Indications

Fenticonazole vaginal cream is used for the treatment of vulvovaginal candidiasis. Fenticonazole vaginal tablet is indicated for: Vulvovaginal candidiasis Trichomoniasis Mixed Vaginal infections caused by Candida Albicans & Trichomonas vaginalis

Composition

Pharmacology

Fenticonazole is a broad-spectrum antimycotic agent with activity against dermatophytes and yeasts. Fenticonazole has also been shown to exhibit antibacterial action, with a spectrum of activity that includes bacteria commonly associated with vaginal infections and antiparasitic action against the protozoan Trichomonas vaginalis. Therefore, Fenticonazole may be an ideal topical alternative to multi-agent treatment of mixed infections involving mycotic, bacterial, dermatophyte and/or Trichomonas spp.

Dosage & Administration

Fenticonazole vaginal cream : Route of application is intravaginal. For adults, one applicator full (about 5 gm) is to be administered into the vagina in the morning and evening for three days. After each application, clean it carefully with warm water and soap. Do not use water which is hotter than 50°C or solvents. Then wipe the applicator and store in its packet. Always wash your hands with mild soap and warm water afterwards. Fenticonazole is not greasy and can easily be removed with water. Fenticonazole vaginal tablet : Trichomonas or mixed (Trichomonas and Candida albicans) vaginal infections: One 600 mg VT (followed by a second administration 24 hours later, if necessary). Candida albicans infections: One single 600 mg VT administration in the evening. Should the symptoms persist, a second administration may be repeated after three days. The tablet must be introduced deep into the vagina and pushed well up to the fornix. To avoid re-infection, it is recommended that the partner undergoes concurrent treatment with Fenticonazole Cream or similar Azole Cream.

Contraindications

Hypersensitivity to Fenticonazole or any component of the formulation.

Side Effects

After intravaginal administration slight transient burning (which usually disappears rapidly) may occasionally happen. Prolonged topical application may cause sensitisation reactions. Fenticonazole is generally well tolerated by the mucous membranes; only exceptionally mild and transient erythematous reactions have been reported. After topical application or intravaginal administration, a slight burning sensation may occur, usually subsiding soon. Should more persistent irritation occur or resistant micro-organism develop, suspend the treatment and seek the doctor's advice. Due to poor absorption of Fenticonazole, no systemic effects should occur, provided the above instructions are carefully observed.

Pregnancy & Lactation

Since there is no data of use during pregnancy or lactation, So Fenticonazole should not be used without physician's advice.

Precautions & Warnings

It should not be used in conjunction with barrier contraceptives. In the event of a hypersensitivity reaction or development of resistant organisms, treatment should be discontinued and take physician consultation.

Therapeutic Class

Topical Antifungal preparations

Storage Conditions

Protect from light & moisture. Keep below 30° C temperature, protected from light & moisture. Do not freeze. Keep out of the reach of children.