Mycospor, 1%, solution for external use, 15 ml, 1 pc.

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.

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.

Instructions for use (Method and dosage)

Mycospor nail kit is used only topically. The ointment is applied to the entire surface of the infected nail in a thin layer once a day, sealed with a special plaster from the kit. It is recommended to apply a bandage for 1 day. After 24 hours, remove the patch and immerse the nail in warm water. After 10 minutes, begin to remove the softened layer of the nail infected with a fungal infection using the scraper from the kit. After this, the nail is dried, treated with ointment again and sealed with a band-aid. It is not recommended to treat the skin adjacent to the nail. If redness or irritation appears on the skin near the nail plate, it is recommended to pre-treat the adjacent tissues with zinc ointment.

An important point is the daily and timely change of dressings. Treatment is carried out until the nail bed becomes smooth and the infected nail plate is completely removed from the keratinized tissue using a scraper. On average, antifungal therapy lasts 1-2 weeks and depends on the thickness of the nail and the severity of the fungal disease. The medication does not affect healthy tissue.

After complete removal of the nail, the attending doctor evaluates the degree of onycholysis and the effectiveness of the therapy. If there is no expected effect, treatment continues with Mycospor cream for 4 weeks.

Compound

Mycospor®

Mycospor® Set

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

Mycospor Set ointment for external use 10g

Compound

100 g of ointment contains:
active ingredients:

bifonazole 1 g, urea 40 g,

auxiliary ingredients

: white beeswax 5 g, white petroleum jelly 34 g, lanolin 20 g.

Pharmacokinetics

When the ointment gets on the affected skin, absorption is 2-4% of the drug dose. When using Mycospor ointment Set for the treatment of nails, the concentration of bifonazole in the blood plasma is always below the detection limit (i.e. < 1 ng/ml), accordingly, no systemic effects are observed.

Bifonazole penetrates the placental barrier in rats.

Indications for use

Onychomycosis (non-surgical removal of fingernails and toes affected by fungus with simultaneous antimycotic action).

Contraindications

There is no risk of acute intoxication, since 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.

Directions for use and doses

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. Do not apply ointment to areas of skin adjacent to the nail. If signs of irritation occur, the skin around the nail can be treated with a zinc-containing 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.

Final antifungal therapy of the nail bed is carried out 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 review of clinical data, there was no evidence of development

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.

Storage conditions

Store at a temperature not exceeding 30 C.

Keep out of the reach of children.

Best before date

3 years.

Do not use after the expiration date stated on the packaging.

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 drug into your eyes.

Do not take orally.

Description

A homogeneous ointment of white color with a yellowish tint.

Conditions for dispensing from pharmacies

Over the counter

Dosage form

ointment for external use

Manufacturer and organization accepting consumer complaints

Bayer AG

Pharmacodynamics

Bifonazole

, the first active ingredient of Mycospor Set ointment, 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 fungistatic 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.

Urea

, the second active ingredient of the Mycospor Set ointment, performs a keratoplasty function: softens the keratin of the infected nail and increases the depth of penetration of bifonazole.

The combination of bifonazole with urea enhances the antimycotic effect of the drug.

Side effects

Skin and subcutaneous tissue disorders

: contact dermatitis, maceration, desquamation, nail lesions (local reactions of the nail and nail bed - such as redness, irritation of the nail bed, splitting of the nail plate), impaired nail pigmentation, erythema, skin irritation, itching, rash (including allergic nature), pain at the site of application, pain in the limb.

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

If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Use during pregnancy and breastfeeding

Pregnancy

Data from preclinical and pharmacokinetic studies show that bifonazole and urea do 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 and urea 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

It is not known whether bifonazole and urea pass into breast milk in women.

Data obtained in experimental animals show that bifonazole and its metabolites are excreted in breast milk.

If it is necessary to use the drug Mikospor Set during lactation, breastfeeding should be stopped.

Fertility

Safety data obtained from preclinical studies suggest that the use of bifonazole does not have any adverse effect on male or female fertility. The use of urea does not have a damaging effect on sperm, but there is no data on the possible effect on female fertility.

Interaction

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.

Overdose

There is no risk of acute intoxication, since 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.

Impact on the ability to drive vehicles and operate machinery

The drug Mikospor Set 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).