Fungoterbin, spray 1%, 30 ml

Antifungal drug for external use.

Terbinafine is the active ingredient of Fungoterbin®, it is an allylamine and has a wide spectrum of antifungal activity.

Terbinafine disrupts the early stage of biosynthesis of the main component of the cell membrane of the fungus (ergosterol) by inhibiting the enzyme squalene epoxidase. Squalene epoxidase is not related to the cytochrome P450 system.

The fungicidal effect is due to the accumulation of squalenes in the fungal cell, which extract lipid components from the membranes.

The lipid pellets accumulate inside the cell, gradually increasing in volume, and rupture the defective cytoplasmic membranes, causing the fungal cell to die.

Terbinafine in low concentrations has fungicidal activity against dermatophytes

The (Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Trichophyton verrucosum, Trichophyton violaceum, Microsporum canis, Epidermophyton floccosum), yeasts (mainly Candida albicans) and some dimorphic fungi (Pityrosporum orbiculare).

Activity against yeast-like fungi, depending on their species, may be fungicidal or fungistatic (prevents further reproduction of yeast-like fungi).

The urea in the spray has keratolytic (softening and causing rejection of the stratum corneum affected by fungal infection) and moisturizing effects, and urea can increase dermatopenetrance (skin penetration) of the dosage form and thus create high concentrations of terbinafine in the skin.

Urea promotes rapid regeneration of the epidermis. Butylhydroxytoluene is an antioxidant and stimulates regeneration processes.

When applied topically, it inhibits free radical reactions.

Indications

Fungal skin diseases caused by dermatophytes such as Trichophyton (including T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum:

foot mycosis / “foot fungus” (tinea pedis);

torso mycosis (tinea corporis), including mycosis of smooth skin and mycosis of large folds;

epidermophytia inguinalis (tinea cruris).

Superficial candidiasis of the skin caused by fungi of the genus Candida (e.g. Candida albicans).

Mottled Lichen (Pityriasis versicolor) caused by Pityrosporum orbiculare.

Active ingredient

Terbinafine

Composition

1 g of the spray for external use contains:

The active substance:

Terbinafina hydrochloride 10 mg (in terms of 100% substance),

Excipients:

Urea (urea), 10 mg;

Butylhydroxytoluene (dibunol), 10 mg;

Ethyl alcohol 95% (ethanol) – 150 mg;

Povidone – 10 mg;

Propylene glycol – up to 1 g

How to take, the dosage

Externally. The drug is applied to the skin 1 or 2 times a day. Before applying the spray, the affected areas should be cleaned and dried.

The product is sprayed on the affected areas in an amount sufficient to thoroughly moisturize them and is also applied to the adjacent areas of both affected and intact skin.

Average duration and frequency of application

Dermatomycosis of the trunk, shins: 1 week1 time daily.

Dermatomycosis of the feet: 1 week once a day.

Skin candida: 1 or 2 times a day for 1 or 2 weeks.

Mixed Lichen: 1 week once or twice a day.

Fungoterbin Spray has limited experience in children, and therefore its use in children under 12 years of age is not recommended.

Special Instructions

During treatment, general rules of hygiene must be followed to prevent reinfection (through underwear, shoes).

A reduction in clinical manifestations is usually seen in the first days of treatment. If treatment is intermittent or stopped prematurely, there is a risk of reinfection.

If after two weeks of treatment there is no sign of improvement, the diagnosis must be verified.

1 vial is for a full course of treatment.

The spray is for external use only.

Contact of the product to the eyes and mucous membranes should be avoided.

If accidental contact occurs, the product should be flushed immediately with running water, and if persistent irritation develops, a physician should be consulted.

Impact on the ability to drive vehicles and operate machinery

No effect.

Pregnant use is possible only if the potential benefit to the mother exceeds the possible risk to the fetus.

If it is necessary to use Fungoterbin® Spray during lactation, it is necessary to avoid contact of the infant with the area treated with Fungoterbin®.

It is not recommended to use on extensive surfaces.

Without prescription.

Synopsis

Colorless transparent liquid.

Features

When applied topically, the drug is absorbed very little (absorption – 5%); it accumulates in the skin, sebaceous glands, hair follicles, subcutaneous tissue and has its effect mainly in the application site.

Contraindications

Hypersensitivity to terbinafine and/or other components of the drug, children under 12 years of age (lack of sufficient experience of use).

With caution

Developed renal or hepatic insufficiency, chronic alcoholism, suppression of medullary hematopoiesis, tumors, metabolic diseases, occlusive diseases of the limb vessels, pregnancy, lactation period.

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Side effects

Fungoterbin is generally well tolerated.

Side effects are usually mild to moderate and transient. When taken orally they may be observed:

Gastrointestinal tract: dyspepsia, abdominal pain, feeling of stomach fullness, nausea, loss of appetite, diarrhea; sometimes impaired taste sensation, including loss of taste (recovered after several weeks of stopping treatment);

Musculoskeletal system: Muscle pain, joint pain

Hematopoietic system: neutropenia, agranulocytosis, thrombocytopenia, rarely – lymphopenia.

Allergic reactions: skin rash in the form of spots, blisters, rarely – toxic epidermal necrolysis, Stevens-Johnson syndrome, anaphylactoid reactions

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Pregnancy use

The experience of using the drug in pregnancy is limited, therefore Fungoterbin should not be used in pregnancy.

Terbinafine is excreted with the breast milk, so if it is necessary to prescribe the drug, it is necessary to consider stopping breastfeeding.

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Similarities

Terbinafin-Teva, Exifin, Lamisil, Fungoterbin, Lamisil Dermgel, Terbisil, Binafin, Termicon, Exiter, Terbinafin, Terbix