Eco-Terbin Spray 1%, No. 1, 30 ml

Dosage form

clear, colorless or slightly yellowish liquid with a lemon scent.

Structure

active substance:

terbinafine hydrochloride - 1.0 g

Excipients:

propylene glycol - 5.0 g

ethanol (ethyl alcohol 95%) - 25.0 g

macrogol cetostearyl ether - 2.0 g

lemon flavoring - 0.1 g

purified water up to 100 ml

Special conditions

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 recurrence of the infection.

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

Care should be taken when applying the spray to damaged skin, as ethanol can cause irritation.

The drug is intended for external use only.

Do not apply the ECO-Terbin spray to the face.

Contact with eyes should be avoided as it may cause irritation.

In case of accidental contact of the drug in the eyes, they should be immediately rinsed with running water, and in case of persistent irritation, you should consult a doctor.

If the drug was accidentally injected into the respiratory tract during inhalation, then, if any symptoms appear, especially if they persist, you should consult your doctor.

With the development of allergic reactions, it is necessary to stop using the drug.

The preparation contains propylene glycol, which in some cases may cause skin irritation.

It should also be borne in mind that the product contains 95% ethanol.

Influence on the ability to drive vehicles, mechanisms

After external use of terbinafine, no effects were reported that affect the ability to drive vehicles or work with other mechanisms.

Drug interactions

There are no known drug interactions for terbinafine spray.

Since compatibility studies have not been conducted, it is not recommended to use the drug in conjunction with other external agents.

Pharmacodynamics

Terbinafine, the active ingredient of the ECO-Terbin preparation, is an allylamine with a wide spectrum of antifungal activity. Terbinafine is active against dermatophytes (Trichophyton rubrum, T. mentagrophytes, T. verrucosum, T. violaccum, T. tonsurans, Microsporum canis, Epidermophiton floccosum), yeasts of the genus Candida (mainly C. albicans) and certain dimorphic fungi (Pityularesporum ). 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 enoxidase 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.

Pharmokinetics

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

Indications

Treatment of fungal infections of the skin, including mycoses of the feet (fungus" of the foot), inguinal epidermophytosis (tinea cruris), fungal infections of the smooth skin of the body (tinea corporis) caused by dermatophytes.

Versicolor versicolor caused by dimorphic fungi.

Contraindications

Hypersensitivity to terbinafine or to any other component of the drug, children under 18 years of age.

Carefully

Hepatic and / or renal failure, alcoholism, inhibition of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive vascular diseases of the extremities.

Application during pregnancy and during breastfeeding

In experimental studies, teratogenic properties of terbinafine have not been identified.

To date, no malformations have been reported with terbinafine.

However, since the clinical experience of using the drug in pregnant women is limited, it should be used only under strict indications.

Small amounts of terbinafine are excreted in breast milk.

It is not known if this small amount can have a negative effect on the baby during breastfeeding, therefore it is not recommended for breastfeeding mothers.

Overdose

Cases of overdose of terbinafine with external use have not been reported, however, with accidental ingestion of the drug, side effects can be expected, as with an overdose of terbinafine in tablet dosage form (headache, nausea, epigastric pain and dizziness).

It should also be borne in mind that the spray contains 95% ethyl alcohol.

Treatment: activated carbon, if necessary, symptomatic supportive therapy.

Side effects

Classification of the frequency of occurrence of adverse reactions: very often (? 1/10)

often (? 1/100, < 1/10)

infrequently (? 1/1000, < 1/100)

rarely (? 1/10000, < 1/1000)

very rare (< 1/10000), including isolated messages.

Immune system disorders:

isolated messages: hypersensitivity reactions (rash).

Violations of the organ of vision:

rarely - eye irritation.

Violation of the skin:

often - peeling of the skin, itching

infrequently - skin damage, crusting, skin lesions, pigmentation disorders, erythema, burning sensation of the skin

rarely - a feeling of dry skin, contact dermatitis, eczema

isolated messages - rash.

Local reactions and others:

infrequently - pain, pain at the site of application, irritation at the site of application

rarely - exacerbation of symptoms of the disease.

In places where the drug is applied, there may be itching, peeling of the skin, pain, irritation, changes in skin pigmentation, burning, erythema, crusting.

These minor symptoms should be distinguished from hypersensitivity reactions such as rashes, which occur in rare cases and require discontinuation of therapy.

In rare cases, the course of a fungal infection may worsen.

If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects not listed in the instructions, inform your doctor.

Structure

active substance:

terbinafine hydrochloride - 1.0 g

Excipients:

propylene glycol - 5.0 g

ethanol (ethyl alcohol 95%) - 25.0 g

macrogol cetostearyl ether - 2.0 g

lemon flavoring - 0.1 g

purified water up to 100 ml

INN / Active ingredient

terbinafine hydrochloride

Specifications

Category

Antifungal

Scope of the drug

Dermatology

Release form

Spray

Manufacturer country

Russia

Way of introduction

Outwardly

Volume, ml.

30 ml

Brand name

ECOlab

Expiration date in days

720

The target audience

Adult

Package weight, g

40

Information on technical characteristics, delivery set, country of manufacture "