Exiter cream d / nar. approx. 1% tube 15g.

Dosage form

Cream for external use is uniform, white or almost white, with a weak characteristic odor.

Structure

100 g

terbinafine hydrochloride 1 g

Excipients: benzyl alcohol - 1 g, polysorbate 60 - 5 g, sorbitan stearate - 2.4 g, cetyl alcohol - 6 g, isopropyl myristate - 6 g, cetyl palmitate - 3 g, sodium hydroxide - 0.122 g, water - 75.478 g.

pharmachologic effect

Antifungal drug for external use with a wide spectrum of antifungal activity. In small concentrations, terbinafine has a fungicidal effect against dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton violaceum, Trichophyton tonsurans, Microsporum canis, Epidermophyton floccusom). Moderately sensitive: molds (mainly Candida albicans) and dimorphic fungi (Pityrosporum orbiculare (also known as Malassezia furfur)). Activity against yeast fungi, depending on their type, can be fungicidal or fungistatic.

Terbinafine specifically alters the early stage of sterol biosynthesis in fungi by inhibiting the enzyme squalene epoxidase located on the fungal cell membrane.

This leads to a deficiency of ergosterol and to intracellular accumulation of squalene, which causes the death of the fungal cell.

Terbinafine does not affect the metabolism of hormones or other drugs.

Pharmacokinetics

Terbinafine diffuses through the dermal layer of the skin and accumulates in the lipophilic stratum corneum, is secreted into sebum, as a result of which high concentrations are created in the hair follicles and nails.

During the first few weeks after the start of administration, terbinafine accumulates in the skin and nail plates in concentrations that provide a fungicidal effect.

Metabolized in the liver to form inactive metabolites

Side effects

Flushing, itching, burning sensation

Selling features

Available without a prescription

Indications

Fungal skin lesions caused by dermatophytes, candidiasis

versicolor versicolor.

Contraindications

Hypersensitivity to terbinafine, to other components of the drug

children's age (up to 12 years), lactation period.

Dosage

Outwardly.

Adults and children over 12 years old.

Before applying the cream, it is necessary to clean and dry the affected skin.

The cream is applied once or twice a day to the affected skin and adjacent areas with a thin layer, gently rubbing.

For infections accompanied by diaper rash (under the mammary glands, in the interdigital spaces, between the buttocks, in the groin area), the places where the cream is applied can be covered with gauze, especially at night.

The duration of the treatment depends on the indication and the severity of the disease.

Average duration of treatment: Dermatomycosis of the trunk, legs: 1 time per day for 1 week.

Dermatomycosis of the feet: 1-2 times a day for 1-2 weeks.

Skin candidiasis: 1-2 times a day for 1-2 weeks.

Versicolor versicolor: 1-2 times a day for 2 weeks.

Name ENG

EXITER

Clinical and pharmacological group

Antifungal drug for external use

ATX code

terbinafine

Dosage

1% x 15g

Structure

100 g

terbinafine hydrochloride 1 g.

Excipients: benzyl alcohol - 1 g, polysorbate 60 - 5 g, sorbitan stearate - 2.4 g, cetyl alcohol - 6 g, isopropyl myristate - 6 g, cetyl palmitate - 3 g, sodium hydroxide - 0.122 g, water - 75.478 g.

Indications

Fungal skin infections caused by pathogens sensitive to terbinafine: trichophytosis, microsporia, epidermophytosis, rubrophytosis, skin candidiasis, versicolor versicolor.

INN / Active ingredient

terbinafine hydrochloride

Storage conditions and periods

At a temperature not higher than 25 degrees.

Expiration date: 3 years

Contraindications

Hypersensitivity to terbinafine, to other components of the drug

children's age (up to 12 years), lactation period.

Specifications

Category

Antifungal

Scope of the drug

Dermatology

Release form

Cream

Manufacturer country

Russia

Package quantity, pcs

one

Way of introduction

Outwardly

Vacation conditions

Without recipe

Brand name

Ozone

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

D01AE15 Terbinafine

Dosage form

Cream for external use

Expiration date in days

1095

Dosage (volume) of the substance in the preparation

terbinafine hydrochloride 1 g

The target audience

Children

Package weight, g

25

Mode of application

:

Outwardly. < br> Adults and children over 12 years old. < br> Before applying the cream, it is necessary to clean and dry the affected skin. The cream is applied once or twice a day to the affected skin and adjacent areas in a thin layer, rubbing lightly. For infections accompanied by diaper rash (under the mammary glands, in the interdigital spaces, between the buttocks, in the groin area), the places where the cream is applied can be covered with gauze, especially at night. The duration of the treatment depends on the indication and the severity of the course of the disease. Average duration of treatment: Dermatomycosis of the trunk, legs: 1 time per day for 1 week. Dermatomycosis of the feet: 1-2 times a day for 1-2 weeks. Skin candidiasis: 1-2 times a day for 1-2 weeks. Versicolor versicolor: 1-2 times a day for 2 weeks. < br>

Information on technical characteristics, delivery set, country of manufacture