Active substanceFluocinolone acetonideFluocinolone acetonide
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  • Dosage form: & nbspointment
    Composition:
    Active substance: fluocionolone acetonide (sinaflan) - 0.025 g.
    Excipients: propylene glycol - 4.975 g, lanolin (lanolin anhydrous) 5.0 g, ceresin 5.0 g, petroleum jelly (petroleum jelly) - 85,0 g.

    Description:Ointment is yellowish white to yellow.
    Pharmacotherapeutic group:Glucocorticosteroid for topical application
    ATX: & nbsp

    D.07.A. C.04   Fluocinolone acetonide

    Pharmacodynamics:
    Glucocorticoid agent (SCS) for external use; inhibits the release of inflammatory mediators. When exposed to the skin, there was a warning of the edge accumulation of neutrophils, which leads to a decrease in inflammatory exudate and production of cytokines; inhibition of migration of macrophages, reduction of infiltration and granulation. Has anti-inflammatory and anti-allergic effect.

    Pharmacokinetics:After absorption from the surface of the skin binds to plasma proteins, it is metabolized in the liver with the formation of inactive metabolites. It is excreted mainly by the kidneys.
    Indications:
    Inflammatory and allergic skin diseases of non-microbial etiology: Eczema, atopic dermatitis, simple chronic lichen (limited neurodermatitis), toxicermy, simple allergic dermatitis, seborrheic dermatitis, itchy skin,
    urticaria, pruritis, diaper rash, erythema multiforme exudative, psoriasis (exudative form); red flat lichen, discoid lupus erythematosus, dyshidrosis of the hands, external otitis, 1st degree burns, insect bites.

    Contraindications:
    Hypersensitivity to the components of the drug; cutaneous manifestations of syphilis; lupus; diaper rash; rosacea; extensive psoriatic plaques; anogenital itching; skin infections caused by bacteria, viruses, fungi - pyoderma, chicken pox, herpes, actinomycosis, blastomycosis, sporotrichosis; trophic ulcers of the lower leg, associated with varicose veins; erosive and ulcerative lesions of the gastrointestinal tract; ulcers and wounds in the areas of application; skin cancer; nevus; atheroma; melanoma; hemangioma; xanthoma; sarcoma; pregnancy; the period of breastfeeding; early childhood (up to 2 years). The drug is not intended for the treatment of eye diseases. If you have any of the diseases listed in this section, always consult a doctor before using the drug.

    Pregnancy and lactation:
    The drug is contraindicated for use during pregnancy.
    It is recommended to stop breastfeeding for the period of treatment with the drug. It is not known to what extent fluocinolone acetonide with external application penetrates into breast milk. Only in exceptional cases, the drug can be administered with extreme caution, for a short time and in limited areas of the skin. It is not recommended to apply the drug on the skin of the mammary glands.
    For children older than 2 years, use the drug once a day on small areas of the skin for not more than 5 days.
    If you have chronic diseases, consult a doctor before using the drug.

    Dosing and Administration:
    Outwardly. Adults and children over 2 years old on the skin, previously rubbed with a tampon moistened with antiseptic liquid, apply a small amount of the drug and lightly rub (adults - 2 to 4 times a day, children over 2 years - once a day).
    Children are prescribed with caution, in small areas of the skin.
    If necessary, you can apply an occlusive dressing, leaving it on the affected surface for up to 3 - 4 days. It is not allowed to apply under the bandage more than 2 g / day. Due to the low absorption of the drug with external application does not have a significant general effect on the body.
    The duration of treatment depends on the nature of the disease and the effectiveness of therapy, usually 5-10 days. If the disease persists, the course of treatment can be extended to 25 days or more. Children are recommended to use the minimum effective dose, not more than 5 days.

