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

    1 ml of the preparation contains:

    Active substance:

    Terbinafine hydrochloride........ 10 mg.

    Excipients: cetomacrogol 1000, propylene glycol,

    isopropanol, purified water.

    Description:Colorless transparent solution.
    Pharmacotherapeutic group:Antifungal agent
    ATX: & nbsp

    D.01.A.E.15   Terbinafine

    Pharmacodynamics:

    Antifungal agent for topical use, with a wide range of antifungal activity. In small concentrations terbinafine has a fungicidal action against dermatophytes (Trychophyton rubrum, T.mentagrophytes, T.verrucosum, T. violaceum, T.tonsurans, Microsporum canis, Epidermophyton floccosum), moldy C.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 does not affect the cytochrome P450 system in humans and,
    respectively, on the metabolism of hormones or other medications.

    Pharmacokinetics:With topical application, absorption - less than 5%, has a minor systemic effect.
    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, T. rubmm, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum.

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

    Contraindications:

    Hypersensitivity to terbinafine or any of the inactive 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 teratogenic properties of terbinafine were not revealed. To date, no developmental deficiencies have been reported with the use of Terbifin®. However, since the clinical experience of using Terbifin® in pregnant women is very limited, it should be used only on strict indications.

    Terbinafine is excreted in breast milk. However, when a nursing mother uses Terbifin® spray, a small amount of active substance is absorbed through the skin, so it is unlikely that the baby will be adversely affected.

    Dosing and Administration:

    Outwardly.

    Adults. Terbifin® Spray can be applied 1 or 2 times a day, depending on the indications. Before using the drug, it is necessary to thoroughly clean and dry the affected areas. The drug is sprayed on the affected areas in an amount sufficient for their thorough moistening, and, in addition, applied to adjacent areas of both affected and intact skin.

    Duration of treatment and the frequency of application of the drug: Deptomycosis of the trunk, legs: 1 Week; 1 time per day dermatomycosis of the foot: 1 Week; 1 time per day

    multicolored lichen: 1 Week; 2 times a day

    Dosing regimen of Terbifin® The spray in elderly people does not differ from the above.

    Use of Terbifin® Spray the children. Experience with the use of Terbifin® spray in children is limited, and therefore the use of the drug in children is not recommended.

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

    No cases of drug overdose have been reported. If Terbifin® spray is accidentally ingested, you can expect the development of side effects such as headache, nausea,pain in epigastrium and dizziness.

    Treatment: Activated carbon, if necessary, symptomatic maintenance therapy.

    Interaction:

    Any drug interactions for Terbifin® spray are not known.

    Special instructions:

    Reducing the severity of clinical manifestations is usually noted in the first days of treatment. In case of irregular treatment or premature termination, there is a risk of recurrence of the infection. In the event that after a week of treatment there are no signs of improvement, the diagnosis should be verified.

    Care should be taken when applying Terbifin® to damaged areas of the track.

    Terbifin® Spray is for external use only. Avoid contact with eyes, as it can cause irritation. In case of accidental ingestion of the drug into the eyes, they should be washed immediately with running water, and in case of persistent irritation, consult a physician.

    If the drug was accidentally injected into the respiratory tract by inhalation, then if there are any symptoms and especially when they persist, consult a doctor.

    Form release / dosage:

    Spray for abuse 1%.

    For 15 ml or 30 ml of the drug in a plastic vial, hermetically sealed with an aluminum ring, equipped with a dosing device. Vial withinstructions for use are placed in a cardboard box.

    Packaging:(1) - plastic bottles with dosing device (1) - packs cardboard
    Storage conditions:The drug should be stored 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 expiry date.
    Terms of leave from pharmacies:On prescription
    Registration number:П N014365 / 02
    Date of registration:10.10.2008
    The owner of the registration certificate:Cipla Ltd.Cipla Ltd. India
    Manufacturer: & nbsp
    Cipla Ltd India
    Representation: & nbspCipla LtdCipla Ltd
    Information update date: & nbsp21.09.2015
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