Polyoxidonium® (Polyoxidonium®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceAzoxime bromideAzoxime bromide
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    suppositories rect. the vagina. 
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    • Dosage form: & nbspVaginal and rectal suppositories
    Composition:

    Composition per suppository

    Active substance: Polyoxidonium® (Azoxime bromide) 6 mg or 12 mg

    Excipients: mannitol, povidone, beta-carotene - up to 9 mg for a dosage of 6 mg or up to 18 mg for a dosage of 12 mg

    The basis: cocoa beans oil - to obtain a suppository with a mass of 1.3 g

    Description:

    Suppressor torpedo-shaped, light yellow with a weak specific smell of cocoa butter.

    Pharmacotherapeutic group:Immunomodulating agent
    ATX: & nbsp

    L.03.A.X   Other immunostimulants

    Pharmacodynamics:

    Polyoxidonium has an immunomodulatory effect, increases the body's resistance to local and generalized infections. The basis of the mechanism of immunomodulatory action of Polyoxidonium is a direct effect on phagocytic cells and natural killers, as well as stimulation of antibody formation.

    Polyoxidonium restores immunity to secondary immunodeficiency states caused by various infections, traumas, burns, autoimmune diseases, malignant neoplasms, complications after surgical operations, the use of chemotherapeutic agents, cytostatics, steroid hormones.

    Along with the immunomodulatory action, Polyoxidonium has a pronounced detoxification and antioxidant activity, has the ability to excrete toxins from the body, salts of heavy metals, inhibits lipid peroxidation. These properties are determined by the structure and high molecular weight nature of Polyoxidonium. The inclusion of polyoxidonium in the complex therapy of cancer patients reduces the intoxication on the background of chemo- and radiotherapy, in most cases it allows treatment without changing the standard therapy scheme due to the development of infectious complications and side effects (myelosuppression, vomiting, diarrhea, cystitis, colitis, etc.) .

    The use of polyoxidonium on the background of secondary immunodeficiency states allows to increase the efficiency and shorten the duration of treatment,significantly reduce the use of antibiotics, bronchodilators, glucocorticosteroids, lengthen the period of remission.

    The drug is well tolerated, does not have mitogenic, polyclonal activity, antigenic properties, does not have allergic, mutagenic, embryotoxic, teratogenic and carcinogenic effects.

    Pharmacokinetics:

    Polyoxidonium in suppositories with rectal administration has a high bioavailability (at least 70%), reaching a maximum concentration in the blood 1 hour after administration. The half-distribution period is about 0.5 hours, the half-elimination period is 36.2 hours. In the body it is hydrolyzed to oligomers, which are excreted mainly by the kidneys. There is no cumulative effect.

    Indications:

    Have of adults and children older 6 years in complex therapy for the correction of immune deficiency:

    chronic recurrent infectious-inflammatory diseases, which are not amenable to standard therapy, both in the stage of exacerbation and in the stage of remission; acute viral, bacterial and fungal infections;

    inflammatory diseases of the urogenital tract, including urethritis, cystitis, pyelonephritis, prostatitis, salpingo-oophoritis, endomyometritis,colpitis, cervicitis, cervicosis, bacterial vaginosis, including viral etiology; various forms of tuberculosis;

    allergic diseases complicated by recurrent bacterial, fungal and viral infections (including pollinosis, bronchial asthma, atopic dermatitis);

    Rheumatoid arthritis, long-term treated with immunosuppressants; with complicated ORZ or ARVI of the course of the disease;

    for activation of regenerative processes (fractures, burns, trophic ulcers);

    - for rehabilitation often and for a long time (more than 4-5 times a year) of ill persons; in the process and after chemo-and radiation therapy of tumors;

    to reduce nephro - and hepatotoxic effects of drugs.

    In the form of monotherapy:

    for the prevention of recurrent herpetic infection;

    for seasonal prevention of exacerbations of chronic foci of infections; for the prevention of influenza and acute respiratory infections in the pre-epidemic period;

    for the correction of secondary immunodeficiencies due to aging or exposure to adverse factors.

