Этривекс

General characteristics. Structure:

Active agent: a klobetazola propionate - 500 micrograms.

Excipients: ethanol 96%-100,00 mg; кокобетаин - 60,00 mg; sodium lauryl sulfate - 170,00 mg; поликватерниум-10 - 20,00 mg; sodium citrate - 26,00 mg; citric acid monohydrate - 2,40 mg; the water purified-621,10 mg.

Pharmacological properties:

Pharmacodynamics. Like other glucocorticosteroids for external use, клобетазол has antiinflammatory, antipruritic and vasoconstrictive properties. The mechanism of antiinflammatory activity of local glucocorticosteroids is not up to the end studied. However it is considered that glucocorticosteroids work by induction of lipokortin - proteins which in turn are A2 phospholipase inhibitors. In turn leads Iigibirovany phospholipases of A2 to suppression of release of arachidonic acid which is a predecessor of such powerful mediators of an inflammation as prostaglandins and leukotrienes. Thus клобетазол due to induction of lipokortin leads to decrease in biosynthesis of the main mediators of an inflammation, and, therefore, has antiinflammatory effect.

Pharmacokinetics. Data on pharmacokinetics indicate that probability of system effects after a clinical use of shampoo of Etriveks extremely low because of low system bioavailability of a klobetazol.
When drawing on extensive sites of skin absorption (damage of integrity or an inflammation of integuments strengthens absorption) and manifestation of system effect is possible. A small part - in kidneys is metabolized generally in a liver; it is removed by kidneys.

Indications to use:

Treatment and prevention of a recurrence of psoriasis of a pilar part of the head of adults (except for pustular and extensive blyashechny psoriasis).

Route of administration and doses:

Outwardly.
It is applied only on skin of a pilar part of the head. A basic course of treatment with daily use of shampoo
Shampoo of Etriveks of 0,05% should be applied daily on dry head skin, carefully rubbing in affected areas. For one drawing on all pilar part of the head about 7,5 ml (a half of a tablespoon) at any quantity of affected areas there are enough.
It is necessary to leave the applied shampoo of Etriveks of 0,05% on the head for 15 minutes (without covering the head), and then to wash away. After drawing a hand it is necessary to wash up carefully. In 15 minutes shampoo should be washed away water and/or to wash up hair usual shampoo. Then to dry up hair, as usual.
Duration of a basic course of treatment with daily putting drug should not exceed 4 weeks. If in four weeks of improvement does not occur, to revise the diagnosis and therapy.

Maintenance therapy using shampoo two times a week
After clarification of the centers and also in case after 4 weeks of a basic course the patient has small amount of psoriasis scales, it is necessary to apply shampoo of Etriveks of 0,05% two times a week to maintenance of therapeutic effect and the prevention of a recurrence. Such maintenance therapy is effective within 6 months.

For prevention of aggravations it is possible to carry out repeated courses of treatment with daily putting shampoo of Etriveks of 0,05%. A course has to be conducted in the presence of the doctor.

Features of use:

Glucocorticosteroids should be applied to external use with care for several reasons, including because of possibility of a recurrence of a disease after the termination of treatment, development of stability (tachyphylaxis) and local or system toxicity.

In rare instances at intensive or prolonged treatment of psoriasis glucocorticosteroids, such treatment or cancellation of glucocorticosteroids provokes the outbreak of generalized pustular psoriasis. Hypersensitivity reactions to glucocorticosteroids are seldom or never observed. The possibility of hypersensitivity reaction should be considered in case of resistance to treatment.

Generally, long continuous therapy with daily drawing glucocorticosteroids, use of occlusive bandages on the head is connected with the increased risk of emergence of system effects. In such cases it is necessary to double the medical watch and to regularly inspect the patient regarding suppression of gipotalyamo-pituitary system. Such system effects disappear after the treatment termination. However at bystry cancellation acute insufficiency of adrenal glands can develop.

