Terbized-Adzhio

General characteristics. Structure:

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

Excipients: sodium hydroxide, benzyl alcohol, sorbitan stearate, cetyl palmitate, cetyl alcohol, alcohol of steariloviya, polysorbate 60, isopropyl myristate, the water purified.

Pharmacological properties:

Pharmacodynamics. Antifungal drug from group of allylamines. Has a wide range of antifungal action. In low concentration тербинафин has fungicidal effect concerning dermatophytes, mold and some dimorphous mushrooms. Activity concerning barmy mushrooms, depending on their look, can be fungicidal or fungistatic.

Terbinafin specifically suppresses an early stage of biosynthesis of sterols in a mushroom cell. It causes deficit of ergosterol and intracellular accumulation of squalene that leads to death of cells of a mushroom. Terbinafin acts by skvalenepoksidaza enzyme inhibition in a cellular membrane of a mushroom.

Enzyme of a skvalenepoksidaz does not belong to system of P450 cytochrome. Terbinafin does not influence metabolism of hormones or other medicines.

Pharmacokinetics. After topical administration тербинафин insignificant degree minimum is soaked up in a system blood stream (less than 5% of a dose), that is systemic action of drug. Terbinafin substantially contacts proteins of a blood plasma (99%). It quickly gets through a blanket of skin and collects in a lipophilic corneous layer. Terbinafin also gets into a secret of sebaceous glands. Drug gets into nail plates in the first several weeks from the beginning of therapy. Terbinafin is metabolized in a liver with formation of inactive metabolites. The majority of inactive metabolites (71%) is removed with urine, a smaller part (22%) – with a stake.

The final elimination half-life makes 11 - 17 hours. It is allocated in breast milk. There are no messages concerning development of cumulation. Changes of equilibrium concentration of a terbinafin in plasma depending on age are not revealed, but at patients with a renal failure or a liver drug removal speed can be slowed down that leads to formation of higher concentration of a terbinafin in blood.

Indications to use:

• The fungal infections of skin caused by such dermatophytes as Trichopyton (for example, T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum.
• Barmy infections of skin, generally those which are caused by sort Candida mushrooms (for example, Candida albicans).
• Multi-colored deprive (Pityriasis versicolor), the caused Pityrosporum orbiculare.

Route of administration and doses:

Apply the adult outwardly. Drug is applied on skin by 1-2 times a day depending on a disease. Duration of treatment depends on weight of a course of a disease.

Before putting cream it is necessary to clear and dry affected areas. Cream is imposed a thin layer on the affected skin and by adjacent sites and slightly rub. At the infections which are followed by an intertrigo of folds of skin (under mammary glands, in interdigital intervals, between buttocks, in inguinal area), places with the applied cream can be covered with a gauze, especially for the night.

Average duration of treatment:

- the epidermophitia is interdigitalny, including "the athlete's foot": 1 week of 1 times a day.
- the epidermophitia is disgidrotichesky, skvamoznogiperkeratichesky: 2 weeks 2 times a day.
- a dermatomycosis pakhovy and trunks – 1 week of 1 times a day.
- skin candidiasis: 1-2 weeks 1-2 times a day.
- multi-colored deprive: 2 weeks 1-2 times a day.

For patients of advanced age correction of a dose is not required.

Reduction of expressiveness of clinical manifestations usually happens within several days of treatment. At irregular treatment or its premature termination there is a risk of a recurrence of an infection. If signs of improvement of a clinical picture are not observed, it is necessary to carry out verification of the diagnosis.

Features of use:

Terbized cream is intended only for external use. It is necessary to avoid contact of drug with eyes. At accidental hit of cream in their eyes it is necessary to wash out carefully flowing water. After putting cream it is necessary to wash up hands carefully.

Use during pregnancy or feeding by a breast. As experience of a clinical use of drug Terb_zed for treatment of pregnant women is limited, during pregnancy it can be applied only when the expected advantage for mother exceeds potential risk for a fruit. Terbinafin is allocated in breast milk. Therefore women should not use drug during feeding by a breast. Babies cannot contact to skin on which applied cream, including with breast skin.

Ability to influence speed of response at control of motor transport or work with other mechanisms. It is not known.

Children. Safety and efficiency of use of drug for treatment of children are not established therefore patients of this age group are not recommended to appoint drug.

Side effects:

In places of applications of drug there can be erubescence, feeling of an itch or burning, however these phenomena seldom result in need to stop treatment. These by-effects should be distinguished from allergic reactions which arise infrequently, but their development always demands the treatment termination. In case of any signs of undesirable reactions it is necessary to stop treatment and to see a doctor.

Interaction with other medicines:

There are no data on interaction with other medicines.

Contraindications:

The increased individual sensitivity to a terbinafin or to other components of drug.

Overdose:

About cases of overdose it was not reported. If cream accidentally gets in an organism, it is possible to expect development of such by-effects, as well as at overdose in case of oral administration of drugs of a terbinafin: nausea, pain in epigastric area, diarrhea, dizziness, a neutropenia, thrombocytopenia.

Treatment: gastric lavage, symptomatic therapy.

Storage conditions:

Period of validity - 2 years. Not to use drug after the termination of the period of validity specified on packaging. To store in the dry place at a temperature not over 25 ºС. Not to freeze. To store in the place, unavailable to children.

Issue conditions:

Without recipe

Packaging:

On 10 g of cream in a tuba, in a cardboard box.