Active substanceNeomycin + Fluocinolone acetonideNeomycin + Fluocinolone acetonide
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  • Flucinar® H
    ointment externally 
    VALEANT, LLC     Russia
  • Dosage form: & nbspointment for external use
    Composition:

    1 g of ointment contains:

    Active substances:

    fluocinolone acetonide 0.25 mg, neomycin sulfate (680 ME/ mg, which corresponds to 3400 ME neomycin) - 5.0 mg

    Excipients: propylene glycol - 50.0 mg, paraffin liquid - 50.0 mg, lanolin-100.0 mg, vaseline-up to 1.0 g.

    Description:light yellow, translucent in a thin layer, oily soft mass.
    Pharmacotherapeutic group:Glucocorticosteroid for topical use + antibacterial.
    ATX: & nbsp

    D.07.C.C.02   Fluorocinolone acetonide in combination with antibiotics

    Pharmacodynamics:

    Flucinp ® H - combined preparat, act conditioned by components included in its composition. As a result of the combined effect of fluocinolone acetonide and neomycin, the drug inhibits the development of inflammatory-allergic skin reactions complicated by bacterial infection.

    Fluocinolone is a synthetic potent glucocorticosteroid for external use. Has anti-inflammatory, antipruritic and

    antiallergic, as well as vasoconstrictive properties. The mechanism of anti-inflammatory action of fluocinolone acetonide is not fully understood. It is believed that fluocinolone acetonide reduces the manifestation of the inflammatory process, inhibiting the synthesis of prostaglandins and leukotrienes by inhibiting the activity of phospholipase A2 and a decrease in the release of arachidonic acid from the cell wall phospholipids. As a result, hyperemia and exudation decrease in the lesion focus. Stabilizes cellular and subcellular, including lysosomal membranes. Reduces the yield of proteolytic enzymes from lysosomes, Reduces the permeability of membranes, reduces mitotic activity, immune responses and the release of inflammatory mediators. When exposed to the skin, the edge accumulation of neutrophils is prevented, which leads to a decrease in inflammatory exudate and production of lymphokines; inhibition of migration of macrophages, reduction of infiltration and granulation processes; It inhibits the phase of alteration and limits the focus of inflammation. Reduces the migration of leukocytes and lymphocytes to the area of ​​inflammation. It inhibits the synthesis or release of cytokines (interleukins and interferon) from lymphocytes and macrophages. Reduces the severity of an early immunological response.

    Neomycin - an aminoglycoside antibiotic, is active against a number of gram-positive microorganisms: Gram-positive cocci - Staphylococcus spp., Streptococcus spp., (Enterococcus, faecalis); aerobic bacteria - Corynebacterium - diphtheriae, Listeria monocytogenes, Bacillus antracis, anaerobic bacteria - Clostridium spp., Actinomyces spp.; Gram-negative microorganisms: aerobic bacteria - Escherichia coli, Salmonella spp., Shigella spp., Proteus spp., Enterobacter aerogenes, Vibrio cholerae, Hemophilus influenzae, Klebsiella pneumoniae, Bordetella pertussis, Pasteurella multocida, Borellia spp., Treponema pallidum; anaerobic bacteria - Leptospira interrogans, Fusobacterium spp.; aerobic gram-negative cocci - Neisseria meningitidis; acid resistant sticks - Mycobacterium tuberculosis. The resistance of microorganisms to neomycin sulfate develops slowly and to a small extent. At low concentrations, it has a bacteriostatic effect (due to a violation of protein synthesis in microbial cells), in high concentrations bactericidal (damages the cytoplasmic membranes of the microbial cell).

    Pharmacokinetics:

    Fluocinolone easily penetrates through the stratum corneum. Do not undergo biotransformation in the skin and cumulate in the stratum corneum. When applied externally, fluocinolone can be absorbed to an insignificant degree from the skin and have a systemic effect. Biotransformiruetsya mainly in the liver. In the form of compounds with glucuronic acid and in small amounts in unbound form is excreted through the kidneys, and also slightly with bile.

    Neomycin penetrates deeper layers of the skin. With prolonged use or on extensive skin surfaces, up to 3% of the applied dose can be absorbed into the systemic blood stream, where it binds to blood proteins (10%), practically does not penetrate into the cells. Poorly penetrates the central nervous system, bones, muscles, adipose tissue. Relatively easily penetrates the placental barrier. Excreted in breast milk. Metabolism is not affected. Half life (T 1/2) - 2-4 h. It is excreted unchanged through the kidneys.
    Indications:

    Diseases of the skin complicated by a secondary bacterial infection caused by a neomycin-sensitive flora;

    - dermatitis allergic;

    - contact dermatitis,

    - professional dermatitis;

    - seborrheic dermatitis;

    - sunny dermatitis;

    - atopic dermatitis;

    - prurigo; pruritis;

    - eczema;

    - exudative erythema multiforme;

    -psoriasis;

    - burns I degree.

