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Butoconazole

Also sold as: Gynazole-1

AzolesPrescription OnlyGeneric Available

Related Medications

Important: Only drugs listed as "Exact Equivalents" (FDA AB-rated) are confirmed interchangeable. All other listings are for informational reference only and do NOT indicate that drugs can be substituted without a physician's explicit guidance.

Insurance Coverage User-Reported

No community coverage data yet for butoconazole.

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Drug Information

Indications & Uses

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 & Administration

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 & Precautions

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.

Side Effects (Adverse Reactions)

ADVERSE REACTIONS Of the 314 patients treated with GYNAZOLE • 1 ® Butoconazole Nitrate Vaginal Cream USP, 2% for 1 day in controlled clinical trials, 18 patients (5.7%) reported complaints such as vulvar/vaginal burning, itching, soreness and swelling, pelvic or abdominal pain or cramping, or a combination of two or more of these symptoms. In 3 patients (1%) these complaints were considered treatment-related. Five of the 18 patients reporting adverse events discontinued the study because of them.

Contraindications

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.

Verify with Primary Sources

Always verify clinical information with authoritative sources.