    Contraindications:

    Individual hypersensitivity. Pregnancy, lactation (no clinical experience is available).

    Carefully:

    Acute kidney failure.

    Dosing and Administration:

    Polyoxidonium suppositories 6 mg and 12 mg are applied rectally and vaginally 1 time per day. The method and dosage regimen is determined by the doctor depending on the diagnosis, severity and severity of the process. Polyoxidonium can be applied rectally and vaginally daily, every other day, or twice a week.

    Polyoxidonium suppositories 12 mg applies in adults rectally by 1 suppository once a day after bowel cleansing; with gynecological diseases and vaginally 1 suppository once a day (at night) is inserted into the vagina in the supine position.

    Polyoxidonium suppositories 6 mg applies: in children over 6 years of age rectally by 1 suppository 1 once a day after cleansing the intestines; in adults rectally and vaginally as a maintenance dose of 1 suppository once a day (at night) is inserted into the vagina in a prone position.

    Standard Application Scheme

    1 suppository 6 mg or 12 mg once a day daily for 3 days, then a day later with a course of 10-20 suppositories.

    If necessary, the course of treatment is repeated after 3-4 months.

    For patients receiving long-term immunosuppressive therapy, oncological,Having acquired an immune system defect - HIV, exposed to radiation, sustained maintenance from 2-3 months to 1 year with Polyoxidonium (adults 12 mg, children over 6 years - 6 mg 1-2 times a week).

    Variants of recommended regimens for use in complex therapy

    When chronic infectious-inflammatory diseases in the stage of exacerbation - according to the standard scheme, in the remission phase - 1 suppository after 1 -2 days, with a total course of 10-15 suppositories.

    With acute infectious processes and for the activation of regenerative processes (fractures, burns, trophic ulcers) - daily for 1 suppository. The course of treatment - 10-15 suppositories;

    When tuberculosis - according to the standard scheme. The course of treatment - at least 15 suppositories, then it is possible to use maintenance therapy for 2 suppositories per week for up to 2-3 months;

    On the background of chemo-and radiation therapy of tumors - 1 suppository daily for 2-3 days before the start of the course of therapy. Further, the frequency of administration of suppositories is determined by the doctor, depending on the tolerability and duration of chemotherapy and radiation therapy;

    For rehabilitation often (more than 4-5 times a year) and long-ill ling and with rheumatoid arthritis - 1 suppository every other day. The course of treatment - 10-15 suppositories;

    For correction of secondary immunodeficiencies, including those arising from aging - 1 suppository 12 mg twice a week. Course - not less than 10 suppositories 2-3 times a year;

    In the form of monotherapy:

    For seasonal prevention of exacerbations of chronic foci of infections, for the prevention of recurrent herpetic infection - every other day of adults on 6-12 mg, at children - 6 mg each. Course -10 suppositories;

    For correction of secondary immunodeficiencies, prevention of influenza and acute respiratory disease - by the standard scheme;

    When gynecological diseases rectally and vaginally - according to the standard scheme.

    Side effects:

    Not found.

    Overdose:

    Not described.

    Interaction:

    Polyoxidonium is combined with many medicines, including compatible with antibiotics, antiviral, antifungal and antihistamine drugs, glucocorticosteroids and cytostatics.

    Special instructions:

    Do not exceed these doses and the duration of treatment without consulting your doctor.

    Form release / dosage:Vaginal and rectal suppositories 6 mg or 12 mg.
    Packaging:

    Suppositories vaginal and rectal 6 mg or 12 mg of 5 pieces in a planar cell package. 2 cell packs in a cardboard box with instructions for use.

    Storage conditions:

    In dry, dark place at a temperature from 2 ° to 15 ° C. Keep out of the reach of children.

    Shelf life:

    2 years. Do not use the drug after the expiry date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:P N002935 / 03
    Date of registration:13.10.2008
    The owner of the registration certificate:NPO PETROVAKS PHARM, LLC NPO PETROVAKS PHARM, LLC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp20.08.2015
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