Terbizil cream for outside. approx. 1% 15g

Release form, composition and packaging

Cream for external use 1% white or almost white, with a slight almond scent.

1 g

terbinafine hydrochloride 10 mg,

-which corresponds to the content of terbinafine 8.8 mg

sodium hydroxide - 1.2 mg, benzyl alcohol - 10 mg, sorbitan monostearate - 19 mg, cetyl palmitate - 20 mg, cetyl alcohol - 40 mg, cetostearyl alcohol (cetyl alcohol 60%, stearyl alcohol 40%) - 40 mg, polysorbate 60 - 61 mg, isopropyl myristate - 80 mg, purified water - 718.8 mg.

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

pharmachologic effect

Terbinafine belongs to the group of allylamines, has a wide spectrum of antifungal activity.

It is active against the dermatophytes Trychophyton, Microsporum and Epidermophyton, as well as yeast fungi, mainly Candida albicans, against Pityrosporum ovale, the causative agent of varicoloured lichen (Pityriasis versicolor).

For Candida spp.

and their mycelial forms, depending on the type of fungus, have a fungicidal or fungistatic effect.

Inhibits squalene epoxidase in fungi and disrupts the early stage of sterol biosynthesis, leading to ergosterol deficiency, accumulation of squalene in the cell and cell death.

Fungicidal action is observed even at low concentrations of the drug and manifests itself in the effect on the synthesis and formation of the membrane of the fungus.

Squalene epoxidase does not belong to the cytochrome P450 (CYP) system, therefore terbinafine does not affect the metabolism of hormones and drugs metabolized by enzymes of the cytochrome P450 system.

Pharmacokinetics

When applied externally, less than 5% of the dose is absorbed, the systemic effect is minimal.

It quickly penetrates the skin and accumulates in the sebaceous glands.

High concentrations are created in hair follicles and hair, after a few weeks of use, it penetrates into the nail plate

accumulates in the stratum corneum and nails in concentrations that provide a fungicidal effect.

Does not accumulate in the body.

Penetrates into breast milk.

Indications for use

- fungal skin infections caused by Trichophyton dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton violaceum, Trichophyton interdigitale, Trichophyton tonsurans), Microsporum canis and gypseum, Epidermophyton

- skin infections caused by yeast-like fungi, mainly Candida (for example, Candida albicans)

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

Contraindications for use

- hypersensitivity to drug components

- lactation period.

With care: pregnancy, childhood (due to lack of sufficient clinical experience).

Dosage regimen

For external use.

Adults and children: after preliminary cleansing and drying of the affected surface, the cream is applied to it in a Terbizilthin layer 1-2 times / day, lightly rubbing it into the affected and adjacent healthy areas of the skin.

Places of physiological skin folds (areas under the mammary glands, interdigital spaces, intergluteal and groin areas) should preferably be covered with gauze after applying the cream, in particular at night.

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

With dermatomycosis of the trunk and legs, the cream is applied 1-2 times / day

the duration of treatment is 1-2 weeks.

In case of dermatomycosis of the feet, apply 1-2 times / day

the duration of treatment is 2-4 weeks.

With candidiasis of the skin, the cream can be applied up to 2 times / day

the duration of treatment is 1-2 weeks.

With multi-colored lichen, the cream can be applied up to 2 times / day

the course of treatment is 2 weeks.

No dose adjustment is required for elderly patients.

Treatment of children is carried out after assessing the balance of benefits and harms.

Overdose

Data on overdose of Terbizilnet cream

Name ENG

TERBISIL

Clinical and pharmacological group

Antifungal drug for external use

ATX code

Terbinafine

Dosage

1% x 15g

Structure

1 g of cream for external use contains: Active substance: terbinafine 10 mg.

Excipients: sodium hydroxide, benzyl alcohol, sorbitan monostearate, cetyl palmitate, cetyl alcohol, cetostearyl alcohol (60% cetyl alcohol, 40% stearyl alcohol), polysorbate 60, isopropyl myristate, purified water.

Indications

fungal skin infections caused by Trichophyton dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton violaceum, Trichophyton interdigitale, Trichophyton tonsurans), Microsporum canis and gypseum, Epidermophyton

skin infections caused by yeast-like fungi, mainly Candida (eg, Candida albicans)

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

Contraindications

hypersensitivity to drug components

lactation period.

With care: pregnancy, childhood (due to lack of sufficient clinical experience).

INN / Active ingredient

Terbinafine

Storage conditions and periods

At a temperature of 15-30 degrees.

Expiration date: 5 years

Specifications

Category

Antifungal

Scope of the drug

General

Release form

Cream

Manufacturer country

Hungary

Package quantity, pcs

one

Way of introduction

Outwardly

Vacation conditions

Without recipe

Brand name

Gedeon richter

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

Item weight, g

15

Expiration date in days

1825

The target audience

Adult

Package weight, g

15

Mode of application

:

Outwardly.

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

Adults.

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

The cream is applied 1 or 2 times a day in a thin layer on the affected skin and adjacent areas and rubbed 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.

Information on technical characteristics, delivery set, country of manufacture