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

    Active substance - terbinafine hydrochloride (terbinafine) 0.15 g or 0.30 g;

    Excipients: ethanol (rectified ethyl alcohol) 5.625 g or 11.25 g, propylene glycol 0.30 g or 0.60 g, poloxamer (proxanol 268) 0.15 g or 0.30 g, purified water 8.775 gili 17.55 g

    Description:

    Transparent colorless or light yellow liquid with a characteristic smell of ethyl alcohol.

    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 low concentrations terbinafine has a fungicidal action against dermatophytes (Trychophyton rubrum, T. mentagrophytes, T. verrucos um, T.violaceum, Ttonsurans, Microsporum canis, Epidermophyton floccosum), molds, certain dimorphic (Pityrosporum orbiculare) and yeast fungi (mainly Candida albicans). Activity with respect to yeast fungi, depending on their type, may be fungicidal or fungistatic.

    Terbinafine specifically changes the early stage of sterol biosynthesis 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:

    With topical application, absorption - less than 5%, has a minor systemic effect.

    Indications:

    Prevention and treatment of fungal skin infections, including:

    - Mycosis of the feet ("fungus" of the foot),

    - inguinal epidermophyte,

    - fungal lesions of smooth skinla, caused by dermatophytes (Trichophytesthyme, microsporia, epidermophytia, rubProfession).

    Multicolored lichen, caused by dimorphogenic mushrooms.

    Fracture caused by molds mushrooms.

    Contraindications:

    Increased Chuvto terbinafine or to anyauxiliary component of the preprat, children under 2 years.

    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 teratogenic properties of terbinafine were not revealed. To date, no developmental defects have been reported with the use of Termicon®. However, since the clinical experience of using Thermicone® in pregnant women is very limited, it should be used only on strict indications.

    Terbinafine is excreted in breast milk.However, in the case of the use of a nourishing mother Thermocon® 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. Thermicone® spray can be apply 1 or 2 times a day, depending onfrom the testimony. Before using the drug, thoroughly clean and dry the affected skin.

    During use, the bottle (bottle) should be kept upright.

    To ensure a uniform spray of the contents, make several short presses on the nozzle-sprayer.

    The drug is applied to the affected areas of the skin and adjacent areas of healthy skin in a sufficient amount for their moisturizing. Duration of treatment and the frequency of 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 a day;

    - inguinal epidermophytia, diaper rash caused by mold fungi: 1 week, 1 time per day.

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

    Application Termicon ® Spray in children.

    Experience in the use of Thermicone ® spray in children from 2 years is limited, and therefore the use of the drug in children is not recommended.

    Side effects:

    AT places of application of the drug may appear reddening, itching or burning sensation. Allergic reactions.

    Overdose:

    No cases of drug overdose have been reported. If, by chance, Thermicone® spray is taken internally, you may expect the development of the same side effects as with an overdose of Termicon® tablets (headache, nausea, epigastric pain and dizziness). It should also take into account the content of the preparation of ethyl alcohol.

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

    Interaction:Any drug interactions for the Thermicone® 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 Thermocon® spray to damaged areas of the skin, since alcohol can cause irritation.

    Thermicone® spray is for external use only. Avoid contact with eyes, as it can cause irritation. In case of accidental ingestion of the drug in the eye, they should be washed immediately with a flowing water, and in case of development of persistent phenomena of irritation it is necessary to consult a doctor.
    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.
    When developing allergic reactions, it is necessary to cancel the drug.

    Effect on the ability to drive transp. cf. and fur:
    Form release / dosage:

    Spray for outdoor use application 1 %. By 15 g or 30 grams per ballAluminum or in a vial ofof lypropylene supplied with a dosing pump, nozzle and protective cap, or in a polyethylene bottle, is equipped withpump with spray and protective cap. One bottle (bottle), along with instructions for use in a pack of cardboard.

    Packaging:aluminum cylinders with dosing pump (1) - packs cardboard
    aluminum cylinders with dosing pump (48) - cardboard boxes
    polypropylene bottles with dosing pump (1) - packs cardboard
    polypropylene bottles with dosing pump (48) - cardboard boxes
    polyethylene bottles with dosing device (1) - packs cardboard
    polyethylene bottles with dosing device (48) - cardboard boxes
    Storage conditions:Storage. At a temperature of no higher than 30 ° C. Do not freeze. Keep out of the reach of children.
    Shelf life:3 years. Do not use after the expiration date.
    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-001548/07
    Date of registration:12.07.2007
    The owner of the registration certificate:OTISIFARM, OJSC OTISIFARM, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp22.09.2015
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