Active substanceTerbinafineTerbinafine
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  • Dosage form: & nbspspray for external use
    Composition:

    Active substances: terbinafine hydrochloride 0.30 g.

    Excipients: isopropanol (isopropyl alcohol), 1,2-propylene glycol, polysorbate 60, macrogol-400 (polyethylene oxide-400), purified water.


    Description:Transparent colorless liquid. Weak opalescence is allowed.
    Pharmacotherapeutic group:Antifungal agent.
    ATX: & nbsp

    D.01.A.E.15   Terbinafine

    Pharmacodynamics:

    Antifungal drug for external use, which has a wide range of antifungal activity. In small concentrations terbinafine has a fungicidal action against dermatophytes (Trychophyton rubrum, Trychophyton mentagrophytes, Trychophyton verrucosum, Trychophyton violaceum, Trychophyton tonsurans, Microsporum canis, Epidermophyton floccosum), moldy Candida albicans) and certain dimorphic fungi (Pityrosporum orbiculare). Activity with respect to yeast fungi, depending on their type, may be fungicidal or fungistatic.

    Terbinafine specifically changes the early stage of biosynthesis of sterols occurring in fungi. This leads to a deficit of ergosterol and to intracellular accumulation of squalene, which causes death of the fungal cell. The action of terbinafine is carried out by inhibiting the enzyme squalene epoxidase located on the cell membrane of the fungus.

    Terbinafine has no effect on the cytochrome P450 system in humans and, accordingly, on the metabolism of hormones or other medications.

    Pharmacokinetics:At external application absorption - less than 5%, renders insignificant system action.
    Indications:

    Prevention and treatment of fungal infections of the skin, including mycosis of the feet ("fungus" of the foot), inguinal epidermophyte (tinea cruris), fungal lesions of smooth skin of the body (tinea corporis), caused by such dermatophytes as Trichophyton (including, Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton violaceum), Microsporum canis and Epidermophyton floccosum.

    Yeast infections of the skin, mainly those that are caused by the genus Candida (eg, Candida albicans), in particular, diaper rash.

    Multicolored lichen (Pityriasis versicolor), called Pityrosporum orbiculare (also known as Malassezia furfur).

    Contraindications:Hypersensitivity to terbinafine or any of the auxiliary ingredients that make up the drug.
    Carefully:

    Hepatic and / or renal failure, alcoholism, oppression of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive diseases of the extremities, children's age (lack of sufficient clinical experience).

    Pregnancy and lactation:

    In experimental studies Teratogenicity of terbinafine is revealed did not have. Until now, not reported on any developmental defects when using Terbix®. But, because clinical experience

    Terbix® in pregnant women is very It is limited, it should be used only for strict indications.

    Terbinafine is excreted in breast milk.

    However, in the case of a lactating mother of Terbix® spray through the skin a small amount of active substance, therefore adverse effect on the baby unlikely.

    Dosing and Administration:

    Outwardly.

    Adults. TerbiX® spray can be used 1 or 2 times a day, depending on the readings. Before using the drug must be thoroughly cleaned and dried affected areas. The drug is sprayed onto affected areas in number, sufficient for their thorough moistening, and, in addition, applied to the adjacent sites of both affected and intact skin.

    Duration of treatment and multiplicity application of the drug:

    dermatomycosis of the trunk, legs: 1 week; 1 time per day

    dermatomycosis of the feet: 1 week; 1 time per day

    multi-colored lichen: 1 week; 2 times per day

    Dosage regimen of Terbix® spray in individuals age does not differ from as described above.

    Children.

    The experience of using Terbiks® spray in children is limited, so the use of drug is not recommended.

    Side effects:

    In places where the product is applied, redness, itching or burning sensation may appear.Allergic reactions.

    Overdose:

    0 cases of drug overdose reported. If by chance Terbix® The spray will be taken inside, you can expect development of side effects: headache, nausea, epigastric pain, and dizziness.

    Treatment: Activated carbon, with necessary - symptomatic maintenance therapy.

    Interaction:

    Any drug interactions for Terbix® spray are not known.

    Special instructions:

    Reduction of the severity of clinical manifestations are usually noted in the early days treatment. In case of irregular treatment or premature termination there is a risk of recurrence of the infection. In case, if after a week of treatment There are signs of improvement Verify the diagnosis.

    Care should be taken when application of Terbix® to damaged areas of the skin, since alcohol can cause irritation.

    The Terbix® Spray is only for external application. Avoid hit him in the eye, as he can cause irritation. At random getting the drug in the eyes, they should be wash immediately with running water, and the development of persistent phenomena irritation is necessary proconsulwith the doctor.

    If the drug was accidentally injected into the inhalation, then in the case of manifestations of any symptoms and, especially with their persistent preservation, it is necessary to consult a doctor.

    When developing allergic reactions it is necessary to cancel the drug.

    Form release / dosage:

    Spray for external use 1% to 30 g in a glass aerosol container or an aerosol aluminum cylinder with a mechanical pump, nozzle and cap in a pack of cardboard together with instructions for use.

    Packaging:cylinders, aerosol, aluminum (1) - packs, cardboard
    balloons, aerosol, glass (1) - packs, cardboard
    Storage conditions:At a temperature of no higher than 30 ° C. Do not freeze. Keep out of the reach of children.
    Shelf life:2 years. Do not use after the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-007955/08
    Date of registration:08.10.2008
    The owner of the registration certificate:ALTAYVITAMINS, CJSC ALTAYVITAMINS, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp21.09.2015
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