Brand and Other Names:Vagistat 1
- Classes: Antifungals, Vaginal
Dosing & Uses
Dosage Forms & Strengths
Prefilled vaginal applicator (5 g of 6.5% ointment) applied intravaginally qHS
Safety & efficacy not established
Vulvovaginal burning, vaginitis, pruritus (5-6%)
Abdominal pain (2%)
Dysuria, nocturia, pharyngitis, and rhinitis (<2%)
Self Tx not recommended for pregnant pts, diabetic pts or pts <12 yo
Pregnancy & Lactation
Pregnancy Category: C
Lactation: not known whether distributed into milk, manufacturer recommends women discontinue breastfeeding while receiving drug
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Peak Plasma: 18 ng/mL in 2-24 hr
Metabolism: glucuronidation of the imidazole ring
Urine as metabolites: 25-27%
Feces as unchanged drug: 59%
Mechanism of Action
Antifungal ointment inhibits P450 system which reduces synthesis of fungal ergosterol