butoconazole

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/Excretion: Negligible with local application.

Half-Life: Not applicable.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
Intravaginal	unknown	12–24 hr	unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity to active ingredients, additives, or preservatives.

Use Cautiously in:

OB: Safety not established, limit use to 2nd and 3rd trimesters.

Adv. Reactions/Side Effects ⬆ ⬇

GU: itching, pelvic pain, soreness, swelling, vulvovaginal burning

Interactions ⬆ ⬇

Drug-drug:

Not known.

Route/Dosage ⬆ ⬇

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

Availability ⬆ ⬇

(Generic available)

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

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.

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.
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.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

45802- Perrigo New York Inc
- 45802-396- gynazole 1
  - 45802-396-01- 1 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-01) > 5.8 g in 1 TUBE, WITH APPLICATOR

45802- Perrigo New York Inc
- 45802-396- gynazole 1
  - 45802-396-02- 1 TUBE, WITH APPLICATOR in 1 CARTON (45802-396-02) > 5.8 g in 1 TUBE, WITH APPLICATOR

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