Fluomizin® (Fluomizin®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceDequalinium chlorideDequalinium chloride
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  • Fluomizin®
    pills the vagina. 
    Invar, OOO     Spain
    • Dosage form: & nbspvaginal tablets
    Composition:

    For 1 tablet:

    active substance: dequalinium chloride 10 mg;

    Excipients: lactose monohydrate, microcrystalline cellulose, magnesium stearate.

    Description:

    Tablets of white color, oval, biconcave.

    Pharmacotherapeutic group:antiseptic
    ATX: & nbsp

    G.01.A.C.05   Dequalinium chloride

    R.02.A.A.02   Dequalinium chloride

    Pharmacodynamics:

    Fluomizin contains the active substance dequalinium chloride, which is a quaternary ammonium compound with a broad spectrum of antimicrobial activity. Dequalinium chloride active against most Gram-positive bacteria Streptococcus spp., including (beta-hemolytic streptococci of groups A and B), Staphylococcus aureus, Listeria spp.; anaerobes Peptostreptococcus (groups D), fungi of the genus Candida (Candida tropicalis, Candida albicans, Candida glabrata), Gram-negative bacteria Gardnerella vaginalis, Escherichia coli, Serratia spp., Klebsiella spp., Pseudomonas spp., Proteus spp., and protozoa (Trichomonas vaginalis).

    Pharmacokinetics:

    In case of intravaginal administration, an extremely small amount of chloride dequalinium is absorbed through the vaginal mucosa into the systemic bloodstream, metabolized to the 2,2-dicarboxylic acid derivative and is excreted unconjugated through the intestine.

    Indications:

    - BAcute vaginosis;

    - candidiasis vaginitis;

    - Trichomonas vaginitis;

    - sanitation of the vagina before gynecological operations and childbirth.

    Contraindications:

    - Hypersensitivity to the components of the drug;

    - Ulcerous lesions of the epithelium of the vagina and cervix.

    It is not recommended the use of dequalinium chloride before the onset of sexual activity.

    Pregnancy and lactation:

    The drug is approved for use throughout pregnancy and lactation.

    Dosing and Administration:

    The recommended dosing regimen is 1 vaginal tablet per day. The vaginal tablet is injected deep into the vagina in the evening before going to sleep, lying on your back, slightly bending your legs.

    During menstruation treatment should be discontinued and continue the previous course after its termination.

    It is necessary to conduct a full course of treatment (6 days) in order to avoid relapse.

    Side effects:

    Extremely rare local reactions of irritation (erosion), itching, burning or reddening of the vaginal mucosa can be observed. However, these unwanted reactions may also be associated with the symptoms of a vaginal infection.

    Very rarely - fever, allergic reactions.

    Overdose:

    Data on overdose are absent.In case of intravaginal administration, an overdose is unlikely.

    Interaction:

    Fluomizin® is incompatible with soap and other anionic surfactants.

    Special instructions:

    Fluomizin® contains auxiliary substances that sometimes do not completely dissolve into the vagina. Therefore, the remains of the vaginal tablet can be found on the underwear. The effectiveness of Fluomizin ® is not affected.

    In rare cases, with excessive dryness of the vagina, there is a possibility that the tablet will remain undissolved. To prevent this, before applying the vaginal tablet, it must be moistened with water (for 1 second under running water).

    During the period of treatment it is recommended to change pads and underwear more often.

    If clinical signs of infection persist after treatment is complete, a second microbiological study should be performed to identify the pathogen and confirm the diagnosis.

    During treatment with the drug it is recommended to abstain from sexual intercourse. To prevent urogenital reinfection, simultaneous treatment of sexual partners is necessary.

    Effect on the ability to drive transp. cf. and fur:

    The drug does not affect the performance of potentially hazardous activities requiring special attention and speed of psychomotor reactions (driving, etc.).

    Form release / dosage:Tablets are vaginal, 10 mg.
    Packaging:

    For 6 tablets in a contour mesh box made of foil aluminum and PVC.

    On 1 contour cellular packing together with the instruction on medical application place in a pack from a cardboard.

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    In a place inaccessible to children.

    Shelf life:

    3 years.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LSR-008618/09
    Date of registration:28.10.2009 / 11.12.2013
    The owner of the registration certificate:Invar, OOOInvar, OOO Spain
    Manufacturer: & nbsp
    MEDINOVA, AG Switzerland
    Representation: & nbspINVAR LLC INVAR LLC Russia
    Information update date: & nbsp04.01.2016
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