Clinical and pharmacological group: & nbsp

Glucocorticosteroids

Included in the formulation
  • Sinaflan
    ointment externally 
    GREEN DUBRAVA, CJSC     Russia
  • Sinaflan
    ointment externally 
    ATOLL, LLC     Russia
  • Sinaflan
    ointment externally 
    ALTAYVITAMINS, CJSC     Russia
  • Sinaflan
    ointment externally 
  • Sinaflan
    liniment externally 
  • Sinaflan
    ointment externally 
  • Sinaflan
    ointment externally 
  • Sinaflan
    liniment externally 
  • Sinaflan
    ointment externally 
  • The Synoderm
    cream externally 
    Galenika ad.     Serbia and Montenegro
  • The Synoderm
    ointment externally 
    Galenika ad.     Serbia and Montenegro
  • The Synoderm
    gel externally 
    Galenika ad.     Serbia and Montenegro
  • Flucinar®
    ointment externally 
    VALEANT, LLC     Russia
  • Flucinar®
    ointment externally 
    VALEANT, LLC     Russia
  • АТХ:

    D.07.A. C.04   Fluocinolone acetonide

    Pharmacodynamics:Glucocorticoid, anti-inflammatory, antiallergic, antipruritic action.

    It binds to specific receptors located in the cytoplasm of cells of target organs and activates the synthesis of mRNA; induces the formation of lipocortin proteins, one of which is lipomodulin, inhibits the activity of phospholipase A2.The disruption of the formation of arachidonic acid actually means inhibition of the synthesis of prostaglandins, since arachidonic acid is a substrate for further metabolism along the cyclooxygenase pathway, and also along the lipoxygenase pathway, with appropriate inhibition of leukotriene synthesis.

    The anti-inflammatory effect of fluocinolone is potentiated by its ability to inhibit the expression of COX-2 genes, which also leads to a decrease in the synthesis of prostaglandins in the inflammatory focus, including pro-inflammatory prostaglandins E2 and I2. Fluocinolone inhibits the expression of intercellular adhesion molecules in the endothelium of blood vessels, disrupting the penetration of neutrophils and monocytes into the focus of inflammation.

    Anti-inflammatory effect is due not only to the stabilization of cell membranes and organelles, including lysosomes; oppression of the formation of prostaglandins, T-helpers, leukotrienes, but also inhibition of hyaluronidase; oppression of the division of mast cells and their degranulation, a decrease in the liberation of mediators of inflammation (histamine, serotonin, bradykinin), suppression of the synthesis of the platelet activation factor.

    The drug affects all types of metabolism. Accelerates protein catabolism.Reduces the utilization of glucose by insulin-dependent tissues, causes hyperglycemia, increases the amount of glycogen, increases the breakdown of fats, delays sodium and water ions, promotes the excretion of potassium, reduces the absorption of calcium ions, causes hypocalcemia, and induces the secretion of parathyroid hormone that mobilizes calcium from bone tissue. Reduces the number of lymphocytes and eosinophils, causes erythrocytosis (stimulates the production of erythropoietins). Reduces the proliferation of connective tissue. Immunodepressive and antiallergic effects are a consequence of a decrease in the migration of B- and T-lymphocytes and their interaction. Increases the anti-shock effect, increases blood pressure (increases the level of catecholamines in the blood), restores the sensitivity of adrenoreceptors to noradrenaline and adrenaline, narrows the vessels, activates liver enzymes involved in the metabolism of xenobiotics (antitoxic action).

    Pharmacokinetics:

    Easily penetrates the skin through the stratum corneum. Not exposed to biotransformation in the skin and cumulates in the stratum corneum (found in the skin even 15 days after its local application). With external application fluocinolone acetonide is absorbed insignificantly in the systemic bloodstream, undergoes biotransformation in the liver with the formation of inactive metabolites. Excreted mainly by the kidneys. Absorption of fluocinolone acetonide is more pronounced when applied to the skin of the face and affected areas of the skin, as well as when using occlusive dressings. In addition, absorption increases with frequent application and application to large areas of the skin. Absorption of the drug in children is more pronounced than in adults.

