Terbinafin

General characteristics. Structure:

Active ingredient: 10 mg of a terbinafin of a hydrochloride.

Excipients: benzyl alcohol, polysorbate 60 (twin 60), sorbitan monostearate, cetyl alcohol, isopropyl myristate, cetyl palmitate, sodium hydroxide, the water purified.

The antifungal drug for topical administration possessing a wide range of antifungal activity.

Pharmacological properties:

Pharmacokinetics. The antifungal drug for topical administration possessing a wide range of antifungal activity. Even in small concentration тербинафин has fungicidal effect concerning dermatophytes (Trychophyton rubrum, T.mentagrophytes, T.verrucosum, T.violaceum, T.tonsurans, Microsporum canis, Epidermophyton flocco-sum), mold (in the main C.albicans) and certain dimorphous mushrooms (Pityrosporum orbicu-lare). Activity concerning barmy mushrooms, depending on their look, can be fungicidal or fungistatic.

Terbinafin in unusual way changes an early stage of the biosynthesis of sterol happening in mushrooms. It leads to deficit of ergosterol and intracellular accumulation of squalene that causes death of a cell of a mushroom. Action of a terbinafin is carried out by inhibition of the enzyme of a skvalenepoksidaza located on a cellular membrane of a mushroom.

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

Pharmacokinetics. At topical administration absorption — 5%, have insignificant systemic action.

Indications to use:

Prevention and treatment of a fungus, 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 (in that number, T. rubrum, T. mentagrophytes, T. verrucosum, T.violaceum), Microsporum canis and Epidermophyton floccosum.

Barmy infections of skin, generally those which are caused by the sort Candida (for example, Candida albicans), in particular an intertrigo.

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

Route of administration and doses:

Adults and children since 12 years. Before putting cream it is necessary to clear and dry affected areas. Cream is applied by one or two times a day with a thin layer on the affected skin and adjacent sites and slightly rub.

At the infections which are followed by an intertrigo (under mammary glands, in interdigital intervals, between buttocks, in inguinal area), sites of application of cream can be covered with a gauze, especially for the night. At extensive fungal infections of a body it is recommended to apply cream in tubas on 30 g.

Average duration of treatment:
- Dermatomycosis of a trunk, shins: 1 week once a day
- Dermatomycosis of feet: 1 week once a day
- Skin candidiasis: 1-2 weeks 1 or 2 times a day
- Multi-colored deprive: 2 weeks 1 or 2 times a day

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 resuming of an infection. If in one-two weeks of treatment improvement signs are not noted, it is necessary to carry out verification of the diagnosis.

The drug dosing mode at elderly people does not differ from the aforesaid. Use of drug for children. Use of this drug for children up to 12 years is not recommended.

Features of use:

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.

Terbinafin cream 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. At development of allergic reactions it is necessary to cancel drug.

Pregnancy and lactation. In pilot studies of teratogenic properties of a terbinafin it was not revealed. So far it was not reported about any malformations at Terbinafin's use. However, as clinical experience of use of 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 cream through skin a small amount of active agent therefore an adverse effect on the baby is improbable is soaked up.

Side effects:

In sites of application of drug reddening, feeling of an itch or burning can appear. Allergic reactions.

Interaction with other medicines:

Any medicinal interactions for Terbinafin of cream are not known.

Contraindications:

Hypersensitivity to a terbinafin or to any of the inactive ingredients which are a part of drug.

With care: a liver and/or renal failure, alcoholism, oppression of a marrowy hemopoiesis, a tumor, a metabolism disease, occlusal diseases of vessels of extremities, children's age up to 12 years (lack of sufficient clinical experience).

Overdose:

About cases of overdose of drug it was not reported. If it is accidental тербинафин cream will be 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).

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

Storage conditions:

Period of validity 2 years. Not to apply after expiry date. In dry, protected from light, the place, unavailable to children, at a temperature not above 25 °C.

Issue conditions:

Without recipe

Packaging:

Cream for external use of 1% on 15 g or 30 g in tubas aluminum or on 30 g in banks from orange glass. Each tuba or to bank together with the application instruction is placed in a pack from a cardboard.