    Side effects:
    Allergic reactions, burning, itching, steroid acne, striae, dry skin, folliculitis.
    With prolonged use, unwanted adverse reactions (NAD) from the skin are possible:
    atrophy of the skin in the place of application;
    local hirsutism (excessive hairiness),
    hypertrichosis (a disease manifested in excessive hair growth that is not characteristic of this area of ​​skin, not corresponding to sex and / or age);
    telangiectasia (persistent expansion of the surface vessels (mainly capillaries) of the skin and mucous membranes in the form of bluish-red spots of various shapes, usually located on the skin of the face, shins, with their location on the mucous membranes of the upper respiratory tract and gastrointestinal tract may bleed);
    purpura (small-spotted capillary hemorrhages in the skin, under the skin or in the mucous membranes);
    disorders of pigmentation of the skin (hyperpigmentation of the skin and mucous membranes (ACTH effect), usually in places of skin friction);
    alopecia (abnormal hair loss, leading to their loss or complete disappearance in certain areas of the head or trunk), especially in women;
    from the immune system: secondary immunodeficiency (exacerbation of chronic infectious diseases, generalization of the infectious process, development of opportunistic infections).
    When applied to large surfaces are possible systemic manifestations: from the digestive system (gastritis, acute gastric ulcer and duodenal ulcers, "steroid" stomach ulcers, ulcers of the digestive tract, hemorrhagic pancreatitis, intestinal atony); by metabolism (adrenal insufficiency, Cushing's syndrome Itsenko- or Cushing's syndrome (excessive formation of adrenal hormones) that is characterized by typical manifestations: metabolic disorders of proteins, fats and carbohydrates, the activation of protein breakdown and form excessive amounts of free fat in the blood, increasing the amount of glucose in the patient's blood, which can lead to the development of "steroid" diabetes mellitus, slowing down the reparative processes.
    If you have a NCD listed in this section, contact your doctor as soon as possible.
    If any of the side effects indicated in the manual are aggravated, or if you notice any other adverse reactions not listed in the instructions, tell your doctor.
    Treatment of NDP is symptomatic on the background of a gradual withdrawal of the drug.
    Overdose:
    Symptoms: itching and burning at the site of application, hyperglycemia (increased blood sugar), glucosuria (glucose (sugar) excretion in the urine), Itenko-Cushing syndrome (excessive formation of adrenal cortex hormones, characterized by a violation of protein, fat and carbohydrate metabolism; activation of the breakdown of proteins and the formation of an excess of free fats in the blood, increasing the amount of glucose in the patient's blood).
    Treatment: symptomatic on the background of a gradual withdrawal of the drug.

    Interaction:
    Pharmaco dynamic: the drug is compatible with antimicrobial drugs. Reduces the activity of antihypertensive, diuretic, antiarrhythmic drugs, potassium preparations. You should consult your doctor if you are taking other medications. Diuretic drugs (except potassium-sparing) increase the risk of hypokalemia.

    Special instructions:
    With extreme care apply to the face area, t. the absorption of the drug increases and even after a short-term use, the possibility of undesirableadverse reactions (telangiectasia, skin atrophy, perioral dermatitis). They are used with caution in girls during puberty; in children older than 2 years (apply the drug once a day in small areas of the skin for not more than 5 days); In patients with atrophic skin changes, especially in elderly people. Avoid contact with eyes. It is recommended to wear loose clothes during treatment. In patients with ordinary or rosacea, treatment may aggravate the disease. To prevent local infectious complications, it is recommended to prescribe in combination with antimicrobial agents.
    Before using the drug, be sure to consult a doctor.
    Features of the drug when it is canceled.

    Effect on the ability to drive transp. cf. and fur:
    Data on the adverse effects of the drug on the ability to drive vehicles, work with mechanisms, etc. are absent.

    Form release / dosage:
    Ointment for external use 0,025%
    Packaging:
    in tubes of aluminum with buds with an internal lacquer coating of 10.0 g; 15.0 g; 20.0 g. Each tube together with the instruction for use is placed in a cardboard pack.

    Storage conditions:Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
    Shelf life:
    5 years. Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-002199
    Date of registration:23.08.2013
    The owner of the registration certificate:GREEN DUBRAVA, CJSC GREEN DUBRAVA, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp20.10.2015
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