Micoderil 1%, 30 g

Lecco / Pharmstandard, Russia

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Product Overview

Composition

1 g 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.

pharmachologic effect

Pharmacodynamics

Naftifine is an antifungal agent for external use, belonging to the class of allylamines. 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. It is active against dermatophytes such as trichophyton, epidermophyton and microsporum, molds (Aspergillus spp.), Yeasts (Candida spp., Pityrosporum) and other fungi (eg Sporothrix schenckii). 

In relation to dermatophytes and aspergillus, naftifine has a fungicidal effect. In relation to yeast fungi, the preparation exhibits fungicidal or fungistatic activity, depending on the strain of the microorganism. Possesses antibacterial activity against gram-positive and gram-negative microorganisms, which can cause secondary bacterial infections. It 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. The half-life of the drug is 2 to 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).

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.

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).

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.

Interaction

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

How to take, course 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, remove the affected part of the nail 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.

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.


Release form

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

Storage conditions

Temperature no more than 25 ° С.


Shelf life

2 years subject to manufacturer's recommended

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