butoconazole


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butoconazole

 [bu″to-kon´ah-zōl]
an imidazole derivative used intravaginally in the form of the nitrate salt as a topical antifungal agent in treatment of vulvovaginal candidiasis.

butoconazole

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

Gynazole-1

(trade name)

Classification

Therapeutic: antifungals
Pregnancy Category: C

Indications

Treatment of vulvovaginal candidiasis.

Action

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).

Pharmacokinetics

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)

ROUTEONSETPEAKDURATION
Intravaginalunknown12–24 hrunknown

Contraindications/Precautions

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

Genitourinary

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

Interactions

Drug-Drug interaction

Not known.

Route/Dosage

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)

Implementation

  • 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.

butoconazole

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

butoconazole

an imidazole antifungal used topically, effective particularly against Candida.
References in periodicals archive ?
Various local agents with similar effects are available, including clotrimazole, butoconazole, and miconazole (1).
M2 EQUITYBITES-May 23, 2012-Perrigo Company wins final FDA approval for butoconazole nitrate 2% vaginal cream(C)2012 M2 COMMUNICATIONS http://www.
Healthcare supplier Perrigo Company (Nasdaq:PRGO) (Nasdaq:TASE) reported on Tuesday the receipt of final approval from the US Food and Drug Administration for its abbreviated new drug application (ANDA) for butoconazole nitrate 2% vaginal cream.
Itraconazole, ketoconazole, fluconazole, miconazole, clotrimazole, butoconazole and nystatin are included under anti-fungals for the treatment of vaginal candidiasis.
meanwhile, has received approval of its ANDA for butoconazole nitrate 2% vaginal cream, the generic equivalent of Gynazole.
Healthcare supplier Perrigo Company (Nasdaq:PRGO) (Nasdaq:TASE) said on Friday that the company has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for butoconazole nitrate vaginal cream, 2%, for the local treatment of vulvovaginal candidiasis (infections cause by Candida).
Reportedly, KV Pharmaceutical Company filed a suit on 29 July 2010 in the US District Court for the District of Delaware, alleging patent infringement to prevent Perrigo from proceeding with the commercialisation of butoconazole nitrate.
Users can then go to the "by class" listing, locate "anti-fungals, vaginal," and determine that butoconazole and miconazole are listed without asterisks and clotrimazole and terconazole are listed with them, for reasons unclear to us.
Femstat 3 made the switch to over-the-counter status with butoconazole nitrate 2% as its main ingredient.