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(byoo toe KOE na zole)

Index Terms

  • Butoconazole Nitrate

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Cream, Vaginal, as nitrate:

Gynazole-1: 2% (5 g, 5.8 g [DSC]) [contains edetate disodium, methylparaben, propylene glycol, propylparaben]

Brand Names: U.S.

  • Gynazole-1

Pharmacologic Category

  • Antifungal Agent, Imidazole Derivative
  • Antifungal Agent, Vaginal


Inhibits biosynthesis of ergosterol, damaging the fungal cell wall membrane, which increases permeability in susceptible fungi (Candida), causing leaking of nutrients



Time to Peak

Plasma: 12 to 24 hours

Use: Labeled Indications

Vulvovaginal candidiasis: Local treatment of vulvovaginal candidiasis due to Candida albicans


Hypersensitivity to butoconazole or any component of the formulation.

Documentation of allergenic cross-reactivity for drugs in this class is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.

Dosing: Adult

Vulvovaginal candidiasis: Intravaginal: Insert 1 applicatorful (∼5 g) intravaginally as a single dose

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.


Intravaginal: Use applicator provided by manufacturer. Insertion should be as far as possible into the vagina without causing discomfort.


Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Avoid temperatures >30°C (>86°F).

Drug Interactions

Progesterone: Antifungal Agents (Vaginal) may diminish the therapeutic effect of Progesterone. Avoid combination

Adverse Reactions

Frequency not defined.

Gastrointestinal: Abdominal cramps, abdominal pain

Genitourinary: Pelvic pain, vulvovaginal burning, vulvovaginal disease (soreness), vulvovaginal pruritus, vulvovaginal swelling


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.

Pregnancy Risk Factor


Pregnancy Considerations

Adverse events have been observed in some animal reproduction studies. Following vaginal administration, small amounts are absorbed systemically. Single dose, topical azole regimens are not recommended for the treatment of vulvovaginal candidiasis; only topical azole therapies with 7 day regimens are recommended in pregnant women with vulvovaginal candidiasis. This product may weaken latex or rubber condoms or diaphragms (CDC [Workowski 2015]).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience abdominal pain or abdominal cramps. Have patient report immediately to prescriber severe vaginal irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.