Pharmacological properties

Pharmacodynamics. a fluotsinolona acetonide — highly active synthetic gks for external use. at use in the form of ointment/gel in concentration of 0.025% renders the significant anti-inflammatory, antipruritic, antiallergic and vasoconstrictive action. has lipophilic properties and it is well absorbed through skin. after drawing 2 g of ointment the products aktg a hypophysis as a result of oppression of a system adrenal glands hypophyses can decrease.

and assume that this means reduces expressiveness of inflammatory process by oppression of products of prostaglandins and leukotrienes as a result of decrease of the activity of a phospholipase And ₂ and release of arachidonic acid from cell membrane phospholipids. Antiallergic action is shown by oppression of development of local hypersensitivity reactions. As a result of local vasoconstrictive action reduces risk of development of exudative reactions. Reduces protein synthesis and adjournment of collagen. Accelerates disintegration of proteins in skin and weakens proliferative processes.

Pharmacokinetics. Fluotsinolona acetonide well gets into a corneal layer of epidermis where gradually kumulirutsya and defined even in 15 days after drawing. It does not biotransformirutsya in skin. After absorption it biotransformirutsya systemically, generally in a liver. It is removed with urine and in smaller quantity with bile, generally in the form of connection with glucuronic acid and also in insignificant quantity in not changed look.

Absorption of a fluotsinolon of acetonide through skin amplifies when drawing it on sensitive skin — sites of anatomic folds of a body and a face 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 increase in absorption of a fluotsinolon of acetonide. Besides, absorption amplifies at frequent use of medicine and on extensive sites of skin. Dermal absorption happens quicker at teenagers, than at adults.

Indication

Short treatment of an acute and serious non-communicable inflammatory illness of skin (without exudation) which is followed by a steady itching or a hyperkeratosis: seborrheal dermatitis, atopic dermatitis, nodular urticaria (papular urticaria), allergic contact dermatitis, a polymorphic erythema, a tubercular lupus, psoriasis, red flat deprive.

Use

It is intended for topical administration. medicament should be applied a thin layer to the affected skin 1–2 times a day.

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

should not carry out Treatment continuously longer than 2 weeks. It is impossible to use medicament on face skin more than 1 week. For a week it is recommended to apply no more than 15 g of ointment/gel (1 tuba).

With care under control of the doctor to use medicament at children aged 2 years — only are more senior than 1 times a day on the small site of skin; not to apply to face skin.

Contraindication

Skin manifestations of syphilis, tuberculosis cutis, pyoderma, chicken pox, herpes, actinomycosis, zymonematosis, sporotrichosis, diaper dermatitis, anogenitalny itching, nevus; an atheroma, a hemangioma, a xanthoma, new growths of skin, a wound and cankers of skin, a wound on sites of appliques, the numerous psoriasis plaques, trophic ulcers connected with a varicosity, erosive cankers of a digestive tract.

should not be applied in bacterial, viral and fungal infections of skin, ordinary and pink eels, perioral dermatitis (dermatitis perioralis), after preventive inoculations and also in case of the confirmed hypersensitivity to a fluotsinolon to acetonide or other GKS and other components of drug.

should not be applied at children under 2 years.

is not recommended to use medicament in the I trimester of pregnancy, during feeding by a breast.

Side effects

from skin and hypodermic cellulose: ugrepodobny damages, post-steroid purpura, oppression of growth of epidermis, burning, itching, irritation, rash, atrophy of hypodermic cellulose, xeroderma, overgrowth of hair on a body or alopecia, depigmentation or hyperpegmentation of skin, atrophy and disturbances of integrity of skin, teleangiectasia, furunculosis, atrophic strips, consecutive infections, local reactions of skin (including perioral, contact, allergic dermatitis). in some cases there can be urticaria or spotty and papular rash, or aggravation of the existing pathological defeats.

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

System disturbances. Use of medicament under an occlusive bandage, considering the increased absorption, can cause the significant systemic action which is shown in the form of hypostases, AG, decrease in body resistance to infections.

System undesirable effects. Secondary immunodeficience (exacerbation of chronic infectious diseases, generalization of infectious process, development of opportunistic infections), 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.

from the immune system: allergic reactions or reactions of hypersensitivity are possible.

