Fenticona30 gm

Fenticona is indicated for the local treatment of the following conditions:

Established/Approved Use

• Vulvovaginal candidiasis (vaginal thrush) caused by Candida albicans and other Candida species.
• Mixed vaginal infections in which susceptible Gram-positive bacteria (e.g. Staphylococcus, Streptococcus species) are present alongside a fungal infection, as fenticonazole also has activity against certain Gram-positive organisms.

Adjunct/Other Use

• May be used as part of the local management of vulvovaginal irritation associated with candidal infection, alongside partner treatment or oral antifungal therapy when advised by a physician.

Fenticona is intended for intravaginal use only and is not effective against systemic fungal infections.

Each applicator dose of Fenticonazole Nitrate [Vaginal Cream] delivers Fenticonazole Nitrate 2% w/w in a smooth vaginal cream base intended for intravaginal application.

Fenticona is a topical antifungal preparation formulated for intravaginal use. It contains fenticonazole nitrate, an imidazole-derivative antifungal agent with additional activity against certain Gram-positive bacteria and some antiprotozoal activity against Trichomonas vaginalis.

Fenticona works locally within the vaginal mucosa and has minimal systemic absorption when used as directed, making it a preferred first-line local option for uncomplicated vulvovaginal candidiasis.

Vaginal antifungal agent (Imidazole derivative) — Fenticona

Fenticonazole Nitrate [Vaginal Cream] contains fenticonazole nitrate, an imidazole antifungal that acts by inhibiting the fungal cytochrome P450-dependent enzyme 14-alpha-demethylase, which is required to convert lanosterol to ergosterol. This blocks ergosterol synthesis, an essential component of the fungal cell membrane, leading to increased membrane permeability, leakage of cellular contents, and fungal cell death (fungicidal at higher local concentrations, fungistatic at lower concentrations).

In addition to its antifungal action, fenticonazole exhibits antibacterial activity against several Gram-positive organisms and inhibitory activity against Trichomonas vaginalis, making Fenticonazole Nitrate [Vaginal Cream] useful in mixed vaginal infections.

Following intravaginal application, systemic absorption of fenticonazole is minimal, which limits the potential for systemic side effects or drug interactions.

Fenticona is for intravaginal use only.

• Wash and dry hands before use.
• Fill the supplied applicator with the cream as directed in the pack insert.
• Lie on your back with knees bent, and gently insert the applicator deep into the vagina, then depress the plunger to release the cream.
• Use preferably at bedtime to allow maximum contact time.
• Wash the applicator after use unless a disposable applicator is provided.
• Avoid contact of the cream with the eyes. If accidental eye contact occurs, rinse thoroughly with water.
• Complete the full course even if symptoms improve earlier, unless a physician advises otherwise.

Because systemic absorption of Fenticona after intravaginal use is minimal, clinically significant systemic drug interactions are unlikely.

• Latex barrier contraceptives: the cream base of Fenticona is oil-based and may weaken latex condoms and diaphragms, reducing their contraceptive and barrier effectiveness. Alternative (non-latex) contraception is advised during treatment and for a few days afterward.
• Other intravaginal products: concurrent use of other vaginal preparations (e.g. spermicides, douches) is not recommended during treatment as it may reduce efficacy.

Fenticona is generally well tolerated when used as directed. Reported side effects include:

Common

• Local burning or stinging sensation at the site of application
• Vaginal or vulvar itching, irritation, or redness

Uncommon

• Vulvovaginal discomfort or a sensation of heat
• Mild pelvic discomfort

Rare

• Allergic/hypersensitivity skin reactions (see Contraindications)

If severe irritation, rash, or signs of an allergic reaction occur, discontinue use and consult a physician.

Fenticona should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus; a physician should be consulted before use, particularly in the first trimester. Systemic absorption after vaginal application is minimal, but formal safety data in pregnancy are limited.

There is limited information on the excretion of fenticonazole into breast milk. Due to minimal systemic absorption, risk to a breastfeeding infant is expected to be low, but a physician should be consulted before use of Fenticona while breastfeeding.

Fenticona is intended for intravaginal use only and must not be taken orally or applied systemically.

• Discontinue use and consult a physician if symptoms of hypersensitivity (rash, severe itching, swelling) occur (see Contraindications).
• The oil-based cream may weaken latex condoms and diaphragms; use alternative contraceptive precautions during treatment (see Interactions).
• If symptoms do not improve within 7 days of completing treatment, or if they recur frequently, consult a physician to rule out resistant infection, mixed infection, or an alternative diagnosis.
• Avoid sexual intercourse during treatment where possible, or inform your partner of the barrier-contraceptive caution above.
• Not intended for use in children who have not reached menarche.

Overdose with Fenticona via the intended vaginal route is unlikely to cause systemic toxicity given its minimal absorption. If the cream is accidentally ingested, or if excessive local irritation occurs, seek immediate medical attention or contact a poison control center. Do not attempt unsupervised home treatment for suspected ingestion or overdose.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Renal/Hepatic impairment: No dose adjustment is established or generally required for Fenticona due to its minimal systemic absorption after vaginal use; however, caution and physician consultation are advised in significant hepatic or renal impairment.

Elderly: No specific dose adjustment is required.

Pediatric: Safety and efficacy have not been established in pre-menarchal children (see Pediatric Uses).

Pregnancy/Lactation: See Pregnancy and Lactation section.

The standard course of Fenticona is 7 consecutive days of once-daily application. The full course should be completed even if symptoms resolve earlier, unless a physician directs otherwise. If symptoms persist after completing the course, medical review is recommended.

Imidazole antifungal, vaginal/topical route — Fenticonazole Nitrate [Vaginal Cream]

Fenticonazole Nitrate [Vaginal Cream] exerts its antifungal effect by inhibiting fungal 14-alpha-demethylase, a cytochrome P450-dependent enzyme necessary for converting lanosterol to ergosterol. Depletion of ergosterol and accumulation of toxic sterol intermediates disrupt the fungal cell membrane, increasing permeability and causing leakage of intracellular contents, which is fungistatic or fungicidal depending on concentration. It also has activity against certain Gram-positive bacteria and against Trichomonas vaginalis.

The safety and efficacy of Fenticona have not been established in pediatric patients, particularly pre-menarchal (pre-pubertal) girls, and it is not recommended for use in this population. Vulvovaginal symptoms in children should be evaluated by a physician for an appropriate diagnosis and treatment plan before considering any vaginal antifungal product.