Mikospor - instructions for use, dose, side effects, contraindications

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 (MIC of 0.5 to 2 μg / ml), Gram-positive cocci, with the exception of enterococci (MIC of 4 to 16 μg / ml). Resistant strains of fungi are very rare. Studies have not confirmed the development of secondary resistance in the 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 (ie <1ng / ml). Minor absorption is detected only after application of 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, yeasts, molds and other species of fungi:

- mycosis stop (dermatophytosis of the skin of the foot and interdigital dermatophytosis 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.

Contraindications:

Hypersensitivity to bifonazole or any other component of the drug.

Pregnancy (first trimester).

Breastfeeding period.

Carefully:

In pregnancy (II and III trimester) (see section "Application during pregnancy and during breast-feeding").

Children's age (see section "Method of administration and dose").

Use with caution in patients who are hypersensitive to other antifungal drugs from the group of imidazole derivatives (econazole, clotrimazole, miconazole).

Pregnancy and lactation:

Pregnancy

Absorption of bifonazole for external use of the drug is negligible (see section "Pharmacokinetics"). Pre-clinical and pharmacokinetic studies show that bifonazole does not have any negative effects on the body of the mother and the fetus. Clinical studies in pregnant women have not been conducted. As a precaution, use of bifonazole in the first trimester of pregnancy should be avoided.

In the second and third trimester of pregnancy, the use of the drug is possible if the potential benefit to the mother exceeds the possible risk to the fetus.

Breastfeeding period

Absorption of bifonazole for external use of the drug is negligible (see section "Pharmacokinetics"). It is not known whether bifonazole penetrates in breast milk in women.

Data received on experimental animals, show that bifonazole excreted in breast milk.

If you need to use Mikospor®, a solution for external use, breastfeeding should be stopped during lactation.

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:

Outerly, the solution is applied a thin layer on the affected skin areas 1 time per day, preferably at night, and gently rubbed.

To achieve a satisfactory result, treatment should be continuous.

The duration of therapy is usually:

- with foot fungal infections (dermatophytosis of the skin of the feet and interdigital dermatophytosis of the feet): 3 weeks;

- with mycosis of the hands (dermatophytosis of the skin of the hands and interdigital dermatophytosis), skin of the body (smooth skin dermatophytosis) and skin folds (inguinal dermatophytosis): 2-3 weeks;

- with pityriasis, erythrasma: 2 weeks;

- with superficial candidiasis skin: 2-4 weeks.

For surface treatment approximately equal to the area palm, just a few drops of the solution (about 3 drops).

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, the Mikospor® solution for external use should only be used under the supervision of a doctor.

If there is no improvement within 7 days or the condition worsens, you should consult your doctor.

Side effects:

General disorders 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.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose:

The risk of acute intoxication is absent, since overdose (application to large areas of the skin under conditions favorable for absorption) after a single application of the drug on the skin or accidental ingestion unlikely.

Interaction:

There are limited data on possible interactions bifonazole for external use application and warfarin, leading to an increase international normalized relations and possible bleeding and bruising. In the case of bifonazole in patients who are on warfarin therapy, careful monitoring of such patients is necessary.

Special instructions:

Use with caution in patients who are hypersensitive to other antifungal drugs from the group of imidazole derivatives (econazole, clotrimazole, miconazole).

If symptoms persist / persist after discontinuation of treatment, consult a physician.

Avoid contact with eyes. Do not take internally.

Mycosorp® solution may be flammable because it contains ethanol. Avoid sources of fire when storing and disposing of it.

Application in pediatric practice

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 old, Mikospor® cream should only be used under the supervision of a doctor.

Effect on the ability to drive transp. cf. and fur:

Mikospor®, a solution for external use, does not adversely affect the performance of potentially hazardous activities requiring increased concentration and speed of psychomotor reactions (driving, working with moving mechanisms, etc.).

Form release / dosage:

Solution for external use, 1%.

Packaging:

To 15 ml in a bottle of dark glass, equipped with a plastic dropper, with a screwed plastic lid, 1 bottle together with instructions for use in a cardboard pack.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N013923 / 02

Date of registration:17.06.2008 / 23.11.2017

Expiration Date:Unlimited

The owner of the registration certificate:Bayer AGBayer AG Germany

Manufacturer: & nbsp

KVP Kiel Germany

Representation: & nbspBAYER, AOBAYER, AO

Information update date: & nbsp07.06.2018

Illustrated instructions

Instructions

Mycospor® (Mycospor®)