Description

Release form, composition and packaging

Cream for external use 1% white, homogeneous, with a weak specific odor.

1 g

terbinafine hydrochloride 10 mg

benzyl alcohol, cetyl palmitate, sodium hydroxide, sorbitan stearate, stearyl alcohol, cetyl alcohol, polysorbate 60, isopropyl myristate, purified water.

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

pharmachologic effect

Antifungal drug for topical use.

Possesses a wide spectrum of antifungal action.

Active against dermatophytes: Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Trichophyton verrucosum, Trichophyton violaceum, Microsporum canis, Epidermophyton floccosum.

In small concentrations, in addition to dermatophytes, terbinafine has a fungicidal effect against molds, yeasts (mainly Candida albicans) and certain dimorphic fungi (Pityrospomm orbiculare).

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 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.

Termikonne affects the isozymes of the cytochrome P450 system in humans and, accordingly, the metabolism of hormones or other drugs.

Pharmacokinetics

When applied topically, absorption is less than 5%, it has a slight systemic effect.

Indications for use

- prevention and treatment of fungal skin infections, 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

- yeast infections of the skin (mainly caused by Candida albicans), in particular, diaper rash

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

Contraindications for use

- hypersensitivity to drug components.

The drug should be used with caution in hepatic and / or renal failure, alcoholism, inhibition of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive limb vascular diseases, in children under 12 years of age (lack of sufficient clinical experience).

Dosage regimen

Thermicon is prescribed externally for adults and children over 12 years old.

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

The cream is applied 1-2 times / day with a thin layer on the affected skin and adjacent areas, 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 average duration of treatment for dermatomycosis of the trunk, legs, feet - 1 time / day for 1 week

with candidiasis of the skin - 1-2 times / day for 1-2 weeks

with multi-colored lichen - 1-2 times / day for 2 weeks.

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

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

If after 1-2 weeks of treatment there are no signs of improvement, the diagnosis should be verified.

The dosage regimen of the drug for elderly patients is the same as for patients of other age groups.

Overdose

No cases of drug overdose have been reported.

If Thermicon is accidentally taken internally, one can expect the development of the same symptoms as with an overdose of tablets: headache, nausea, epigastric pain and dizziness.

Treatment: activated carbon, if necessary

Name ENG

TERMICON

Clinical and pharmacological group

Antifungal drug for external use

ATX code

Terbinafine

Dosage

1% x 15g

Structure

1 g of cream contains: Active ingredient: terbinafine hydrochloride - 10 mg.

Excipients: cetyl alcohol (lanet 16), stearyl alcohol or cetostearyl alcohol (lanet 0" grits), benzyl alcohol, cetyl palmitate (cutina SR), polysorbate 60, isopropyl myristate, sorbitan stearate, sodium hydroxide, purified water

Indications

prevention and treatment of fungal skin infections, 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

yeast infections of the skin (mainly caused by Candida albicans), in particular, diaper rash

versicolor versicolor (Pityriasis versicolor), caused by Pityrosporum orbiculare.

Storage conditions and periods

At a temperature not higher than 30 degrees.

Expiration date: 3 years

INN / Active ingredient

Terbinafine

Contraindications

hypersensitivity to drug components.

The drug should be used with caution in hepatic and / or renal failure, alcoholism, inhibition of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive limb vascular diseases, in children under 12 years of age (lack of sufficient clinical experience).

Specifications