Mycospor, cream 1% tube 15g (BAYER PHARMA, GERMANY)

Compound

Mycospor®

Mycospor® Set

pharmachologic effect

The main component Bifonazole, being an imidazole, has pronounced antimycotic activity . The fungicidal (destructive) effect manifests itself against dermatophytes . With prolonged exposure (more than 6 hours) to high concentrations (5 μg/ml), a complete fungicidal effect .

Fungistatic activity is recorded against fungi (molds, yeasts). Resistant strains are extremely rare. In primary resistant strains, secondary resistance practically does not occur. The mechanism of action of Bifonazole is based on the suppression of the biological synthesis of ergosterol at two levels at once, which significantly distinguishes it from other antifungal agents. With the double action of the component, the cytoplasmic fungal membrane is damaged not only at the structural level, but also at the functional level.

Urea has a keratoplastic effect, enhances the penetration of bifonazole and softens the keratin membrane of the infected nail plate.

Urea potentiates the action of bifonazole, enhancing the antimycotic effect.

Directions for use and doses

Mycospor®

Cream, solution for external use

Externally. The cream or solution is applied in a thin layer to the infected areas of the skin and rubbed in. A single dose based on a surface area the size of a palm is: for a cream - a column 1 cm long, for a solution - 3 drops. Frequency of use: 1 time per day, at night. Treatment should be continuous and include:

- for mycoses of the feet (dermatophytosis of the skin of the feet and interdigital dermatophytosis of the feet) - 3 weeks;

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

— pityriasis versicolor, erythrasma — 2 weeks;

— superficial skin candidiasis — 2–4 weeks.

No separate studies have been conducted in children. Based on a review of clinical data, there was no evidence of adverse side effects when using the drug in children. However, in children, the drug Mikospor®, solution for external use should be used only under the supervision of a physician.

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

Mycospor® Set

Ointment for external use

Externally. For adults and children, 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 treated nail is sealed with a plaster and left under the bandage for 24 hours, after which the bandage is changed. After removing the patch, immerse the treated surface in warm water for about 10 minutes and then carefully remove the softened part of the infected nail with a scraper. The nails treated in this way are thoroughly dried, the ointment is applied again and sealed with a plaster. The areas of skin adjacent to the nail should not be covered with ointment. If signs of irritation occur, the skin around the nail can be treated with zinc paste before applying the patch.

The dressing is changed every day. Treatment is continued until the softened nail plate infected with the fungus can no longer be removed with a scraper and the nail bed becomes smooth. This usually takes 7–14 days, depending on the extent of the infection and the thickness of the nail.

Conduct final antifungal therapy of the nail bed using the drug Mikospor®, cream for external use once a day for 4 weeks.

With more pronounced dystrophy of the nail plates, their removal using urea is more effective.

No separate studies have been conducted in children. Based on a review of clinical data, there was no evidence of adverse side effects when using the drug in children. However, in children, the drug Mikospor® Set should be used only under the supervision of a physician.

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

Buy Mycospor cream 1% 15g in pharmacies

Instructions for use Mikospor cream 1% 15g

Composition of 100 g of cream contains:

Active substance:

micronized bifonazole 1 g;

Excipients (in 1 g of cream): benzyl alcohol - 2 g; cetostearyl alcohol (cetyl alcohol - 60%, stearyl alcohol - 40%) - 10 g; cetyl palmitate - 3 g; octyldodecanol - 13.5 g; polysorbate 60 - 1.50 g; sorbitan stearate – 2 g;

purified water - up to 100 g.

Pharmacological action Mikospor - bifonazole, the active substance of the solution, is an imidazole derivative and has a wide antifungal spectrum of action.

The drug is active against:

Dermatophytes. Yeast-like fungi. Mold fungi. Malassezia furfur. Corynebacterium minutissimum. Mycospore suppresses at two different stages the synthesis of ergosterol, which is part of the cell wall of the fungus, which causes changes in its structure and properties.

Indications Dermatophytosis (including microsporia, trichophytosis, rubrophytosis); candidiasis of the skin, nail folds, nails, genitals; pityriasis versicolor; erythrasma; interdigital diaper rash; hyperhidrosis of the feet.

