Pharmacological properties

Pharmacodynamics. the flyutikazona propionate is gks-medicine with high anti-inflammatory activity and very low level of oppression gipotalamo - a hypophysial and adrenal system at topical administration therefore its therapeutic index is one of the widest of all topical steroids provided for today.

propionate has high system activity at p / to application, but very low activity at oral, perhaps, thanks to a metabolic inactivation. According to the researches in vitro its high affinity to GKS-receptors of the person is established.

propionate does not show unpredictable hormonal effect and noticeable influence on central nervous system and peripheral nervous system, digestive, cardiovascular or respiratory systems.

Pharmacokinetics

Absorption. At topical and oral administration bioavailability very low in connection with limited absorption of medicine through skin or in a GIT and in connection with intensive metabolism of the first passing. The oral bioavailability approaches zero therefore system influence of a flyutikazon of propionate at accidental use of cream/ointment inside will be low.

Distribution. By data of researches it is shown that system circulation is reached by very insignificant quantity of orally accepted flyutikazon of propionate which is quickly removed with bile and is excreted with a stake. Flyutikazona propionate is not late in any body tissues and does not contact melanin.

Metabolism. According to pharmacokinetic researches on animals, a flyutikazon propionate quickly is removed and exposed to extensive metabolic clearance. The person has a broad metabolic clearance and, respectively, removal — fast. Drug, getting through skin into system circulation, it is quickly inactivated. The main mechanism of metabolism is hydrolysis to carboxylic acid which shows very low glucocorticoid and anti-inflammatory activity.

Removal. According to researches on animals, the way of removal does not depend on a route of administration of a flyutikazon of propionate. It is removed mainly with a stake, and this process is for 48 h fully completed

Indication

Dermatosis sensitive to treatment by corticosteroids, such as:

• atopic dermatitis;
• numulyarny dermatitis (diskoidny eczema);
• knotty itch;
• psoriasis (except for widespread blyashechny psoriasis);
• idle time chronic deprive (neurodermatitis), red flat deprive;
• seborrheal dermatitis;
• contact or allergic dermatitis;
• diskoidny lupus erythematosus;
• generalized erythrosis (as additional tool);
• reaction to stings of insects;
• red heat rash.

Children. Treatment of atopic dermatitis at children aged from 3 months in the absence of effect of treatment by less powerful corticosteroids.

Use

Kutiveyt, cream

Adults and children aged from 3 months. Cream is especially favorable for treatment of the damp or becoming wet surfaces of skin. Drug is applied with a thin layer on affected areas of skin by 1 or 2 times a day. Treatment duration at daily application makes up to 4 weeks before improvement fortune, then it is necessary to reduce the frequency of putting cream or to change treatment by less powerful medicine. After putting cream it is necessary to provide enough time for absorption before the subsequent drawing the emoliyent.

After achievement of control over a disease the frequency of application of topical corticosteroids should be lowered gradually to full cancellation and as maintenance therapy to apply emoliyenta.

at sudden phase-out of topical corticosteroids, especially strong.

Duration of treatment of adults and patients of advanced age. In case of aggravation of symptoms or lack of improvement during 2–4 weeks the diagnosis and treatment should be revised.

Children aged from 3 months. At children the probability of emergence of local or system side reactions at application of topical corticosteroids is higher therefore in general by it appoint shorter courses of treatment and less powerful medicines, than for adults.

Kutiveyt Cream should be applied with care to ensuring causing minimum effective amount of medicine.

Duration of treatment of children. If at use of cream for children within 7–14 days there does not occur improvement, treatment should be stopped and to doobsledovat the child. If within 7–14 days of treatment the control of a disease is reached, further it is necessary to apply minimal effective doses during as it is possible smaller time. Treatment duration at daily application should not exceed 4 weeks

Kutiveyt, ointment

Adults and children aged from 3 months. Ointment is especially favorable for treatment of dry surfaces of skin and also skin with lishayny or scaly defeats. Drug is applied with a thin layer on affected areas of skin by 1 or 2 times a day. Treatment duration at daily application makes up to 4 weeks before improvement fortune, then it is necessary to reduce the frequency of putting ointment or to change treatment by less powerful medicine. After putting ointment it is necessary to provide enough time for absorption of medicine before the subsequent drawing the emoliyent.

