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

    Active substance: terbinafine hydrochloride 0.2 g,

    Excipients: Propylene glycol, Macrogol 300 (polyethylene glycol 300), Ethanol (ethyl alcohol 96%), Purified water.

    Description:

    Transparent or slightly opalescent, colorless or with a yellowish tint of color liquid.

    Pharmacotherapeutic group:Antifungal agent
    ATX: & nbsp

    D.01.A.E.15   Terbinafine

    Pharmacodynamics:

    Antifungal drug for external use, allylamine derivative with a wide range of antifungal activity. Specifically, it 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.

    In small concentrations terbinafine has a fungicidal action against dermatophytes (Trichophyton rubrum, T.mentagrophytes, T.verrucosum, T. violaceum, T.tonsurans, Microsporom 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 has no effect on the cytochrome P450 system in humans and, accordingly, on the metabolism of hormones for other medicaments.

    Pharmacokinetics:With topical application, absorption is 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 dermatophytes, such as Trichophyton (including, T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum. ',

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

    Contraindications:

    Hypersensitivity to the components of the drug, children under 12 years.

    Carefully:

    Hepatic and / or renal failure, alcoholism, oppression of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive, vascular disease of the extremities.

    Pregnancy and lactation:

    In experimental studies teratogenic properties of terbinafine were not revealed. Until now, there have been no reports of any malformations developed with the use of the drug. However, because there is no data on the safety of terbinafine during pregnancy, it should be used only on strict indications, when the expected positive effect of treatment for the mother exceeds the potential risk to the fetus.

    Terbinafine is excreted in breast milk. However, in the case of the use of terbinafine feeding mother in the form of a spray, only a small amount of active substance is absorbed through the skin, therefore, an adverse effect on the baby is unlikely.However, due to the lack of sufficient experience in the use of the drug during breastfeeding, breastfeeding should be discontinued at the time of treatment.

    Dosing and Administration:

    Outwardly.

    Adults and children from the age of 12: the spray is applied to the affected areas of the skin (after cleansing and drying) and adjacent areas 1 or. 2 times a day in an amount sufficient to thoroughly moisturize. Average duration and frequency of drug use:

    - dermatomycosis of the trunk, shins -1 weeks, 1 time per day;

    - dermatomycosis stop -1 a week, once a day;

    - multi-colored lichen - 1 week, 2 times a day.

    Elderly patients. Dosage regimen in elderly people does not differ from described above.

    Side effects:

    Redness in the place of application, a sensation of itching or burning, but these phenomena rarely led to the need to stop treatment.

    Rarely: allergic reactions.

    Overdose:

    There were no reported cases of overdose with topical application of the drug.

    If you randomly take the drug inside, the following symptoms are possible: headache, nausea, epigastric pain, dizziness. It should also take into account the presence of ethanol in the formulation.

    Treatment: Activated carbon, if necessary, symptomatic therapy

    Interaction:When using the drug in a dosage form, the spray of interaction with other medicinal products is unknown.
    Special instructions:

    The drug is intended for external use only. It should be avoided getting on the mucous membrane of the eyes. In case of contact with eyes, rinse with plenty of running water, and in case of persistent irritation, consult a physician. If the drug was accidentally injected into the respiratory tract by inhalation, then, in case of any symptoms, and especially when they are preserved, it is necessary to consult a doctor.

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

    With care, apply Lamella in the dosage form of the spray to the damaged areas of the skin, since alcohol can cause irritation.

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

    When treating Lamitel, general hygiene rules should be followed to prevent re-infection (through underwear, shoes).

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

    Form release / dosage:

    Spray for external use 1 %.

    Packaging:

    For 20 ml of the drug in a polymer bottle with a spray gun and a lid.

    1 bottle with instructions for use in a cardboard box.

    Storage conditions:

    At a temperature of 15 - 25 ° C in the original packaging.

    Keep out of the reach of children!

    Shelf life:3 years. Do not use after the expiration date printed on the package.
    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-009370/08
    Date of registration:25.11.2008
    Expiration Date:Unlimited
    The owner of the registration certificate:K.O. Ромфарм Компани С.Р.Л.K.O. Ромфарм Компани С.Р.Л. Romania
    Manufacturer: & nbsp
    Representation: & nbspРомфарма ОООРомфарма ООО
    Information update date: & nbsp14.02.2018
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