Dosing and uses of Femstat 3, Gynazole 1 (butoconazole)
Adult dosage forms and strengths
vaginal cream
- 2%
Candidiasis
Gynazole: 1 applicatorful of cream (approximately 5 g of the cream) intravaginally as single dose
Mycelex 3: 1 applicator full of cream into the vagina qHS for 3 consecutive days; may need to extend treatment for up to 6 days in pregnant women (2nd or 3rd trimester only)
Pediatric dosage forms and strengths
Safety & efficacy not established
Femstat 3, Gynazole 1 (butoconazole) adverse (side) effects
Frequency not defined
Pelvic/abd pain
Vulvar/vaginal irritation
Warnings
Contraindications
Hypersensitivity to drug
1st trimester of pregnancy
Cautions
Hypersensitivity to other azoles
Pregnancy and lactation
Pregnancy category: C
Lactation: not known if excreted in breast milk; use caution
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 Femstat 3, Gynazole 1 (butoconazole)
Peak Plasma Time: 12-24 hr
Absorption: systemic (1.7%)
Mechanism of action
Imidazole; alters fungal cell membrane permeability