Pharmacological properties

Pharmacodynamics. the main effect of a klobetazol of propionate concerning skin is nonspecific anti-inflammatory action thanks to vasoconstriction and reduction of synthesis of collagen.

Pharmacokinetics. Penetration of a klobetazol of propionate through skin at different persons a miscellaneous can also increase when using occlusive bandages or at inflammation or injury of skin. Persons with healthy skin have C _max a klobetazola of propionate in blood plasma — 0.63 ng/ml can be reached in 8 h after the second drawing (in 13 h after the first drawing) 30 g of 0.05% of ointment. After drawing the second dose of 30 g of 0.05% of cream of a klobetazol of _{propionate C max} in blood plasma can be slightly higher, than when putting ointment and be reached in 10 h. Other peak concentration (about 2.3 ng/ml and 4.6 ng/ml) can be observed respectively at patients with psoriasis and eczema in 3 h after single drawing 25 g of 0.05% of ointment of a klobetazol of propionate. After absorption, medicament most likely passes the same metabolic way, as corticosteroids after system use through skin. However system metabolism of a klobetazol is up to the end not established.

Indication

Psoriasis (except for widespread blyashechny psoriasis), steady eczemas, red flat deprive, a diskoidny lupus erythematosus and other diseases of skin which do not respond to treatment by less active gks.

Cream is especially effective

for therapy of the damp or becoming wet surfaces of skin. ointment is suitable for treatment of dry surfaces of skin and also skin with the lishayny or shelled defeat. cream/ointment is applied a thin layer on affected areas of skin by 1–2 times a day before improvement of a state. as well as at use of other highly active corticosteroids, after achievement of control of a disease the treatment should be stopped. improvement occurs individually, at patients who well perceive therapy, the result can appear in several days. no more than 4 weeks are recommended to continue treatment; if improvement of a state did not occur, it is necessary to specify or revise the diagnosis.

For prevention of exacerbation of a disease can conduct repeated short courses of treatment the medicament Kloveyt. If it is necessary long continuous therapy by steroids, it is necessary to apply other, not such strong medicines. At very steady defeats, especially in places of a hyperkeratosis, the anti-inflammatory effect of the medicament Kloveyt if necessary can be enhanced in the way a nakrytiya of an affected area a polyethylene film. For achievement of positive take apply occlusive dressing on all night long. Already reached effect is maintained by simple putting medicament on skin without shelter a film.

Contraindication

Not treated infections of skin. pink eels. ordinary eels. an itching without inflammation. perianal and genital itching. perioral dermatitis. hypersensitivity to medicament components. the dermatosis at children aged till 1 year including dermatitis.

Side effects

Infection and invasion: opportunistic infections.

Immune system: local hypersensitivity.

Endocrine system: oppression gipotalamo - a hypophysial and adrenal system: cushingoid signs (for example a crescent-shaped face, 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: an itching, feeling of local burning / pain in skin, a local atrophy of skin *, atrophic strips on skin *, teleangiectasias *, thinning of skin *, wrinkling of skin *, drying of skin *, pigmentation changes *, a hypertrichosis, aggravation of the main symptoms, allergic contact dermatitis / dermatitis, a pustulous form of psoriasis, an erythema, rash, urticaria.

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

* disturbances from skin are secondary to local and/or system oppression gipotalamo - a hypophysial and adrenal system.

Special instructions

use Drug with care at patients with local reaction of hypersensitivity to corticosteroids or any excipients in the anamnesis. local reactions of hypersensitivity (see side effects) 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 persons can be result of the increased system absorption of GKS. In case of any of the above-stated symptoms the use of medicament should be stopped gradually by reduction of frequency of drawing or replacement by less powerful corticosteroid. The sudden termination of treatment can result in glucocorticoid insufficiency (see. Side EFFECTS). Risk factors of emergence of system effects are:

— the power and composition of topical steroid;

— use duration;

— drawing on the big area of skin;

— uses on the surfaces of the adjoining skin, for example, in zones of an intertrigo or in the place of an occlusive bandage (at babies of a diaper can play a role of an occlusive bandage);

— the increased hydration of the keratosic layer;

— use on sites with a thin integument, for example on a face; drawing on the injured skin or under other conditions when disturbance of a skin barrier is observed.

Children. In comparison with adults at children the bigger quantity of a topical corticosteroid can be absorbed in proportion and therefore they are more susceptible to system side effects. 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. It is necessary to avoid if it is possible, prolonged use of GKS at children at the age of 1–12 years as at them the probability of emergence of adrenal suppression is higher.

Children more susceptible to development of atrophic changes at use of GKS. If Kloveyt is necessary for treatment of children, it is recommended that it proceeded several days and was reconsidered 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 imposing 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 therapy of the infected inflammatory damages of skin 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 treatment.

Chronic ulcers of the lower extremities. Sometimes topical corticosteroids apply to therapy of the dermatitis arising around chronic ulcers of the lower extremities. However such use is associated with increase in frequency of emergence of reactions of local hypersensitivity and risk of local infections.

Putting cream on the person. Putting cream on face skin is undesirable as this site is to more subject atrophic changes. In case of need use should be limited several days.

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

Use during pregnancy and feeding by a breast. Pregnancy. Data on Kloveyt's use for pregnant women are limited.

Topical administration of corticosteroids can cause disturbance of pre-natal development in pregnant animals. Compliance of these data on the person is not established. It is necessary to appoint Kloveyt during pregnancy only in case the expected advantage for mother exceeds risk for a fruit. Apply the minimum quantity of medicament during 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 GKS 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 Kloveyt during feeding by a breast only when the expected advantage for mother exceeds risk for the child. At appointment during feeding as a breast cream should not be applied on mammary glands in order to avoid accidental hit of cream through a mouth to the child.

Children. Drug is contraindicated for treatment of a dermatosis, including deramatita at children aged till 1 year.

Ability to influence speed of response at control of vehicles or work with other mechanisms. The research on studying such influence was not conducted. Considering a profile of side reactions, influence on speed of response at control of vehicles or work with other mechanisms is not expected.

Interaction

It is shown that the combined use with medicaments which can inhibit suras za4 (for example with ritonaviry, itrakonazoly) slows down metabolism of corticosteroids that can cause system effect. as far as such interaction is clinically significant, depends on a dose of drug, a way of introduction gks and capacities of inhibitor of suras za4.

Overdose

Symptoms. at usual use kloveyt it can be absorbed in the quantities sufficient for emergence of system effect. a likelihood of development of acute overdose very insignificant, however in case of chronic overdose or the wrong use there can be signs of a hypercorticoidism.

Treatment. In case of overdose of Kloveyt it is necessary to cancel gradually by reduction of frequency of putting cream or its substitution with less powerful corticosteroid, considering risk of emergence of GKS-insufficiency.

according to a clinical condition of the patient or according to national recommendations about treatment of poisonings in case of their existence.

Storage conditions

At a temperature not above 25 °C. not to freeze.