陰道感染塞劑 CANDIDAL VULVOVAGINITIS.

Antifungal Agent, Imidazole Derivative; Antifungal Agent, Topical; Antifungal Agent, Vaginal.

After vaginal administration of Fenticonazole in humans, the absorption rate can be considered negligible. A pharmacokinetic study conducted on two groups of patients receiving Fenticonazole nitrate 1000 mg via vaginal administration showed that the average absorption rate in patients with vulvovaginal candidiasis was 1.81 ± 0.57% of the dose, while in healthy volunteers with normal vaginal mucosa or patients with cervical cancer, the average absorption rates were 0.58% and 1.12%, respectively.【文字內容由仿單翻譯而來】

Hypersensitivity to FENTICONAZOLE
Pregnancy (Azole 類藥品於鼠類研究中有致畸胎性，但局部、短期治療，利益仍大於好處)
Do not apply to breasts during lactation.
Children and infants.

There is limited data on the use of Fenticonazole in pregnant women.Reproductive toxicity studies via oral administration were conducted in rats and rabbits, including studies on fertility, teratogenicity, perinatal and postnatal toxicity.Pregnant female rats were orally administered Fenticonazole at doses of 0, 10, 40, and 160 mg/kg/day from day 6 to day 15 of pregnancy. In the 160 mg/kg/day dose group, a significant increase in post-implantation loss and a decrease in fetal body weight were observed, along with cleft palates in both litters.Oral administration of Fenticonazole at a dose of 80 mg/kg/day to pregnant rabbits resulted in fetal malformations or skeletal abnormalities/variations. A fetal malformation was also observed in one fetus from both the 40 mg/kg/day dose group and the control group. Due to the types, distribution, and severity of the abnormalities observed in different groups, these malformations could not be attributed to the drug.High-dose Fenticonazole administration during organ development in rats and rabbits resulted in embryotoxicity, which occurred at the maternal toxic dose in rats.Fenticonazole did not exhibit teratogenic effects in either rats or rabbits.Fenticonazole did not affect the neurobehavioral postnatal development of rat pups.Although transdermal absorption is considered negligible, the risks cannot be excluded. Fenticonazole should be used during pregnancy only under the supervision of a physician.【文字內容由仿單翻譯而來】

Animal studies via oral administration indicate that Fenticonazole and/or its metabolites can be excreted in milk. Since the absorption of Fenticonazole after vaginal administration is negligible, it is expected that little to no transfer to breast milk will occur. However, due to the lack of human data on the excretion of Fenticonazole and/or its metabolites into breast milk after this route of administration, the risk to the infant cannot be excluded. Fenticonazole should be used during breastfeeding only under the supervision of a physician.【文字內容由仿單翻譯而來】

When used as directed, the absorption rate of Fenticonazole Nitrate vaginal capsules is very low, and systemic adverse reactions are not expected. Mild, transient burning sensations may occur after use. Long-term use of topical products may cause allergic reactions.【文字內容由仿單翻譯而來】

Insert 1 capsule (200 mg) at bedtime for 3 days or insert 1 capsule (600 mg) at bedtime as a single dose.

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Store below 25°C