After achievement of control over a disease the frequency of application of topical corticosteroids should be lowered gradually to full cancellation and as maintenance therapy to apply emoliyenta.

at the sudden termination of reception of topical corticosteroids, especially strong.

Duration of treatment of adults and patients of advanced age. In case of aggravation of symptoms or lack of improvement during 2–4 weeks the diagnosis and treatment should be revised.

Children aged from 3 months. At children the probability of emergence of local or system side reactions at application of topical corticosteroids is higher therefore in general by it appoint shorter courses of treatment and less powerful medicines, than for adults.

Kutiveyt Ointment should be applied with care to ensuring causing minimum effective amount of medicine.

Duration of treatment of children. If at use of ointment for children within 7–14 days there does not occur improvement, treatment should be stopped and to doobsledovat the child. If within 7–14 days of treatment the control of a disease is reached, further it is necessary to apply minimal effective doses during the shortest possible time. Treatment duration at daily application should not exceed 4 weeks

Kutiveyt, cream and ointment

Patients of advanced age. According to clinical trials, the difference in the response to treatment between patients of advanced age and young patients is not revealed. As at patients of advanced age are more probable deterioration in function of kidneys or a liver that can cause a medicine discharge delay at system absorption, it is necessary to apply minimal effective doses of medicine and during the shortest time of treatment to achievement of desirable result.

Liver/renal failure. In case of system absorption (at application on a big surface and for a long time) metabolism and elimination of medicine can slow down and the risk of system toxicity increases. Therefore it is necessary to apply minimal effective doses during the shortest possible time to achievement of desirable result.

Children. Cream and Kutiveyt ointment apply to treatment of children aged from 3 months

Contraindication

Hypersensitivity to active ingredient or any component of medicine. not treated infections of skin. pink eels. ordinary eels. perioral dermatitis. perianal and genital itch. an itch without inflammation. a dermatosis at children aged up to 3 months, including dermatitis and diaper rash.

Side effects are classified by

by bodies and systems and frequency of emergence. frequency of emergence of side effects is determined by such criteria: very often (≥1/10), it is frequent (≥1/100, 1/10), infrequently (≥1/1000, 1/100), is rare (≥1/10,000, 1/1000), is very rare (1/10,000), including isolated cases.

Infection and invasion: very seldom — opportunistic infections.

from the immune system: very seldom — hypersensitivity.

from an endocrine system: very seldom — oppression gipotalamo - a hypophysial and adrenal system: increase in weight body/obesity; an increase delay a body weight/growth inhibition at children; cushingoid signs (lunopodobny person, central obesity); decrease in level of endogenous cortisol; hyperglycemia/glucosuria; AG; osteoporosis; cataract; glaucoma.

from skin and hypodermic cellulose: often — an itch; infrequently — feeling of local burning of skin; very seldom — skin thinning, atrophic striya, teleangiectasias, a hypertrichosis, pigmentation change, allergic contact dermatitis, aggravation of the main symptoms, a pustulous form of psoriasis, an erythema, rashes, urticaria.

Special instructions

use Drug with care for treatment of 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 increase in system absorption of topical steroids. In case of any of the above-stated symptoms the use of medicine should be stopped gradually by decrease in frequency of drawing or replacement by less powerful corticosteroid. The sudden termination of treatment can cause GKS-insufficiency (see. Side EFFECTS).

Risk factors of emergence of system effects are:

• power and composition of topical steroid;
• application duration;
• drawing on the big area of a body;
• application on the surfaces of skin which adjoin 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);
• increased hydration of the keratosic layer;
• application on sites with a thin integument, for example on a face;
• application on sites of the injured skin or under other conditions where the skin barrier is broken.

