Hypersensitivity to active ingredients, additives, or preservatives;
OB: Single dose, topical azole regimens are not recommended for vulvovaginal candidiasis during pregnancy; only 7–day topical azole regimens are recommended.
Use Cautiously in:
Lactation: Safety not established in breastfeeding;
Pedi: Safety and effectiveness not established in children.
Vag (Adults ): One applicatorful as a single dose.
US Brand Names⬆⬇
Gynazole-1
Action⬆⬇
Affects the permeability of the fungal cell wall, allowing leakage of cellular contents.
Therapeutic effects:
Inhibited growth and death of susceptible Candida, with decrease in accompanying symptoms of vulvovaginitis (vaginal burning, itching, discharge).
Classifications⬆⬇
Therapeutic Classification: antifungals (vaginal)
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
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.
Inform patient that therapeutic response is usually seen after 1 wk.
Instruct patient on proper use of vaginal applicator. Medication should be inserted high into the vagina at bedtime. Instruct patient to remain recumbent for ≥30 min after insertion. Advise use of sanitary napkins to prevent staining of clothing or bedding. Dispose of applicator after each use.
Advise patient to report to health care professional ↑ skin irritation or lack of response to therapy. A 2nd course may be necessary if symptoms persist.
Advise women of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Vaginal medication may cause minor skin irritation in sexual partner. Advise patient to refrain from sexual contact during therapy. Medication contains mineral oil which can weaken latex or rubber products including condoms or vaginal contraceptive diaphragms; avoid use of such products for 72 hr. Another method of contraception should be used during treatment.
