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

    1 g of cream contains:


    active substance: terbinafine hydrochloride 10 mg;


    Excipients: cetyl alcohol 40 mg, stearic alcohol 40 mg, cetyl palmitate 20 mg, gasoline alcohol 10 mg, sorbitan stearate 19 mg,

    isopropyl myristate 80 mg, sodium hydroxide 2 mg, polysorbate 60 60 mg, purified water 718 mg.

    Description:Description: a homogeneous cream of white or almost white color.
    Pharmacotherapeutic group:antifungal agent.
    ATX: & nbsp

    D.01.A.E.15   Terbinafine

    Pharmacodynamics:

    Antifungal preparation for topical use, having a wide spectrum antifungal activity. In low concentrations terbinafine possesses fungicidal activity against dermatophytes (Trychophyton rubrum, Trychophyton mentagrophytes, Trychophyton verrucosum, Trychophyton violaceum, Trychophyton tonsurans, Microsporum canis, Epidermophyton Jloccosum), molds and

    of certain dimorphic fungi (Pityrosporum orbiculare). Activity with respect to yeast is fungicidal or fungistatic in nature depending on the type of fungi.

    Terbinafine, inhibiting squalene epoxidase in the cell membrane of the fungus, specifically suppresses the early stage of the synthesis of sterols in the fungal cell, which leads to ergosterol deficiency, intracellular accumulation of squalene and death of the fungal cell. Squalene-Epoxidase is not associated with the cytochrome P system450, so terbinafine does not affect metabolism of hormones and drugs, the metabolism of which is associated with system of cytochrome P450.

    Pharmacokinetics:

    Pharmacokinetics: for topical application, absorption is less than 5 %, rendersminor systemic action.

    Indications:

    Prevention and treatment of fungal skin diseases (trichophytosis / microsporia, rubrofitia) caused by, sensitive pathogens, including foot mycoses "foot fungus" and inguinal epidermophyte; yeast infections (skin candidiasis), multi-colored lichen.

    Contraindications:Hypersensitivity to terbinafine or to the components of the drug.
    Carefully:Renal and / or hepatic insufficiency, alcoholism, oppression of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive diseases of the vessels of the extremities; pregnancy, lactation, children's age before 12 years (lack of sufficient clinical experience).
    Dosing and Administration:

    Outwardly.

    Before applying Exxin® Cream, it is necessary to clean and dry the affected areas. The cream is applied a thin layer on the affected skin and 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 and frequency of application:

    Dermatomycosis of the trunk, shins -1 week 1 time per day.

    Inguinal epidermophytia: 1-2 weeks 1 time per week.

    Dermatomycosis of the feet ("foot fungus") -1 week 1 time per day.

    Candidiasis of the skin - 1-2 weeks 1 or 2 times a day. Multicolored lichen - 2 weeks 1 or 2 times a day.

    The duration of treatment depends on the indication and severity of the disease.

    Reduction in the severity of clinical manifestations is noted in the first days of treatment.

    For the prevention of relapses mycosis stop - 2-3 courses for 2 weeks with a break of 7 days.

    Dosage regimen Exxin® cream in elderly people does not differ from the above.

    Side effects:Itching and burning of the skin, hyperemia in the place of application.
    Overdose:

    With external application - unlikely.

    Symptoms at random ingestion: headache, nausea, gastralgia, dizziness, frequent urination, rash.

    Treatment: activated charcoal, if necessary, symptomatic maintenance therapy.

    Interaction:Any drug interactions for Exxin® Cream are unknown.
    Special instructions:

    Reducing the severity of clinical manifestations is usually noted in the first days of treatment. Irregular application or early termination of treatment increases the risk; development of relapse.

    If after 2 weeks.there is no improvement in the condition, it is necessary to repeatedly identify the causative agent of the disease and its sensitivity to drug.

    In the process of treatment, it is necessary to follow the general rules. Hygiene for the prevention of re-infection (through underwear, shoes).

    Avoid getting the cream in the eyes and the mucous membrane of the nasal cavity, mouth.

    Effect on the ability to drive transp. cf. and fur:The drug has a minor systemic effect, so it is unlikely to influence the driving of vehicles and other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions.
    Form release / dosage:

    Cream for external use 1%.

    Packaging:For 10 g in a tube of lacquered aluminum. Each tube with instruction for use is placed in a cardboard pack.
    Storage conditions:

    At a temperature of no higher than 25 ° C. Do not freeze.

    Keep out of the reach of children.

    Shelf life:

    Shelf life 3 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N011536 / 02
    Date of registration:30.11.2011
    The owner of the registration certificate:Dr. Reddy's Laboratories Ltd.Dr. Reddy's Laboratories Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspDr. Reddy`c Laboratoris Ltd.Dr. Reddy`c Laboratoris Ltd.
    Information update date: & nbsp18.09.2015
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