Bifosin

General characteristics. Structure:

Cream for external use of 1% colourless with a whitish or grayish shade or colourless with a grayish and cream shade, homogeneous.

Active ingredient: бифоназол 10 mg

Excipients: macrogoal 400 (poly(ethylene oxide) 400), macrogoal 4000 (poly(ethylene oxide) 4000), propylene glycol.

 

Powder for external use of 1% of color, white or light-cream with a grayish shade; drug has to pass through a silk sieve No. 46 completely.

10 mg operating вещество:бифоназол

Excipients: zinc oxide - 150 mg/g, starch corn, talc.

 

Solution for external use of 1% transparent, colourless or slightly painted.

Active ingredient: бифоназол 10 mg

Excipients: macrogoal 400 (poly(ethylene oxide) 400).

 

Spray for external use of 1% in the form of the transparent colourless or slightly painted liquid.

Active ingredient: бифоназол 10 mg

Excipients: propylene glycol - 0.3 ml, isopropanol - 0.4 ml, a macrogoal 400 (poly(ethylene oxide) 400) - to 1 ml.

Pharmacological properties:

Antifungal drug of a broad spectrum of activity for external use, derivative an imidazole. Malassezia furfur works fungitsidno for dermatophytes (Trichophyton, Microsporum, Epidermophyton), fungistaticly for drozhzhepodobny and mold mushrooms (Aspergillus ferrus, Scopulariopsis brevicaulis). It is active concerning bacteria: a gram-positive stick of Corynebacterium minutissimum (MPK fluctuates in the range from 0.5 to 2 mkg/ml) and concerning gram-positive cocci (MPK of 4-16 mkg/ml), except for Enterococcus spp.

Target of effect of drug is ergosterol - the most important component of a membrane of mushrooms. Bifonazol suppresses synthesis of ergosterol at two stages of its education that leads to structural and functional damage of a cytoplasmic membrane of mushrooms.

The minimum effective concentration - 5 ng/ml lasting influence not less than 6 h; at concentration of 3 ng/ml growth of quickly proliferating mycelium of Trichophyton mentagrophytes is contained.

Renders on drozhzhepodobny mushrooms of the sort Candida fungistatic, and in concentration of 20 ng/ml - fungicidal action.

 

Pharmacokinetics. Absorption

Well gets into the struck skin layers. Absorption - 0.6-0.8%, concentration of a bifonazol in a blood plasma is not defined. When putting cream on the affected skin absorption makes 2-4%, concentration in a blood plasma - 2 ng/ml.

Distribution

In 6 h after use concentration of a bifonazol in skin reaches or many times over surpasses the minimum effective concentration for the main mushrooms causing dermatomycoses: 1 mg/cm2 in an upper layer of epidermis (Stratum corneum) and 5 mg/cm2 in Stratum papillare.

Duration of finding of a bifonazol in skin during 36-48 h (at cream use - 48-72 h).

Removal

T1/2 makes 19-32 h of skin (depends on its density).

Indications to use:

Treatment of the damages of skin caused by dermatophytes, drozhzhepodobny, mold mushrooms, and also Malassezia furfur and Corynebacterium minutissimum:

— mycoses of feet and brushes;

— dermatomycoses of smooth skin;

— chromophytosis;

— superficial candidiasis of skin;

— erythrasma;

— a dermatomycosis of a pilar part of the head (powder for external use, solution for external use, spray for external use).

Route of administration and doses:

It is necessary to use drug 1 time/, for the night.

External use cream, powder for external use or solution for external use apply with a thin layer on an affected area of skin and carefully rub.

Spray for external use is sprayed on affected areas in the quantity sufficient for their careful moistening, and, besides, applied on adjacent sites as struck, and intact skin.

For the site of the size of a palm there are usually enough strips of cream 0.5-1 cm long or several drops of solution (about 3 ml).

For achievement of satisfactory result, treatment has to be continuous and is continued during the next recommended periods: at mycoses of feet and interdigital intervals of feet - 3-4 weeks, at dermatomycoses of smooth skin - 2-3 weeks, at superficial candidiasis of skin - 2-4 weeks, at a chromophytosis, an erythrasma - 2 weeks, at a dermatomycosis of a pilar part of the head - 4 weeks.

After disappearance of clinical displays of mycosis of Bifosin® continue to apply for the purpose of prevention of a recurrence, using drug of 1 times / within 2 weeks.

Spray for external use, solution to external use and powder for external use are preferable to treatment of dermatomycoses of a pilar part of the head.

Features of use:

At absence or insufficient efficiency it is necessary to inspect in addition the patient (a condition of immunity, blood, endocrine system, microcirculation of area of defeat) and to adjust treatment according to results of inspection.

To avoid hit of drug in eyes.

Use in pediatrics.

Use for babies (aged till 1 year) is possible only under control of the doctor.

Influence on ability to driving of motor transport and to control of mechanisms

Drug does not exert impact on ability to manage vehicles, mechanisms and occupations other dangerous types of activity requiring special attention and bystry reactions.

Side effects:

Local reactions: hyperemia, irritation of skin, burning sensation, allergic reactions, eczema, skin itch, vesicular rash, maceration, peeling, hyperemia; very seldom - development of allergic dermatitis.

Side effects are reversible and disappear after the therapy termination.

Interaction with other medicines:

Drug can be used along with other medicines as any reactions of medicinal interaction are not revealed.

Contraindications:

— period of a lactation (breastfeeding);

— hypersensitivity to drug components.

With care: chest age (till 1 year), pregnancy (the I trimester).

 

Use of the drug BIFOSIN® at pregnancy and feeding by a breast
Data of researches show that drug has no negative effect on an organism of mother and a fruit.

Use of drug in the I trimester of pregnancy is possible only according to strict indications. In II and III trimesters of pregnancy drug is used according to indications as drug is used outwardly and has no systemic action.

In the period of a lactation it is necessary to stop breastfeeding.

 

Use for children
Bifosin's use for babies is possible only under careful control of the doctor.

With care: chest age (till 1 year).

Overdose:

Extremely low system absorption of drug at external use makes overdose almost impossible.

Storage conditions:

Drug in the form of external use cream, powder for external use and solution for external use should be stored in dry, protected from light, the place at a temperature from 15 to 25 °C. A period of validity - 2 years.

Drug in the form of spray for external use should be stored in the place protected from light at a temperature not above 25 °C. A period of validity - 2 years.

Issue conditions:

Without recipe

Packaging:

30 g - aluminum (1) - packs cardboard.
30 g - banks polyethylene (1) - packs cardboard.
15 ml - a bottle dropper of dark glass (1) - a pack cardboard.
20 ml - bottles polymeric (1) with the sprayer - packs cardboard.