Pharmacological properties

Pharmacodynamics. the mechanism of action consists in reduction of expressiveness of inflammatory processes by oppression of products of prostaglandins and leukotrienes owing to oppression of activity of a phospholipase a2 and reduction of release of arachidonic acid from cell membrane phospholipids.

GKS slow down release of cytokines (interleukins-1 and-2 and gamma interferon) from lymphocytes and macrophages, oppress release by eosinophils of mediators of inflammation, reduce metabolism of arachidonic acid. Reduce permeability of vessels, suppress phagocytosis.

Antiallergic action consists in oppression of development of local allergic reactions.

Owing to local vasopressor action medicament reduces protein synthesis, collagen adjournment, accelerates disintegration of proteins in skin and slows down proliferative processes. Slows down the correct cell fission therefore it is applied at treatment of keloids and psoriasis.

Stimulating with

steroid receptors, medicament promotes formation of proteins of the lipokortin having antiedematous effect.

acetonide renders to Fluotsinolon's

significant anti-inflammatory, antiallergic, antiexudative and antipruritic action. Even in insignificant concentration has fast anti-inflammatory and antiallergic effect.

Pharmacokinetics. Fluotsinolona acetonide easily gets into skin through its enveloping keratosic layer.

Absorption of a fluotsinolon of acetonide through skin amplifies when drawing on sensitive skin of the site of anatomic folds of a body and the person and also on skin with the injured epidermis or inflammatory process. Use of an occlusive bandage causes increase in temperature and humidity of skin that also leads to strengthening of absorption of a fluotsinolon of acetonide. Besides, absorption amplifies at frequent use of medicine and on big sites of skin.

Dermal absorption is higher than

at children, than at adults.

through skin medicament is metabolized by

After absorption (absorption no more than 1%) mainly in a liver.

Insignificant absorption of medicament has no systemic action and does not suppress function of bark of adrenal glands. Use of occlusive bandages substantially increases bioavailability that can lead to development of the all-resorptive effects characteristic of the fluorinated GKS.

by

It is removed with urine and in insignificant quantity with bile in the form of conjugates of glucuronides in not changed look.

Indication

Short topical treatment of acute and serious non-communicable diseases of skin (dry forms), psoriasis of a hairy part of the head, seborrheal dermatitis, flat deprive.

Use Drug is intended to

by

for topical administration.

to Adults and children 16 years are aged more senior than

: medicament is applied by 1–2 times a day with a thin layer on an affected area, slightly rubbing in skin. The maximum duration of treatment is no more than 10 days, on face skin — not longer 1 week

Follows

with care, under control of the doctor to use medicament to children aged from 16 years only 1 time a day on the small site of skin; not to apply the child to face skin.

recommends to apply

Within a week no more than 15 g of cream (1 tuba).

should not use medicament under an occlusive bandage. Only in case of psoriasis it is allowed to apply the closed bandage which should be changed every day.

Contraindication

Hypersensitivity to active ingredient or other components of drug; infectious diseases of skin (bacterial, virus, fungal), including skin manifestations of syphilis, tuberculosis cutis, pyoderma, chicken pox, herpes, actinomycosis, zymonematosis, sporotrichosis; pink and ordinary eels; diaper dermatitis; perioral dermatitis; anogenitalny itching; new growths of skin, skin tumor; nevus; atheroma; hemangioma; xanthoma; wounds and cankers of skin, a wound on sites of appliques; the numerous psoriasis plaques, trophic ulcers of a shin connected with a varicosity; erosive cankers of a digestive tract. do not apply after preventive inoculations.

Side effects

from skin and hypodermic cellulose: burning, an itching of skin, dermatitis (including contact and perioral), steroid eels, striya, irritation and xeroderma, a folliculitis; at prolonged use — an atrophy of skin and disturbance of integrity of skin, an atrophy of hypodermic cellulose, atrophic strips, oppression of growth of epidermis, a local hirsutism, a hypertrichosis, a teleangiectasia, a poststeroid purpura, disturbance of pigmentation of integuments, an alopecia, especially at women. exacerbation of the existing skin diseases is possible.

from an organ of sight: at external use on an eyelid skin the cataract or glaucoma can sometimes develop.

from the immune system: spotty and papular rashes, urticaria, inflammation of hair follicles, secondary immunodeficience (exacerbation of chronic infectious diseases, generalization of infectious process, development of opportunistic infections).

