Pharmacological properties

Pharmacodynamics. the main effect of a klobetazol of propionate in relation to skin is anti-inflammatory action thanks to vasoconstriction and decrease in synthesis of collagen in skin.

Pharmacokinetics. Penetration of a klobetazol of propionate through skin has significant individual differences and can increase when using occlusive bandages or when drawing on the inflamed or injured skin. In one research at persons with healthy skin average C _max a klobetazola in blood plasma made 0.63 ng/ml and 30 g of 0.05% of ointment of a klobetazol of propionate were reached in 8 h after repeated drawing (in 13 h after the first drawing). After drawing the second dose of 30 g of 0.05% of _{cream C max} in blood plasma were slightly higher, than when putting ointment, and were reached in 10 h. In other clinical trial average C _max (2.3 and 4.6 ng/ml) at patients with psoriasis and eczema respectively — in 3 h after single drawing 25 g of 0.05% of ointment of a klobetazol of propionate. After absorption through skin drug, most likely, is metabolized in the same way, as after system use. However system metabolism of a klobetazol is up to the end not studied.

Indication

Psoriasis (except for widespread blyashechny psoriasis), the dermatosis which is badly responding to treatment red flat deprive, the diskoidny lupus erythematosus and other diseases which are not responding to treatment by less active gks.

to

with a thin layer on affected areas of skin 1 or 2 times a day. at achievement of control over a disease the use of a klobetazol should be cancelled gradually. in the conditions of the good response to treatment, control over a disease can be reached for several days. treatment should not last more than 4 weeks the maximum dose should not exceed 50 g a week. in case of lack of improvement for 2–4 weeks the diagnosis and treatment should be revised. for control of aggravations it is possible to conduct repeated short courses of therapy by medicament dermoveyt. if long-term continuous treatment is necessary, it is necessary to use less active corticosteroids.

At resistant damages of skin, especially in case of a hyperkeratosis, anti-inflammatory action of Dermoveyt it is possible to strengthen with the help a nakrytiya of the place of applique by a polyethylene film. For achievement of positive take apply a hermetic bandage on all night long. Already reached effect is maintained by simple putting medicament on skin without covering a film.

Contraindication

Hypersensitivity to medicament components, not treated infections of skin, a rozatse, ordinary eels, an itching without inflammation, a perianal and genital itching, perioral dermatitis. dermoveyt it is not shown for treatment of a dermatosis at children aged till 1 year, including dermatitis and diaper rash.

Side effects are classified by

by bodies and systems and for emergence frequency. on frequency are distributed on such categories: very often (≥1/10), it is frequent (≥1/100 and 1/10), infrequently (≥1/1000 and 1/100), is rare (≥1/10,000 and 1/1000), is very rare (1/10,000, including isolated cases).

Infection and invasion: very seldom — opportunistic infections.

Immune system: very seldom — locally hypersensitivity.

Endocrine system: very seldom — oppression gipotalamo - a hypophysial and adrenal system: cushingoid signs (for example the lunopodobny person, the central obesity), a delay of increase in mass of a body/growth at children, osteoporosis, glaucoma, a hyperglycemia/glucosuria, a cataract, AG, increase in weight body/obesity, decrease in level of endogenous cortisol, an alopecia, fragility of hair.

Skin and hypodermic fabrics: often — an itching, feeling of local burning / pain in skin; infrequently — a local atrophy of skin *, atrofichny strips on skin *, teleangiectasias *; very seldom — thinning of skin *, wrinkling of skin *, siccation of skin *, pigmentation change *, a hypertrichosis, aggravation of the main symptoms, allergic contact dermatitis / dermatitis, a pustulous form of psoriasis, an erythema, rashes, urticaria, an acne.

General disturbances and disturbances in the site of application: very seldom — irritation/pain in the site of application.

* Disturbances from skin which are secondary in relation to local and/or system gipotalamo - hypophysial adrenally to oppression.

Special instructions

use Drug with care for treatment of patients with local reaction of hypersensitivity to corticosteroids or to other substances in the anamnesis. local reactions of hypersensitivity (see side reactions) can remind symptoms of a disease which treat.

hypercorticoidism Demonstration (Cushing's syndrome) and the return suppression gipotalamo - a hypophysial and adrenal system with oppression of function of adrenal glands at some patients can be result of increase in system absorption of topical steroids. In case of emergence any of the above-stated symptoms use of medicament needs to be cancelled gradually by decrease in frequency of drawing or replacement by less strong corticosteroid. The sudden termination of treatment can provoke glucocorticosteroid insufficiency (see. Side REACTIONS).

Risk factors of emergence of system effects: force of action and composition of topical steroid; use duration; drawing on the big area of skin; use on the surfaces of skin which adjoin for example in zones of an intertrigo or in sites of application of an occlusive bandage (at newborns of a diaper can play a role of an occlusive bandage); the increased hydration of a corneal layer; use on sites with a thin integument, for example on a face; use on sites of the injured skin or under other conditions when the skin barrier is broken.

