infections?+
Butoconazole nitrate inhibits ergosterol synthesis by blocking the fungal enzyme lanosterol 14α‑demethylase, disrupting cell membrane formation.
Can Gynazol be used for recurrent yeast infections?+
Yes, a healthcare provider may prescribe Gynazol for recurrent vulvovaginal candidiasis when appropriate.
Is Gynazol available over the counter?+
No, Gynazol is a prescription‑only product and must be obtained with a doctor's prescription.
What are common side effects of using Gynazol?+
Common side effects include mild vaginal irritation, burning, itching, redness, and temporary changes in discharge.
When should I seek medical attention for side effects?+
Seek medical help if you experience severe allergic reactions such as swelling of the lips, tongue, throat, or a rash that spreads.
Can I use Gynazol while pregnant or breastfeeding?+
Safety data for pregnancy and lactation are limited; discuss potential risks with your healthcare provider before use.
Should I avoid other vaginal products while using Gynazol?+
Yes, avoid using other topical antifungals, vaginal contraceptives, spermicidal gels, or douches unless advised by a clinician.
How long does treatment with Gynazol usually last?+
The duration of therapy is determined by the prescribing clinician based on the severity of the infection.
Is it safe to use antibiotics together with Gynazol?+
Antibiotics can alter vaginal flora; use them together only under medical guidance to ensure effective treatment.
What should I do if I miss a dose of Gynazol?+
If a dose is missed, apply it as soon as you remember unless it is close to the time of the next scheduled dose; follow your provider’s instructions.
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 Plc.
Origin
EU

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