Gynazole 1 (butoconazole nitrate)

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Butoconazole nitrate is administered intravaginally as a 2% cream. Butoconazole nitrate vaginal cream is for intravaginal administration only and should not be administered orally; contact with the eyes should be avoided.

Butoconazole nitrate vaginal cream should be used for self-medication of recurrent vulvovaginal candidiasis only in otherwise healthy, nonpregnant women previously diagnosed by a clinician.

Patients should be instructed how to use the vaginal applicator and should be given a copy of the instructions provided by the manufacturer.

Butoconazole nitrate vaginal cream contains a mineral oil base that may weaken rubber or latex products, including condoms or vaginal contraceptive diaphragms, and use of such products within 72 hours following treatment with intravaginal butoconazole is not recommended.

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There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

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There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• No disease contraindications

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Rare or Very Rare

• Abnormal vaginal bleeding
• Anaphylaxis
• Angioedema
• Bronchospastic pulmonary disease
• Dyspnea
• Toxic epidermal necrolysis
• Urticaria

Less Frequent

• Dysmenorrhea
• Fever
• Genital organ pruritus
• Vaginal discharge

Rare or Very Rare

• Acute abdominal pain
• Chills
• Contact dermatitis
• Cystitis
• Dizziness
• Facial edema
• Flu-like symptoms
• General weakness
• Headache disorder
• Nausea
• Pruritus of skin
• Skin rash
• Vaginal burning
• Vaginal irritation
• Vaginitis
• Vulvovaginal pain

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Reproduction studies in pregnant rats receiving 6 mg/kg of butoconazole nitrate intravaginally daily (3-7 times the usual human intravaginal dose) during the period of fetal organogenesis have shown an increased fetal resorption rate and decreased litter size, but evidence of teratogenicity was not observed. Adverse reproductive effects have not been reported following oral administration of butoconazole nitrate to pregnant rats at dosages up to 50 mg/kg daily (5 times the usual human dosage based on mg/m2) throughout organogenesis. Orally administered dosages of 100, 300, or 750 mg/kg daily (10, 30, or 75 times, respectively, the usual human dosage) in pregnant rats have resulted in fetal malformations (e.g., abdominal wall defects, cleft palate), but maternal stress was evident at these higher dosages and may have been a contributing factor. Teratogenic effects were not observed in rabbits receiving oral butoconazole nitrate doses associated with maternal stress (i.e., 150 mg/kg; 24 times the usual human dosage based on mg/m2). Like other imidazole antifungal agents, butoconazole has been associated with dystocia in rats when therapy with the drug was extended through parturition; however, this effect has not been observed in rabbits.

There are no adequate and controlled studies to date with butoconazole nitrate in pregnant women during the first trimester. The manufacturer states that intravaginal butoconazole should be used during pregnancy only if the potential benefits justifies the possible risks to the fetus. The CDC and others state that a 7-day regimen of an intravaginal azole antifungal can be used, if necessary, for the treatment of vulvovaginal candidiasis in pregnant women.

Since it is not known whether butoconazole is distributed into milk, the drug should be used with caution in nursing women.

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