In comparison with adults at children the bigger quantity of a topical corticosteroid can be absorbed in proportion and therefore they are more sensitive to system side reactions. It is connected with the fact that children have an underdeveloped skin barrier and the big surface of skin concerning body weight in comparison with adults.

Children. It is necessary to avoid where it is possible, prolonged use of topical corticosteroids at newborns and children aged up to 12 years as at them the probability of emergence of adrenal suppression is higher.

to development of atrophic changes at use of topical corticosteroids. Treatment of children by Dermoveyt has to last, whenever possible, no more than 5 days. The expediency of continuation of treatment has to be revised weekly.

Risk of infection when imposing an occlusive bandage. Risk of developing bacterial infections increases in warm and damp conditions which can arise under occlusive bandages therefore before overlaying of a new bandage it is necessary to process leather carefully every time.

Treatment of psoriasis. It is necessary to apply topical corticosteroids to treatment of psoriasis with care as it was in certain cases reported about emergence of a recurrence, development of tolerance, risk of generalization of pustulous psoriasis and development of the symptoms of local or system toxicity caused by disturbance of barrier function of skin. In case of use for treatment of psoriasis the patient has to be under careful medical observation.

Accompanying infections. Every time at treatment of inflammatory defeats which were infected it is necessary to appoint the corresponding antibacterial drugs. In case of spread of an infection topical corticosteroids it is necessary to cancel and appoint the corresponding antibacterial therapy.

Chronic ulcers of legs. Sometimes topical corticosteroids apply to treatment of dermatitis which arises around chronic ulcers of legs. However such use is associated with increase in frequency of emergence of reactions of local hypersensitivity and risk of local infections.

Drawing on the person. Putting ointment/cream on face skin is undesirable as this area is most inclined to atrophic changes. In case of need use should be limited for 5 days.

Drawing on eyelids. When putting ointment/cream on eyelids it is necessary to avoid hit of medicament in eyes as at repeated use it can provoke a cataract and glaucoma.

Period of pregnancy and feeding by a breast

Pregnancy. Data on Dermoveyt's use for pregnant women are limited.

Topical administration of corticosteroids at pregnant animals can provoke disturbances of pre-natal development. There are no similar data on the person. It is necessary to apply Dermoveyt during pregnancy only in cases when the expected advantage for mother exceeds risk for a fruit. Apply the minimum quantity of medicament on an extent of the minimum term of treatment.

Feeding by a breast. Safety of use of a klobetazol of propionate during feeding by a breast is not established. It is unknown whether can lead use of topical corticosteroids to such system absorption as a result of which in breast milk the amount of medicament which is giving in to measurement will be revealed. It is necessary to apply Dermoveyt during feeding by a breast only in cases when the expected advantage for mother exceeds risk for the child. In case of Dermoveyt's appointment during feeding by a breast cream should not be applied on a breast in order to avoid accidental hit of cream through the child's mouth.

Influence on ability to run vehicles and to work with other mechanisms. Researches concerning studying such influence were not conducted. In view of a profile of side reactions, influence on speed of response when driving or during the work with other mechanisms is not expected.

Interaction

It is established that the combined use with medicaments which can inhibit cyp 3a4 (for example with ritonaviry, itrakonazoly) slows down metabolism gks that can provoke system effect. as far as such interaction is clinically significant, depends on a dose of drug, a way of introduction gks and capacities of CYP inhibitor 3a4.

Overdose

Symptoms and signs. at usual use dermoveyt it can be absorbed in the quantities sufficient for emergence of system effect. probability of acute overdose very insignificant, however in case of chronic overdose or the wrong use there can be signs of a giperkortizolizm.

Treatment. In case of overdose of Dermoveyt it is necessary to cancel gradually by decrease in frequency of putting cream/ointment or substitution by its less strong corticosteroid taking into account risk of emergence of glucocorticosteroid insufficiency. Further treatment is carried out according to a condition of the patient or according to national recommendations about treatment of poisonings.

Storage conditions

At a temperature up to 30 °C.

Information for professional activity of health and pharmaceutical workers.

, having addressed to LLC GlaksoSmitKlyayn Pharmasyyutikals Ukraina: 02152, Kiev, Pavel Tychina Avenue, 1B, ph.: (044) 585-51-85, www.ua.gsk.com. You can report about the undesirable phenomenon in LLC GlaksoSmitKlyayn Pharmasyyutikals Ukraina by ph.: (044) 585-51-85 or e-mail: oax70065@gsk.com, you can report about the complaint to quality of medicament by ph.: (044) 585-51-85, +38 (050) 381-43-49 or e-mail: ua.complaints@gsk.com. Trademarks belong or are used according to the license by GSK group of companies.

©2018 GSK Group of companies or their licensor.

UA/VAL/0009/18.12.30