Exoderyl® (Exoderil®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceNaphthyfinNaphthyfin
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    • Dosage form: & nbspcream for external use
    Composition:

    1 g of cream contains:

    active substance: naftifin hydrochloride 10.0 mg.

    Excipients: sodium hydroxide 1.2 mg, benzyl alcohol 10.0 mg, sorbitan stearate 19.0 mg, cetyl palmitate 20.0 mg, cetyl alcohol 40.0 mg, stearyl alcohol 40.0 mg, polysorbate 60 mg, 61.0 mg, isopropyl myristate 80.0 mg, purified water 718.8 mg.

    Description:white, homogeneous or slightly grainy, a shiny cream with a weak characteristic odor.
    Pharmacotherapeutic group:antifungal agent
    ATX: & nbsp

    D.01.A.E.22   Naphthyfin

    Pharmacodynamics:Naphthyfine is an antifungal agent for external use, which belongs to the class of allylamines. The mechanism of action is associated with the inhibition of squalene-2,3-epoxidase, which leads to a decrease in the formation of ergosterol, which is part of the cell wall of the fungus. It is active against dermatophytes, such as trichophyton, epidermophyton and microsporum, mold (Aspergillus spp.), yeast fungi (Candida spp., Pityrosporum) and other fungi (for example, Sporothrix schenckii). For dermatophytes and aspergillas naphthyline is fungicidal. With regard to yeast fungi, the preparation shows fungicidal or fungistatic activity, depending on the strain of the microorganism. Has antibacterial activity against Gram-positive and Gram-negative microorganisms, which can cause secondary bacterial infections. Has an anti-inflammatory effect, which contributes to the rapid disappearance of symptoms of inflammation, especially itching.
    Pharmacokinetics:

    With external application it penetrates well into various layers of the skin, creating stable antifungal concentrations in its various layers. After application of systemic absorption on the skin, less than 6 % naphthyfin. The absorbed amount is partially metabolized and excreted by the kidneys and through the intestine. The half-life of the drug is 2-3 days.

    Indications:

    - fungal infections of skin and skin folds (tinea corporis, tinea inguinalis), in t.ch. interdigital mycoses (tinea manum, tinea pedum);

    - fungal infections of the nails (onychomycosis);

    - candidiasis of the skin;

    - pityriasis lichen;

    - dermatomycosis (with or without accompanying itching).

    Contraindications:Hypersensitivity to naphthyfine, benzene alcohol or other components of the drug; pregnancy and lactation (safety and efficacy not determined).
    Carefully:Children's age (clinical experience is limited).
    Pregnancy and lactation:contraindicated
    Dosing and Administration:

    Outwardly.

    When skin is affected Exoderyl® is applied once a day to the affected surface of the skin and adjacent areas, (approximately 1 cm of healthy skin around the edges of the affected area) after they have been thoroughly cleaned and dried. Duration of therapy with dermatomycosis - 2-4 weeks (if necessary - up to 8 weeks), with candidiasis - 4 weeks.

    When the nails are affected Exoderyl® is applied 2 times a day to the affected nail. Before the first use of the drug, remove the affected part of the nail with scissors or a nail file. The duration of therapy with onychomycosis is up to 6 months.

    To prevent recurrence, treatment should be continued for at least 2 weeks after the disappearance of clinical symptoms.

    Side effects:In some cases, local reactions can occur: dry skin, skin hyperemia and burning. Side effects are reversible and do not require withdrawal of treatment.
    Overdose:No cases of overdose have been reported.
    Interaction:

    No interaction with other drugs was noted.

    Special instructions:

    Precautions for use:

    The drug Exoderyl® is not intended for use in ophthalmology. Do not allow the product to enter the eyes.

    Effect on the ability to drive transp. cf. and fur:Exoderyl® does not adversely affect the ability to drive vehicles and perform other activities requiring concentration of attention and speed of psychomotor reactions.
    Form release / dosage:

    Cream for external use 1%. For 15 or 30 grams of cream in an aluminum tube. 1 tuba together with instructions for use in a cardboard bundle.

    Packaging:(15) - tube (1) / aluminum tube, instructions for medical use / - Cardboard tutu
    (30) - tube (1) / aluminum tube, instructions for medical use / - Cardboard tutu
    Storage conditions:

    At a temperature of no higher than 30 ° C. Keep out of the reach of children!

    Shelf life:

    5 years. Do not use after the expiration date.

    Terms of leave from pharmacies:Without recipe
    Registration number:П N011273 / 01
    Date of registration:07.09.2011
    The owner of the registration certificate:Sandoz GmbHSandoz GmbH Austria
    Manufacturer: & nbsp
    Representation: & nbspSANDOZ SANDOZ Switzerland
    Information update date: & nbsp31.07.2015
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