Active substancePovidone-iodinePovidone-iodine
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  • Dosage form: & nbspVaginal suppositories
    Composition:

    1 suppository contains:

    active substance: povidone-iodine 200 mg (corresponding to 18-24 mg of active iodine);

    Excipients: macrogol-1000 2800 mg.

    Description:Torpedo-like homogeneous suppositories of dark brown color.
    Pharmacotherapeutic group:Antiseptic
    ATX: & nbsp

    D.08.A.G.02   Povidone-iodine

    Pharmacodynamics:

    Has antiseptic, disinfectant, antifungal and antiprotozoal effect. It blocks amino groups of cellular proteins. Has a wide spectrum of antimicrobial action. It is active against bacteria (including Escherichia coli, Staphylococcus aureus), fungi, viruses, protozoa. When released from the complex with polyvinylpyrrolidone in contact with skin and mucous membranes, iodine forms with the proteins of the cells of iodine bacteria, coagulates them and causes the death of microorganisms. Has a rapid bactericidal effect on Gram-positive and Gram-negative bacteria (with the exception of M. tuberculosis).

    Pharmacokinetics:With topical application, there is almost no reabsorption of iodine from the mucous membrane.
    Indications:

    Acute or chronic vaginitis (mixed, nonspecific infection), bacterial vaginosis (caused by Gardnerella vaginalis), candidiasis, infection Trichomonas vaginalis.

    Infections of the vagina after treatment with antibiotics or steroid preparations.

    Prevention before surgical or diagnostic interventions in the vagina.

    Contraindications:

    Hypersensitivity to iodine and other constituents of the drug; dysfunction of the thyroid gland (nodal colloid goiter, endemic goiter and Hashimoto tiroiditis, hyperthyroidism) (see p.section "Special instructions"); adenoma of the thyroid gland; herpetiform dermatitis of Dühring; simultaneous application of radioactive iodine; children under 8 years old (see section "Special instructions").

    Carefully:

    Pregnancy and lactation.

    Pregnancy and lactation:

    Application of Betadine® It is not recommended from the 3rd month of pregnancy and during lactation. If necessary, in these cases, treatment is possible under individual medical supervision.

    Dosing and Administration:

    For insertion into the vagina. It is recommended to moisten the suppository with water and inject it deep into the vagina in the evening before going to bed.

    For 1 suppository to enter deep into the vagina: with acute vaginitis 1-2 times a day for 7 days, with chronic and subacute vaginitis - 1 time per day before bedtime for 14 days (possibly longer).

    It is also recommended to use hygienic pads during the course of treatment. Do not stop using suppositories during menstruation.

    Side effects:

    Reactions of hypersensitivity to the drug, hyperemia, pruritus.

    In rare cases, it can cause hypersensitivity reactions, for example, contact dermatitis with the formation of psoriasis-like red small bullous elements.If these phenomena occur, the drug should be discontinued.

    Prolonged application of povidone-iodine can lead to absorption of significant amounts of iodine. In some cases, the development of iodine-induced hyperthyroidism is described, mainly in patients with a previously existing thyroid disease.

    Overdose:

    For acute iodine intoxication, the following symptoms: metallic taste in the mouth, increased salivation, burning sensation or pain in the mouth or throat; irritation and swelling of the eyes; skin reactions; gastrointestinal disorders and diarrhea; impaired renal function and anuria; circulatory insufficiency; edema of the larynx with secondary asphyxia, pulmonary edema, metabolic acidosis, hypernatremia.

    Treatment: should be symptomatic and supportive therapy with special attention to electrolyte balance, kidney and thyroid function.

    Interaction:

    Incompatible with other disinfectant and antiseptic agents, especially containing alkalis, enzymes and mercury.

    Joint application povidone iodine and hydrogen peroxide, as well as enzyme preparations containing silver and tauloridine, for treating wounds, as well as antiseptic drugs, leads to a mutual decrease in efficiency.

    In the presence of blood, the bactericidal effect may decrease, but with an increase in the concentration of the solution, the bactericidal activity may be increased.

    Special instructions:

    Due to the oxidative properties of povidone-iodine, its traces can lead to false-positive results of some types of studies for the detection of latent blood in feces, as well as blood or glucose in the urine.

    During the application of povidone iodine, iodine absorption by the thyroid gland may decrease, which may affect the results of some diagnostic studies (eg, thyroid scintigraphy, determination of protein-bound iodine, measurements with radioactive iodine), and may interact with iodine preparations used for the treatment of diseases of the thyroid gland. To obtain undistorted results of thyroid scintigraphy after long-term povidone-iodine therapy, it is recommended to withstand a sufficiently long period of time without this drug.

    In case of thyroid dysfunction, the drug can be used only as directed by a physician. If symptoms of hyperthyroidism occur during the course of treatment, the function of the thyroid gland should be checked.It is necessary to monitor the function of the thyroid gland in newborns and breast-fed infants whose mothers used Betadine®.

    Caution should be observed with regular use of the drug in patients with previously diagnosed kidney failure. Betadine should be avoided on a regular basis® in patients receiving lithium preparations.

    The use of povidone iodine is allowed from the newborn period, but taking into account the form of release - vaginal suppositories, the drug is not recommended for use before 8 years and be careful when introducing virgins.

    Coloring on the skin and tissues is easily washed off with water. After contact with the drug, avoid contact with the product in the eye

    Suppositories have a spermicidal effect, and therefore it is not recommended to use them in persons planning a pregnancy.

    During the use of suppositories, the use of sanitary napkins can be recommended.

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

    Proper use of the drug does not affect the ability to drive vehicles and control mechanisms.

    Form release / dosage:Vaginal suppositories, 200 mg.
    Packaging:

    For 7 vaginal suppositories in the blister of PVC / PE film.

    For 1 or 2 blisters in a cardboard box together with instructions for use.

    Storage conditions:

    Store in a dry place at a temperature of 5 to 15 ° C.

    Keep out of the reach of children.

    Shelf life:

    5 years.

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

    Terms of leave from pharmacies:Without recipe
    Registration number:П N015282 / 01
    Date of registration:10.10.2008 / 31.10.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:Egis Pharmaceutical Plant OJSCEgis Pharmaceutical Plant OJSC Hungary
    Manufacturer: & nbsp
    Representation: & nbspEGIS ZAO Pharmaceutical Plant EGIS ZAO Pharmaceutical Plant Hungary
    Information update date: & nbsp24.01.2017
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