At prolonged use on extensive sites of skin system side effects are possible

: hypostases, AG, development or exacerbation of chronic gastritis, steroid stomach ulcer, a hyperglycemia, a glucosuria, delay of reparative processes, insufficiency of adrenal glands, oppression of growth and development in children, Itsenko's syndrome — Cushing.

Special instructions

Treatment needs to be carried out by

under control of the doctor.

Drug is used only short courses (not to apply continuously more than 10 days) on small sites of skin. At prolonged use on extensive sites of skin the frequency of emergence of side effects and a possibility of development of hypostases, AG, a hyperglycemia, decrease in resistance increases.

Before each repeated putting medicament residues of old medicament should be washed away warm soap solution or solution of an antiseptic agent. During treatment it is recommended to wear free clothes.

to apply

With care on parts of the body with thin skin (person, inguinal areas, axillary hollows) as increase in absorption and high risk of development of side effects (teleangiectasias, perioral dermatitis), even after short use are possible.

not to apply

on skin of mammary glands.

should not apply cream along with other medicines to external use.

Should avoid hit of medicament in eyes.

At the phenomena of irritation of skin in the site of application of cream it should be cancelled.

should carry out by

in case of development of an infection in the place of use of cream the corresponding antibacterial or antifungal treatment.

are possible

At external use of drug: decrease in products of AKTG a hypophysis because of oppression gipotalamo - a hypophysial and adrenal system, decrease in level of cortisol in blood and development of an iatrogenic syndrome of Cushing disappearing after medicament withdrawal.

Should carry out by

periodic control of function of bark of adrenal glands by definition of cortisol in blood and in urine after stimulation of adrenal glands of AKGT at prolonged use.

With care to use medicament at patients with psoriasis as topical administration of GKS on the sites affected with psoriasis can lead to distribution of the recurrence caused by development of tolerance, to risk of generalized pustulous psoriasis and the system toxicity caused by skin dysfunction.

With care to use medicament in the presence of an atrophy of hypodermic cellulose, especially at elderly people.

Should avoid putting medicament on eyelids or skin around eyes to patients with a closed-angle and open angle glaucoma and also with a cataract because of possible increase in expressiveness of symptoms of a disease.

during treatment is not recommended to make to

smallpox inoculations and also to carry out other types of immunization.

Period of pregnancy and feeding by a breast. Drug is contraindicated during pregnancy and feeding by a breast.

Children. Drug is not used at children aged up to 16 years.

Ability to influence the speed of reactions at control of vehicles and work with other mechanisms. Does not influence

Interaction

can use Drug with antimicrobic means of local and systemic action.

Combined use with GKS of systemic action increases efficiency of the medicament Flutsar-Darnitsa, but at the same time the likelihood of development of side effects increases.

Combined use of medicament with NPVP increases risk of development of system and local side effects.

effect of immunosuppressive medicines can strengthen Flutsar-Darnits's

and suppress effect of the immunostimulating, hypotensive, diuretic, antiarrhytmic medicines, potassium drugs.

Diuretic medicines (except kaliysberegayushchy) raise a hypopotassemia likelihood of development.

Insignificant absorption of the medicament Flutsar-Darnitsa at external use does not cause interaction with other drugs.

during medicament treatment is not recommended to make to

smallpox inoculations and also to carry out other types of immunization (especially at prolonged use on extensive sites of skin) because of possible lack of the adequate immunological answer in the form of products of the corresponding antibodies.

Overdose

At prolonged use on extensive sites of skin there can be system manifestations of overdose which are shown strengthening of side effects.

Symptoms: hypostases, AG, a hyperglycemia, a glucosuria, hypersensitivity to infections, and in hard cases — Itsenko's syndrome — Cushing; local — an itching, burning of skin in the site of application of drug.

Treatment: medicament withdrawal, symptomatic therapy.

Storage conditions

In original packing at a temperature not vyshe25 °C. not to freeze.