LEKKO Mikoderil cream for external use 1% tube 30 g No. 1

Release form

Cream for external use 1% white, homogeneous, with a weak specific odor.

pharmachologic effect

Naftifine - active ingredient

Mikoderila is an antifungal agent belonging to the allylamine class. The mechanism of its action is due to the ability to inhibit squalene-2,3-epoxidase, as a result of which the formation of ergosterol, which is part of the cell wall of the fungus, decreases. Naftifine affects squalene epoxidase and does not affect the cytochrome P450 system. The drug is active against molds (Aspergillus), dermatophytes (Microsporum, Epidermophyton, Trichophyton), yeast and yeast-like fungi (Candida spp., Pityrosporum), as well as some other types of fungi (for example, Sporothrix schenckii). On dermatophytes and molds, naftifine has a fungicidal effect, on yeast fungi, depending on the strain of the microorganism, it has a fungicidal or fungistatic effect.Has antibacterial activity against gram-negative and gram-positive microorganisms that cause the development of secondary bacterial infections. Due to its anti-inflammatory properties, the drug contributes to the rapid disappearance of symptoms of inflammation, especially itching.

Indications

- fungal infections of smooth skin and skin folds (tinea corporis, tinea inquinalis)

- interdigital mycoses (tinea manum, tinea pedum)

- fungal infections of the nails (onychomycosis)

- candidiasis of the skin

- pityriasis versicolor

- dermatomycosis (with or without itching).

Contraindications

- hypersensitivity to naftifine, benzyl alcohol or other components of the drug

- pregnancy and lactation (the safety and efficacy of the drug in this category of patients has not been studied).

With caution: childhood (clinical experience is limited).

Application during pregnancy and lactation

The safety profile of naftifine when used during pregnancy and lactation has not been studied, therefore Mikoderil is contraindicated in women during these periods of life.

special instructions

According to the instructions, Micoderil is not intended for use in ophthalmology.

Treatment with the drug is carried out in courses.

Care should be taken when applying the ointment / solution to avoid contact with open wounds.

Structure

1 g of cream: active substance: naftifine hydrochloride - 10 mg

additional components: isopropyl myristate - 80 mg, cetostearyl alcohol - 80 mg, polysorbate 60 - 61 mg, cetyl palmitate - 20 mg, sorbitan stearate - 19 mg, benzyl alcohol - 10 mg, sodium hydroxide - 1.2 mg, purified water - up to 1000 mg.

Method of administration and dosage

Outwardly.

In case of skin lesions, Mikoderil is applied 1 time / day to the affected skin surface and adjacent areas, after thorough cleaning and drying (capturing approximately 1 cm of a healthy skin area along the edges of the affected area).

The duration of therapy for dermatomycosis is 2-4 weeks (if necessary - up to 8 weeks), with candidiasis - 4 weeks.

In case of nail damage, Mikoderil is applied 2 times / day to the affected nail.

Before the first use of the drug, the affected part of the nail is removed as much as possible with scissors or a nail file.

The duration of therapy for opychomycosis is up to 6 months.

To prevent relapse, treatment should be continued for at least 2 weeks after the disappearance of clinical symptoms.

Side effects

There may be reactions at the site of application: dry skin, skin flushing and burning.

Side effects are reversible and do not require treatment withdrawal.

If any of the side effects indicated in the instructions are aggravated, or any other side effects not indicated in the instructions are noted, you should immediately inform your doctor about it.

Drug interactions

The interaction of Mikoderil with its simultaneous use with other drugs has not been noted.

Storage conditions

Temperature no more than 25 ° С.

Shelf life 2 years

Active substance

Naftifin

Name ENG

MYCODERIL

Clinical and pharmacological group

Antifungal drug for external use

ATX code

Naftifine

Dosage

1% x 30g

Structure

1 g of cream: active substance: naftifine hydrochloride - 10 mg

additional components: isopropyl myristate - 80 mg, cetostearyl alcohol - 80 mg, polysorbate 60 - 61 mg, cetyl palmitate - 20 mg, sorbitan stearate - 19 mg, benzyl alcohol - 10 mg, sodium hydroxide - 1.2 mg, purified water - up to 1000 mg.

Indications

fungal infections of smooth skin and skin folds (tinea corporis, tinea inquinalis)

interdigital mycoses (tinea manum, tinea pedum)

fungal infections of the nails (onychomycosis)

candidiasis of the skin

pityriasis versicolor

dermatomycosis (with or without itching)

Storage conditions and periods

Store at a temperature not exceeding 25 ° C.

Shelf life 2 years.

INN / Active ingredient

Naftifin

Contraindications

hypersensitivity to naftifine, benzyl alcohol or other components of the drug

pregnancy and lactation (the safety and efficacy of the drug in this category of patients has not been studied).

With caution: childhood (clinical experience is limited).

Specifications

Category

Antifungal

Scope of the medicinal product

Dermatology

Release form

Cream

Manufacturer country

Russia

Package quantity, pcs

one

Scope of application

Dermatology

Way of introduction

Locally

,

Outwardly

Vacation conditions

Without recipe

Brand name

OTCPharm

The amount of the dosage form in the primary package

30 g

Primary packaging type

Tuba

Type of consumer packaging

Pack of cardboard

Dosage form

Cream for external use

Packaging

Cardboard box

Dosage (volume) of the substance in the preparation

naftifine hydrochloride - 10.0 mg

The target audience

Adult

Expiration date in days

730

Package weight, g

45

Mode of application

:

Outwardly. < br> With skin lesions, Mikoderil is applied 1 time / day to the affected skin surface and adjacent areas, after thorough cleaning and drying (capturing approximately 1 cm of healthy skin along the edges of the affected area). < br> Duration of therapy for dermatomycosis - 2-4 weeks (if necessary - up to 8 weeks), with candidiasis - 4 weeks. < br> In case of nail damage, Micoderil is applied 2 times / day to the affected nail.

Before the first use of the drug, the affected part of the nail is removed as much as possible with scissors or a nail file. < br> Duration of therapy for opychomycosis is up to 6 months. < br> To prevent relapse, treatment should be continued for at least 2 weeks after the disappearance of clinical symptoms. < br>

Information on technical characteristics, delivery set, country of manufacture