Shampoo of Etriveks of 0,05% is intended only for treatment of psoriasis of a pilar part of the head and should not be applied on other parts of a body. In particular, shampoo of Etriveks of 0,05% is not recommended for drawing for face skin, eyelids, sites of folded skin (axillary hollows, genital and proctal area) and for erozirovanny sites of skin as it increases risk of emergence of the local undesirable phenomena, such as atrophic changes of skin, a teleangiectasia or dermatitis.

Drug is recommended for short-term use; if necessary carrying out short repeated courses is possible.
At hit of shampoo of Etriveks of 0,05% in eyes it is necessary to wash out immediately their large number waters.

Influence on ability to driving and other mechanisms:
As the glucocorticosteroid for external use, shampoo of Etriveks of 0,05% does not influence ability to manage vehicles and to be engaged in other potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Side effects:

At emergence of signs of hypersensitivity treatment should be stopped immediately.

Frequency of side effects is distributed in the following order: often (in 1% - 10% of cases); infrequently (in 0,1% - 1% of cases); seldom (in 0,01% - 0,1% of cases); very seldom (less than 0,01% of cases), including messages on single side effects.

From skin and a hypodermic fatty tissue:
Infrequently: a sensation of discomfort, a folliculitis, acne rash (in drug sites of application), a cutaneous dropsy, telangiectasias, psoriasis (aggravation), a dermatalgia, an itch, a small tortoiseshell, a skin atrophy, a xeroderma, an alopecia, irritation of skin, tightening of skin, an erythema, rash, allergic contact dermatitis.

From an organ of sight (at accidental hit in eyes): Infrequently: irritation of eyes

From a nervous system: Infrequently: headache

As клобетазол prolonged daily use belongs to the glucocorticosteroids relating to the class for external use, drawing on the extensive areas of skin or drawing large numbers can lead to the system absorption sufficient for development of characteristic signs of a hypercorticoidism (Cushing's syndrome) or suppression гипоталямо - pituitary and adrenal system which carries tranzitorny (short-term) and quickly reversible character. However, as shampoo of Etriveks of 0,05% is applied for only 15 minutes, system absorption is observed only in rare instances and therefore the risk of suppression гипоталямо - pituitary and adrenal system at use of shampoo is much lower, than when drawing powerful glucocorticosteroids. During clinical tests of shampoo of Etriveks of 0,05% about suppression cases гипоталямо - the pituitary and adrenal system was not reported. Prolonged and/or intensive treatment by powerful glucocorticosteroids can cause local atrophic changes, such as a local atrophy of skin, a striya, a teleangiectasia, an erythema, a purpura, contact dermatitis. At hit on face skin very powerful glucocorticosteroids can cause perioral dermatitis, an atrophy of skin or an aggravation of a rozatse.
There are messages on pigmentation change, developing of acne rash, pustular rashes and a hypertrichosis at external use of powerful glucocorticosteroids.

Interaction with other medicines:

Medicinal interactions are not known.

Contraindications:

- Hypersensitivity to active ingredient or to any of drug ingredients.
- The skin diseases caused by mikobakterialny, viral, fungal or parasitic infections.
- Children up to 18 years.
- Not to allow hit of shampoo of Etriveks of 0,05% in eyes and on eyelids (risk of development of glaucoma, cataract) or on ulcerated skin surfaces.

Pregnancy and period of a lactation:
Use is contraindicated during pregnancy and the period of breastfeeding.

Overdose:

The acute overdose is very improbable, however at chronic overdose or the wrong use hypercorticoidism signs can appear. In such situation treatment should be cancelled gradually. However because of risk of acute suppression of function of adrenal glands it needs to be done under observation of the doctor.

Storage conditions:

At a temperature not above + 25 °C to Store in the place, unavailable to children!

Issue conditions:

According to the recipe

Packaging:

Shampoo of 0,05% on 30 ml, 60 ml, 125 ml in a bottle from polyethylene of high density with the screwing-up cover (for bottles on 30 ml) or with a cap (for bottles on 60 ml and 125 ml). On 1 bottle together with the application instruction place in a cardboard machka.