Fenticonazole Nitrate 2%

Fenticonazole Nitrate 2% belongs to a group of medicines called antifungals. It works by stopping the growth of fungus and is used to treat infections of the mouth, throat, vagina and other parts of the body. It kills fungi by destroying the fungal cell membrane.

Fenticonazole Nitrate 2% is for external use only. You should use it in the dose and duration as advised by your doctor. It is best to use it at night time for better results.

• Vulvovaginal Candidiasis: Used for treatment of vaginal fungal infections.
• Trichomoniasis: Used for treatment of Trichomonas vaginalis infections.
• Mixed Vaginal Infections: Used for mixed infections caused by Candida Albicans and Trichomonas vaginalis.

Topical Antifungal preparations

Antifungal (Imidazole Derivative)

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. The main mechanism of action of fenticonazole is based on the inhibition of the synthesis of aspartate acid proteinase.

Fenticonazole Nitrate kills and stops the growth of the fungi by destroying its cell membrane.

Adult Dose:

• Vaginal Cream: 1 applicator full (about 5 g) intravaginally morning and evening for 3 days.
• Vaginal Tablet (Candidiasis): 1 single 600 mg VT in the evening; may repeat after 3 days if needed.
• Vaginal Tablet (Trichomoniasis/Mixed): 1 600 mg VT; may repeat 24 hours later if needed.

For vaginal use only. Insert deep into the vagina using an applicator. Best used at night before going to bed. Wash hands thoroughly before and after use.

If you miss a dose of Fenticonazole Nitrate 2%, take it as soon as possible; however, if it is almost time for your next dose, skip the missed dose.

Common Side Effects:

• Vaginal burning sensation
• Itching
• Irritation
• Transient erythematous reactions

Precautions:

• Do not use with barrier contraceptives (condoms, diaphragms) as they may be damaged.
• Avoid contact with eyes; if accidental exposure occurs, rinse immediately with plenty of water.
• Inform your doctor if symptoms do not improve within 3 days.
• If hypersensitivity reaction or resistant organisms develop, discontinue treatment and consult physician.

Contraindications: Hypersensitivity.

Drug Interactions: Due to low systemic absorption after application, interactions with other drugs are unlikely.

Food Interactions: No interaction found/established.

Use in Pregnancy: Fenticonazole Nitrate 2% may be unsafe; animal studies have shown harmful effects on the developing baby.

Use in Lactation: Fenticonazole Nitrate 2% is probably unsafe; limited data suggests drug may pass into breastmilk and harm the baby.

Pediatric Use: Not recommended for use in children.

Geriatric Use: No specific dosage adjustment is necessary for elderly patients.

Renal Impairment: No interaction found/established.

Hepatic Impairment: No interaction found/established.

Overdose: Overdosage is unlikely due to low systemic absorption after vaginal application.

Storage: Keep below 30 degree C, protected from light and moisture. Do not freeze. Keep out of reach of children.

Fenticonazole Nitrate 2%