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Generic Name

Fenticonazole Nitrate
Therapeutic Class: Topical Antifungal preparations

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

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
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.

Administration
Follow the instructions to use Fenticonazole cream-

• Screw the applicator onto the tube in place of the cap.
• Squeeze the tube gently at its lower end, so as to fill the applicator at 5 gm mark. Unless prescribed by the physician, the applicator must be completely filled up to 5 gm.
• After taking measured amount cream, remove the applicator from the tube, which should be closed immediately with the cap.
• In a lying down position, with knees raised and spread apart, delicately insert the applicator into the vagina as deeply as possible. Push the piston to penetrate cream completely, then pull out the applicator without touching the piston.

Follow the instructions to use Fenticonazole vaginal tablet:

• Pull out plunger until it stops. Place a vaginal tablet into the applicator.
• Insert applicator containing the tablet carefully as deeply as possible into the vagina (best lying on your back).
• Push plunger until it stops, there by depositing the tablet into the vagina. Remove the applicator.
• After use, remove plunger completely by pulling it out of the applicator. Then wash it in warm (not boiling) soapy water, rinse & dry carefully.
• Pregnant woman must follow physician’s instructions.

Interaction
Not investigated. Since systemic absorption of Fenticonazole after application is low, interactions with other drugs are unlikely.

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.

Use in Special Populations
The use of Fenticonazole vaginal cream in children is not recommended.

Overdose Effects
Because of the low systemic absorption after vaginal application, overdosage is unlikely.

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