This cream contains mineral oil. Mineral oil may weaken
latex or rubber products such as condoms or vaginal contraceptive diaphragms;
therefore, use of such products within 72 hours following treatment with
GYNAZOLE•1® Butoconazole Nitrate Vaginal Cream USP, 2% is not recommended.
Recurrent vaginal yeast infections, especially those that
are difficult to eradicate, can be an early sign of infection with the human
immunodeficiency virus (HIV) in women who are considered at risk for HIV
If clinical symptoms persist, tests should be repeated to
rule out other pathogens, to confirm the original diagnosis, and to rule out
other conditions that may predispose a patient to recurrent vaginal fungal
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Long term studies in animals have not been performed to
evaluate the carcinogenic potential of this drug.
Butoconazole nitrate was not mutagenic when tested in the
Ames bacterial test, yeast, chromosomal aberration assay in CHO cells,
CHO/HGPRT point mutation assay, mouse micronucleus, and rat dominant lethal
Impairment Of Fertility
No impairment of fertility was seen in rabbits or rats
administered butoconazole nitrate in oral doses up to 30 mg/kg/day (5 times the
human dose based on mg/m²) or 100 mg/kg/day (10 times the human dose based on
Pregnancy Category C - In pregnant rats administered
6 mg/kg/day of butoconazole nitrate intravaginally during the period of
organogenesis, there was an increase in resorption rate and decrease in litter
size; however, no teratogenicity was noted. This dose represents a 130- to
353-fold margin of safety based on serum levels achieved in rats following intravaginai
administration compared to the serum levels achieved in humans following
intravaginai administration of the recommended therapeutic dose of butoconazole
Butoconazole nitrate has no apparent adverse effect when administered
orally to pregnant rats throughout organogenesis at dose levels up to 50 mg/kg/day
(5 times the human dose based on mg/m²). Daily oral doses of 100,300 or 750 mg/kg/day
(10,30 or 75 times the human dose based on mg/m² respectively) resulted in
fetal malformations (abdominal wall defects, cleft palate), but maternal stress
was also evident at these higher dose levels. There were, however, no adverse effects
on litters of rabbits who received butoconazole nitrate orally, even at
maternally stressful dose levels (e.g., 150 mg/kg, 24 times the human dose
based on mg/m²).
Butoconazole nitrate, like other azole antifungal agents,
causes dystocia in rats when treatment is extended through parturition. However,
this effect was not apparent in rabbits treated with as much as 100 mg/kg/day
orally (16 times the human dose based on mg/m²).
There are, however, no adequate and well-controlled
studies in pregnant women. GYNAZOLE • 1 ® Butoconazole Nitrate Vaginal Cream
USP, 2% should be used during pregnancy only if the potential benefit justifies
the potential risk to the fetus.
It is not known whether this drug is excreted in human
milk Because many drugs are excreted in human milk, caution should be exercised
when butoconazole nitrate is administered to a nursing woman.
Safety and effectiveness in children have not been