Mikoderil cream 1%, 15g

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

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 (for example 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.

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

Naftifine has an anti-inflammatory effect, which 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. T 1/2 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).

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).

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).

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

Interaction

Has not been studied.

How to take, course 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 a healthy skin area along the edges of the affected area). 

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, remove the affected part of the nail 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.

Special instructions

Course treatment is required.

The drug Mikoderil is not intended for use in ophthalmology.

Avoid contact with 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).

Storage conditions

At a temperature not exceeding 25 ° C.

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