Contraindications Hypersensitivity, infancy (use only under medical supervision).

Side effects: Mild redness and irritation of the skin, burning; local reactions at the edges or on the nail bed (irritation, redness, maceration, peeling, contact dermatitis); allergic reactions.

How to take, course of administration and dosage Externally. Apply a thin layer to infected areas of the skin and rub in. A single dose based on a surface area the size of a palm is: for a cream - a column 1 cm long, for a solution - 3 drops.

Frequency of use: 1 time per day, at night. Treatment should be continuous and include:

for mycoses of the feet (dermatophytosis of the skin of the feet and interdigital dermatophytosis of the feet) - 3 weeks; mycoses of the hands (dermatophytosis of the skin of the hands and interdigital dermatophytosis), body skin (dermatophytosis of smooth skin) and skin folds (dermatophytosis inguinal) - 2–3 weeks; pityriasis versicolor, erythrasma - 2 weeks; superficial skin candidiasis - 2–4 weeks. No separate studies have been conducted in children. Based on a review of clinical data, there was no evidence of adverse side effects when using the drug in children. However, in children, the drug Mikospor®, solution for external use should be used only under the supervision of a physician.

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

Release form Cream

Storage conditions At a temperature not exceeding 25 °C

Shelf life 5 years

Active ingredient: Bifonazole

Conditions for dispensing from pharmacies Without a prescription

Dosage form cream

Prescription: Children over 1 year old, For adults, Children as prescribed by a doctor, Pregnant women in the 2nd and 3rd trimester as prescribed by a doctor

Indications Fungus, Nail fungus

Release form

Cream for external use 1%. 15 g each in an aluminum tube with a screw-on plastic cap. 1 tube is placed in a cardboard box.

Solution for external use 1%. 15 ml in a dark glass bottle, equipped with a plastic dropper, with a screw-on plastic cap. 1 bottle is placed in a cardboard box.

Ointment for external use. 10 g of ointment in an aluminum tube with a screw-on plastic cap. 1 tube is placed in an individual cardboard box; a pack of ointment together with a package of waterproof plaster, a scraper, and a dispenser are placed in a common cardboard box.

Mycospor 10g nail set

pharmachologic effect

Antifungal agent.

Composition and release form Mikospor 10g nail set

Cream - 100 gr.:

• active ingredient: bifonazole micronized 1.00 g;
• auxiliary ingredients: benzyl alcohol 2.00 g, cetostearyl alcohol [cetyl alcohol 60%, stearyl alcohol 40%] 10.00 g, cetyl palmitate 3.00 g, octyldodecanol 13.50 g, polysorbate 60 1.50 g, sorbitan stearate 2 .00 g, purified water up to 100.0 g.

15 g in an aluminum tube with a screw-on plastic cap, 1 tube along with instructions for use in a cardboard box.

Description of the dosage form

Homogeneous white cream.

Directions for use and doses

Externally, the cream is applied in a thin layer to the affected areas of the skin once a day, preferably at night, and rubbed in gently.

To achieve a satisfactory result, treatment must be continuous.

The duration of therapy is usually:

• for mycoses of the feet (dermatophytosis of the skin of the feet and interdigital dermatophytosis of the feet): 3 weeks;
• for mycoses of the hands (dermatophytosis of the skin of the hands and interdigital dermatophytosis), body skin (dermatophytosis of smooth skin) and skin folds (dermatophytosis inguinal): 2-3 weeks;
• for pityriasis versicolor, erythrasma: 2 weeks;
• for superficial skin candidiasis: 2-4 weeks.

To treat a surface approximately equal to the area of ​​the palm, a small amount of cream is sufficient (a column of cream about 1 cm long).

No separate studies have been conducted in children. Based on a review of clinical data, there was no evidence of adverse side effects when using the drug in children. However, in children, Mycospor®, a cream for external use, should only be used under the supervision of a physician.

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

Pharmacodynamics

Bifonazole, the active substance of MICOSPOR® cream, is an imidazole derivative and has a wide spectrum of antimycotic action.

