Gynazole•1® Butoconazole Nitrate Vaginal Cream USP, 2% is a prescription vaginal cream used to treat yeast infections (VVC) in non-pregnant women.
- Rapid initial relief of symptoms (e.g., itching, burning, irritation, discharge, and rash)1,2
– 75% of women experienced first relief of symptoms within approximately 24 hours1
- Butoconazole provides antimicrobial activity against Candida pathogens; demonstrated by in vitro data, the 48-hour MIC90 with butoconazole was 0.01 against all species tested including, but not limited to, C albicans, C glabrata, and C tropicalis3 C tropicalis3
- Butoconazole has been demonstrated to be clinically effective in infection caused by C albicans
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.
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.
Important Safety Information for Gynazole•1® Butoconazole Nitrate Vaginal Cream USP, 2%
Gynazole•1 Butoconazole Nitrate Vaginal Cream USP, 2% is contraindicated in patients with a history of hypersensitivity to any components of the product.
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 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.
If clinical symptoms persist, tests should be repeated to rule out other pathogens, to confirm original diagnosis, and to rule out other conditions that may predispose a patient to recurrent vaginal fungal infections.
5.7% of patients (18/314) receiving Gynazole•1 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.
- 2% of patients discontinued treatment due to adverse events
- 1% of patients were evaluated to have treatment-related complaints
- Seidman LS, Skokos CK. An evaluation of butoconazole nitrate 2% Site Release® vaginal cream (Gynazole·1®) compared to fluconazole 150 mg tablets (Diflucan®) in the time to relief of symptoms in patients with vulvovaginal candidiasis. Infect Dis Obstet Gynecol. 2005; 13:197-206.
- Brown D, Henzl MR, Kaufman RH; Gynazole 1 Study Group. Butoconazole nitrate 2% for vulvovaginal candidiasis: new, single-dose vaginal cream formulation vs. seven-day treatment with miconazole nitrate. J Reprod Med. 1999;44:933-938.
- Lynch ME, Sobel JD. Comparative in vitro activity of antimycotic agents against pathogenic vaginal yeast isolates. J Med Vet Mycol. 1994;32:267-274.
- Gynazole·1® Prescribing Information. Perrigo, November 2014.