Дермовейт

General characteristics. Structure:

Ointment for external use of 0.05% of white or almost white color, soft, translucent.

Active ingredient: klobetazola propionate of 50 mg *

Excipients: propylene glycol - 5 g, sorbitan sesquioleate - 500 mg, white soft paraffin - to 100 g.

* nominal quantity of a klobetazol of propionate - 53.75 mg (taking into account 7.5% of surplus).

Pharmacological properties:

GKS for external use. Prevents regional accumulation of neutrophils, reduces inflammatory exudation and products of lymphokines, slows down migration of macrophages, reduces intensity of processes of infiltration and granulation, renders local antiinflammatory, antipruritic, antiallergic anti-exudative effects.

Pharmacokinetics. Absorption

Outside GKS can be exposed to system absorption from intact healthy skin. Extent of transdermal absorption of GKS for external use is defined by a number of factors, including a basis of medicine and integrity of an epidermal barrier. Occlusion, an inflammation and/or other pathological process from skin are also capable to increase transdermal absorption.

Average Cmax of a klobetazol in plasma is reached in 13 h after the first application and in 8 h after repeated drawing on healthy skin of 30 g of a klobetazol in the form of 0.05% of ointment and makes 0.63 ng/ml. In 10 h after application of the second dose (30 g) of a klobetazol in the form of cream its Cmax slightly exceeds that ointments. In a separate research in 3 h after single use of 25 g of 0.05% of ointment of a klobetazol for patients with psoriasis and eczema of Cmax makes 2.3 ng/ml and 4.6 ng/ml respectively.

Distribution

Use of pharmakodinamichesky final points for external use is necessary for assessment of system exposure of glucocorticosteroids in communication that concentration of the drug circulating in blood was much lower than a detection limit.

Metabolism

After absorption through GKS skin for external use are metabolized in the same pharmacokinetic ways, as GKS for system use. They are metabolized, mainly, in a liver.

Indications to use:

The drug Dermoveyt® is highly active GKS for external use which is shown for use for adults, elderly people and children 1 years for relief of symptoms of an inflammation and a skin itch at the dermatosis sensitive to therapy of GKS are aged more senior.

— psoriasis (excepting widespread blyashechny psoriasis);

— eczema (various forms);

— red flat deprive;

— diskoidny lupus erythematosus;

— the dermatosis steady against therapy by less active GKS for external use.

As drug in the form of ointment promotes preservation of moisture in skin, it is recommended to apply ointment to external use of Dermoveyt® at the damages of skin which are followed by its dryness, a hyperkeratosis and a thickening.

Route of administration and doses:

Outwardly.

Ointment is applied by a thin layer in the quantity sufficient for a covering of all struck area, 1-2, carefully rubbed. Use duration — before emergence of effect or if necessary up to 4 weeks. If it is required to continue treatment, then it is recommended to reduce gradually the frequency of drawing or to pass a pas use of less active drug. It is necessary to provide sufficient time for influence after each putting the drug Dermoveyt® before use of an emollient. For treatment of exacerbations of skin diseases conduct repeated courses the drug Dermoveyt®.

In especially resistant cases, especially in the presence of a hyperkeratosis, the effect of ointment for external use of Dermoveyt® can be strengthened by means of imposing for the night on a scope of drug of an occlusive bandage that usually is followed by positive effect. Further the reached effect manages to be supported without use of an occlusive bandage.

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

The maximum weekly dose should not exceed 50 g a week.

Atopic dermatitis (eczema)

Treatment klobetazoly should be cancelled gradually at once after achievement of control over a disease, and treatment by an emollient has to be continued as a maintenance therapy.

Sudden cancellation of a klobetazol can lead to a recurrence of earlier being available dermatosis.

Eczema (various forms)

Patients with a frequent recurrence of a disease

In case of an acute disease as soon as the effect of a continuous course of outside treatment is reached by a glucocorticosteroid, the possibility of its discontinuous use can be considered (once a day, two times a week, without occlusive bandage). It is shown that such treatment effectively reduces the frequency of development of a recurrence.

