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Description of the medicament Klobeskin cream of 0.05% of a tube of 25 g on this page — the simplified author's version of website apteka911 created on the basis of the instruction(s) for use. Before acquisition or use of medicament you have to consult with the doctor and study the original instruction of the producer (it is applied to each packing of drug).

only with the fact-finding purpose and should not be used as the management to self-treatment. Only the doctor can make the decision on prescribing of medicament and also define doses and ways of its use.

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Frequently asked questions

How much is Klobeskin cream of 0.05% of a tube of 25 g?

Can give this medicine to children?

What storage conditions at Klobeskin cream (Health)?

What analogs at Klobeskin No. 1 cream?

Full analogs Klobeskin cream of 0.05% of a tube of 25 g are:

• Derilife cream 0.5mg/g of a tube of 50 g
• Dermoveyt cream of 0.05% of a tube of 25 g
• Karizon cream 0.5mg/1g of a tube of 15 g

What country of origin at Klobeskin (Health)?

Structure

Active ingredient: clobetasol;

1 g of medicament the klobetazola of the propionate micronized 0.5 mg

Excipients: glycerin monostearate; white wax; cetostearyl alcohol; polyethyleneglycol stearate propylene glycol; citric acid monohydrate, sodium; chlorcresol; the water purified.

Dosage form

Cream.

Main physical and chemical properties: opaque cream of white or almost white color, uniform consistence.

Pharmacological group

Corticosteroids for use in dermatology. Highly active corticosteroids (group IV). ATX D07A D01 code.

Pharmacological properties

Pharmacological.

Main effect of a klobetazol of propionate on the relation of 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 in case of inflammation or injury of skin. At persons with healthy skin the maximum concentration of a klobetazol of propionate in blood plasma of 0.63 ng/ml in one research 30 g of 0.05% of ointment of a klobetazol of propionate were observed through 8:00 after the second drawing (in 13 hours after the first drawing). After drawing the second dose of 30 g of 0.05% of cream of a klobetazol of propionate the maximum concentration in blood plasma were slightly higher, than when putting ointment and were observed through 10:00. In other research the maximum concentration (about 2.3 ng/ml and 4.6 ng/ml) were observed respectively at patients with psoriasis and eczema through 3:00 after single drawing 25 g of 0.05% of ointment of a klobetazol of propionate. After absorption, drug, most likely, passes the same metabolic way, and corticosteroids after system appointment through skin. However system metabolism of a klobetazol is up to the end not established.

Indication

is highly active GKS of local action which is appointed to elderly people and children aged from 1 year only for short-term treatment of rather steadier inflammatory and pruritic manifestations steroid of a sensitive dermatosis who are insensitive to less active corticosteroids.

Such diseases are:

· Psoriasis (except for widespread blyashechny psoriasis)

· The dermatosis which is difficult responding to treatment

· Red flat deprive

· Diskoidny lupus erythematosus

· Other diseases of skin which do not respond to treatment by less active GKS.

Contraindication

· Sensitivity to any components of drug.

· Not treated infections of skin.

· Rozatsea.

· Ordinary eels.

· An itching without inflammation.

· Perianal and genital itching.

· Perioral dermatitis.

· Cream is intended for treatment of a dermatosis at children aged till 1 year, including dermatitis and diaper pour.

Interaction with other medicines and other types of interactions

Was shown that with products, CYP3A4 can inhibit combined use (for example, ritonavir, itrakonazol), slows down metabolism of corticosteroids, can cause raised system effect. As far as such interaction is clinically significant, depends on a dose of drug, a way of introduction of GKS and power of CYP3A4 inhibitor.

Feature of use

Drug should be used with care at patients with local reaction of hypersensitivity to corticosteroids or any excipients in the anamnesis. Local reactions of hypersensitivity (see the Section "Side reactions") can remind disease symptoms, is treated.

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 emergence any of above-mentioned symptoms medicament should be stopped gradually by reduction of frequency of drawing or replacement by less powerful GKS. The sudden termination of treatment can lead to GKS insufficiency (see the Section "Side reactions").

Risk factors of emergence of system effects are:

· Power and structure of GKS;

· Use duration;

· Drawings on the big area of skin;

· Use on the surfaces of skin, touch, for example in zones of an intertrigo or in the site of application 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;

· Use on sites of the injured skin or under other conditions where disturbance of a skin barrier is observed.

In comparison with adults at children the bigger quantity of GKS 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.

Children. Should be avoided where it is possible, prolonged use of GKS to babies and children up to 12 years as at them the probability of emergence of adrenal suppression is higher. Children are more susceptible to development of atrophic changes at use of GKS. Treatment by cream of children has to last, whenever possible, no more than 5 days. The expediency of continuation of treatment needs to be looked through every week. Not to use medicament to children under occlusive bandages.

Risk of infection when imposing occlusal et knitting. Risk of developing bacterial infections increases in warm and damp conditions pleated of skin or under occlusive bandages therefore before imposing of a new occlusive bandage it is necessary to process leather carefully every time.

