Dosing and uses of Vagistat 1 (tioconazole)
Adult dosage forms and strengths
vaginal ointment
- 6.5%
Vaginal Candidiasis
Prefilled vaginal applicator (5 g of 6.5% ointment) applied intravaginally qHs
Pediatric dosage forms and strengths
Safety & efficacy not established
Vagistat 1 (tioconazole) adverse (side) effects
1-10%
Vulvovaginal burning, vaginitis, pruritus (5-6%)
Headache (5%)
Infection (3%)
Abdominal pain (2%)
Dysuria, nocturia, pharyngitis, and rhinitis (<2%)
Warnings
Contraindications
Hypersensitivity
Self Tx not recommended for pregnant pts, diabetic pts or pts <12 yo
Pregnancy and lactation
Pregnancy category: C
Lactation: not known whether distributed into milk, manufacturer recommends women discontinue breastfeeding while receiving drug
Pregnancy categories
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.
Pharmacology of Vagistat 1 (tioconazole)
Peak Plasma: 18 ng/mL in 2-24 hr
Metabolism: glucuronidation of the imidazole ring
Excretion
Urine as metabolites: 25-27%
Feces as unchanged drug: 59%
Mechanism of action
Antifungal ointment inhibits P450 system which reduces synthesis of fungal ergosteroL
