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

auxiliary ingredients: alcohol benzyl 2,00 g, cetostearyl alcohol [cetyl alcohol 60%, stearyl alcohol 40%] 10.00 g, cetyl palmitate 3.00 g, octyl dodecanol 13.50 g, polysorbate 60 1.50 g, sorbitan stearate 2.00 g , purified water up to 100.0 g.

Description:

A homogeneous cream of white color.

Pharmacotherapeutic group:Antifungal agent

ATX: & nbsp

D.01.A.C.10 Bifonazole

Pharmacodynamics:

Bifonazole, an active substance of the cream of MIKOSPOR®, is an imidazole derivative and has a wide 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 fungiotic effect on yeast and molds, 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 <1 ng / ml). Minor absorption is detected only after applying the cream 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 48-72 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 (I trimester);

- the period of breastfeeding.

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 with external application of the drug is negligible (see the section "Pharmacokinetics"), it is not known whether the penetration bifonazole in breast milk in women.

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

If you need to use the drug during breastfeeding, you should decide whether to stop it.

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:

Externally, the cream is applied a thin layer on the affected skin areas 1 time per day, preferably at night, and gently rub.

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, small enough the amount of cream (a column of cream about 1 cm long).

There were no separate studies in children. Based on the review of clinical data, no evidence of development adverse effects of the drug in children. However, in children, the preparation Mikospor®, a cream for external use, should be used only 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.

Overdose:

No risk of acute toxicity, as overdose (applying to extensive areas of skin under conditions conducive to absorption) after a single application of the drug to 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 in the international normalized relationship 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.

With increased sensitivity to cetostearyl alcohol it is recommended to use bifonazole dosage forms that do not contain cetostearyl alcohol (eg, Mycospor®, topical solution 1%) instead of the cream.

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

Form release / dosage:

Cream for external use, 1%.

Packaging:

For 15 grams in an aluminum tube with a screwed plastic lid, 1 tube each, along with instructions for use in a cardboard box.

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 / 03

Date of registration:17.06.2008 / 17.10.2017

Expiration Date:Unlimited

The owner of the registration certificate:Bayer AGBayer AG Germany

Manufacturer: & nbsp

KERN PHARMA, S.L. Spain

Representation: & nbspBAYER, AOBAYER, AO

Information update date: & nbsp07.06.2018

Illustrated instructions

Instructions

Mycospor® (Mycospor®)