Description

Release form, composition and packaging

Gel for external use 1% shiny, from white to almost white.

100 g

terbinafine 1 g

benzyl alcohol - 0.5 g, carbomer - 1 g, isopropyl myristate - 10 g, butyl hydroxytoluene - 0.02 g, sorbitan laurate - 1 g, polysorbate 20 - 5 g, sodium hydroxide (in the form of sodium hydroxide solution 30% m / m) - 0.1 g , ethanol 96% (vol.) - 10 g, water - 71.38 g.

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

pharmachologic effect

Antifungal drug for external use with a wide spectrum of antifungal activity. In small concentrations, terbinafine has a fungicidal effect against dermatophytes (Trychophyton rubrum, Trychophyton mentagrophytes, Trychophyton verrucosum, Trychophyton violaceum, Trychophyton tonsurans, Microsporum canis, Epidermophyton floccosum), molds (mainly some Candida albicans) and molds (mainly some Candida albicans) and fungi. Activity against yeast fungi, depending on their type, can be fungicidal or fungistatic.

Terbinafine specifically alters the early stage of sterol biosynthesis that occurs in fungi.

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

Terbinafine works by inhibiting the enzyme squalene epoxidase, located on the cell membrane of the fungus.

Terbinafine has no effect on the cytochrome P450 system in humans and, accordingly, on the metabolism of hormones or other drugs.

Pharmacokinetics

When applied externally, the absorption of terbinafine is less than 5%.

The systemic effect is insignificant.

Indications for use

- fungal infections of the skin, incl.

mycoses of the feet (tinea pedis), inguinal epidermophytosis (tinea cruris), fungal infections of the smooth skin of the body (tinea corporis) caused by dermatophytes such as Trichophyton (including Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyrichophyton verrucosum, violin canis and Epidermophyton floccosum

- versicolor versicolor (Pityriasis versicolor), caused by Pityrosporum orbiculare (Malassezia furfur).

Contraindications for use

- hypersensitivity to terbinafine or to any component of the drug.

- the period of breastfeeding

- children under 18 years of age.

With caution: care should be taken when applying the drug to damaged skin areas, because

alcohol contained in the preparation may cause irritation.

Dosage regimen

Outwardly.

Before using the drug Lamisil Dermgel for the first time, pierce the sealing membrane with the tip on the outside of the cap.

Lamisil Dermgel is used in adults 1 time / day for any of the indications.

Before using the drug, it is necessary to thoroughly clean and dry the affected areas.

The drug is lightly rubbed into the areas of both the affected and adjacent intact skin.

In the case of infections accompanied by diaper rash (under the mammary glands, between the fingers, in the gluteal and inguinal folds), the area of application of the gel can be covered with gauze, especially at night.

The duration and frequency of application of the drug Lamisil Dermgel for dermatomycosis of the trunk, legs - 1 week, 1 time / day

with dermatomycosis of the feet - 1 week, 1 time / day

with multi-colored lichen - 1 week, 1 time / day.

A decrease in the severity of clinical manifestations is usually noted in the first days of treatment.

In case of irregular treatment or premature termination of it, there is a risk of recurrence of the infection.

In the event that after a week of treatment there are no signs of improvement, the diagnosis should be verified.

For elderly patients, no dosage adjustment is required.

Overdose

No cases of overdose of Lamisil Dermgel have been reported.

Symptoms: accidental ingestion of the drug tube

Name ENG

LAMISIL DERMGEL

Clinical and pharmacological group

Antifungal drug for external use

ATX code

Terbinafine

Dosage

100 g: terbinafine 1 g

Structure

terbinafine 1 g. Excipients: benzyl alcohol - 0.5 g, carbomer - 1 g, isopropyl myristate - 10 g, butyl hydroxytoluene - 0.02 g, sorbitan laurate - 1 g, polysorbate 20 - 5 g, sodium hydroxide (in the form of sodium hydroxide solution 30% m / m) - 0.1 g, ethanol 96% (vol.) - 10 g, water - 71.38 g.

Indications

Fungal infections of the skin, incl.

mycoses of the feet (tinea pedis), inguinal epidermophytosis (tinea cruris), fungal infections of the smooth skin of the body (tinea corporis) caused by dermatophytes such as Trichophyton (including Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyrichophyton verrucosum, violin canis and Epidermophyton floccosum

versicolor versicolor (Pityriasis versicolor) caused by Pityrosporum orbiculare (Malassezia furfur).

Contraindications

children under 12 years of age

lactation period (breastfeeding)

hypersensitivity to terbinafine or to any other component of the drug.

Storage conditions and periods

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

The shelf life is 3 years.

INN / Active ingredient

Terbinafine

Specifications