Butoconazole Nitrate

Pronunciation: BYOO-toe-KOE-nuh-zole NYE-trate
Class: Vaginal antifungal agent

Trade Names

Femstat 3
- Vaginal cream 2%

Mycelex-3
- Vaginal cream 2%

Pharmacology

Increases cell membrane permeability in susceptible fungi.

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Indications and Usage

Local treatment of vulvovaginal candidiasis (moniliasis).

Contraindications

Hypersensitivity to imidazoles.

Dosage and Administration

Nonpregnant Women

Intravaginal 1 applicator (about 5 g) at bedtime for 3 days; may continue up to 6 days if needed.

Pregnant Women

Intravaginal Use only during second or third trimester, 1 applicator (about 5 g) at bedtime for 6 days.

Storage/Stability

Store at room temperature. Avoid heat above 40°C (104°F). Do not freeze.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Genitourinary

Vulvar/vaginal burning; urinary frequency.

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Intractable candidiasis

May be symptom of unrecognized diabetes or reinfection; evaluate patient carefully.

Irritation or sensitization

If this occurs, discontinue use.

Patient Information

  • Teach patient correct application technique.
  • Instruct patient to use sanitary napkin to prevent staining clothing.
  • Caution patient to refrain from sexual intercourse or advise partner to use condom to prevent reinfection.
  • Explain importance of informing sexual partner of possible infection and of seeking appropriate medical treatment.
  • Caution patient against using tampons during treatment.
  • Tell patient to notify health care provider if any of the following symptoms occur after initiation of therapy: headache; body aches; local irritation, burning or rash; vaginal swelling or discharge; sensitivity to light.

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