    Biotransformation in the liver (after entering the systemic circulation) to inactive metabolites (CYP3A4). The half-life is 1.3-1.7 hours.

    Indications:Acute and severe uninfected inflammatory skin lesions, including eczema of various genesis and localization, atopic dermatitis, psoriasis (including scalp), lichen planus, seborrheic dermatitis (including hairy areas of the skin), itchy skin of various genesis, discoid lupus erythematosus, allergic skin diseases, erythema multiforme, scrapie, 1st degree burns, sunburn, insect bites.

    XII.L20-L30.L20.8   Other atopic dermatitis

    XII.L20-L30.L20   Atopic dermatitis

    XII.L20-L30.L21   Seborrheic dermatitis

    XII.L20-L30.L23   Allergic contact dermatitis

    XII.L20-L30.L24   Simple irritant contact dermatitis

    XII.L20-L30.L28.0   Simple chronic lichen

    XII.L20-L30.L29   Itching

    XII.L20-L30.L30.0   Coin-like eczema

    XII.L20-L30.L30.9   Dermatitis, unspecified

    XII.L40-L45.L40   Psoriasis

    XII.L40-L45.L43   Lichen red flat

    XII.L50-L54.L50   Hives

    XII.L50-L54.L51   Erythema multiforme

    XII.L55-L59.L55   Sunburn

    XII.L55-L59.L56.2   Photocontact dermatitis [berloque dermatitis]

    XII.L55-L59.L58   Radiation dermatitis radiation

    XII.L80-L99.L93.0   Discoid lupus erythematosus

    XIX.T20-T32.T30   Thermal and chemical burns, unspecified

    XX.W50-W64.W57   Bite or sting with a non-toxic insect or other non-venous arthropod

    Contraindications:Hypersensitivitynost; bacterial, viral and fungal skin disease, pyoderma, anogenital pruritus, lupus, skin manifestations of syphilis, wound skin lesions, precancerous and neoplastic diseases of the skin, diaper rash, extensive psoriatic lesions (plaques), pink and acne vulgaris (in case of use in the ordinary or pink acne possibly worsening of the disease); leg sores associated with varicose veins, children up to 2 years, erosive and ulcerativee lesions of the digestive tract, ulcers and wounds on the application areas; skin cancer, nevus, atheroma, melanoma, hemangioma, xanthoma, sarcoma; pregnancy, breast-feeding.
    Carefully:At girls during puberty, children are more senior 2 years, the person of advanced age.
    Pregnancy and lactation:

    Controlled teratogenicity tests with topical application of fluocinolone acetonide were not carried out during pregnancy. Do not use in the first trimester of pregnancy; use in the II and III trimester of pregnancy is possible only if the perceived benefit to the mother exceeds the potential risk to the fetus.

    Action category for the fetus by FDA - C.

    It is not known to what extent fluocinolone acetonide with external application penetrates into breast milk, so during lactation appoint with extreme caution, only in exceptional cases, briefly and in limited areas of the skin. Use the drug on the skin of the mammary glands is not allowed.

    Dosing and Administration:Outwardly. It is applied to the affected skin 1-4 times a day. Course - no more than 1-2 weeks, when applied to the skin of the face - no more than 1 weeks. For "dry" skin diseases, an ointment is recommended (it is possible to use a dressing), with moist changes on the skin - cream and liniment, in case of damage to the hairy areas of the body - gel and liniment. The preparation in the form of a gel is also shown to patients who do not tolerate it as an ointment because of the components of the ointment base.
    Side effects:

    Local reactions: burning, skin itching, acne, post-steroid vascular purpura, suppression of epidermal growth, skin atrophy and telangiectasia, dry skin, perioral dermatitis, striae, folliculitis, increased hair loss or alopecia, melanoderma or discoloration of the skin, secondary infected skin lesionspropensity to develop pyoderma and candidiasis, ecchymosis).

