Exoderil cream d / nar. approx. 1% 15g # 1

Release form, composition and packaging

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Cream for external use is white, homogeneous or slightly grainy, shiny, with a weak characteristic odor.

1 g

naftifine hydrochloride 10.0 mg

sodium hydroxide - 1.2 mg, benzyl alcohol - 10.0 mg, sorbitan stearate - 19.0 mg, cetyl palmitate - 20.0 mg, cetyl alcohol - 40.0 mg, stearyl alcohol - 40.0 mg, polysorbate 60 - 61.0 mg, isopropyl myristate - 80.0 mg, purified water - 718.8 mg.

15 g - aluminum tubes (1) - cardboard packs.

30 g - aluminum tubes (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 has a fungicidal effect. 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, which 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

Absorption and distribution When applied externally, naftifine penetrates well into various layers of the skin, reaching concentrations sufficient for the implementation of the antifungal effect.

After application of the cream to the skin, less than 6% of the active substance is systemically absorbed.

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

T1 / 2 is 2-3 days.

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).

Contraindications for use

- pregnancy (safety and effectiveness not determined)

- lactation period (safety and effectiveness have not been determined)

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

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.

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

In case of onychomycosis, before the first application of the cream, 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 the drug Exoderil® with other drugs.

Application during pregnancy and lactation

The use of Exoderil® during pregnancy and lactation is contraindicated (safety and efficacy have not been determined).

Special instructions The drug is not intended for use in ophthalmology.

Should be avoided

Name ENG

EXODERIL

Clinical and pharmacological group

Antifungal drug for external use

ATX code

Naftifine

Structure

1 g of cream contains: active substance: naftifine hydrochloride - 10.0 mg.

Excipients: sodium hydroxide - 1.2 mg, benzyl alcohol - 10.0 mg, sorbitan stearate - 19.0 mg, cetyl palmitate - 20.0 mg, cetyl alcohol - 40.0 mg, stearyl alcohol - 40.0 mg, polysorbate 60 - 61.0 mg, isopropyl myristate - 80.0 mg, purified water - 718.8 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).

Storage conditions and periods

The drug should be stored out of the reach of children at a temperature not exceeding 3C.

The shelf life is 3 years.

Contraindications

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

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

Carefully

Children's age (clinical experience is limited).

INN / Active ingredient

naftifine hydrochloride

Specifications

Category

Antifungal

Scope of the drug

General

Release form

Cream

Manufacturer country

Austria

Way of introduction

On the skin

Vacation conditions

Without recipe

Brand name

Sandoz

The amount of the dosage form in the primary package

15 g

Primary packaging type

Tuba

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Antifungal agent

Anatomical and therapeutic characteristics

D01AE22 Naftifine

Dosage form

Cream for external use

Expiration date in days

1093

Package weight, g

25

Mode of application

:

In case of skin lesions, 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.

< br> 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