Included in the formulation
АТХ:D.01.A.C.60 Bifonazole in combination with other drugs
Pharmacodynamics:Bifonazole, the first active substance of the ointment, is an imidazole derivative and has a broad spectrum of antimycotic action. Bifonazole has fungicidal action against dermatophytes (in particular, with respect to Trichophyton spp.). The complete fungicidal effect is achieved with a bifonazole concentration of 5 μg / ml 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 spp., 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 0.5-2 μg / ml), Gram-positive cocci, with the exception of enterococci (minimum inhibitory concentration 4-16 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.
Urea, the second active substance of the ointment, performs keratoplastic function: softens the keratin of the infected nail and increases the penetration depth of bifonazole.
The combination of bifonazole with urea increases the antimycotic effect of the drug.
Pharmacokinetics:When the ointment hits the affected skin, the absorption is 2-4% of the dose. When applying ointment for the treatment of nails, the concentration of bifonazole in the blood plasma is always below the detection limit (ie less than 1ng / ml); accordingly, no systemic effects are observed. Bifonazole penetrates the placental barrier in rats.
Indications:Onychomycosis (non-surgical removal of finger-infected fingers and feet with fungal nails with simultaneous antimycotic action).
I.B35-B49.B35.1 Mycosis of nails
I.B35-B49.B37.2 Candidiasis of skin and nails
Contraindications:Pregnancy (I trimester); hypersensitivity to bifonazole or any other component of the drug.
Carefully:Pregnancy (II and III trimesters) and lactation period, children's age.
Use with caution in patients who are hypersensitive to other antifungal drugs from the group of imidazole derivatives (econazole, clotrimazole, miconazole).
Pregnancy and lactation:For the first trimester of pregnancy, the drug is not recommended. In the II and III trimesters of pregnancy, the drug is possible if the potential benefit to the mother is greater than the potential risk to the fetus or child.
It is not known whether the bifonazole in breast milk in women. If you need to use the drug during lactation, you should decide whether to stop breastfeeding.
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. In the absence of other prescriptions, the ointment is applied to the infected nail once a day in an amount sufficient to cover the entire surface of the nail with a thin layer.Then the processed nail is pasted with adhesive tape and left under the bandage for 24 hours, after which the bandage is changed. After removal of the patch, the treated surface is immersed in warm water for about 10 minutes and then carefully remove the softened part of the infected nail with a scraper. Treated in this way, the nails are carefully dried, again applied to the ointment and sealed with a patch. Do not cover with ointment skin areas adjacent to the nail. In case of signs of irritation, the skin around the nail before applying the patch can be treated with zinc-containing paste.
Change bandages are produced every day. The treatment is continued until the softened nail plate infected with the fungus ceases to be removed by the scraper and the nail bed becomes smooth. This usually takes 7-14 days, depending on the extent of infection and the thickness of the nail.
The drug acts only on the infected nail plate, without affecting the healthy areas.
After removal of the affected nail plate, the attending physician should check whether the onycholysis is completed, if necessary, completely cleaning the nail bed and prescribing the final antifungal therapy.The final antifungal therapy of the nail bed should be performed with the drug for external use once a day for 4 weeks.
Side effects:From the skin and subcutaneous tissues: contact dermatitis, maceration, desquamation, nail lesions (local reactions from the nail and nail bed - such as redness, irritation of the nail bed, splitting of the nail plate), violation of the pigmentation of the nail, erythema, skin irritation, pruritus, rash (including allergic ).
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:The success of the treatment depends to a large extent on the thoroughness of removing the affected areas of the nail and the subsequent processing of the nail bed.
In very rare cases, there may be an allergic reaction to the patch. In case of such an allergic reaction, you should consult your doctor and apply a different kind of patch orrubber fingertips.