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Therapeutic Category
- DERMATOLOGICAL DRUGS
- ANTIFUNGAL DRUGS
- Pharmaceutical Form : Cream
- Composition : %Fenticonazole nitrate 2
- Active Substance : Fenticonazole nitrate
CLINICAL PHARMACOLOGY:
medi – fent is a broad spectrum antimycotic. Its active ingredient is fenticonazole. An imidazole derivative synthesized by Recordati.
Fenticonazole has been shown to be effective against all tested strains of Tricophyton mentagrophytes, T. verucosum, T. rubrum, T. tonsurans and T. terrestre; aginst Microsporum canis, M. gypseum, M. auddouini, M. vulvum, N.cookei, aginst Epidermophyton floccosum, Candida albicans, Cryptococcus neoformas, Geotrichum candicum; Torulopsis glabrata, Sporotricum schenki, Aspergillus niger, A fumingatus, A. flavus, and Penicillin crysogenum. medi – fent is also effective aginst some Gram-positive bacteria, Staphylococcus. Streptococcus. medi – fent has been shown to be active against Trichomonas vaginalis and is therefore also highly effective against the mycoses associated with bacterial superinfections.
INDICATIONS AND USAGE:
For the treatment of cutaneous infections due to dermatophytes and pytriasis versicolor.
- Dermatomycosis caused by dermatophytes (Trichophyton, Microsporum, Epidermophyton) at different location: Tinea coroporis, tinea cruris, tinea pedis, tinea manuum, tinea faciei, tinea barbae, tinea unguium.
- Cutaneous candidiasis (intertrigo, perleche, facecandidiasis, “napkin” rash, perineal and scotal candidiasis ) balanitis, balanoposthisis, onychia and paronychia.
- Pytiriasis versicolor (caused by pytriosporum orbiculare and P.ovale)
- Otomycosis (due to Candida or moulds) only if no lesions of eardrum are present.
- Mycosis with bacterial superinfections ( caused by Gram- positive bacteria)
CONTRAINDICATIONS:
Proven hypersensitivity to the product and other imidazole derivatives.
Although transcutaneous and vaginal absorption of fenticonazole is very poor, use of the preparation is not recommended in pregnancy.
WARNINGS:
The use, especially if on a long term basis, of products for topical application, could induce sensitization phenomena. In this case, discontinue the treatment and seek the doctor’s advice.
SIDE EFFECTS
Medi – Fent is generally well tolerated on the skin and mucous membranes, only very rare case of minor and provisional erythematous reactions have been reported.
After topical administration, a slight burning sensation may occur which normally disappears immediately.
If irritation occurs and persists or if resistant microorganisms develop, suspend treatment and seek medical advice.
Medi – Fent is only slightly absorbed so no effects on the system as a whole should occur, if instructions for use are properly followed.
DOSAGE AND ADMINISTRATION:
Medi- Fent cream should be applied 1-2 times a day, according to physician’s directions after washing and drying the affected part.
Treatment with Medi – Fent should be regularly done until the lesions are completely healed.
Medi – Fent cream is not greasy, does not stain, and can easily be removed with water.
STORAGE CONDITIONS:
Store Medi – Fent cream in a dry place between (15 – 30) ˚C.
Packing:
Tube of 20 gr.