Gel especially is suitable

for treatment of the skin covered with hair and at patients who badly transfer a basis of ointments and creams. the form of gel allows to put it in small amounts, and, thus, to apply low medicament doses on big sites of skin and also to apply on skin of the parts of a body covered with hair.

Treatment needs to be carried out by

under control of the doctor.

Before each repeated putting medicament residues of old medicament should be washed away soap solution or solution of an antiseptic agent. During treatment it is recommended to wear free clothes. Not to apply on skin of mammary glands.

not to use medicament along with other medicines for external use.

to

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

Under special control should apply ointment/gel at patients with psoriasis as topical administration of glucocorticoids on the sites affected with psoriasis can lead to distribution of pathological process or a recurrence, caused by development of tolerance and also to risk of generalized pustulyarny psoriasis and the system toxicity caused by skin dysfunction.

not to use medicament more than 2 weeks without interruption. 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 body resistance increases.

At external use of medicament adrenal glands hypophyses, decrease in level of cortisol in blood and development of an iatrogenic syndrome of Cushing who disappears after medicament withdrawal are possible

decrease in development of AKTG a hypophysis, oppression of a system.

should carry out by

in case of development of an infection in the place of use of ointment/gel the corresponding antibacterial or antifungal treatment. If symptoms of an infection do not disappear, it is necessary to stop use of medicament for treatment of an infection.

Should avoid putting medicament on eyelids or skin around eyes to patients with a closed-angle and open angle glaucoma and also to patients with a cataract because of possible increase in expressiveness of symptoms of a disease. It is necessary to avoid hit of medicament in eyes. At irritation of skin in the site of application of ointment/gel it is necessary to cancel drug.

On face skin and also in inguinal area to apply only in case of special need as increase in absorption and high risk of development of side effects (teleangiectasias, dermatitis perioralis), even after short use is possible.

Should use with care medicament in the presence of an atrophy of hypodermic cellulose, mainly at elderly people.

As ointment contains propylene glycol, medicament can cause irritation of skin at use.

As ointment contains lanolin, its use can cause local reaction (for example contact dermatitis).

Gel contains parahydroxybenzoates which can cause allergic reactions (perhaps, delayed).

Gel contains propylene glycol which can cause irritation of skin.

Use during pregnancy and feeding by a breast. Drug is contraindicated during pregnancy. For treatment the feeding by a breast should be stopped.

Pregnancy. As a result of researches on animals it is confirmed that GKS have teratogenic effect even at use in low doses. Teratogenic influence at animals was confirmed also when drawing powerful corticosteroids on skin. Controlled researches for assessment of possible teratogenic action at pregnant women at topical administration on skin were not conducted therefore data on effects of medicament on a course of pregnancy and/or embryonic development, fetation, childbirth, post-natal development are insufficient. The potential risk for the person is unknown.

Flucinarum should not be applied during pregnancy except for emergency if the potential advantage of use of medicament for mother exceeds risk for a fruit. Drug is contraindicated in the I trimester of pregnancy.

feeding Period breast. It is unknown whether the fluotsinolona can get acetonide into breast milk after topical administration. After intake of GKS the significant concentration in breast milk which can cause side effects in the newborn child, did not define.

Children. Drug is not used at children under 2 years.

Ability to influence speed of response at control of vehicles or work with other mechanisms. Medicine does not limit mental and motive ability and also ability to run vehicles and to work with mechanisms.

Interaction

can use Drug with antimicrobic means of local and systemic action. the combined use with gks systemic action increases efficiency of drug, but at the same time the likelihood of development of side effects raises. the combined use of medicament with npvp increases risk of development of system and local side effects. can strengthen effect of hypotensive, diuretic, antiarrhytmic medicines, potassium drugs. diuretic medicines (except kaliysberegayushchy) raise a hypopotassemia likelihood of development. during medicament treatment it is not recommended to do 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 development of the corresponding antibodies.

Drug can strengthen action of immunosuppressive and weaken effect of the immunostimulating medicines.

Overdose

At long use on extensive sites of skin overdose symptoms which are shown by increase in severity of side effects, including burning of skin in the site of application of drug, a glucosuria, hypostases, ag, decrease in body resistance to infections can arise. the itching, a hyperglycemia, a syndrome itsenko — Cushing are possible. symptomatic treatment against the background of gradual medicament withdrawal.

Storage conditions

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