Candidiasis, vulvovaginal:
Note: A longer duration of 7 to 14 days may be necessary in patients with complicated infection (ie, recurrent or severe infection, infection with non-albicans Candida, or infection in an immunocompromised host) (CDC [Workowski 2021]; HHS [OI adult 2020]). Not effective against Candida glabrata (IDSA [Pappas 2016]).
Cream 2%: Intravaginal: Insert 1 applicatorful (~5 g) as a single dose (CDC [Workowski 2021]).
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, Vaginal, as nitrate:
Gynazole-1: 2% (5 g) [contains edetate (edta) disodium, methylparaben, propylene glycol, propylparaben]
No
Intravaginal: Use applicator provided by manufacturer. Do not use applicator if tip has been removed. Do not warm applicator prior to administration. Insertion should be as far as possible into the vagina without causing discomfort.
Candidiasis, vulvovaginal: Local treatment of vulvovaginal candidiasis due to Candida albicans.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.
Gastrointestinal: Abdominal cramps, abdominal pain
Genitourinary: Pelvic pain, vulvovaginal burning, vulvovaginal disease (soreness), vulvovaginal pruritus
Local: Local swelling
Hypersensitivity to butoconazole or any component of the formulation.
Documentation of allergenic cross-reactivity for imidazole antifungals is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
Dosage form specific issues:
• Vaginal cream: Contains mineral oil that may weaken latex or rubber (condoms or diaphragms); use of these products within 72 hours of treatment is not recommended.
Other warnings/precautions:
• HIV infection consideration: HIV infection should be considered in sexually-active women with difficult to eradicate recurrent vaginal yeast infections.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Progesterone: Antifungal Agents (Vaginal) may diminish the therapeutic effect of Progesterone. Risk X: Avoid combination
This product may weaken latex or rubber condoms or diaphragms (CDC [Workowski 2021]).
Following vaginal administration, small amounts are absorbed systemically.
Single dose, topical azole regimens are not recommended for the treatment of vulvovaginal candidiasis during pregnancy; only topical azole therapies with 7-day regimens are recommended in pregnant patients with vulvovaginal candidiasis (CDC [Workowski 2021]).
It is not known if butoconazole is present in breast milk.
The manufacturer recommends that caution be exercised when administering butoconazole to breastfeeding patients.
Inhibits biosynthesis of ergosterol, damaging the fungal cell wall membrane, which increases permeability in susceptible fungi (Candida), causing leaking of nutrients
Absorption: ~2%
Distribution: Vaginal fluid: Median retention: 4.2 days (Seidman 2005; Weinstein 1994).
Time to peak, plasma: 12 to 24 hours
Cream (Gynazole-1 Vaginal)
2% (per gram): $25.99
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