Treatment of psoriasis. should 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 pustular 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 the inflammatory infected defeats should 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 should apply topical corticosteroids to treatment of the dermatitis arising around chronic ulcers of legs. However such use is associated with increase in frequency of reactions of local hypersensitivity and increase in risk of local infections.

Putting cream on the person. Putting cream on face skin is undesirable as this site more vulnerable to atrophic changes. In case of need uses it has to be limited for 5 days.

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

It was reported about cases of serious osteonekrozny infections (including a necrotizing fascitis) and system immunosuppression (that sometimes brings to the return of damages of Kaposi sarcoma) at prolonged use of a klobetazol of propionate more recommended doses (see the Section "Route of Administration and Doses"). In certain cases patients at the same time applied other strong peroral / local corticosteroids or immunosuppressors (for example, a methotrexate, a mofetila mikofenolat).

If treatment by local corticosteroids of clinically justified more than 4 weeks, it is necessary to consider the possibility of use of less powerful medicament of corticosteroids.

Excipients. are a part of medicine: cetostearyl alcohol which can lead to local skin reactions (for example contact dermatitis); propylene glycol which can cause irritation of skin; chlorcresol which can cause allergic reactions.

Use during pregnancy and feeding by a breast

Pregnancy. Data on medicament use to pregnant women are limited.

Topical administration of corticosteroids a pregnant animal can cause disturbances of pre-natal development. The applicability of these data on the person is not established. Pregnant women can apply Klobetazol, only if the expected advantage for mother is more risk for a fruit. It is necessary to apply the minimum quantity with the minimum duration 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 it will be found amount of drug, gives in to measurement. It is necessary to apply cream during feeding by a breast only in cases when the expected advantage for mother exceeds risk for the child. At appointment during feeding as a breast cream should not be applied on a breast in order to avoid accidental hit of cream through the child's mouth.

Ability to influence speed of response at control of transport or other mechanisms

Researches on studying such influence were not conducted. Considering a profile of side reactions, influence on speed of response at control of motor transport or work with other mechanisms is not expected.

Route of administration and doses

Klobetazol propionate belongs to the class of the most strong local corticosteroids (group IV), and prolonged use can lead to serious side effects (see the Section "Features of Use"). If treatment by local corticosteroids clinically justified after 4 weeks, it is necessary to consider less powerful medicament of corticosteroids. Repeated, but short courses of a klobetazol of propionate can be used for control of aggravations (see. More detailed below).

for treatment of the damp and becoming wet sites of skin. Cream it is soft to p to put

with a thin layer, covering all affected areas of skin, 1 or 2 times a day before emergence of improvement of clinical manifestations, then to reduce the frequency of use or to change medicament for less powerful. At good the response to treatment of improvement is reached for several days. After each putting cream to wait some time before its full absorption before applying emollient.

in case of deterioration or lack of improvement of clinical manifestations within 2-4 weeks the diagnosis and treatment should be reconsidered.

can apply repeated short courses of treatment To control of aggravations. Treatment should not continue more than 4 weeks. If continuous long-term treatment is necessary, it is necessary to use less powerful drugs.

Maximum week dose should not exceed 50 g

In cases of steadier defeats, especially with a hyperkeratosis, the effect of medicament in case of need can be enhanced, having covered an affected area of skin with an occlusive polyethylene bandage. Usually for achievement of satisfactory result sufficient imposings of an occlusal film only for the night. The reached improvement usually is supported by putting cream without use of an occlusive bandage.

At achievement of control of a disease of use of a klobetazol should be cancelled gradually and also to continue emollient use as maintenance therapy.

at sudden cancellation of a klobetazol.

For topical administration.

Dermatosis, difficult responds to treatment. Patients with frequent exacerbations of a disease. As soon as during an acute period of a disease reached effect from continuous a course of topical administration of GKS, it is necessary to consider its intermittent uses (once a day, two times a week, without occlusive bandage). It is shown that such treatment effectively reduces the frequency of aggravations.

Should continue to apply medicament to all earlier affected areas skin or to the known sites of potential aggravation. Such scheme of use should be combined with constant daily use emoliyentiv. It is regularly necessary to estimate a clinical condition and also advantage and risk from treatment continuation.

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

Overdose

Symptoms. At usual use cream can be absorbed in the quantities sufficient for emergence of system effect. Probability of emergence of acute overdose is very insignificant, however in case of chronic overdose or the wrong use there can be signs of a hypercorticoidism.

Treatment. in case of overdose medicament should be cancelled gradually by reduction of frequency of putting cream or substitution it on less powerful GKS considering risk of emergence of GKS of insufficiency.

it agrees a clinical condition of the patient or according to national recommendations about treatment of poisonings in the presence.

Side reactions

Side effect, data on which are given below, classified by bodies and systems and for emergence frequency: very often ≥ 1/10, it is frequent ≥ 1/100 and ≥ 1/1000 and

Infection and an invasion.

Very seldom opportunistic infections.

from the immune system.

Very seldom local hypersensitivity.

from an endocrine system.

It is very rare: oppression gipotalamo - a hypophysial and adrenal system: cushingoid signs