Mikoderil cream for external use, 1%, tube 15 g, No. 1

Release form

Cream

Packaging

Tube 15 g

pharmachologic effect

Mikoderil - antifungal agents for external use, belonging to the class of allylamines.

Their active ingredient is naftifine.

The mechanism of action is associated with inhibition of squalene-2,3-epoxidase, which leads to a decrease in the formation of ergosterol, which is part of the cell wall of the fungus.

Naftifine, affecting squale epoxidase, does not affect the cytochrome P-450 system.

Naftifine is active against dermatophytes such as Trichophyton, Epidermophyton, Microsporum, yeast and yeast-like fungi (Candida spp., Pityrosporum), molds (Aspergillus) and other fungi (such as Sporothrix schenckii).

In relation to dermatophytes and aspergillus, naftifine acts fungicidal.

In relation to yeast fungi, the drug exhibits fungicidal or fungistatic activity, depending on the strain of the microorganism.

Naftifine has antibacterial activity against gram-positive and gram-negative microorganisms that cause secondary bacterial infections.

Naftifine has an anti-inflammatory effect that promotes the rapid disappearance of symptoms of inflammation, especially itching.

Pharmacokinetics

When applied externally, it penetrates well into various layers of the skin, creating stable antifungal concentrations in its various layers.

After application to the skin, less than 6% of naftifine is absorbed systemically.

The absorbed amount is partially metabolized and excreted by the kidneys and through the intestines.

T1 / 2 of the drug is 2-3 days.

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).

Application during pregnancy and lactation

The use of the drug during pregnancy and lactation is not recommended (the safety and efficacy of the drug in this category of patients has not been studied).

special instructions

Course treatment is required.

The drug Mikoderil is not intended for use in ophthalmology.

Avoid contact with the eyes and open wounds.

Use in pediatrics: the drug should be used with caution in children under 18 years of age (the effectiveness and safety of the drug has not been proven).

Structure

1 g of cream contains:

Active ingredient: naftifine hydrochloride 10 mg

Excipients: sodium hydroxide - 1.2 mg

benzyl alcohol - 10 mg

sorbitan stearate - 19 mg

cetyl palmitate - 20 mg

polysorbate 60 - 61 mg

cetostearyl alcohol - 80 mg

isopropyl myristate - 80 mg

purified water - up to 1000 mg

Method of administration and dosage

Outwardly.

In case of skin lesions, Mikoderil is applied once a 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).

3 Duration of therapy for dermatomycosis - 2-4 weeks (if necessary - up to 8 weeks), with candidiasis - 4 weeks.

In case of nail damage, Mikoderil is applied 2 times a 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 onychomycosis 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

In some cases, local reactions can be observed: 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 are noted

Name ENG

MYCODERIL

Clinical and pharmacological group

Antifungal drug for external use

ATX code

Naftifine

Dosage

1% x 15g

Structure

1 g of cream contains: Active ingredient: naftifine hydrochloride 10 mg

Excipients: sodium hydroxide - 1.2 mg

benzyl alcohol - 10 mg

sorbitan stearate - 19 mg

cetyl palmitate - 20 mg

polysorbate 60 - 61 mg

cetostearyl alcohol - 80 mg

isopropyl myristate - 80 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).

INN / Active ingredient

naftifine

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).

Storage conditions and periods

At a temperature not exceeding 25 ° C.

Specifications

Category

Antifungal

Scope of the drug

Leather

Release form

Cream

Manufacturer country

Russia

Package quantity, pcs

one

Way of introduction

On the skin

Vacation conditions

Without recipe

Brand name

OTCPharm

The amount of the dosage form in the primary package

15 g

Primary packaging type

Tuba

Type of consumer packaging

Pack of cardboard

Dosage form

Cream for external use

Dosage (volume) of the substance in the preparation

10 mg

Expiration date in days

730

Package weight, g

twenty

Mode of application

:

Outwardly.

In case of skin lesions, Mikoderil is applied once a 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).

3 Duration of therapy for dermatomycosis - 2-4 weeks (if necessary - up to 8 weeks), with candidiasis - 4 weeks. < br> < br> In case of nail damage, Mikoderil is applied 2 times a 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 onychomycosis is up to 6 months.

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

Information on technical characteristics, delivery set, country of manufacture