Gynofort® (Gynofort®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceButoconazoleButoconazole
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  • Gynofort®
    cream the vagina. 
    GEDEON RICHTER, OJSC     Hungary
    • Dosage form: & nbspCream vaginal
    Composition:
    In 1 g of cream contains:
    Active substance: Butoconazole nitrate 20 mg;
    Excipients: sorbitol, mineral oil, glyceryl monostearate, polyglyceryl-3-oleate, wax, silicon dioxide colloid, disodium edetate, methyl parahydroxybenzoate, propyl parahydroxybenzoate, propylene glycol, water.
    Description:Homogeneous cream from white to white with a gray shade of color, free from foreign particles and without visible stratification.
    Pharmacotherapeutic group:Antifungal agent
    ATX: & nbsp

    G.01.A.F.15   Butoconazole

    Pharmacodynamics:
    Butoconazole, an imidazole derivative, has a fungicidal activity against fungi Candida, Trichophyton, Microsporum, Epidermophyton. The most effective in candidiasis. Blocking the formation of ergosterol from the lanosterol in the cell membrane increases the permeability of the membrane, which leads to lysis of the fungal cell.
    The vaginal cream is a water-in-oil emulsion, therefore it imparts a bioadhesive property to the butoconazole carrier (adhesion (from Latin adhaesio - adherence) to the adhesion of surfaces of dissimilar solid and / or liquid bodies Adhesion is caused by intermolecular interaction in the surface layer Bioadhesion leads to an increase bioavailability and duration of action of the drug substance). With intravaginal application butoconazole is located on the mucous membrane of the vagina for 4-5 days.
    Pharmacokinetics:The cream has a high bioadhesive property. With intravaginal administration, 1.7% of the administered dose is absorbed. The maximum concentration in the blood is reached after 13 hours and is 2-18.6 ng / ml. Butoconazole is subjected to intensive metabolism, partially excreted through the intestine and kidneys.
    Indications:Candidiasis of the vagina caused by Candida albicans.
    Contraindications:Hypersensitivity to any of the components of the drug. Periods of pregnancy and lactation. Children under 18 years of age (efficacy and safety not established).
    Pregnancy and lactation:The drug is contraindicated in pregnancy and lactation.
    Dosing and Administration:
    Intravaginal.
    Treatment consists of a single application of the contents of one applicator (about 5 g), inserted into the vagina at any time of the day.
    In case of persistence of the symptoms of the disease, a mycological examination should be repeated.
    Instructions for using the applicator:
    1. Remove the foil from the packaging and remove the applicator. Do not remove the special cap placed on the applicator.Firmly holding the applicator with one hand and pulling the other by the ring, pull the piston out of the applicator to the limit (see Fig. 1, 2).
    2. The applicator is designed for single use. You can not use the applicator if the cap is removed. Do not heat the applicator before use.
    3. Carefully insert the applicator as deep as possible into the vagina (Figure 3a - use by the patient, Fig. 3B - application by the doctor).
    4. Slowly pressing the piston, squeeze the cream out of the applicator (see Fig. 4, 5).
    5. Remove the empty applicator from the vagina and discard it.
    Side effects:Burning, itching, soreness and edema of the vaginal wall, pain / spasms in the lower abdomen.
    Overdose:Ginofort® Cream is for intravaginal use. No drug overdose has been reported.
    Interaction:Ginofort® Cream contains mineral oil that damages products made of latex or rubber (including condoms or intravaginal diaphragms), therefore it is not recommended to use the above contraceptive for 72 hours after using Gynofort®. Other methods of contraception should be used.
    Special instructions:
    If clinical signs of infection persist after completion of treatment, a second mycological examination should be performed to identify the pathogen and confirm the diagnosis.
    The appearance of irritation of the mucous membrane of the vagina or painful sensations serves as an indication to stop the treatment with Ginofort® cream. In case of accidental ingestion of Gynofort® into the gastrointestinal tract, gastric lavage and symptomatic treatment should be performed.
    Use with caution, as the composition of the drug includes parabens, which can cause an allergic reaction.
    Effect on the ability to drive transp. cf. and fur:The use of the Gynofort® preparation does not affect the ability to drive and operate machinery.
    Form release / dosage:
    Vaginal cream 2%.
    Packaging:For 5 g of the drug in a polypropylene applicator. Each applicator is placed in a polysterene bag and then packaged in a laminated bag. The package, together with instructions for medical use, is placed in a cardboard box.
    Storage conditions:At a temperature of 15 to 25 ° C. Keep out of the reach of children!
    Shelf life:
    3 years.
    Do not use after the expiration date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N015895 / 01
    Date of registration:18.09.2009
    Expiration Date:Unlimited
    The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary
    Manufacturer: & nbsp
    Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary
    Information update date: & nbsp17.04.2017
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