Дермовейт

Дермовейт – outside drug with antiinflammatory action.

Form of release and structure

Дермовейт release in the following dosage forms:

• Ointment for external use of 0,05%: almost white or white color, translucent, soft (on 25 g in aluminum tubas, on 1 tuba in a cardboard pack);
• Cream for external use of 0,05%: almost white or white color, translucent, soft (on 25 g in aluminum tubas, on 1 tuba in a cardboard pack).

Is a part of 100 g of ointment:

• Active agent: propionate of a klobetazol – 0,05 g;
• Auxiliary components: sorbitan sesquioleate – 0,5 g; propylene glycol – 5 g; white soft paraffin – to 100 g.

Is a part of 100 g of cream:

• Active agent: propionate of a klobetazol – 0,05 g;
• Auxiliary components: monohydrate of citric acid – 0,05 g; glyceryl monostearate – 11 g; substitute of wax of bee 6621 - 1,25; cetostearyl alcohol – 8,4 g; propylene glycol glyceryl oleate (арлацель 165) – 1,5 g; propylene glycol – 47,5 g; chlorocresol – 0,075 g; sodium citrate – 0,05 g; the purified water – to 100 g.

Indications to use

Дермовейт appoint to adults, including patients of advanced age, and children of 1 year for relief of symptoms of a skin itch and an inflammation at the dermatosis showing sensitivity to therapy by glucocorticosteroids. Indications to use of drug are:

• Diskoidny lupus erythematosus;
• Psoriasis (except widespread blyashechny psoriasis);
• Red flat deprive;
• The dermatosis showing resistance to therapy by less active outside glucocorticosteroids;
• Various forms of eczema.

Дермовейт in the form of ointment promotes preservation of moisture in skin therefore it is recommended to be applied at damages of skin which are followed by its dryness, a thickening and a hyperkeratosis.

Contraindications

• Widespread blyashechny psoriasis;
• Pink eels (rozatsea);
• Bacterial, fungus and viral skin diseases (including a tuberculosis cutis, a herpes simplex, chicken pox, an actinomycosis);
• Carcinoma cutaneum;
• Perianal and genital itch;
• Acne;
• Uzlovaya prurigo of the Guide;
• Skin itch in lack of an inflammation;
• Perioral dermatitis;
• Age till 1 year;
• Period of chest feeding (lactation);
• Hypersensitivity to drug components.

Pregnant women of Dermoveyt need to apply with care.

Route of administration and dosage

Дермовейт apply outwardly.

Drug in the form of ointment or cream should be applied with a thin layer 1-2 times a day in the quantity sufficient for a covering of all struck area and to rub carefully. Дермовейт apply before emergence of therapeutic effect (if necessary – up to 4 weeks). If more long therapy is required, the frequency of drawing is recommended to be reduced or passed to use of less active drug gradually. Before use of an emollient after each putting drug it is necessary to provide sufficient time for Dermoveyt's influence. At treatment of exacerbations of skin diseases it is possible to conduct repeated medical courses.

In especially resistant cases, especially at a hyperkeratosis, Dermoveyt's effect can be strengthened by means of imposing for night of an occlusive bandage on a drug scope that usually gives positive effect which manages to be supported further without use of this method.

If within 2-4 weeks the state does not improve or aggravated, it is necessary to revise the diagnosis and the carried-out therapy.

As much as possible a dose – 50 g a week.

At treatment of atopic dermatitis (eczema) at once after achievement of control over a disease Dermoveyt's use needs to be cancelled gradually, and treatment by an emollient can be continued in the form of a maintenance therapy. Sharp drug withdrawal can lead to a recurrence of earlier being available dermatosis.

At various forms of eczema the patient with a frequent recurrence of a disease at acute disease of Dermoveyt apply continuously. After achievement of effect it is possible to consider the possibility of its discontinuous use (without occlusive bandage once a day, twice a week). Such use of drug is effective for decrease in frequency of development of a recurrence.

Dermoveyt's drawing needs to be continued on all earlier affected areas of skin or on the known areas of a potential aggravation. Such scheme of use of drug has to be combined with daily routine use of emollients.

It is necessary to carry out regular assessment of a state, and also to estimate advantage and risk of therapy continuation.

At children development of system and local side effects is more probable, than at adults. In this regard by it, as a rule, appoint shorter medical courses with use of less active means. When using Dermoveyt's at children it is necessary to be careful to provide therapeutic effect at the minimum quantity of the used drug.

At patients of advanced age of Dermoveyt it has to be applied during shorter period and in the minimum quantity sufficient for achievement of necessary clinical effect.

At system absorption of Dermoveyt (at long use on the extensive surfaces of skin) its removal and metabolism can be slowed down that results in the increased risk of emergence of system toxicity. In these cases drug has to be used during shorter period and in the minimum quantity, but sufficient for achievement of necessary clinical effect.

