Fenticona

Approved Indications:

• Vulvovaginal candidiasis: Treatment of acute or recurrent vulvovaginal infections caused by Candida albicans and other Candida species.
• Cutaneous candidiasis: Fungal skin infections including intertrigo and diaper dermatitis due to Candida spp.
• Tinea infections (dermatophytosis): Including tinea corporis (body), tinea cruris (groin), and tinea pedis (foot) caused by Trichophyton, Microsporum, and Epidermophyton species.
• Pityriasis versicolor: Caused by Malassezia furfur.

Important Off-label (Clinically Accepted) Uses:

• Mixed vaginal infections: When caused by Candida spp. in combination with Gardnerella vaginalis or Trichomonas vaginalis (used with caution and clinical judgment).
• Vaginal prophylaxis post-antibiotic therapy: To reduce risk of candidal overgrowth.

A. Vaginal Formulations (Capsules/Suppositories):

• Adult Women:
• 600 mg vaginal capsule: Insert one capsule once at bedtime as a single dose, or
• 200 mg vaginal capsule: Insert one capsule daily at bedtime for 3 consecutive days.
• Recurrent or persistent infections: A second course may be repeated after 7 days.

B. Vaginal Cream:

• 2% cream: Apply intravaginally once daily at bedtime for 3 consecutive nights.
• External application: Apply thin layer to vulvar area once or twice daily.

C. Cutaneous (Topical) Use:

• Apply 1–2 times daily to affected skin after cleaning and drying the area.
• Duration:
• Candidiasis and dermatophytosis: Usually 2–4 weeks.
• Pityriasis versicolor: Usually 1–2 weeks.

Pediatrics:

• Not routinely recommended; limited safety and efficacy data available.

Elderly:

• No dose adjustment required; use standard adult dose.

Special Populations:

• Renal impairment: No dose adjustment necessary (topical use).
• Hepatic impairment: No dose adjustment necessary (topical/vaginal use).

Administration Tips:

• For vaginal use: Administer at bedtime to ensure prolonged contact.
• Avoid sexual intercourse during treatment course.
• Do not use tampons during therapy.

Fenticonazole nitrate is an imidazole antifungal agent that inhibits the synthesis of ergosterol, a key component of fungal cell membranes. By blocking the enzyme lanosterol 14α-demethylase, fenticonazole disrupts membrane integrity, leading to increased permeability, leakage of intracellular contents, and ultimately cell death. Additionally, fenticonazole exhibits antibacterial activity against Gram-positive cocci and antiparasitic activity against Trichomonas vaginalis, enhancing its efficacy in mixed infections.

• Absorption: Vaginal absorption is limited but sufficient for local action; systemic absorption is minimal after topical or vaginal use.
• Distribution: Primarily remains localized at the site of application; not significantly distributed systemically.
• Metabolism: Hepatic metabolism occurs after systemic absorption, but systemic exposure is negligible.
• Elimination: Excreted via urine and feces in trace amounts.
• Half-life: Not clearly defined due to minimal systemic absorption.
• Bioavailability: Very low systemic bioavailability when administered via vaginal or topical routes.

• Pregnancy:
  Not assigned a formal FDA pregnancy category. Use is not recommended in the first trimester due to limited safety data. If needed during later trimesters, should only be used under medical supervision when potential benefit outweighs risk.
• Lactation:
  Unknown whether fenticonazole is excreted into breast milk. Due to low systemic absorption, the risk to the nursing infant is likely low, but caution is advised, especially if applied near the breast.
• Recommendation:
  Avoid vaginal use during early pregnancy. Topical use may be considered during lactation with caution and appropriate hygiene.

• Primary Class: Antifungal (Topical and Vaginal)
• Subclass: Imidazole antifungal derivative

• Known hypersensitivity to fenticonazole or any imidazole derivatives.
• Known allergy to any component of the formulation.
• Use during first trimester of pregnancy (unless clearly indicated).
• Concurrent use with latex contraceptive devices (may weaken rubber barrier).

• Pregnancy: Avoid during first trimester unless absolutely necessary.
• Vaginal irritation: Discontinue if burning, itching, or worsening symptoms occur.
• Allergic reactions: Monitor for hypersensitivity reactions including rash, swelling, or severe itching.
• Avoid intercourse during treatment: As it may reduce effectiveness and irritate mucosa.
• Interaction with contraceptive devices: Cream or suppository base may weaken latex condoms or diaphragms.
• Pediatric safety: Not established in children below 12 years of age.

Common (Localized):

• Vaginal burning or itching
• Local irritation or discomfort
• Erythema
• Vulvovaginal dryness

Less Common:

• Headache
• Pelvic pain
• Dysuria (painful urination)
• Abdominal cramps

Rare but Serious:

• Hypersensitivity reaction
• Vulvar edema
• Contact dermatitis

Onset & Severity:

• Most side effects are mild, local, and transient.
• Usually occur within the first few applications.

• Latex contraceptives: Topical or vaginal use may degrade latex, reducing contraceptive efficacy. Use alternative birth control methods during therapy and for at least 5 days after last dose.
• Other vaginal products: Avoid simultaneous use with spermicides, douches, or other intravaginal agents.
• Systemic medications: No clinically significant systemic drug-drug interactions due to negligible absorption.
• CYP450 involvement: Minimal systemic metabolism; CYP enzyme interactions are not relevant.

• Updated Clinical Use Guidance (within last 2 years):
• Emphasis on avoiding use during first trimester of pregnancy unless benefit clearly outweighs risk.
• WHO/European recommendations stress appropriate use only after confirmed fungal diagnosis to avoid resistance.
• Patient Counseling: Reinforced advice to avoid intercourse, tampon use, and latex contraceptives during therapy.
• No changes in approved dosing or formulation in recent regulatory updates.

• Vaginal Capsules/Cream:
• Store at 25°C (77°F); excursions permitted to 15°C–30°C (59°F–86°F).
• Protect from light and moisture.
• Do not freeze.
• Keep tightly closed.
• Shelf life: Refer to product packaging (typically 2–3 years if unopened).
• Handling precautions: Wash hands before and after application. Avoid eye contact.