Terbinafin

General characteristics. Structure:

Active ingredient: 10 mg of a terbinafin of a hydrochloride in 1 drug.

Excipients: a macrogoal-400, propylene glycol, povidon-K17, a macrogoal глицерилгидроксистеарат, ethanol of 95% (in terms of anhydrous), the water purified.

Pharmacological properties:

Pharmacodynamics. The antifungal drug for external use possessing a wide range of antifungal activity. In low concentration has fungicidal activity 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 yeast has fungicidal or fungistatic character depending on a species of mushrooms.

Terbinafin, inhibiting a skvalenepoksidaza in a cellular membrane of a mushroom (not belonging to system of P450 cytochrome), 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.

Terbinafin does not exert impact on metabolism of hormones or other. Hp.

Pharmacokinetics. At topical administration absorption less than 5%, has insignificant systemic action.

Indications to use:

Prevention and treatment of fungal infections of skin, including mycoses of feet (foot "fungus"), an inguinal epidermophitia (tinea cruris), 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:

Outwardly. Spray is applied on affected areas of skin (after clarification and dehumidification) also by adjacent areas 1 or 2 of time a day in the quantity sufficient for careful moistening.

Duration and frequency rate of use:

• a dermatomycosis of a trunk, shins - 1 times a day during 1 week;
• a dermatomycosis of feet of-1 times a day during 1 week;
• multi-colored deprive - 1 week, 2 times a day.

The mode of dosing of Terbinafin of spray at elderly people does not differ from the aforesaid.

Features of use:

Use at pregnancy and a lactation. In pilot studies of teratogenic properties of a terbinafin it was not revealed. So far it was not reported about any malformations at use of a terbinafin. However, as clinical experience of use of a terbinafin for pregnant women is very limited, it should be applied only according to strict indications.

Terbinafin is allocated with breast milk. However, in case of use by the nursing mother of Terbinafin of spray, through skin a small amount of active agent therefore an adverse effect on the baby is improbable is soaked up.

Reduction of expressiveness of clinical manifestations is usually noted in the first days of treatment. In case of irregular treatment or its premature termination there is a risk of a recurrence of an infection. If in a week of treatment improvement signs are not noted, it is necessary to verify the diagnosis.

It is necessary to be careful when drawing Terbinafin's of spray on the damaged sites of skin as alcohol can cause irritation.

Terbinafin spray is intended only for external use. It is necessary to avoid hit it in eyes as it can cause irritation. At accidental hit of drug in eyes, they should be washed out immediately flowing water, and in case of development of the resistant phenomena of irritation it is necessary to consult with the doctor.

If the drug was accidentally administered in respiratory tracts at inhalation, then, in case of any symptoms and, especially at their permanent preservation, it is necessary to consult with the doctor.

Terbinafin spray contains propylene glycol which can cause irritation of skin. At development of allergic reactions it is necessary to cancel drug.

Influence on control of motor transport and mechanisms. After external use of a terbinafin it was not reported about any effects influencing ability to control of vehicles or work with other mechanisms.

Side effects:

At assessment of frequency of occurrence of various side reactions the following gradation are used: often - 1-10%; not often - 0.1-1%; seldom - 0.01-0.1%; frequency is unknown (according to the available data it is impossible to establish emergence frequency).

Disturbances from immune system. Frequency is unknown: hypersensitivity.

Disturbances from organs of sight. Seldom: irritation of eyes.

The general disturbances and reactions in a site of application. Not often: pain, pain and irritation in a site of application. Seldom: aggravation of symptoms.

In isolated cases allergic reactions (an eurysynusic itch, rash, violent rashes and urticaria) demanding drug withdrawal are possible.

Interaction with other medicines:

Any medicinal interactions for Terbinafin of spray are not known. As researches of compatibility were not conducted, it is not recommended to use drug together with other means for external use.

Contraindications:

Hypersensitivity to drug components, children's age (up to 12 years).

With care. Renal/liver failure, alcoholism, oppression of a marrowy hemopoiesis, tumor, metabolism disease, occlusal diseases of vessels of extremities.

Overdose:

Owing to low system absorption the overdose of spray is extremely improbable. If accidentally Terbinafin spray is accepted inside, it is possible to expect development of the same by-effects, as well as at overdose of tablets (a headache, nausea, pains in epigastriums and dizziness). It is also necessary to consider the content in alcohol drug (33% on weight).

Treatment: absorbent carbon, if necessary - a symptomatic maintenance therapy.

Storage conditions:

At a temperature from 2 to 20 °C in the dry, protected from light place. To store in the place, unavailable to children. A period of validity - 2 years. Not to apply after a period of validity.

Issue conditions:

Without recipe

Packaging:

Spray for external use of 10 g and 20 g. On 10 and 20 g in the bottles of neutral glass corked by the blooming microsprayer with a raspylitelny nozzle and a protective cap. Each bottle is placed in a pack from a cardboard.