Side effects

During therapy development of disturbances from some systems of an organism which are shown in the form of the following side effects is possible:

• Endocrine system: very seldom – oppression гипоталамо - pituitary and adrenal system, signs of cushingoid (obesity on the central type, a crescent-shaped face), a growth inhibition and/or a delay of increase in body weight at children, glaucoma, osteoporosis, a glucosuria and/or a hyperglycemia, a hypertension, a cataract, obesity or increase in body weight, an alopecia, decrease in level of endogenous cortisol, fragility of hair;
• Immune system: very seldom – hypersensitivity;
• Skin and hypodermic fabrics: often – morbidity or burning sensation, an itch; infrequently – striya, a local atrophy of skin, a teleangiectasia; very seldom – thinning, rugosity of skin, a small tortoiseshell, aggravation of symptoms of a disease, a xeroderma, a hypertrichosis, pigmentation change, pustular psoriasis, allergic contact dermatitis, rash, an erythema (many of the described skin manifestations are secondary in relation to system and/or local effects of oppression гипоталамо - pituitary and adrenal system);
• Parasitic and infectious diseases: very seldom – the infections caused by opportunistic organisms;
• General frustration: very seldom – morbidity and/or irritation in a site of application.

When drawing Dermoveyt's on big surfaces throughout a long span (for example, more than 14 days), at patients such system side effects as can develop: hypercorticoidism symptoms, gastritis, increase in intraocular pressure, ulceration of a mucous membrane of digestive tract.

Special instructions

Дермовейт it is necessary to apply with care at patients with existence in the anamnesis of local hypersensitivity to glucocorticosteroids or to any of drug excipients.

Local reactions of hypersensitivity often have similarity to symptoms of the proceeding disease. At some patients because of the increased system absorption of outside glucocorticosteroids development of reversible oppression гипоталамо - pituitary and adrenal system and a hypercorticoidism (Cushing's syndrome) is possible that can result in glucocorticosteroid insufficiency. At emergence of any of the described disturbances of Dermoveyt it is necessary to cancel, gradually reducing the frequency of its drawing, or to replace it with less active glucocorticosteroid. The sharp termination of therapy can lead to development of glucocorticosteroid insufficiency.

Strengthening of system effects is observed with the following risk factors:

• Drawing on area with thin skin (for example, on the person);
• Drug use duration;
• Dosage form and activity of a glucocorticosteroid for external use;
• Dermoveyt's drawing on extensive sites of skin;
• The increased hydration of a corneous layer of skin;
• Putting drug on the closed areas of skin (under occlusive bandages (at babies diapers and diapers can play a role of an occlusive bandage) or in intertriginozny zones);
• Dermoveyt's drawing on the injured skin or in the presence of other states which can be followed by disturbance of integrity of a skin barrier.

At babies and children is more senior the bigger percent of absorption of glucocorticosteroids for external use can be noted, than at adults in this connection at this category of patients the risk of development of system side effects is higher.

It is necessary to avoid purpose of outside glucocorticosteroids for an appreciable length of time at children, especially at therapy of children of younger age as it can lead to oppression of function of adrenal glands. During therapy it is necessary to undergo medical observation at least once a week. As a result of prolonged use of Dermoveyt on a face more often than on other body parts, there can be atrophic changes of skin that needs to be considered at treatment of a diskoidny lupus erythematosus, heavy eczema and psoriasis with localization on a face.

Treatment of psoriasis can be followed by drug resistance, resuming of symptoms of a disease, development of a generalized pustular form of psoriasis and system or local side reactions because of disturbance of barrier function of skin. At therapy of a disease attentive observation of the patient is especially important.

In cases of accession of consecutive infection it is necessary to carry out the corresponding antibacterial treatment. At any signs of development of generalization of an infection it is necessary to stop external use of Dermoveyt and to carry out the corresponding therapy by antibacterial medicines.

It is necessary to clear carefully skin before imposing of a new occlusive bandage as wet warm conditions which it creates promote developing of a bacterial infection.

Therapy of dermatitis around chronic ulcers of shins can be followed by the increased risk of development of local infections and the increased frequency of emergence of local reactions of hypersensitivity.

Dermoveyt's drawing on face skin is undesirable as this area is more subject to development of atrophic changes. In need of putting drug on face skin, its use it is necessary to limit several days. When putting drug on eyelids it is necessary to watch that it did not get into eyes (because of risk of developing of glaucoma or a cataract).

Medicinal interaction

Simultaneous use of Dermoveyt with the drugs capable to inhibit CYP3A4 isoenzyme (for example, with itrakonazoly and ritonaviry), oppresses metabolism of a glucocorticosteroid, leading to increase in its system exposure. Degree of the clinical importance of this interaction depends on a route of administration and Dermoveyt's dose, and also on activity of inhibitor of an isoenzyme of CYP3A4.

Terms and storage conditions

To store in the place, unavailable to children, at a temperature up to 30 °C.

Period of validity – 2 years.