Medically reviewed by Drugs.com. Last updated on Sep 10, 2020.
(byoo toe KOE na zole)
- Butoconazole Nitrate
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Cream, Vaginal, as nitrate:
Gynazole-1: 2% (5 g) [contains edetate disodium, methylparaben, propylene glycol, propylparaben]
Brand Names: U.S.
- 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 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.
Vulvovaginal candidiasis: Intravaginal: Insert 1 applicatorful (∼5 g) intravaginally as a single dose. Note: A longer duration 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 2015]; HHS [OI adult 2020]).
Refer to adult dosing.
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.
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).
Progesterone: Antifungal Agents (Vaginal) may diminish the therapeutic effect of Progesterone. Avoid combination
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
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.
• HIV infection consideration: HIV infection should be considered in sexually-active women with difficult to eradicate recurrent vaginal yeast infections.
This product may weaken latex or rubber condoms or diaphragms (CDC [Workowski 2015]).
Pregnancy Risk Factor C 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 (CDC [Workowski 2015]).
What is this drug used for?
• This drug is used to treat vaginal yeast infections.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
• Vaginal irritation
• Abdominal pain
• Pelvic pain
• Abdominal cramps
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
More about butoconazole topical
- Side Effects
- During Pregnancy or Breastfeeding
- Dosage Information
- En Español
- 3 Reviews
- Drug class: vaginal anti-infectives
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