Terbinafin

General characteristics. Structure:

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

Excipients: alcohol, the water purified a macrogoal 400, propylene glycol.

Antifungal drug for local use with fungicidal and a fungistasis.

Pharmacological properties:

Pharmacodynamics. Terbinafin represents allylamine derivative with a wide range of antifungal action. In therapeutic concentration тербинафин has fungicidal effect concerning drozhzhepodobny, dimorphous mushrooms, and also dermatophytes. Terbinafin's action can be fungicidal or fungistatic, depending on a species of mushrooms. Terbinafin specifically suppresses an early stage of biosynthesis of sterols in a mushroom cell.

Terbinafin acts due to suppression of activity of enzyme of a skvalenepoksidaza in a cellular membrane of a mushroom. It results in deficit of ergosterol and to intracellular accumulation of squalene that causes death of a cell of a mushroom. Enzyme of a skvalenepoksidaz is not a component of system of P 450 cytochrome therefore тербинафин does not influence metabolism of hormones or other medicines. Terbinafin is effective concerning dermatophytes of the sorts Trichophyton, Microsporum, Epidermophyton, drozhzhepodobny mushrooms of the sort Candida (in the main Candida albicans), and also Pityrosporum orbiculare (Malassezia furfur) – scaly (multi-colored) depriving of the activator.

Pharmacokinetics. Medicine quickly diffuses through an epidermal layer of skin and collects in a lipophilic corneous layer. Terbinafin also cosecretes in skin fat therefore its high concentration in hair follicles, hair and fat skin are created. After 7 days of topical administration of a terbinafin fungicidal concentration is measured in a corneous layer of skin within 7 days.

At Terbinafin's use from the place of application less than 5% of its dose are soaked up owing to what systemic action of medicine can be neglected.

Indications to use:

- the fungal infections of skin caused by such dermatophytes as Trichophyton (including T. rubrum, T.mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermopyton floccosum;

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

Route of administration and doses:

Medicine is intended for use for adults and children 12 years are more senior. Terbinafin apply one or twice a day, depending on indications. Before use of medicine it is necessary to clear and dry affected areas carefully. Solution is applied on affected areas and intact sites of skin adjoining to them in the quantity sufficient for their careful moistening, if necessary using cotton plugs for optimization of this process. The site of application of medicine is covered with a gauze bandage.

Duration of treatment and frequency rate of use of medicine:

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

Efficiency and safety of solution of a terbinafin for treatment of mycoses of feet of "mokasinovy" type, and also heavy mycoses of feet with the accompanying onychomycoses are not studied.

Reduction of expressiveness of clinical manifestations is 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.

Features of use:

Solution of a terbinafin is intended only for external use. It is not necessary to put solution on a face. It is necessary to avoid hit in eyes as it can cause irritation. At accidental hit of drug in eyes, they should be washed out flowing water.

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

The propylene glycol which is a part of medicine can cause irritation of skin.

At treatment by Terbinafin it is necessary to follow the general rules of hygiene for prevention of a possibility of repeated infection (through linen, footwear, etc.).

Influence on ability to drive the car and to work with mechanisms. External use of solution does not exert impact on ability to management of transport and mechanisms.

Side effects:

In sites of application of solution reddening, feeling of an itch or burning, a skin peeling, pain or irritation can appear, however the termination of treatment because of these phenomena is required seldom. These, not so serious by-effects, it is necessary to distinguish from seldom arising allergic reactions (for example, generalized rash and/or reddening, a small tortoiseshell, a Quincke's disease, repeated allergic reaction) which development demands the treatment termination. The exacerbation of a fungal infection is in rare instances possible.

Use at pregnancy and a lactation. Because there are no data on safety of a terbinafin during pregnancy and feeding by a breast, it is only necessary to appoint medicine when the expected positive effect at mother exceeds potential risk for a fruit. It is known what тербинафин is allocated with breast milk therefore it is not necessary to appoint drug during chest feeding.

Interaction with other medicines:

Interaction of solution of a terbinafin for topical administration with other medicines is unknown.

Contraindications:

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

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

Use for children. It is not necessary to apply medicine at children under 5 years due to the lack of clinical data.
There is no enough data on safety and efficiency of use of medicine for children aged up to 12 years.

Patients of advanced age. Dose adjustment is not required. Side effects do not differ from those which are observed at patients of other age groups.

Overdose:

Data on overdose at topical administration of Terbinafin are absent. If accidentally solution is accepted inside, it is possible to expect development of such by-effects as a headache, nausea, pains in epigastriums and dizziness. In such cases the gastric lavage and/or the supporting symptomatic treatment can be necessary. It is also necessary to consider the content in alcohol medicine (23,5%).

Treatment: absorbent carbon, if necessary - a symptomatic maintenance therapy in the conditions of a hospital.

Storage conditions:

To store in the place protected from light at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity 2 years.

Issue conditions:

Without recipe

Packaging:

On 25 ml, 30 ml in the bottles from polyethyleneterephthalate placed together with a leaf insert for the consumer in packs from a cardboard.