Терфалин®

General characteristics. Structure:

Active ingredient: 0,3 g of a terbinafin of a hydrochloride.

Excipients: ethanol of 96%, a macrogoal (Eumulgin B2), propylene glycol (monopropylene glycol), the water purified.

Pharmacological properties:

Pharmacodynamics. TERFALIN ® spray is to synthetic derivatives of allylamine which has a wide antifungal action spectrum.

Action of a terbinafin is carried out by inhibition of the enzyme of a skvalenepoksidaza located on a cellular membrane of a mushroom, specifically suppresses an early stage of synthesis of sterol in a mushroom cell that results in deficit of ergosterol, intracellular accumulation of squalene and death of a cell of a mushroom.

ТЕРФАЛИН® spray in small concentration has fungicidal effect concerning dermatophytes (Trychophyton rubrum, T.mentagrophytes, T.verrucosum, T.violaceum, T.tonsurans, Microsporum canis, Epidermophyton floccosum), mold (in the main C.albicans) and certain dimorphous mushrooms (Pityrosporum orbiculare). Activity concerning barmy mushrooms, depending on their look, can be fungicidal     or  fungistatic.

Terbinafin does not exert impact on system of P450 cytochrome at the person and, respectively, on metabolism of hormones or other medicines.

Pharmacokinetics. Very small quantity of a dose (less than 5%) at topical administration is absorbed through skin, respectively system absorption is insignificant. Terbinafin quickly gets into a thermal layer of skin and collects in a lipophilic corneous layer.

High concentration are created in hair follicles and hair, in several weeks of use gets also into nail plates, collects in a corneous layer of skin (concentration increases by 10 times for the 2nd day after reception of 250 mg, for the 12th day - by 70 times) and nails (speed of diffusion exceeds nail growth rate) in the concentration providing fungicidal     action.

It is metabolized in a liver with formation of inactive metabolites. T1/2 - 16-18 p. T1/2 of a terminal phase - 200-400 h. It is removed through skin, kidneys (70%) in the form of metabolites. Does not kumulirut. It is allocated with breast milk. If duration of treatment lasts from 1 to 7 days, the elimination half-life of a terbinafin from a corneous layer raises by 3 times.

Indications to use:

Prevention and treatment of fungal infections of skin:

- dermatomycoses of feet (foot "fungus") and large folds (tinea cruris), the fungal infections of smooth skin of a body (tinea corporis) caused by such dermatophytes as Trichophyton (including T.rubrum, T.mentagrophytes, T.verrucosum, T.violaceum), Microsporum canis and Epidermophyton floccosum;

- multi-colored deprive (Pityriasis versicolor), the caused Pityrosporum orbiculare (also known under the name Malassezia furfur).

Route of administration and doses:

Drug is used one or twice a day depending on indications. Duration of treatment varies according to indications and weight of an infection. Before use it is necessary to clear and dry affected areas carefully. Drug is sprayed on affected areas in the quantity sufficient for their careful moistening, and, besides, applied on adjacent sites as struck, and intact skin.

The recommended treatment duration:

- Dermatomycosis of smooth skin and large folds: 1 week, 1 times/days

- Dermatomycosis of feet: 1 week, 2 times/days

- Multi-colored deprive: 1 week, 2 times/days.

Clinical improvement occurs within several days. In case of irregular treatment or premature its termination is available risk of a recurrence of an infection. If in a week improvement signs are not noted, it is necessary to define repeatedly an infestant and its sensitivity to drug.

For elderly people of change of the mode of dosing it is not required.

Features of use:

ТЕРФАЛИН®, spray for topical administration of 1%, is intended only for external use, and not intended for intake, intranasal use, use in ophthalmologic practice and intravaginalny use.

It is necessary to avoid hit of drug on a mucous membrane of eyes. At hit of drug in eyes, they should be washed out immediately flowing water and if necessary to consult with the doctor.

In cases of irritation, allergic reactions or deteriorations in health it is necessary to stop use of drug and it is necessary to appoint the corresponding treatment.

With care apply drug on the damaged sites of skin as alcohol can cause irritation.

There are no bases to assume that for elderly people it is required to change a drug dosing or that they note the side effects differing from those at patients of younger age. In case of use in this age group of drug it is necessary to consider a possibility of the accompanying abnormal liver function or kidneys.

The infected sites should not be fitted by close clothes.

Patients with an infection of legs have to wear well adjusted and ventilated shoes. It is necessary to change footwear and socks, at least, once a day.

Observance of the recommended treatment duration is important for achievement of the best clinical effect.

It is necessary to wash hands after each use for prevention of planting from the infected sites.

Pregnancy and lactation. Adequate and well controlled tests for pregnant women it was not carried out. During pregnancy it is applied with care and only in the presence of strict indications. For the period of treatment it is necessary to stop breastfeeding.

Features of influence of medicine on ability to manage the vehicle or potentially dangerous mechanisms. It is not established.

Side effects:

Often: in sites of application of drug reddening, feeling of an itch or burning can appear.

Seldom: allergic reactions.

Interaction with other medicines:

There are no data on medicinal interaction concerning topical administration of a terbinafin.

Contraindications:

- hypersensitivity to any of drug components;

- lactation period;

- children's age up to 12 years;

- chronic or active diseases of a liver, HPN (KK less than 50 ml/min.).

Overdose:

It is possible only at accidental intake. Symptoms: a headache, dizziness, nausea, vomiting, pains in epigastriums, rash, a frequent urination. It is also necessary to consider the content in alcohol drug (28,7% of alcohol).

Treatment: use of absorbent carbon and symptomatic and maintenance therapy.

Storage conditions:

To store at a temperature not above 25 °C in the dry, protected from light place. To store in the place, unavailable to children! Period of storage 2 years. Not to apply after a period of storage.

Issue conditions:

Without recipe

Packaging:

On 30 ml of drug place in the bottle from polyethylene of high density of white color supplied with the spraying device with a plastic cover.

On a bottle paste the self-adhesive label.

On 1 bottle together with the instruction on a medical use in the state and Russian languages place in a pack cardboard with the hologram of firm – producer.