Название документа

Pharmacological properties

Pharmacodynamics. active ingredient of medicament of a fluotsinolon acetonide — the fluorinated glucocorticoid.

At topical administration has anti-inflammatory, antiallergic, antipruritic effect. Contacts the specific receptors located in cytoplasm of cells of target organs and activates synthesis of mRNK; induces formation of proteins-lipokortinov, one of which — ipomodulin — suppresses activity of a phospholipase of A 2, . Influences all types of metabolism. Accelerates catabolism of proteins. Reduces glucose utilization by insulin-dependent fabrics, is the reason of a hyperglycemia, increases quantity of a glycogen, strengthens disintegration of fats, detains ions of sodium and water, promotes potassium removal, reduces absorption of calcium ions, causes a hypocalcemia, induces secretion of parathormone which mobilizes calcium from a bone tissue. Reduces quantity of lymphocytes and eosinophils, stimulates products of erythropoietins. Anti-inflammatory action is caused by oppression of activity of a phospholipase of A 2 and also stabilization of cell membranes and organellas, in particular lysosomes. Slows down formation of arachidonic acid and products of her metabolism: prostaglandins, thromboxane, leukotrienes. Inhibits hyaluronidase; suppresses division of mast cells, interferes with their degranulation, reducing release of mediators of inflammation: histamine, serotonin, bradykinin. Suppresses synthesis of a factor of activation of thrombocytes. Reduces proliferation of connective tissue. Immunosuppressive and antiallergic effects are a consequence of reduction of migration and quantity In - and T lymphocytes, disturbance of their interaction.

Pharmacokinetics. Fluotsinolona acetonide easily gets into skin through its enveloping keratosic layer. It is not metabolized in skin, and accumulates in its keratosic layer; it can be revealed even in 15 days after drawing. After dermal absorption, medicament is metabolized mainly in a liver, removed with urine and, in insignificant quantity, with bile, in the form of conjugates of glucuronides — in not changed look.

Indication

Short treatment of an acute and serious non-communicable inflammatory illness of skin (dry forms) which are followed by a persistent itching or a hyperkeratosis: seborrheal dermatitis, atopic dermatitis, urtikarny deprive, contact allergic eczema, a polymorphic erythema, a tubercular lupus, psoriasis, flat deprive.

Use Drug is intended to

by

for topical administration. ointment needs to be applied to skin a thin layer 1–2 times a day. it is not necessary to apply ointment under an occlusive bandage. only in psoriasis it is allowed to use the closed bandage which needs to be changed daily. it is not necessary to carry out treatment continuously longer than 2 weeks it is impossible to apply on face skin for a week no more than 1 tuba (15 g of ointment) are recommended to apply more than 1 week. follows with care and under control of the doctor to use medicament at children aged from 2 years, only 1 time a day, on the small site of skin; not to apply to face skin. duration of a course of treatment usually is 1–2 weeks

Contraindication

Hypersensitivity to components of medicament and others gks. infectious diseases of skin (bacterial, virus, fungal), including skin manifestations of syphilis, a tuberculosis cutis, a pyoderma, pink and ordinary eels, the diaper dermatitis, an anogenitalny itching, perioral dermatitis, skin tumors, trophic ulcers connected with a varicosity. glaucoma, cataract. period of pregnancy and feeding by a breast. age up to 2 years. it is not necessary to apply after preventive inoculations.

Side effects

Allergic reactions: in some cases there can be urticaria, allergic contact dermatitis;

from skin and its appendages: the burning sensation, a skin itching, irritation of skin, atrophic strips, spotty and papular rash, a post-steroid purpura, maceration or xeroderma in the place of applique, the overgrowth of hair on a body or an alopecia, decolouration or a hyperpegmentation of skin, an atrophy and disturbance of integrity of skin, a hyperkeratosis, striya, telangiectasias, perioral dermatitis, a furunculosis, aknepodobny rashes, delay of healing of wounds and cankers, are possible development of secondary infectious damages of skin and exacerbation of the existing skin diseases;

from a GIT: when drawing on big sites of skin the development or exacerbation of chronic gastritis, steroid stomach ulcer is possible;

from an endocrine system: at long use on big sites of skin, system manifestations are possible (insufficiency of adrenal glands, Itsenko's syndrome — Cushing, a hyperglycemia);

from a cardiovascular system: AG;

from an urinary system: development of hypostases is possible;

from sense bodys: at external use on an eyelid skin the cataract or glaucoma can sometimes develop.

Special instructions

not to apply continuously more than 2 weeks at long use on big sites of skin the frequency of manifestations of side effects and a likelihood of developing hypostases, ag, a hyperglycemia, decrease in resistance increases.

needs to carry out by

in case of development of an infection in the site of application of ointment the corresponding antibacterial or antifungal treatment.

At use of medicament the decrease in products of adrenocorticotropic hormone a hypophysis because of oppression of a system napochechnik — a hypophysis, decrease in level of cortisol in blood and development of an iatrogenic syndrome of Cushing who disappears after medicament phase-out is also possible

. It is necessary to avoid putting medicament on eyelids or skin around eyes at patients with a closed-angle and open angle glaucoma and also at patients with a cataract, considering a possibility of strengthening of symptoms of a disease.

On face skin, in axillary and also inguinal area to apply only in the presence of direct indications as increase in absorption of medicament is possible and also risk of development of side effects (teleangiectasias, perioral dermatitis) even after short use increases.

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

Should apply with care medicine in the presence of an atrophy of hypodermic cellulose, mainly at elderly people. During treatment do not recommend to do a smallpox inoculation and also to carry out other types of immunization.

should not apply ointment along with other medicines for external use.

Use during pregnancy and feeding by a breast. Drug is contraindicated during pregnancy. During medicament treatment the feeding by a breast needs to be stopped.

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. Drug in the recommended doses does not influence speed of response at control of vehicles or work with other mechanisms.

Interaction

Drugs gks systemic action increase efficiency of medicine, but at the same time raise a likelihood of development of side effects. the combined use with npvp increases risk of development of system and local side effects. reduces activity 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 p to do to

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

effect of immunosuppressive medicaments can strengthen

Sinaflan-Fitofarm and reduce efficiency of the immunostimulating medicines.

Overdose

Naggers, burning in the site of application of ointment, hypostases, ag, decrease in body resistance of an infection, a hyperglycemia, a glucosuria, a syndrome itsenko — Cushing. symptomatic treatment against the background of gradual medicament withdrawal.

Storage conditions

At a temperature of 8-15 °C.

Characteristics
Active ingredients Fluotsinolona acetonide
Amount of active ingredient 0.25 mg/g
Applicant Phytopharmaceutical
Code of automatic telephone exchange Fluotsinolon's D07AC04 acetonide
Interaction with food It doesn't matter
Light sensitivity Not sensitive
Market status The branded generic
Origin Chemical
Prescription status According to the prescription
Primary packing tuba
Producer PHYTOPHARMACEUTICAL CIAO
Quantity in packing 15 g
Release form ointment for external use
Route of administration External
Sign Domestic
Storage temperature from 5 °C to 25 °C
Trade name Synaflanum

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Sinaflan-Fitofarm ointment of a tube of 15 g

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