Fentizol VT600 mg

Fentizol VT 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.
• Established/approved use: Vaginitis and vulvovaginitis due to organisms sensitive to fenticonazole, including mixed vaginal infections where a susceptible gram-positive bacterial component (e.g. Staphylococcus or Streptococcus species) coexists with candidal infection.

Fentizol VT is intended for intravaginal use only and is not appropriate for oral, systemic, ophthalmic, or non-vaginal cutaneous use.

Each vaginal tablet of Fenticonazole Nitrate [Vaginal Tablet] contains fenticonazole nitrate as the active ingredient, along with pharmaceutically inert excipients (such as binders, lubricants, and disintegrants) that form the tablet base and facilitate dissolution within the vaginal cavity. Strength varies by manufacturer/formulation (commonly available as 200 mg or 600 mg vaginal tablets/pessaries).

Fentizol VT is an imidazole-derivative antifungal agent formulated specifically as a vaginal (intravaginal) tablet, also referred to as a pessary or ovule, intended for local treatment of vulvovaginal candidiasis. This vaginal tablet formulation is distinct from the fenticonazole nitrate vaginal cream formulation of the same active ingredient, and the two are not interchangeable without medical guidance.

Fentizol VT works by disrupting the fungal cell membrane, leading to fungistatic and, at higher local concentrations, fungicidal activity against susceptible Candida species, along with activity against certain gram-positive bacteria that may coexist in mixed vaginal infections.

Fentizol VT belongs to the imidazole antifungal therapeutic class, specifically the subclass of topical/local vaginal antifungal agents used in gynecological practice.

Mechanism of Action

Fenticonazole Nitrate [Vaginal Tablet] acts primarily by inhibiting fungal cytochrome P450-dependent 14-alpha-demethylase, an enzyme required for the conversion of lanosterol to ergosterol. Depletion of ergosterol and accumulation of abnormal sterol precursors disrupts the structural integrity and function of the fungal cell membrane, resulting in growth inhibition (fungistatic effect).

At higher local concentrations achieved with intravaginal administration, Fenticonazole Nitrate [Vaginal Tablet] exerts a direct fungicidal effect through non-specific disruption of fungal cell membrane permeability. It also demonstrates in-vitro activity against certain gram-positive bacteria (e.g. staphylococci and streptococci), which is clinically useful in mixed vaginal infections.

Pharmacokinetics

Following intravaginal administration, systemic absorption of fenticonazole nitrate is minimal, with the drug acting predominantly at the local (vaginal mucosal) site of application. Only trace amounts reach the systemic circulation under normal use.

Fentizol VT should be inserted high into the vagina at bedtime, using the applicator if provided. It is for intravaginal use only and must not be swallowed. The full course should be completed as directed even if symptoms resolve early.

Clinically significant systemic drug interactions with Fentizol VT are not well established, given its minimal systemic absorption following intravaginal use. However, the following local/product-related interaction is clinically relevant:

• Latex barrier contraceptives/devices: Some formulations of Fentizol VT contain oil-based excipients that may weaken latex condoms and diaphragms, reducing their contraceptive and barrier-protection reliability. Alternative (non-barrier or non-latex) contraception is advisable during treatment and for a few days afterward; consult a physician or pharmacist regarding the specific product's excipient base.

No other topical or systemic vaginal medications should be used concurrently without medical advice, to avoid altered local absorption or additive local irritation.

Fentizol VT is generally well tolerated when used as directed. Reported adverse effects are predominantly local and include:

• Local burning sensation, itching, or irritation at the site of application
• Vulvovaginal redness or discomfort
• Mild pelvic or lower abdominal discomfort (uncommon)
• Hypersensitivity reactions such as rash or localized allergic response (rare)

If severe irritation, swelling, or signs of an allergic reaction occur, discontinue use of Fentizol VT and seek medical advice.

Pregnancy: Data on the use of Fentizol VT in pregnancy are limited. As with other imidazole vaginal antifungals, Fentizol VT should be used during pregnancy only if clearly needed and if the potential benefit justifies the potential risk to the fetus; use should be under medical supervision. Manual (finger) insertion rather than use of a mechanical applicator may be advised during pregnancy to reduce the risk of mechanical trauma to the cervix — follow the prescribing physician's specific instructions.

Lactation: Because systemic absorption after intravaginal use is minimal, significant transfer into breast milk is not expected; however, Fentizol VT should still be used during breastfeeding only on the advice of a physician.

• Fentizol VT is for vaginal use only; it must not be taken orally or applied to other body sites.
• Discontinue and consult a physician if local irritation, burning, or a hypersensitivity reaction worsens or persists.
• Complete the full prescribed course of Fentizol VT even if symptoms improve early, to reduce the risk of relapse or incomplete treatment.
• Some formulations of Fentizol VT may contain oil-based excipients that can damage latex condoms and diaphragms; use alternative contraceptive protection during treatment and for several days afterward (see Interactions).
• Avoid sexual intercourse during treatment where possible, or use non-latex barrier protection, to reduce irritation and prevent reduced contraceptive efficacy.
• If symptoms do not improve after completing the course, or if symptoms recur frequently, seek medical review to confirm the diagnosis, as recurrent or persistent symptoms may indicate a different or resistant organism.
• Avoid use during menstruation unless directed otherwise by a physician.

Overdose with Fentizol VT is unlikely given its intravaginal route and minimal systemic absorption. Accidental ingestion or use of an excessive number of tablets is not expected to cause serious systemic toxicity, but may cause local gastrointestinal or mucosal irritation. If accidental oral ingestion occurs or if excessive local irritation develops, seek immediate medical attention or contact a poison control center; do not attempt unsupervised home treatment beyond removing the product and rinsing the affected area with water.

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

Pediatric Population

Fentizol VT is intended for use in sexually mature/reproductive-age women. Safety and efficacy in pediatric and premenarchal populations have not been established, and use in this group is not recommended without specialist gynecological evaluation.

Elderly

Specific dosing studies in elderly women are limited; Fentizol VT may be used in postmenopausal women when vulvovaginal candidiasis is diagnosed, following the standard adult regimen, under medical guidance.

Renal/Hepatic Impairment

Because systemic absorption of Fentizol VT following intravaginal use is minimal, no specific dose adjustment is established for renal or hepatic impairment; however, caution and physician guidance are advised.

Duration of treatment with Fentizol VT depends on the product strength: a single-dose 600 mg regimen requires only one insertion, while a 200 mg regimen is typically continued once daily at night for 3 consecutive nights. The full course should always be completed as prescribed, even if symptoms resolve earlier, to reduce the risk of recurrence.

Fenticonazole Nitrate [Vaginal Tablet] is classified as an imidazole antifungal, within the broader category of azole antifungal agents used for local (vaginal) treatment of candidal and mixed vaginal infections.

Fenticonazole Nitrate [Vaginal Tablet] inhibits fungal ergosterol synthesis by blocking cytochrome P450-dependent 14-alpha-demethylase, disrupting fungal cell membrane integrity (fungistatic effect), and at higher local concentrations directly damages the fungal cell membrane (fungicidal effect). It also has activity against certain susceptible gram-positive bacteria.

Fentizol VT is not intended for use in premenarchal children. Safety and efficacy in the pediatric population have not been established, as vulvovaginal candidiasis requiring this treatment predominantly occurs in sexually mature/reproductive-age individuals. Use in adolescents should only be considered under specialist gynecological supervision.