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Dosage form: & nbspcream for external use.
Composition:1 g of cream contains:
Active substances: terbinafine hydrochloride in terms of 100% substance - 0.01 g, urea-0.10 g;
Excipients: butyl hydroxy toluene (dibunol), macrogol cetostearate (Eumulgin® B 2), cetostearyl alcohol [cetyl alcohol 60%, stearic alcohol 40%], poloxamer (emixol-268), imidourea (Germall®), propylene glycol, paraffin liquid (medical vaseline oil) , purified water - up to 1 g.
Description:The cream is white or almost white with a subtle smell.
Pharmacotherapeutic group:Antifungal agent
ATX: & nbsp
  • Antifungal preparations for topical use others in combination
  • Pharmacodynamics:Antifungal agent for topical use. Terbinafine - active substance Fungoterbina NEO, is an allylamine and has a wide range of antifungal effects.
    Terbinafine disrupts the biosynthesis of ergosterol in the fungi in the early stages. 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. This enzyme does not belong to the cytochrome P450 system, therefore terbinafine does not affect the metabolism of hormones or other medications.
    Terbinafine has a fungicidal effect against dermatophytes, molds and some dimorphic fungi. Activity with respect to yeast-like fungi, depending on their type, may be fungicidal or fungistatic.
    Urea is the second active ingredient of Fungoterbin NEO, has a softening, exfoliating and moisturizing effect, it can increase dermatopenrint (penetration into the skin) and create high concentrations of terbinafine in the skin. Urea promotes water binding and softening of the stratum corneum.
    Pharmacokinetics:

    When topical application of the cream is absorbed less than 5% of the dose, so the systemic effect of the drug is minimal. With a single application on the skin surface area of ​​30 cm2 in urine, a 3.5% dose is detected. The drug quickly penetrates the skin and accumulates in the sebaceous glands.

    Indications:Treatment and prevention of fungal diseases:
    Fungal skin infections caused by dermatophytes such as Trychophyton (eg, T. rubrum, T.mentagrophytes, T.verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum.
    Skin infections caused by yeast-like fungi of the genus Candida (eg, Candida albicans).
    Multicolored lichen (Pityrosporum versicolor), caused by Pityrosporum orbiculare (also known as Malassezia furfur).
    Contraindications:Hypersensitivity to the components of the drug, children's age (up to 2 years).
    Carefully:Hepatic and / or renal failure, alcoholism, blood diseases, skin tumors, metabolic disorders, vascular pathologies of limbs, children up to 12 years, pregnancy, lactation.
    Pregnancy and lactation:In experimental studies teratogenic properties of terbinafine were not revealed. The use of the drug during pregnancy is possible in cases where the potential benefit to the mother exceeds the risk to the fetus.
    Dosing and Administration:Outwardly. The drug is applied to the skin once or twice a day. Before applying the cream, it is necessary to clean and dry the affected areas. The cream is applied a thin layer on the affected skin and lightly rubbed. To improve the effectiveness of treatment, it is possible to use occlusive dressings. 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.
    Duration and frequency of application:
    Dermatomycosis of trunk, drumsticks: 1 time per day 1 week.
    Dermatomycosis of the feet: 1 time per day 1 week.
    Candidiasis of the skin: 1 or 2 times a day for 1-2 weeks. Multicolored lichen: 1 or 2 times a day for 2 weeks.
    Side effects:In rare cases, redness, sensation of itching or burning at the site of application of the cream was noted, however, these phenomena rarely led to the need to stop treatment. The above symptoms should be distinguished from allergic reactions, for example, urticaria, which occur rarely, however, when they appear, you must stop treatment.
    Overdose:No cases of drug overdose have been reported. In case of accidental ingestion, it is possible to expect the development of the same side effects as in overdose of Fungoterbin® tablets, including: headache, nausea, gastralgia, dizziness, frequent urination, rash.
    Treatment: Activated carbon, if necessary, conduct symptomatic therapy. The phenomena of overdose of urea with external application are not known.
    Interaction:Any drug interactions with terbinafine and urea are not known externally.
    Special instructions: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 are no signs of improvement after 1-2 weeks of therapy, the diagnosis should be verified.
    The cream is for external use only. Avoid contact with the eyes, nose and mouth. If the product gets on the mucous membrane, rinse it with water and, if necessary, consult a doctor.
    Form release / dosage:Cream for external use.
    Packaging:By 10, 15, 20, 25, 30, 40, 50 or 100 g in aluminum tubes or in polyethylene laminated tubes. Each tube together with instructions for medical use of the drug is placed in a pack of cardboard.
    Storage conditions:At a temperature not exceeding 20 ° C.
    Keep out of the reach of children.
    Shelf life:2 years. Do not use the drug after the expiry date printed on the package.
    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-004847/10
    Date of registration:27.05.2010
    The owner of the registration certificate:NIZHFARM, JSC NIZHFARM, JSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp2016-01-30
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