Griseofulvin (Griseofulvin)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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  • Griseofulvin
    pills inwards 
    BIOSINTEZ, PAO     Russia
    • Dosage form: & nbsppills
    Composition:

    One tablet contains:

    of the active substance: griseofulvin (in terms of the active substance) - 125 mg;

    Excipients: potato starch, milk sugar (lactose), calcium stearate, polyvinylpyrrolidone (povidone), low molecular weight.

    Description:

    Tablets are white or white with a yellowish hue of color, flat-cylindrical with a bevel.

    Pharmacotherapeutic group:antifungal agent
    ATX: & nbsp

    D.01.B.A.01   Griseofulvin

    Pharmacodynamics:

    Antifungal antibiotic, effective against fungi of the genus Trichophyton, Microsporum, Epydermophyton Achorionum; disturbs the structure of the mitotic spindle and cell wall synthesis from chitin-containing fungi, fungal cells inhibits division in the metaphase and protein synthesis due to disturbances due to the messenger RNA. It accumulates in the skin cells, hair and nails, which are the precursors of keratin, making keratin resistant to fungal infestation. As the isolation of infected keratin is replaced by a healthy tissue.

    Pharmacokinetics:

    Absorption is high: the microcrystalline form is 25-70%, the ultra-microcrystalline form is almost 100%. The intake of fatty foods increases absorption.Time to reach the maximum concentration of the drug in the plasma after ingestion - 4-5 hours, the maximum concentration of the drug in the plasma - 0,5-5 mg / l. The connection with plasma proteins is 80%. Selectively accumulates in the horny layer of the skin and its appendages, as well as in the liver, fatty tissue, skeletal musculature. A small amount is distributed in the fluids and tissues of the body. Penetrates through the placenta.

    Metabolized in the liver with the formation of inactive metabolites (6-methylgrisooflavina and glucuronide derivative). The half-life of the drug is 24 hours. It is excreted by the kidneys (including 1% in unchanged form) and through the intestine (36% unchanged).

    Indications:

    Mycosis of the skin, hair and nails (favus, trichophytosis, microsporia of the scalp, microsporia of smooth skin, dermatomycosis of the beard and mustache, epidermophytia of smooth skin, inguinal epidermophytia, onychomycosis).

    Contraindications:

    Hypersensitivity, porphyria, systemic lupus erythematosus, lupus-like syndrome, systemic blood diseases, leukopenia, organic liver and kidney diseases, hepatic insufficiency, malignant neoplasms, pregnancy, lactation period, children's age (up to 2 years - efficacy and safety of use not studied).

    Dosing and Administration:

    Inside, during or after a meal, for one or more doses.

    Adults - in a daily dose of 500 mg. In severe fungal infections, the dose is increased.

    Children - in a daily dose of 10 mg / kg.

    The duration of treatment for severe mycoses is up to 12 months.

    The course of treatment for lesions of the skin of the body - 2-4 weeks, the scalp - 4-6 weeks, stop - 4-8 weeks, fingers - at least 4 months, toes - at least 6 months.

    The highest daily dose is 1 g.

    Side effects:

    From the nervous system: headache, dizziness, weakness, fatigue, insomnia, peripheral neuropathy, impaired coordination, disorientation, paresthesia of the limbs, confusion

    From the digestive system: nausea, vomiting, diarrhea, gastralgia, candidal stomatitis, hepatitis

    From the hematopoiesis: granulocytopenia, agranulocytosis, and leukopenia.

    Allergic reactions: urticaria, skin rash, itching, Quincke edema photosensitivity, lupus-like syndrome, erythema multiforme, toxic epidermal necrolysis (Lyell's syndrome).

    Interaction:

    Strengthens the action of ethanol.

    Reduces the activity of estrogen-containing oral contraceptives, anticoagulants of indirect type of action due to the induction of microsomal liver enzymes.

    Barbiturates and primidon reduce antifungal activity.

    Special instructions:Due to the negative impact on reproductive function (both in men and women) it is necessary to use effective non-hormonal methods of contraception.

    Griseofulvin is not used for the treatment of mild infections, in which only the use of antifungal agents for external use is sufficient.

    Effect on the ability to drive transp. cf. and fur:Patients should refrain from engaging in potentially hazardous activities requiring increased attention and speed of psychomotor reactions
    Form release / dosage:

    Tablets, 125 mg.

    Packaging:

    For 10 tablets in a planar cell package.

    2 contour squares with instructions for use in a pack of cardboard.

    Storage conditions:

    In a dry place, at a temperature not exceeding 20 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years 6 months.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-000101
    Date of registration:03.12.2009
    The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia
    Manufacturer: & nbsp
    Representation: & nbspBIOSINTEZ JSC BIOSINTEZ JSC Russia
    Information update date: & nbsp26.12.2015
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