Active substanceClotrimazoleClotrimazole
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  • Dosage form: & nbspvaginal tablets
    Composition:

    1 Vaginal tablet contains:

    active substance: Clotrimazole 100 mg, or 200 mg, or 500 mg;

    Excipients: lactose, corn starch, croscarmellose sodium (only in dosages of 100 mg and 500 mg), microcrystalline cellulose (only in a dosage of 200 mg), methylparahydroxybenzoate, propyl parahydroxybenzoate, talc, magnesium stearate, silicon dioxide colloid.

    Description:

    Tablets 100 mg: white torpedo tablets.

    Tablets 200 mg: white oblong tablets, having a risk on one side.

    Tablets 500 mg: white oblong tablets, having a risk on one side.

    Pharmacotherapeutic group:Antifungal agent
    ATX: & nbsp

    G.01.A.F.02   Clotrimazole

    Pharmacodynamics:

    Antifungal agent from the group of imidazole derivatives for external and local (intravaginal) use reduces the synthesis of ergosterol, which is an integral part of the cell membrane of the microbial wall, and leads to a change in its structure and properties.

    In small concentrations, it acts fungistatically, and in large concentrations (more than 20 μg / ml) it is fungicidal, not only on proliferating cells. In fungicidal concentrations, it interacts with mitochondrial and peroxidase enzymes, resulting in an increase in the concentration of hydrogen peroxide to a toxic level, which also contributes to the destruction of fungal cells. It is active against pathogenic dermatophytes (Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis), yeast and mold fungi (genus Candida, Torulopsis glabrata, genus Rhodotorula, Pityrosporum orbiculare).

    Pharmacokinetics:When clotrimazole is administered intravaginally, the absorption is 3-10% of the dose administered. High concentrations in the vaginal secretion and low blood concentrations persist for 48-72 hours. In the liver, it is rapidly metabolized to inactive metabolites.
    Indications:

    - Adults and adolescents (after the onset of sexual activity).

    - Genital infections caused by yeast-like fungi of the genus Candida;

    Genital superinfections caused by microorganisms sensitive to clotrimazole.

    Contraindications:

    - Hypersensitivity to clotrimazole or excipients;

    - I trimester of pregnancy;

    - Menstrual period.

    Carefully:Lactation period.
    Pregnancy and lactation:In the second and third trimesters of pregnancy and lactation, candyzole® vaginal tablets should be used only if the potential benefit to the mother exceeds the possible risk to the fetus.
    Dosing and Administration:

    Locally (intravaginal application).

    Adults and adolescents (after the onset of sexual activity) vaginal tablets Kandizol® is administered in the evening in the vagina as deep as possible in the supine position with slightly bent legs, daily for 6 days for 1 vaginal tablet of 100 mg, or for 3 days to 1 vaginal tablet of 200 mg, or once 1 tablet of 500 mg.

    A second course of treatment is possible after consulting a doctor.

    Side effects:Itching, burning and edema of the vaginal mucosa, vaginal discharge, headache, gastralgia, frequent urination, intercurrent cystitis, pain during intercourse, burning sensation in the penis at the sexual partner, skin allergic reactions.
    Overdose:

    The risk of overdose is almost non-existent, since the drug acts locally.

    In the case of an unintended use of the drug (inside), the following symptoms are possible: anorexia, nausea, vomiting,gastralgia, impaired liver function; rarely - drowsiness, hallucinations, pollakiuria.

    There is no specific antidote. Must be administered orally Activated carbon. If necessary, treatment is symptomatic.

    Interaction:With vaginal administration, Kandizol® reduces the activity of amphotericin B and other polyene antibiotics. When used simultaneously with nystatin or natamycin, the activity of clotrimazole may decrease.
    Special instructions:

    To prevent urogenital reinfection, simultaneous treatment of sexual partners is necessary.

    With a simultaneous infection of the labia and adjacent areas (candidiasis vulvitis), local treatment with Kandizol® cream should also be performed.

    During pregnancy, vaginal pills should be treated without an applicator.

    Patients with hepatic insufficiency should periodically monitor the functional state of the liver.

    When signs of hypersensitivity or irritation appear, the treatment is stopped.

    If there is no effect within 3 weeks, you should confirm the diagnosis.

    Form release / dosage:Vaginal tablets are 100 mg, 200 mg, 500 mg.
    Packaging:6 or 10 tablets per strip of aluminum. 1 strip per pack of cardboard with instructions for use complete with an applicator.
    Storage conditions:

    In dry, the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:3 years. Do not use the drug after the expiration date.
    Terms of leave from pharmacies:Without recipe
    Registration number:P N 015544/01
    Date of registration:28.10.2009
    Expiration Date:Unlimited
    The owner of the registration certificate:Micro Labs LimitedMicro Labs Limited India
    Manufacturer: & nbsp
    Representation: & nbspMICRO LABS LIMITED MICRO LABS LIMITED India
    Information update date: & nbsp21.11.2017
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