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an imidazole derivative used intravaginally in the form of the nitrate salt as a topical antifungal agent in treatment of vulvovaginal candidiasis.


(byoo-toe-kon-a-zole) ,


(trade name)


Therapeutic: antifungals
Pregnancy Category: C


Treatment of vulvovaginal candidiasis.


Affects the permeability of the fungal cell wall, allowing leakage of cellular contents. Not active against bacteria.

Therapeutic effects

Inhibited growth and death of susceptible Candida, with decrease in accompanying symptoms of vulvovaginitis (vaginal burning, itching, discharge).


Absorption: 2% is systemically absorbed following intravaginal administration.
Distribution: Unknown. Action is primarily local.
Metabolism and Excretion: Negligible with local application.
Half-life: Not applicable.

Time/action profile (plasma concentrations)

Intravaginalunknown12–24 hrunknown


Contraindicated in: Hypersensitivity to active ingredients, additives, or preservatives.
Use Cautiously in: Obstetric / Lactation: Safety not established, limit use to 2nd and 3rd trimesters.

Adverse Reactions/Side Effects


  • itching
  • pelvic pain
  • soreness
  • swelling
  • vulvovaginal burning


Drug-Drug interaction

Not known.


Vaginal (Adults and Children ≥12 yr) 1 applicatorful single dose.

Availability (generic available)

Vaginal cream: 2% (5–g prefilled applicator)

Nursing implications

Nursing assessment

  • Inspect involved areas of skin and mucous membranes before and frequently during therapy. Increased skin irritation may indicate sensitization and warrant discontinuation of medication.

Potential Nursing Diagnoses

Risk for infection (Indications)
Risk for impaired skin integrity (Indications)


  • Consult health care professional for proper cleansing technique before applying medication.
  • Diagnosis should be reconfirmed with smears or cultures before a second course of therapy to rule out other pathogens associated with vulvovaginitis. Recurrent vaginal infections may be a sign of systemic illness.
  • Vaginal: Applicators are supplied for vaginal administration.

Patient/Family Teaching

  • Instruct patient to apply medication as directed for full course of therapy, even if feeling better. Therapy should be continued during menstrual period.
    • Advise patient to avoid using tampons while using this product.
    • Instruct patient on proper use of vaginal applicator. Medication should be inserted high into the vagina at bedtime. Instruct patient to remain recumbent for at least 30 min after insertion. Advise use of sanitary napkins to prevent staining of clothing or bedding.
    • Advise patient to consult health care professional regarding intercourse during therapy. Vaginal medication may cause minor skin irritation in sexual partner. Advise patient to refrain from sexual contact during therapy. Advise patient that this medication may weaken latex or rubber contraceptive products. Another method of contraception should be used during treatment.
    • Advise patient to report to health care professional increased skin irritation or lack of response to therapy. A second course may be necessary if symptoms persist.
    • Advise patient to dispose of applicator after each use.
  • Inform patient that therapeutic response is usually seen after 1 wk.

Evaluation/Desired Outcomes

  • Resolution of infection.
  • Decrease in skin irritation and vaginal discomfort.


/bu·to·con·a·zole/ (bu″to-kon´ah-zōl) an imidazoleantifungal used as the nitrate salt in the treatment of vulvovaginal candidiasis.


an imidazole antifungal used topically, effective particularly against Candida.
References in periodicals archive ?
In a separate asset purchase transaction, a subsidiary of Perrigo Company plc (NYSE: PRGO; TASE) will acquire the assets of Lumara Health's Women's Healthcare business including Clindesse (clindamycin phosphate) Vaginal Cream, 2%, Gynazole-1 (Butoconazole Nitrate Vaginal Cream USP, 2%), and Evamist (estradiol transdermal spray) for $82 million.
Clindesse and Gynazole-1 are well-established treatment options with high patient satisfaction, so it's great to be able to prescribe them for my patients again.
Important Safety Information for Gynazole-1 (Butoconazole Nitrate Vaginal Cream USP, 2%)
24, 2013 /PRNewswire/ -- Ther-Rx Corporation, a women's health-focused pharmaceutical company and subsidiary of K-V Pharmaceutical Company (OTCQB Marketplace: KVPHA/KVPHB), and Perrigo Company (Nasdaq: PRGO; TASE) announced today that Gynazole-1 (Butoconazole Nitrate Vaginal Cream USP, 2%), indicated for the local treatment of yeast infections (vulvovaginal candidiasis infections caused by Candida) in non-pregnant women[sup.
We are pleased to be able to once again offer Gynazole-1 to prescribing healthcare providers and to patients in need of therapy," said Greg Divis, President of Ther-Rx and CEO of K-V Pharmaceutical Company.
Under the proposed reorganization plan, K-V expects to emerge from Chapter 11 with its entire product portfolio, including Makena, Clindesse, Gynazole-1 and Evamist.
5) the possibility of further delay or inability to obtain FDA approvals to relaunch Clindesse and Gynazole-1 and the possibility that any other product relaunch may be delayed or unsuccessful;
Food and Drug Administration for its abbreviated new drug application (ANDA) for butoconazole nitrate 2% vaginal cream, the generic equivalent of Gynazole-1.
3) the possibility of delay or inability to obtain FDA approvals of Clindesse and Gynazole-1 and the possibility that any product relaunch may be delayed or unsuccessful;
Food & Drug Administration (FDA) to obtain approval to resume shipping of key women's healthcare branded products, including Clindesse and Gynazole-1, and is also preparing for the potential approval of Gestiva(TM) later this fiscal year.
One of the products, Gynazole-1, was also distributed internationally to Eastern Europe, South America, Asia, and Canada.