Butoconazole Brand Name– Gynazole-1
What is Butoconazole
Butoconazole is an imidazole antifungal agent. It is fungicidal in vitro against Candida spp. and is clincally effective in treating vulvovaginal candidiasis.
Butoconazole is available as a vaginal preparation. Butoconazole was FDA-approved in 1985 for the treatment of vulvovaginal candidiasis.
In December 1995, multiple-dose butoconazole formulations were approved for over-the-counter (OTC) use.
A single dose vaginal product (Gynazole-1®) was FDA-approved in July 2000 as a prescription-only product.
Indications
- Candida albicans
- Candida glabrata
- Candida sp.
- Candida tropicalis
- Epidermophyton floccosum
- Microsporum canis
- Microsporum gypseum
- Trichophyton mentagrophytes
- Trichophyton rubrum
- Trichophyton sp.
- Trichophyton tonsurans
- vulvovaginal candidiasis
Side Effects
- abdominal pain
- pelvic pain
- pruritus
- vaginal irritation
- vaginal pain
Of the 314 patients treated with butoconazole intravaginally for 1 day in controlled clinical trials, 18 patients (5.7%) experienced an adverse event; however, these events were considered treatment-related in only 3 patients (1%).
Butoconazole-associated adverse events consist primarily of localized vaginal irritation including burning, pruritus, swelling, and vaginal pain or soreness. Systemic events include pelvic pain, abdominal pain, and abdominal cramping
Monitoring Parameters
- laboratory monitoring not necessary
Contraindications
- abdominal pain
- azole antifungals hypersensitivity
- breast-feeding
- children
- contraceptive devices
- diabetes mellitus
- fever
- human immunodeficiency virus (HIV) infection
- immunosuppression
- infants
- menstruation
- neonates
- ocular exposure
- onychomycosis
- ophthalmic administration
- pregnancy
- vaginal discharge
Interactions
There are no drug interactions associated with Butoconazole products.
