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: cetomacrogol 1000, cetostearyl alcohol, light liquid paraffin, white mild paraffin, propylene glycol, macrogol glycerylricinoleate (cremophor EL), sodium hydrogen phosphate dihydrate, trolamine, benzyl alcohol, purified water.

    Description:Homogeneous white or almost white homogeneous cream.
    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 small concentrations terbinafine has a fungicidal action against dermatophytes (Trychophyton rubrum, T.mentagrophytes, T.verrucosum, T. violaceum, T.tonsurans, Microsporum 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 specifically changes the early stage of biosynthesis of sterols 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:At external application absorption - less than 5%, renders insignificant system action.
    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 such dermatophytes as

    Trichophyton (at Tom number of, T. rubrum, T. mentagrophytes, T. verrucosum, T. violaceum), Microsporum canis and Epidermophyton floccosum.

    Yeast infections of the skin, mainly those that are caused by the genus Candida (eg, Candida albicans), in particular, diaper rash.

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

    Contraindications:Hypersensitivity to terbinafine or any of the inactive ingredients that make up the drug.
    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. Until now, there have been no reports of any developmental deficiencies in the use of Myconorm. However, since the clinical experience of terbinafine 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 using the cream-feeding Myconorm, 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 and children from the age of 12:

    Before applying the cream, it is necessary to clean and dry the affected areas. The cream is applied once or twice a day with 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. In case of extensive fungal lesions of the body, it is recommended to use a cream in tubes of 30 g.

    Average duration of treatment:

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

    Dermatomycosis stop: 1 week 1 time per day Skin Candidiasis: 1-2 weeks 1 or 2 times a day

    Multicolored lichen: 2 weeks 1 or 2 times a day

    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.In the event that after one or two weeks of treatment there are no signs of improvement, the diagnosis should be verified.

    The dosage regimen of the Myconorm of the cream in elderly people does not differ from the above.

    Use of the drug in children. The use of this drug in children under 12 years is not recommended.

    Side effects:In places where the product is applied, redness, itching or burning sensation may appear. Allergic reactions.
    Overdose:

    No cases of drug overdose have been reported. If, by chance, Myconorm cream is taken internally, the same side effects can be expected, as in the case of an overdose of terbinafine tablets (headache, nausea, epigastric pain and dizziness).

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

    Interaction:

    Any drug interactions for the myconorm of the cream 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.

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

    Form release / dosage:

    Cream for external use 1%.

    Packaging:For 15 g in tubes of aluminum. Tuba with instructions for use packed in a cardboard box
    Storage conditions:In a dry, dark place at a temperature of 5 ° C to 25 ° C. Do not freeze. Keep out of the reach of children.
    Shelf life:2 years. Do not use after expiry date.
    Terms of leave from pharmacies:Without recipe
    Registration number:LS-002113
    Date of registration:12.03.2012
    Expiration Date:Unlimited
    The owner of the registration certificate:Roushan Pharma Co., Ltd.Roushan Pharma Co., Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspRoushan Pharma Co., Ltd.Roushan Pharma Co., Ltd.
    Information update date: & nbsp07.06.2018
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