In comparison with adults at children and teenagers the bigger quantity of a topical corticosteroid can be absorbed in proportion and therefore they are more inclined 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. It is necessary to avoid where it is possible, prolonged daily use of topical corticosteroids at children aged up to 12 years as at them the probability of emergence of adrenal suppression is higher.

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 violation of barrier function of skin. In case of application for treatment of psoriasis the patient has to be under careful medical observation.

Putting cream/ointment on the person. Long putting cream/ointment on face skin is undesirable as this site is more vulnerable concerning development of atrophic changes.

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

Accompanying infections. Every time at treatment of the infected inflammatory defeats it is necessary to appoint the corresponding antibacterial medicines. At spread of an infection topical corticosteroids it is necessary to cancel and appoint the corresponding antibacterial therapy.

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.

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

Obvious oppression of function of bark of adrenal glands (morning level of cortisol in blood plasma of 5 mkg/dl) it is improbable at use of cream/ointment Kutiveyt in therapeutic doses if only do not process 50% of a body surface at adults and do not use 20 g of medicament a day.

as excipient is included Into composition of Kutiveyt cream imidourea which product of metabolism is formaldehyde in trace quantities. Formaldehyde can be the cause of an allergic sensitization or irritation at contact with skin.

as excipients are included Into composition of Kutiveyt cream cetostearyl alcohol and propylene glycol which can cause local skin reactions.

Use during pregnancy and feeding by a breast

Pregnancy. Data relatively of application of a flyutikazon of propionate for pregnant women are limited. Topical administration of corticosteroids at pregnant animals can result in anomalies of fetation though the relation of these data to people is not established. However it is necessary to appoint a flyutikazon propionate during pregnancy only when the expected advantage of use of medicine for mother is above possible risk for a fruit and the child. Apply a medicine minimal effective dose throughout minimum possible period.

Feeding by a breast. Safety of application of topical corticosteroids during feeding by a breast is not established. It is unknown whether can lead application of topical corticosteroids to such system absorption as a result of which in breast milk the amount of medicine which can be measured will be revealed. During the research on laboratory rats at achievement of a certain level of medicine in blood plasma after p / to introduction signs of existence of a flyutikazon of propionate in breast milk are revealed. It is necessary to appoint cream/ointment of a flyutikazon of propionate during feeding a breast only when the expected advantage of use of medicine for mother exceeds possible risk for the child. In case of appointment during feeding as a breast cream/ointment should not be applied on a breast for the purpose of avoidance of accidental hit of cream/ointment in the child's mouth.

Fertility. There are no topical corticosteroids given for impact assessment on fertility of the person.

Ability to influence speed of response at control of vehicles or work with other mechanisms. Researches on studying such influence were not conducted. Considering a profile of side reactions, influences on speed of response at control of vehicles or work with other mechanisms do not expect.

Interaction

It is established that simultaneous application with medicines which can inhibit cyp 3a4 (for example ritonavir, itrakonazol) slows down metabolism of corticosteroids that can be the cause of system effect. such interaction clinically significantly depends on a dose of medicine, a way of introduction of a corticosteroid and power of CYP inhibitor 3a4.

Overdose

Symptoms. the flyutikazona propionate at topical administration can be absorbed in the quantity sufficient for emergence of system effect. the sharp overdose is very improbable. in case of chronic overdose or abuse there can be signs of a hypercorticoidism (see side effects).

Treatment. In case of overdose the use of cream/ointment should be stopped gradually by decrease in frequency of drawing or replacement by less powerful topical corticosteroid, in view of risk of development of GKS-insufficiency. Further treatment is carried out according to a clinical condition of the patient.

Storage conditions

At a temperature below 30 °C not to freeze.

Information for professional activity of health and pharmaceutical workers.

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