Bifonazole has a fungicidal effect against dermatophytes (in particular, against Trichophyton spp.). The full fungicidal effect is achieved at a bifonazole concentration of 5 μg/ml and a duration of exposure of at least 6 hours. Bifonazole has a fungietatic effect against yeast and mold fungi, as well as 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 observed; For a fungicidal effect, a bifonazole concentration of 20 μg/ml is required. Bifonazole is also active against Corynebacterium minutissimum (MIC from 0.5 to 2 μg/ml), gram-positive cocci, with the exception of enterococci (MIC from 4 to 16 μg/ml). Resistant strains of fungi are very rare. Studies have not confirmed the development of secondary resistance in primarily sensitive strains. Bifonazole inhibits ergosterol biosynthesis at two different levels, which distinguishes it from other antifungals and other azole derivatives. This dual action leads to structural and functional damage to the fungal cytoplasmic membrane.

Pharmacokinetics

Bifonazole penetrates well into the affected layers of the skin. 6 hours after application, concentrations in various 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 papillary layer. Thus, all concentrations obtained are within the range of antifungal activity.

When applied to intact skin, a small amount of bifonazole is absorbed (0.6-0.8% of the drug dose); The level of bifonazole concentration in the blood plasma is always below the detection limit (i.e.

Bifonazole penetrates the placental barrier in rats.

Indications for use Mikospor 10g nail set

Fungal skin diseases caused by dermatophytes, yeast-like fungi, molds and other types of fungi:

• mycoses of the feet (dermatophytosis of the skin of the feet and interdigital dermatophytosis of the feet);
• mycoses of the hands (dermatophytosis of the skin of the hands and interdigital dermatophytosis);
• dermatophytosis of smooth body skin;
• dermatophytosis of the groin area;
• superficial skin candidiasis;
• pityriasis versicolor;
• erythrasma.

Contraindications

Hypersensitivity to bifonazole or any other component of the drug; pregnancy (first trimester); breastfeeding period.

Carefully:

During pregnancy (II and III trimester).

Childhood.

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

Use of Mycospor 10g nail kit during pregnancy and breastfeeding

Pregnancy

Absorption of bifonazole when used externally is negligible. Data from preclinical and pharmacokinetic studies show that bifonazole does not have any negative effects on the body of the mother and fetus. Clinical studies have not been conducted in pregnant women. As a precaution, the use of bifonazole should be avoided during the first trimester of pregnancy.

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

Breastfeeding period

Absorption of bifonazole when used externally is negligible; it is unknown whether bifonazole passes into breast milk in women.

Data obtained in experimental animals show that bifonazole is excreted in breast milk.

If it is necessary to use the drug during breastfeeding, the issue of stopping it should be decided.

Fertility

Safety data obtained from preclinical studies suggest that the use of bifonazole does not have any adverse effect on male or female fertility.

special instructions

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

If symptoms increase/persist after stopping treatment, you should consult a doctor.

Avoid getting the cream into your eyes.

Do not take orally.

In case of hypersensitivity to cetostearyl alcohol, it is recommended to use dosage forms of bifonazole that do not contain cetostearyl alcohol instead of cream (for example, Mikospor®, solution for external use 1%).

Application in pediatric practice

No separate studies have been conducted in children. Based on a review of clinical data, there was no evidence of adverse side effects when using the drug in children. However, in children under 1 year of age, Mikospor® cream should only be used under medical supervision.

Impact on the ability to drive vehicles and operate machinery

The drug Mikospor®, a cream for external use, does not have a negative effect on the performance of potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions (driving a car, working with moving mechanisms, etc.).

Overdose

There is no risk of acute intoxication, since an overdose (application to large areas of skin under conditions favorable for absorption) after a single application of the drug to the skin or accidental ingestion is unlikely.

Side effects of Mycospor 10g nail set

General disorders and local reactions: pain at the application site, peripheral edema (at the application site).

Skin and subcutaneous tissue disorders: contact dermatitis, allergic dermatitis, erythema, itching, rash, urticaria, blisters, peeling and dry skin, eczema, skin irritation, maceration, burning sensation of the skin.

Side effects are reversible and disappear after discontinuation of the drug.

Drug interactions

There is limited data on a possible interaction between topical bifonazole and warfarin, resulting in increased international normalized ratio and possible bleeding and bruising. When bifonazole is used in patients on warfarin therapy, careful monitoring of such patients is necessary.