GYNAZOLE 1 (butoconazole nitrate)

There are 0 contraindications.

There are 0 severe contraindications.

There are 1 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
No disease contraindications

There are 7 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Abnormal vaginal bleeding Anaphylaxis Angioedema Bronchospastic pulmonary disease Dyspnea Toxic epidermal necrolysis Urticaria

There are 20 less severe adverse reactions.

More Frequent	Less Frequent
None.	Dysmenorrhea Fever Genital organ pruritus Vaginal discharge

Rare/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

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.

No enhanced Geriatric Use information available for this drug.