Exoderil solution for external use 1 % 10ml

Release form, composition and packaging

Solution for external use transparent, colorless or slightly yellow in color, with an ethanol odor

1 ml

naftifine hydrochloride 10 mg

propylene glycol - 50 mg, ethanol - 400 mg, purified water - 475 mg

10 ml - dark glass bottles with a dropper stopper with a plastic screw cap with a first opening control or with a polyethylene / polypropylene dropper cap (1) - cardboard packs.

20 ml - dark glass bottles with a dropper stopper with a plastic screw cap with a first opening control or with a polyethylene / polypropylene dropper cap (1) - cardboard packs.

30 ml - dark glass vials with a dropper stopper with a plastic screw cap with a first opening control or with a polyethylene / polypropylene dropper cap (1) - cardboard packs.

pharmachologic effect

Antifungal drug for external use from the group of allylamines.

The mechanism of action is associated with inhibition of the synthesis 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

The drug is active against dermatophytes Trichophyton, Epidermophyton, Microsporum, yeasts (Candida spp., Pityrosporum), molds (Aspergillus spp.) And other fungi (Sporotrix schenckii).

In relation to dermatophytes and aspergillus, naftifine acts fungicidal.

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

The drug has an antibacterial effect against gram-positive and gram-negative microorganisms that can cause secondary bacterial infections

The drug has an anti-inflammatory effect, which contributes to the rapid disappearance of symptoms of inflammation, especially itching.

Pharmacokinetics

Naftifine quickly penetrates the skin, creating stable antifungal concentrations in its different layers, which makes it possible to use it once a day.

Indications for use

fungal infections of the skin and skin folds (tinea corporis, tinea inguinalis), incl.

interdigital mycoses (tinea manum, tinea pedum)

fungal infections of the nails (onychomycosis)

candidiasis of the skin

pityriasis versicolor

dermatomycosis (with or without accompanying itching)

Exoderil is effective in the treatment of mycoses affecting the area of ​​the skin with hyperkeratosis, as well as in the hair growth zone.

Contraindications for use

pregnancy (safety and efficacy not determined)

lactation period (safety and effectiveness have not been determined)

hypersensitivity to naftifine or propylene glycol

Application of the drug to the wound surface is contraindicated.

With caution: childhood (clinical experience is limited).

Dosage regimen

Exoderil should be applied to the affected skin surface and adjacent areas 1 time / day, after thorough cleaning and drying, capturing approximately 1 cm of healthy skin along the edges of the affected area.

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

With onychomycosis, before the first application of the solution, it is necessary to remove the affected part of the nail as much as possible with scissors and a nail file.

The drug should be used 2 times / day, the duration of treatment is up to 6 months

To prevent recurrence of infection, therapy should be carried out for at least 2 weeks after the disappearance of clinical symptoms.

Overdose

No cases of overdose have been reported.

Side effect

Local reactions: in some cases - dry skin, flushing, burning

Side effects are reversible and do not require discontinuation of therapy.

Drug interactions

There was no drug interaction of Exoderil with other drugs.

Application during pregnancy and lactation

The use of the drug Exoderil is contraindicated during pregnancy and lactation (safety

Name ENG

EXODERIL

Clinical and pharmacological group

Antifungal drug for external use

ATX code

Naftifine

Dosage

1% x 10ml

Structure

1 ml of solution contains: active substance: naftifine hydrochloride - 10 mg

excipients: propylene glycol - 50 mg, ethanol - 400 mg, purified water - 475 mg.

Indications

fungal infections of the skin and skin folds (tinea corporis, tinea inguinalis), incl.

interdigital mycoses (tinea manum, tinea pedum)

fungal infections of the nails (onychomycosis)

candidiasis of the skin

pityriasis versicolor

dermatomycosis (with or without accompanying itching).

Exoderil is effective in the treatment of mycoses affecting areas of the skin with hyperkeratosis, as well as in areas of hair growth.

Storage conditions and periods

At a temperature not higher than 30 degrees.

Expiration date: 5 years

after opening - 6 months

Contraindications

Hypersensitivity to naftifine or propylene glycol

pregnancy and lactation (safety and efficacy have not been determined).

Application of the drug to the wound surface is contraindicated.

Carefully

Children's age (clinical experience is limited).

INN / Active ingredient

naftifine

Specifications

Category

Antifungal

Scope of the medicinal product

Dermatology

Release form

Solution

Manufacturer country

Austria

Package quantity, pcs

one

Way of introduction

On the skin

Vacation conditions

Without recipe

Volume, ml.

10 ml

Brand name

Sandoz

The amount of the dosage form in the primary package

10 ml

Primary packaging type

Bottle

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Antifungal agent

Anatomical and therapeutic characteristics

D01AE22 Naftifine

Dosage form

Solution for external use

Dosage (volume) of the substance in the preparation

one%

Expiration date in days

1825

Package weight, g

thirty

Mode of application

:

Outwardly.

Exoderil is applied once a day to the affected skin surface and adjacent areas (approximately 1 cm of healthy skin along the edges of the affected area) after thorough cleaning and drying.

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, Exoderil 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