Putting drug has to be continued on all earlier affected areas of skin or on the known areas of a potential aggravation. Such scheme of use has to be combined with routine daily use of emollients. It is necessary to carry out regular assessment of a state, and also advantage and risk of treatment continuation.

Special groups of patients

Children

At children development of local and system side effects at outside therapy by glucocorticosteroids is more probable and, as a rule, they need carrying out shorter courses of treatment with use of less active means, than from adults.

It is necessary to be careful when using a klobetazol at children to provide its drawing in the minimum quantity providing therapeutic effect.

Patients of advanced age

Clinical trials did not reveal any distinctions in a drug effektivost at elderly and younger patients. Big prevalence of reduced function of a liver or kidneys at patients of advanced age can lead to delay of removal of drug in case of its system absorption. Therefore, it has to be applied at elderly patients in the minimum quantity and during shorter period, but at the same time providing achievement of necessary clinical effect.

Patients, with a renal failure and/or a liver

In case of system absorption of drug (when drawing on the extensive surfaces of skin during the long period) his metabolism and removal can be slowed down, resulting in the increased risk of development of system toxicity. Therefore, it has to be applied at such patients in the minimum quantity and throughout shorter period, at the same time providing achievement of necessary clinical effect.

Features of use:

The drug Dermoveyt® should be used with care at patients with existence in the anamnesis of local hypersensitivity to GKS or to any of excipients as a part of drug. Local reactions of hypersensitivity can have similarity to symptoms of the proceeding disease. Some persons as a result of the increased system absorption of GKS for external use can have manifestations of a hypercorticoidism (Cushing's syndrome) and reversible oppression гипоталамо - pituitary and adrenal system, leading to glucocorticosteroid insufficiency. If any of the above is observed, it is necessary to cancel drug, gradually reducing the frequency of its drawing, or to replace it with less active GKS. The sudden termination of treatment can lead to development of glucocorticosteroid insufficiency.

The following belongs to risk factors of strengthening of system effects: activity and a dosage form of GKS for external use, the use duration, putting drug on extensive sites of skin, use in the closed areas of skin (i.e. in intertriginozny zones or under occlusive bandages (diapers and diapers at babies can play a role of an occlusive bandage), the increased hydration of a corneous layer of skin, use on areas with thin skin, such as person, drawing on the injured skin or at other states which can be followed by disturbance of integrity of a skin barrier. In comparison with adults at children and babies the bigger percent of absorption of GKS for external use in this connection this category of patients is more subject to risk of development of system side effects can be noted. It is caused by the fact that children have an unripe skin barrier and bigger value of the relation of surface area of a body to body weight in comparison with adults.

Use for children

It is necessary to avoid purpose of GKS for external use for an appreciable length of time, especially at treatment of children of younger age since at the same time functions of adrenal glands can be oppressed. Use of the drug Dermoveyt® for children demands observation from the doctor at least 1 time a week. On a face more often than on other body parts, as a result of prolonged use of local GKS there can be atrophic changes of skin that shall be considered at treatment of psoriasis, a diskoidny lupus erythematosus and heavy eczema with localization of rashes on a face.

Use at psoriasis

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

The accompanying infection

At accession of consecutive infection it is necessary to carry out the corresponding antibacterial therapy. At any signs of generalization of an infection it is necessary to stop external use of GKS and to carry out the corresponding treatment by antibacterial drugs.

Risk of development of an infection at occlusion

The warm wet conditions created when imposing an occlusive bandage promote developing of a bacterial infection therefore it is necessary to clear surely carefully skin before imposing of a new bandage.

Chronic ulcers of shins

Outside glucocorticosteroids are sometimes used for treatment of dermatitis around chronic ulcers of shins. However such use can be followed by the increased frequency of emergence of local reactions of hypersensitivity and the increased risk of development of local infections.

Drawing on face skin

Drawing on face skin is undesirable since this area is more subject to development of atrophic changes. In case of drawing on face skin treatment should be limited several days.

Drawing on eyelids

When putting cream on eyelids it is necessary to watch that drug did not get into eyes because repeated influence of cream can cause a cataract and glaucoma.

