Included in the formulation
АТХ:D.01.A.C.10 Bifonazole
Pharmacodynamics:Bifonazole is an imidazole derivative and has a broad spectrum of antimycotic action.
Bifonazole has a fungicidal action against dermatophytes (in particular, with respect to Trichophyton spp.). The complete fungicidal effect is achieved with a concentration of 5 μg / ml bifonazole and an exposure time of at least 6 hours. Bifonazole has a fungistatic effect against yeast and mold fungi, and Malassezia furfur. When affected by yeast fungi, for example, Candida species, at a concentration of 1-4 μg / ml, a predominantly fungistatic effect of bifonazole is noted; for the fungicidal effect, a concentration of bifonazole of 20 μg / ml is required. Bifonazole is also active in relation to Corynebacterium minutissimum (minimum inhibitory concentration from 0.5 to 2 μg / ml), Gram-positive cocci, with the exception of enterococci (minimum inhibitory concentration from 4 to 16 μg / ml).
Resistant strains of fungi are very rare. Studies have not confirmed the development of secondary stability in primary sensitive strains.
Bifonazole inhibits the biosynthesis of ergosterol at two different levels, which distinguishes it from other antifungal agents and other azole derivatives. This double action leads to structural and functional damage to the cytoplasmic membrane of fungi.
Pharmacokinetics:Bifonazole well penetrates into the affected layers of the skin. After 6 hours after application, the concentrations in different layers of the skin reach from 1000 μg / cm3 in the upper layer of the epidermis (in the stratum corneum) to 5 μg / cm3 in the papillate layer. Thus, all the concentrations obtained are within the range of antifungal activity.
When applied to intact skin, an insignificant amount of bifonazole is absorbed (0.6-0.8% of the dose of the drug); the concentration level of bifonazole in the blood plasma is always below the detection limit (that is, less than 1 ng / ml).Minor absorption is detected only after applying a solution of bifonazole on the inflamed skin (2-4% of the dose of the drug). Thus, since very low concentrations of bifonazole are produced in the blood plasma when it is applied locally (usually no more than 5 ng / ml), no systemic effects are observed.
The duration of stay in the skin (determined by the protective effect against fungal infection in guinea pigs) is 36-48 hours.
Bifonazole penetrates the placental barrier in rats.
Indications:Fungal skin diseases caused by dermatophytes, yeast-like, mold fungi, and Malassezia furfur and Corynebacterium minutissimum: foot mycoses (dermatophytosis of the skin of the feet and interdigital dermatophyte of the feet); mycosis of the hands (dermatophytosis of the skin of the hands and interdigital dermatophytosis); dermatophytosis of smooth skin of the body; dermatophytosis of the inguinal region; superficial candidiasis of the skin; pityriasis lichen; erythrasma.
I.B35-B49.B35.4 Mycosis of the trunk
I.B35-B49.B35.3 Mycosis of the feet
I.B35-B49.B35.2 Mycosis brushes
I.B35-B49.B35.6 Epidermophytosis inguinal
I.B35-B49.B36.0 Multicolored lichen
I.B35-B49.B37.2 Candidiasis of skin and nails
XII.L00-L08.L08.1 Erythrasm
Contraindications:Hypersensitivity to bifonazole or any other component of the drug.
Carefully:Pregnancy and lactation; childhood.
Pregnancy and lactation:Pregnancy
Absorption of bifonazole for external use of the drug is negligible. The research data show that bifonazole does not have any negative effect on the mother and fetus. However, the use of the drug during this period is possible if the potential benefit to the mother exceeds the potential risk to the fetus or the baby.
Lactation
It is not known whether the bifonazole in breast milk in women. Absorption of bifonazole for external use of the drug is negligible. However, the use of the drug during this period is possible if the potential benefit to the mother exceeds the potential risk to the fetus or the baby.
Fertility
The safety data obtained from preclinical studies suggest that the use of bifonazole does not have any negative effect on male and female fertility.
Dosing and Administration:Outwardly, the solution is applied a thin layer on the affected skin areas 1 time per day, preferably overnight, and gently rubbed.
To achieve a satisfactory result, treatment should be continuous.The duration of therapy is usually: with foot mycoses (dermatophytosis of the skin of the foot and interdigital foot dermatophytosis) - 3 weeks, with mycosis of the hands (dermatophytosis of the skin of the hands and interdigital dermatophytosis), skin of the body (dermatophytosis of smooth skin) and skin folds (inguinal dermatophytosis) - 2 -3 weeks, with pityriasis, erythrasma - 2 weeks, with superficial candidiasis of the skin - 2-4 weeks.
For the treatment of a surface approximately equal to the area of the palm, a few drops of the solution (about 3 drops) are sufficient.
Side effects:Common violations and local reactions: pain at the site of application, peripheral edema (at the site of application).
Disturbances from the skin and subcutaneous tissues: contact dermatitis, allergic dermatitis, erythema, pruritus, rash, hives, blisters, scaling and dry skin, eczema, skin irritation, maceration, burning sensation of the skin.
Side effects are reversible and disappear after drug withdrawal.
Overdose:There is no evidence of an overdose of the drug. Treatment is symptomatic.
Interaction:Absorption of bifonazole for external use of the drug is negligible. Cases of interaction with other drugs are unknown.
Special instructions:Use with caution in patients who are hypersensitive to other antifungal drugs from the group of imidazole derivatives (econazole, clotrimazole, miconazole).
Avoid contact with eyes.
Use in Pediatrics
There were no separate studies in children. Based on the review of clinical data, there is no evidence of adverse side effects in the use of the drug in children. However, in children younger than 1 year, the solution should be used only under the supervision of a doctor.