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Butoconazole: Drug information

Butoconazole: Drug information
(For additional information see "Butoconazole: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Gynazole-1
Pharmacologic Category
  • Antifungal Agent, Imidazole Derivative;
  • Antifungal Agent, Vaginal
Dosing: Adult
Candidiasis, vulvovaginal

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) (Ref). Not effective against Candida glabrata (Ref).

Cream 2%: Intravaginal: Insert 1 applicatorful (~5 g) as a single dose (Ref).

Dosing: Kidney Impairment: Adult

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

Dosing: Hepatic Impairment: Adult

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

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

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

Contraindications

Hypersensitivity to butoconazole or any component of the formulation.

Warnings/Precautions

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.

Dosage Forms: US

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, propylparaben]

Generic Equivalent Available: US

No

Pricing: US

Cream (Gynazole-1 Vaginal)

2% (per gram): $28.56

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

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.

Use: Labeled Indications

Candidiasis, vulvovaginal: Local treatment of vulvovaginal candidiasis due to Candida albicans.

Metabolism/Transport Effects

None known.

Drug Interactions

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

Reproductive Considerations

This product may weaken latex or rubber condoms or diaphragms (CDC [Workowski 2021]).

Pregnancy Considerations

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]).

Breastfeeding Considerations

It is not known if butoconazole is present in breast milk.

The manufacturer recommends that caution be exercised when administering butoconazole to breastfeeding patients.

Mechanism of Action

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

Pharmacokinetics (Adult Data Unless Noted)

Absorption: ~2%

Distribution: Vaginal fluid: Median retention: 4.2 days (Seidman 2005; Weinstein 1994).

Time to peak, plasma: 12 to 24 hours

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (BE) Belgium: Gynomyk;
  • (BR) Brazil: Femmesil | Femynazol | Gynazole-1 | Nitrato de butoconazol | Umma;
  • (DO) Dominican Republic: Femstat;
  • (EC) Ecuador: Femstat | Volusol;
  • (EG) Egypt: Butoconazole sabaa | Butoconil | Sedalostate;
  • (FR) France: Gynomyk;
  • (HU) Hungary: Gynazol;
  • (KR) Korea, Republic of: Bucozole;
  • (LU) Luxembourg: Gyno-myk;
  • (LV) Latvia: Gynofort;
  • (MX) Mexico: Femstal | Gynafem;
  • (MY) Malaysia: Gynofort;
  • (NL) Netherlands: Gyno-myk;
  • (PE) Peru: Ginoxinol | Volusol;
  • (PK) Pakistan: Femstat;
  • (PR) Puerto Rico: Femstat | Mycelex-3;
  • (RO) Romania: Gynofort;
  • (RU) Russian Federation: Gynofort
  1. Gynazole-1 (butoconazole) [prescribing information]. Allegan, MI: Padagis; May 2022.
  2. Pappas PG, Kauffman CA, Andes DR, et al. Clinical practice guidelines for the management ofcandidiasis: 2016 update by the Infectious Disease Society of America. Clin Infect Dis.2016;62(4):409-417. doi:10.1093/cid/civ1194 [PubMed 26810419]
  3. 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(4):197-206. doi:10.1080/10647440500240615 [PubMed 16338779]
  4. US Department of Health and Human Services (HHS) Panel on Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/adult-adolescent-oi/guidelines-adult-adolescent-oi.pdf. Accessed May 6, 2020.
  5. Weinstein L, Henzel MR, Tsina IW. Vaginal retention of 2% butoconazole nitrate cream: comparison of a standard and a sustained-release preparation. Clin Ther. 1994;16(6):930-934. [PubMed 7697689]
  6. Workowski KA, Bachmann LH, Chan PA, et al; Centers for Disease Control and Prevention (CDC). Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep. 2021;70(4):1-187. doi:10.15585/mmwr.rr7004a1 [PubMed 34292926]
Topic 9178 Version 143.0

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