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

    10 g of cream contains:

    Active substances: terbinafine hydrochloride - 0.1 g;

    Excipients: gasoline alcohol, sodium hydroxide, cetyl palmitate, cetyl alcohol, stearic alcohol, polysorbate 60, isopropyl myristate, sorbitan stearate, purified water.

    Description:Cream from white to white with a yellowish hue of color, with a weak specific odor.
    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 under 12 years of 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 the application of a mother's nursing cream, TerbiX® cream is absorbed through the skin a small amount of active substances, so adverse effects on the baby are unlikely.

    Dosing and Administration:

    Adults and children from 12 years.

    Before applying the cream, it is necessary to thoroughly clean and dry the affected areas. The cream is applied once or twice a day with a thin layer on the affected skin, adjacent areas and lightly rubbed. In infections accompanied by intertrigo (under the mammary glands, in the interdigital spaces, between the buttocks, in the groin area), the places of application of the cream can be covered with gauze, especially at night.

    Average duration of treatment:

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

    dermatomycosis of the feet: 1 week; 1 per day

    candidiasis of the skin: 1-2 weeks; 1 or 2 times a day

    multi-colored lichen: 2 weeks; 1 or 2 times a day

    Reduction in the severity of clinical manifestations is usually noted in the early days treatment. In case of irregular treatment or premature termination there is a risk of renewal of infection.

    In the event that after 1-2 weeks of treatment There are signs of improvement carry out verification of the diagnosis.

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

    Children. It is not recommended to use this drug in children under 12 years.

    Side effects:

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

    Overdose:

    About cases of drug overdose not reported. If by chance Terbix® the cream will be taken orally, you can expect development of side effects: headache, nausea, epigastric pain, and dizziness.

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

    Interaction:

    Any drug interactions for TerbiX® cream 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.

    Terbiks® Cream 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.

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

    Effect on the ability to drive transp. cf. and fur:

    Form release / dosage:Cream for external use 1% 10 grams in an aluminum tube. Each tube together with the instruction for use is placed in a pack of cardboard.
    Packaging:(1) - aluminum tubes (1) - cardboard packs
    Storage conditions:

    Store at a temperature not exceeding 20 ° C, in a dry place inaccessible to children.

    Shelf life:

    2 years.

    The drug should not be used after the expiry date indicated on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-010214/08
    Date of registration:15.12.2008
    The owner of the registration certificate:ALTAYVITAMINS, CJSC ALTAYVITAMINS, CJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp21.09.2015
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