STENAZOLE-V VAGINA SOFTGEL CAPSULES (Each capsule contains FENTICONAZOLE NITRATE 600mg)

Indications

• Dermatophytosis
• Candidiasis
• Tinea infections
• Superficial fungal infections

Dosage

Children: Refer to the BNF for Children for specific paediatric dosing recommendations.

Adults: Refer to the BNF for specific adult dosing recommendations.

Mechanism of action

Fenticonazole inhibits the enzyme sterol 14-demethylase (ERG11), which is critical for ergosterol synthesis in fungi. By blocking this pathway, fenticonazole disrupts the integrity of the fungal cell membrane. Additionally, it inhibits the secretion and activity of aspartyl proteinases and interferes with the function of bacterial and fungal cytochrome oxidases and peroxidases.

Pharmacodynamics

Fenticonazole exhibits fungicidal properties against a broad spectrum of fungi, including dermatophytes, yeasts, and some molds. Its ability to inhibit ergosterol synthesis leads to increased membrane permeability and ultimately cell death. The drug's action against proteinases further contributes to its antifungal efficacy.

Pharmacokinetics

The pharmacokinetics of fenticonazole involve absorption following topical application, with variable systemic absorption depending on the formulation and site of application. The drug is metabolized in the liver, and its metabolites are excreted primarily via urine and feces. The half-life of fenticonazole may vary based on the route of administration.

Pregnancy

Fenticonazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

It is not known whether fenticonazole is excreted in human milk. Caution should be exercised when administering to nursing women.

Storage

Store at room temperature, away from light and moisture. Keep out of reach of children.

Indications

• Vaginal candidiasis
• Vulval candidiasis

Dosage

Children: For children, the recommended dosage is 1 pessary to be inserted at night for vaginal and vulval candidiasis, with a repeat dose if necessary. Further dosage details should be referred to in the BNF for Children.

Adults: For vaginal use, a single dose of 600 mg may be administered at night. Alternatively, treatment may involve 200 mg daily for a course of 3 days.

Mechanism of action

Fenticonazole nitrate exerts its antifungal effects by inhibiting the enzyme lanosterol 14-alpha demethylase, which is crucial for the conversion of lanosterol to ergosterol. This results in impaired membrane synthesis and function, leading to cell death in susceptible fungi.

Pharmacodynamics

Fenticonazole demonstrates a broad spectrum of antifungal activity, particularly against Candida species. Its mechanism disrupts fungal cell membrane integrity, affecting membrane permeability and ultimately resulting in cell lysis. The drug is also known for its anti-inflammatory properties, which can aid in reducing symptoms associated with vulvovaginal infections.

Pharmacokinetics

Fenticonazole is administered topically, and its systemic absorption is minimal when used in recommended doses. The pharmacokinetics of fenticonazole have not been extensively studied; however, it is expected to have localized effects with limited systemic distribution. The onset of action is typically rapid, providing relief from symptoms soon after application.

Adverse effects

• Paraesthesia
• Vaginal burning
• Skin reactions
• Angioedema

Interactions

• Intravaginal preparations may damage latex condoms and diaphragms

Precautions

• Avoid intravaginal preparations in young girls who are not sexually active, unless there is no alternative

Pregnancy

Oral antifungal treatment should be avoided during pregnancy. Pregnant women may require a longer duration of treatment, usually about 7 days, to clear the infection.

Storage

Store in a cool, dry place away from direct sunlight.

Formulations

• Vaginal cream
• Vaginal pessaries

Mechanism of action

Fenticonazole is an imidazole antifungal reported to inhibit the ERG11 product (sterol 14-demethylase), disrupting ergosterol synthesis. It also inhibits the secretion and activity of aspartyl proteinases, and blocks bacterial and fungal cytochrome oxidases and peroxidases.