Influence on ability to driving of motor transport and to control of mechanisms

Researches on studying of influence of a klobetazol on ability to control of vehicles or work with mechanisms were not conducted. Proceeding from a profile of side reactions of a klobetazol for external use, any adverse influence on such types of activity it is not expected.

Side effects:

The undesirable phenomena given below are listed depending on anatomo-physiological classification and frequency of occurrence. Frequency of occurrence is defined as follows: very often (≥1/10), it is frequent (≥1/100 and <1/10), infrequently (≥1/1 000 and <1/100), is rare (≥1/10 000 and <1/1 000), is very rare (<1/10 000, including separate cases). Categories of frequency were created on the basis of clinical trials of drug and post-registration observation.

Infectious and parasitic diseases: very seldom - the infection caused by opportunistic organisms.

From immune system: very seldom - hypersensitivity.

From endocrine system: very seldom - oppression гипоталамо - pituitary and adrenal system. Signs of cushingoid (a crescent-shaped face, obesity on the central type), a delay of an increase of body weight and/or a growth inhibition at children, osteoporosis, glaucoma, a hyperglycemia and/or a glucosuria, a cataract, a hypertension, increase in body weight or obesity, decrease in level of endogenous cortisol, an alopecia, fragility of hair.

From skin and hypodermic fabrics: often - an itch, burning sensation or morbidity; infrequently - a local atrophy of skin *, striya *, teleangiectasias *; very seldom - thinning *, rugosity of skin, a xeroderma *, pigmentation change *, a hypertrichosis, aggravation of symptoms of a disease, allergic contact dermatitis, pustular psoriasis, an erythema, rash, a small tortoiseshell.

* Skin manifestations are secondary in relation to local and/or system effects of oppression гипоталамо - pituitary and adrenal system.

General frustration and disturbances together introductions: very seldom - irritation and/or morbidity in a site of application.

When drawing on big surfaces during a long span (for example, more than 2 weeks), at patients system side effects can develop: gastritis, ulceration of a mucous membrane of a GIT, increase in intraocular pressure, hypercorticoidism symptoms.

Interaction with other medicines:

It was shown that simultaneous use of the drugs capable to inhibit CYP3A4 isoenzyme (for example, a ritonavira and an itrakonazola) oppresses metabolism of GKS, leading to increase in their system exposure. Degree of the clinical importance of this interaction depends on a dose and a route of administration of GKS and activity of inhibitor of an isoenzyme of CYP3A4.

Contraindications:

— bacterial, viral and fungus diseases of skin (including herpes simplex, chicken pox, tuberculosis cutis, actinomycosis);

— pink eels (rozatsea);

— to the ayena;

— carcinoma cutaneum;

— nodal prurigo of the Guide;

— perioral dermatitis;

— a skin itch in otstutstvy inflammations;

— perianal and genital itch;

— widespread blyashechny psoriasis;

— age till 1 year;

— lactation period;

— hypersensitivity to active ingredient and auxiliary components of drug.

With care it is necessary to use drug at pregnancy.

 

Use of the drug DERMOVEYT® at pregnancy and feeding by a breast

GKS should not be applied to external use at pregnancy in high doses a long time. At researches it was not established that use of drug during pregnancy exerts negative impact on health of the woman or a fruit.

Drug should be used during pregnancy only if the potential advantage for mother surpasses potential risk for a fruit.

Use of drug in the period of a lactation is contraindicated.

Overdose:

Symptoms: the drug Dermoveyt® at external use can be absorbed in the quantities sufficient to cause development of system effects. Development of acute overdose is improbable. However in case of chronic overdose or the wrong use of the drug Dermoveyt® hypercorticoidism symptoms can develop.

Treatment: in case of overdose of the drug Dermoveyt® it is necessary to cancel gradually drug, reducing the frequency of drawing or replacing with less active GKS, under observation of the doctor in view of risk of emergence of adrenal insufficiency.

Further treatment should be carried out taking into account a clinical situation or according to recommendations of the toxicological centers at their existence.

Storage conditions:

Drug should be stored in the place, unavailable to children, at a temperature not above 30 °C. A period of validity - 2 years.

Issue conditions:

According to the recipe

Packaging:

25 g - aluminum (1) - packs cardboard.