Active substanceClotrimazoleClotrimazole
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  • Dosage form: & nbspvaginal tablets
    Composition:

    1 Vaginal tablet contains:

    active substance: clotrimazole in terms of 100% of the substance 100 mg;

    Excipients: lactose monohydrate, potato starch, microcrystalline cellulose, citric acid, magnesium stearate.

    Description:Tablets white or almost white, oval, biconvex.
    Pharmacotherapeutic group:Antifungal agent
    ATX: & nbsp

    G.01.A.F.02   Clotrimazole

    Pharmacodynamics:

    Clotrimazole-Acrichin is an antifungal agent for a wide range of effects for topical application. The antimycotic effect of the active active agent clotrimazole (imidazole derivative) is associated with a disruption in the synthesis of ergosterol, which is part of the cell membrane of fungi, which changes the permeability of the membrane and causes subsequent cell lysis.In small concentrations, it acts fungistatically, and in large concentrations it acts fungicidal, and 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.

    Effective against dermatophytes, yeast-like and mold fungi, as well as the causative agent of a multicolored lichen Pityriasis versicolor (Malazessia furfur) and the causative agent of erythrasma. Has antimicrobial effect against gram-positive (staphylococcus, streptococcus) and gram-negative bacteria (Bacteroides, Gardnerella vaginalis), as well as Trichomonas vaginalis.
    Pharmacokinetics:When Clotrimazole-Acrychin is administered intravaginally, the absorption is 3-10% administereddose. 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:

    - Genital infections caused by yeast-like fungi of the genus Candida and / or Trichomonas vaginalis (candidiasis vulvovaginitis, trichomoniasis);

    - genital superinfections caused by microorganisms sensitive to clotrimazole;

    - fromanatomy of the birth canal before delivery.

    Contraindications:Hypersensitivity to clotrimazole or excipients, in the first trimester of pregnancy. Use of tablets during menstruation should be avoided.
    Carefully:

    Lactation period.

    Pregnancy and lactation:In clinical and experimental studies, it has not been established that the use of the drug during pregnancy or during lactation has a negative effect on the health of a woman or fetus (child). However, the question of the appropriateness of prescribing the drug should be decided individually after consulting a doctor.
    Dosing and Administration:

    Locally.

    For intravaginal use only. Vaginal tablets are administered in the evening in the vagina, as deep as possible, in the supine position with slightly bent legs, daily for 6 days for 1 100 mg vaginal tablet. A second course of treatment is possible after consulting a doctor.

    For the sanitation of the birth canal, a single administration of a single tablet is recommended.
    Side effects:

    Itching, burning and swelling of the vaginal mucosa, vaginal discharge, headache, gastralgia, frequent urination,intercurrent cystitis, a burning sensation in the penis of a sexual partner, pain during intercourse.

    Overdose:

    The use of the drug in elevated doses does not cause any reactions and conditions that are life-threatening.

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

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

    Interaction:

    With vaginal administration, Clotrimazole-Akrihin reduces the activity of amphotericin B and other polyene antibiotics. With simultaneous application with nystatin, the activity of Clotrimazole-Acrychin may decrease.

    Special instructions:

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

    For trichomoniasis, for more successful treatment with Clotrimazole-Acrychin, other drugs that have a systemic effect should be used (for example, metronidazole inside).

    With a simultaneous infection of the labia and adjacent areas (candidiasis vulvitis), additional local treatment with the drug Clotrimazole cream.

    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 4 weeks, you should confirm the diagnosis.
    Form release / dosage:

    Vaginal tablets are 100 mg.

    Packaging:

    6 tablets per contour cell package.

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

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° 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:Without recipe
    Registration number:P N000682 / 01
    Date of registration:30.07.2007 / 21.06.2017
    Expiration Date:Unlimited
    The owner of the registration certificate:AKRIKHIN HFK, JSC AKRIKHIN HFK, JSC Russia
    Manufacturer: & nbsp
    Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia
    Information update date: & nbsp30.01.2018
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