    From the side gastrointestinal tract: vomiting, pancreatitis, bleeding and perforation of the gastrointestinal tract, flatulence, hiccough, nausea, steroid ulcer of the stomach and duodenum, esophagitis, increased or decreased appetite, increased activity of hepatic enzymes.

    From the side endocrine system: suppression of adrenal function, suppression of the function of the pituitary-adrenal system,steroid diabetes or the manifestation of latent diabetes mellitus, delayed sexual development in children, menstrual irregularities, Itenko-Cushing's syndrome, reduced tolerance to carbohydrates, and slowed growth in children.

    From the side metabolism: negative nitrogen balance due to protein catabolism, hypocalcemia, weight gain, sweating.

    From the side musculoskeletal system: growth retardation and ossification processes in children (premature closure of epiphyseal growth zones), muscle tendon rupture, muscle weakness, steroid myopathy, osteoporosis (very rarely pathological fractures, aseptic necrosis of the head of the humerus and femur), muscle mass reduction (atrophy).

    From the side of cardio-vascular system: loss of potassium, arrhythmia, arterial hypertension, steroid myopathy, heart failure (development or enhancement of symptoms), characteristic of hypokalemia, hypercoagulation, hypokalemic alkalosis, bradycardia (up to cardiac arrest), ECG changes, increased blood pressure, thrombosis. In patients with acute myocardial infarction - slowing the formation of scar tissue, the spread of the foci of necrosis, rupture of the heart muscle.

    From the side nervous system: headache, delirium, disorientation, hallucinations, depression, insomnia, vertigo, convulsive seizures, increased intracranial pressure, euphoria, manic-depressive psychosis, nervousness or anxiety, dizziness, pseudotumor of the cerebellum.

    From the side view: posterior subcapsular cataract, trophic corneal changes, exophthalmos, increased intraocular pressure (with possible damage to the optic nerve), propensity to develop secondary infection (bacterial, fungal, viral).

    Other: with prolonged use and / or application to large body surfaces: peripheral edema, slowing down the processes of regeneration, secondary immunodeficiency (exacerbation of chronic infectious diseases, reduced resistance to infections - generalization of the infectious process, the development of opportunistic infections), allergic reactions (urticaria, maculopapular rash).

    Overdose:

    Symptoms: irritation of the skin at the site of application (itching, burning), hyperglycemia, glucosuria, Itenko-Cushing syndrome.

    Treatment: symptomatic on the background of a gradual withdrawal of the drug.

    Interaction:

    Hypotensive drugs. Fluocinolone acetonide reduces the activity of antihypertensive drugs.

    Potassium-containing preparations. Fluocinolone acetonide reduces the activity of potassium preparations.

    Vaccines. During the treatment of fluocinolone with acetonide, vaccination should not be carried out in connection with the immunosuppressive effect of fluocinolone acetonide.

    The drug reduces the effectiveness of diuretics and increases the risk of hypokalemia (except for potassium-sparing diuretics)

    Hypoglycemic drugs - reducing the rate of decrease in blood glucose.

    Cardiac glycosides are a risk of glycosidic intoxication.

    Rifampicin, barbiturates and phenytoin - decrease in the effect of the drug.

    Antipsychotic drugs, azathioprine, carbutamide - risk of developing cataracts.

    M-cholinoblockers, nitrates - increased intraocular pressure.

    Special instructions:

    Use only short courses on small areas of the skin. Children older than 2 years are prescribed with caution once a day on small areas of the skin. Duration of appointment in children should not exceed 5 days.

    With extreme caution apply to the skin of the eyelids or in the eye area in patients with glaucoma or cataract (possibly increasing the symptoms of the disease).When applied to the skin of the face, the absorption of the drug increases and even after short-term use, the occurrence of side effects (telangiectasia, skin atrophy, perioral dermatitis) increases, so use the drug in this area with extreme caution.

    With caution appoint patients with atrophic skin changes, especially the elderly. It is recommended to wear loose clothes during treatment.

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