Treatment of fungal infections of nails of hands and feet.
Composition:
1 g Ointment contains 10 mg of bifonazole and 400 mg of urea. The preparation contains lanolin.
Action:
An imidazole derivative with a wide range of antifungal activity. Bifonazole acts on dermatophytes, yeasts, molds and other fungi, such asMalassezia furfur and onCorynebacterium minutissimum. For dermatophytes, e.g.Trichophyton spp., bifonazole is fungicidal. Bifonazole has fungicidal activity at a concentration of approximately 5 μg / ml and after an exposure lasting more than 6 hours. For yeasts, e.g.Candida species bifonazole in a concentration of 1-4 μg / ml fungicidal, while at a concentration of 20 μg / ml fungicidal. Cases of pre-Bifonazole-resistant fungi are very rare. Previous studies have not shown the development of secondary resistance among the originally sensitive strains. Bifonazole inhibits the synthesis of ergosterol necessary for building the fungal cell wall and leads to structural and functional failure of the cytoplasmic membrane. The urea contained in the preparation works keratolytic. It softens the keratin of the infected nail, which allows its non-invasive and painless removal. In addition, it increases the penetration of bifonazole in infected leg nails, thereby enhancing the antifungal activity of the preparation. It penetrates very well into the infected skin layer. A small amount of the drug applied to intact skin is absorbed into the bloodstream (0.6-0.8% of the dose). Also, after administration to the skin affected by the inflammatory process, only small amounts are absorbed (2-4% of the dose). The occurrence of any systemic effects after topical administration is unlikely.
Contraindications:
Hypersensitivity to bifonazole or to any of the ingredients.
Precautions:
Caution use in patients with hypersensitivity to other antifungal imidazole derivatives (eg econazole, Clotrimazole, miconazole). The use experience in children is limited; in young children, bifonazole should only be used under the supervision of a physician. Due to the lanolin content, the preparation may cause local skin reactions (eg contact dermatitis).
Pregnancy and lactation:
Preclinical and pharmacokinetic studies have shown no adverse effects on the pregnant woman and fetus, however, no clinical data are available. In the first trimester of pregnancy, use only after assessing the benefit / risk ratio. It is not known whether bifonazole is excreted in human milk. In breastfeeding women, use only after an assessment of the benefit / risk ratio. During the lactation period, bifonazole should not be used in the chest area.
Side effects:
The following may occur: contact dermatitis, maceration of the skin, peeling of the skin, nail disorder, nail discoloration, erythema, irritation, pruritus, rash. The side effects subsided after the end of treatment. Very rarely, allergy to the patch was observed (then you can change the type of patch used or apply a rubber finger cover).
Dosage:
Outwardly. Apply a thin layer of ointment once a day to the entire surface of the affected nail, then cover the nail with a plaster for about 24 hours. Dressing should be changed daily, and the limb should be soaked after removing the patch for about 10 minutes in warm water. Using a scraper, carefully remove the softened layer of the infected nail. Dry the nails thoroughly, apply the ointment again and put on the dressing. The treatment is repeated until all infected layers of the nail are removed and its surface smoothes. The duration of treatment is usually about 7-14 days, then it is recommended to continue the treatment with a cream formulation, applying it once a day for the Next 4 weeks. After removing the nail and before starting further antifungal therapy, it should be checked if onycholysis is complete and if necessary - clean the nail bed from the remains of the plate.
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