    Contraindications:Hypersensitivity, cutaneous manifestations of syphilis, skin tuberculosis, diaper rash, rosacea, extensive psoriatic plaques, anogenital itching; skin infections caused by bacteria, viruses - pyoderma, chicken pox, herpes, actinomycosis, blastomycosis, sporotrichosis,trophic ulcers of the leg, associated with varicose veins, erosive and ulcerative lesions of the gastrointestinal tract, wounds on the application areas, skin cancer, nevus, atheroma, melanoma; hemangioma, xanthoma, sarcoma, pregnancy, lactation period, children's age (up to 2 years).
    Carefully:With caution, use in people the presence of atrophic skin changes, especially in the elderly.
    Pregnancy and lactation:contraindicated
    Dosing and Administration:

    Outwardly.

    Have adults: a small amount of ointment is applied in a thin layer to the affected areas, 1 skin 2-3 times a day, after the inflammation has subsided - 1-2 times a day. If there is a need for a bandage, then an air-permeable dressing should be used. In case of excessive, peeling of the stratum corneum of the epidermis (lichenization) or excessive keratinization of the altered areas, the ointment can be applied under. closed bandage (occlusive), which must be changed every 24-48 hours. The course of continuous treatment is not more than 2 weeks. Do not apply over a day more than 2 g of ointment. - Children: The drug is used in children older than 2 years, once a day, in limited areas of the skin, a short course.

    Side effects:There may be itching and irritation.Sometimes it is possible to attach a secondary infection caused by neomycin-resistant microorganisms. With prolonged use on the face, the appearance of steroid-acne, telangiectasias, striae, skin atrophy, perioral dermatitis, depigmentation; alopecia or hirsutism. There may be a urticaria or maculopapular rash. With prolonged use or application to extensive surfaces, it is possible to develop systemic side effects of glucocorticosteroids, as well as oto- and nephrotoxic effects of neomycin.
    Overdose:Overdose is extremely rare. If the drug is applied improperly on extensive skin surfaces, systemic side effects of glucocorticosteroid and oto- and nephrotoxic effects of neomycin may occur. When the drug is canceled, the overdose phenomenon passes by itself.
    Interaction:During treatment should not be vaccinated against smallpox, or plan other types of immunization. When the drug is resorbed into the total bloodstream, the glucocorticosteroid reduces the effectiveness of insulin, oral hypoglycemic drugs, antihypertensive drugs, anticoagulants; reduces the content of salicylates in the blood, reduces the concentration of praziquantel in the blood serum.Increase the risk of side effects: androgens, estrogens, oral contraceptives, anabolic steroids (hirsutism, acne); antipsychotic drugs; carbutamide, azathioprine (cataract); holinoblokatory, antihistamines, tricyclic antidepressants, nitrates (glaucoma); diuretics (hypokalemia); cardiac glycosides (digitalis intoxication). Continuous use simultaneously with gentamicin, ethacrynic acid or colistin increases the risk of nephro- and ototoxic effects.
    Special instructions:

    Do not exceed the course of treatment. Do not use, long on large areas of skin. If it is necessary to apply the drug to the skin of the face and skin folds, treatment should be short.

    When a secondary infection occurs at the site of application of the ointment, agents with a more pronounced antibacterial or antifungal effect should be used.

    Effect on the ability to drive transp. cf. and fur:The drug does not limit the psycho-physical activity, the ability to drive vehicles and maintain machinery in motion.
    Form release / dosage:

    Ointment for external use.

    For 15 grams of ointments in aluminum tubes with a membrane and caps made of artificial material (with the enemy), enameled outside (with a seal), on the inside coated with chemically resistant lacquer. Tubes are packed in lithographed individual cardboard packs.

    In each pack insert instruction for use.

    Packaging:tubes, aluminum (1) - packs, cardboard
    Storage conditions:Store at a temperature not exceeding 25 ° C. Keep out of the reach of children.
    Shelf life:

    3 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N014912 / 01
    Date of registration:09.06.2009
    The owner of the registration certificate:VALEANT, LLC VALEANT, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspVALEANT LLC VALEANT LLC Russia
    Information update date: & nbsp07.08.2015
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