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

    In 100 g of cream contains active substance: terbinafine hydrochloride 1.0 g. Excipients: benzyl alcohol - 1.0 g; polysorbate-60 - 5.0 g; sorbitan stearate - 2.4 g; cetyl alcohol - 6.0 g; isopropyl myristate 6.0 g; cetyl palmitate - 3.0 g; sodium hydroxide - 0.122 g; water 75.478 g.

    Description:Homogeneous cream white or almost white with a weak characteristic 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 (Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton verrucosum, Trichophyton violaceum, Trichophyton tonsurans, Microsporum canis, Epidermophyton floccusom). Moderately sensitive: moldy Candida albicans) and dimorphic fungi (Pityrosporum orbiculare (also known as Malassezia furfur)). Activity with respect to yeast fungi, depending on their type, can be fungicidal or fungistatic.

    Terbinafine specifically changes the early stage of sterol biosynthesis in fungi, by inhibiting the enzyme squalene epoxidase located on the cell membrane of the fungus. This leads to a deficit of ergosterol and to intracellular accumulation of squalene, which causes death of the fungal cell.

    Terbinafine does not affect the metabolism of hormones or other medications.

    Pharmacokinetics:

    With external application, absorption is less than 5%, has a minor systemic effect.

    Indications:

    Fungal skin infections caused by pathogens sensitive to terbinafine: trichophytosis, microsporia, epidermophytia, rubrophytic, skin candidiasis, multicolored lichen.

    Contraindications:Hypersensitivity to terbinafine, to other components of the drug; children's age (up to 12 years), lactation period.
    Carefully:

    Renal / hepatic insufficiency, alcoholism, oppression of bone marrow hematopoiesis, tumors, metabolic diseases, occlusive diseases of the vessels of the extremities.

    If you have one of the diseases listed in this section, you should consult your doctor before starting the drug.

    Pregnancy and lactation:

    There are no data on the safety of terbinafine during pregnancy. therefore terbinafine should be used during pregnancy only if the intended benefit to the mother exceeds the possible risk to the fetus.

    Terbinafine is excreted in breast milk, so the drug should not be used by nursing mothers.
    Dosing and Administration:

    Outwardly.

    Adults and children over 12 years.

    Before applying the cream, it is necessary to clean and dry the affected areas of the skin.The cream is applied once or twice a day to the affected areas of the skin and adjacent areas with a thin layer, lightly rubbing. 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. The duration of treatment depends on the indication and severity of the disease. Average duration of treatment:

    Dermatomycosis of trunk, drumsticks: 1 time per day 1 week.

    Dermatomycosis of feet: 1-2 times a day 1-2 weeks.

    Candidiasis of the skin: 1-2 times a day 1-2 weeks.

    Multicolored lichen: 1-2 times a day for 2 weeks.

    Use of the drug in children under 12 years of age

    The use is not recommended, since safety and efficacy have not been studied. Elderly patients

    Dosage regimen changes are not required.

    Reducing the severity of clinical manifestations is usually noted in the first days of treatment. In the case of irregular treatment or premature termination, there is a risk of renewal of infection. If there is no improvement within 1 week of treatment, consult a doctor.

    If you forgot to apply the drug

    If you forget to apply the drug again, you should apply it as soon as possible. But if the time of application of the next dose of the drug is approaching, skip the forgotten one and continue to apply in accordance with the recommendations. Do not use a double dose instead of a forgotten dose or more than 2 times a day.

    Side effects:

    From the sense organs: eye irritation.

    From the skin: skin peeling, pigmentation disorder, erythema, burning sensation of the skin, dry skin, contact dermatitis, eczema.

    Some messages: rash.

    Local reactions: pain in the application site, irritation at the site of application. There may be an exacerbation of symptoms.

    Allergic reactions: redness, papules, vesicles If you experience any side effects, in that application, you should consult your doctor.
    Overdose:

    Overdose with external application is unlikely. If you accidentally swallow the drug, you may experience systemic side effects from the digestive tract (nausea, gastralgia, lack of appetite, diarrhea), as well as headache, dizziness, frequent urination, rash.

    If the above symptoms occur, discontinue use and consult a doctor.

    Treatment: Activated carbon, symptomatic maintenance therapy.
    Interaction:The drug interactions terbinafine in the drug form of the cream are not described.
    Special instructions:

    If you have any questions about the use of this drug, consult your doctor.

    The drug is intended for external use only. Avoid contact with the eyes, nose, mouth, as it can cause irritation. In case of accidental ingestion of the drug into the eyes, they should be immediately rinsed with running water, and in case of persistent irritation, consult a doctor. When developing allergic reactions, it is necessary to cancel the drug.

    In the process of treatment, it is necessary to follow the general rules of hygiene to prevent re-infection (through linen, shoes).

    To improve the effectiveness of treatment it is recommended to avoid contact with possible external sources of fungal infection.

    Irregular application or premature discontinuation of treatment increases the risk of recurrence of the disease.

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

    The drug does not affect the management of vehicles and employment of other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

    Form release / dosage:

    Cream for external use 1%.

    By 10, 15, 20 or 30 g in tubes are aluminum.

    By 10, 15, 20, 25, 30 or 50 g in cans of dark glass such as BTS made of glass fiber with pull-on lids. The label is self-adhesive on the can.

    Each tube or jar, together with the instruction for use, is placed in a cardboard package (pack) of cardboard for consumer containers.

    It is allowed to bundle 2 or 3 cardboard packages (packs) into a group package (shipping container) from cardboard for consumer packaging.

    Packaging:cans of dark glass (1) - packs cardboard
    tubes, aluminum (1) - packs, cardboard
    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C.

    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:LP-002560
    Date of registration:04.08.2014
    The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp18.09.2015
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