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

    One suppository contains:

    Active substance

    Povidone-iodine

    200 mg *)

    Received according to the following prescription:

    Iodine

    30 mg

    PolyvinylpyrrolidoMr.

    180 mg

    Excipients

    Macrogol-1500 (polyethylene oxide-1500)

    2.66 g

    Macrogol-400 (polyethylene oxide-400)

    0.14 g

    *)With the activity of povidone-iodine 10%: in the case of other activity, the substances respectively reduce or increase the amount of the base

    Description:

    Suppositories from brown to dark brown, torpedo-shaped. Marble surface is allowed.

    Pharmacotherapeutic group:Antiseptic
    ATX: & nbsp

    D.08.A.G.02   Povidone-iodine

    Pharmacodynamics:

    Antiseptic preparation. It blocks amino groups of cellular proteins. Has a wide spectrum of antimicrobial action.

    It is active against Gram-positive and Gram-negative bacteria (including Escherichia coli, Staphylococcus aureus), Mycoplasma, chlamydia, fungi (eg, genus Candida), viruses, protozoa.

    The active substance of the drug - iodine - is in the form of a complex with polyvinylpyrrolidone (povidone), which refers to iodophors, which bind iodine.

    The concentration of active iodine is 0.1-1%. In combination with polyvinylpyrrolidone iodine significantly loses local irritating effect and therefore is well tolerated when application to mucous membranes, skin and wound surfaces. After contact with skin and mucous membranes iodine gradually and evenly released, having a bactericidal effect on microorganisms.

    At the application site, a thin colored layer remains, which is retained until the entire amount of iodine is freed.

    Pharmacokinetics:

    Suction and distribution

    When povidone-iodine comes into contact with the mucosa, iodine absorption and an increase in its content in the blood (the concentration returns to the initial value) is possible 7-14 days after the last drug administration). In patients with normal thyroid function, increased absorption of iodine does not cause significant changes in its hormonal function.

    Excretion

    Iodine is excreted mainly by the kidneys. The half-life period (T1/2) after intravaginal application is about 48 hours.

    Indications:

    Acute and chronic infectious and inflammatory diseases of the vagina (trichomonas, fungal, viral, nonspecific, mixed infections): bacterial vaginitis.

    Prevention of infectious-inflammatory complications beforeegynecological interventions (artificial termination of pregnancy, installation and removal of the intrauterine device, diathermocoagulation of the cervix, hysterosalpingography and others).

    If necessary, please consult with your doctor before using the medication.

    Contraindications:

    Hypersensitivity to iodine and other components of the drug, thyrotoxicosis (hyperthyroidism),herpetiform dermatitis Dühring, adenoma of the thyroid gland, simultaneous use of radioactive iodine, children under 8 years old.

    Carefully:Chronic kidney failure, pregnancy, the period of breastfeeding, old age.
    Pregnancy and lactation:

    Iodine penetrates the placental barrier and is excreted in breast milk. The use of Iodasept is not recommended with II trimester of pregnancy and during breastfeeding.

    Use of the drug Yodasept in these periods is possible only if the intended benefit to the mother exceeds the potential risk to the fetus and the baby. If you need to use the drug in these cases, treatment is possible under individual medical supervision. In newborns and infants, whose mothers used Yodasept, it is necessary to monitor the function of the thyroid gland.

    Dosing and Administration:

    Intravaginal. Preliminarily releasing the suppository from the contour cell packaging, it is injected, lying on its back, deep into the vagina.

    With acute vaginitis - 1 suppository 2 times a day for 7 days, with subacute and chronic vaginitis - 1 suppository once a day before bedtime for 14 days (regardless of the phase of the menstrual cycle).

    For preoperative prevention of complications of infectious genesis in gynecology the drug is administered intravaginally 2 times a day (morning and evening) for 1-7 days.

    If there is no improvement after treatment or new symptoms appear, you should consult your doctor.

    Use the drug only according to the method of administration and the doses specified in the instructions.

    If necessary, please consult with your doctor before using the medication.

    Side effects:

    Reactions of hypersensitivity to the drug) at the site of application: hyperemia, pruritus.

    Allergic reactions are possible, including contact dermatitis with the formation of psoriasis-like red small bullous elements. If these phenomena occur, the drug should be discontinued.

    If any of the side effects indicated in the manual are aggravated, or if you notice any other side effects, not listed and instructions, tell your doctor.

    Overdose:

    Symptoms

    For acute iodine intoxication are characteristic: 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

    Symptomatic therapy and maintenance of the function of vital organs and systems (including electrolyte balance, kidney function and thyroid gland).

    Interaction:

    Povidone-iodine It is incompatible with oxidants, alkali salts and substances with acid reaction.

    It is not recommended to use povidone-iodine simultaneously with hydrogen peroxide and products containing mercury, silver and enzymes.

    Special instructions:

    In the presence of blood, the bactericidal action of povidone-iodine may decrease.

    In the case of non-hypnotic hyperthyroidism and other diseases of the thyroid gland (especially in elderly patients) the drug is used only under strict indications and under constant medical supervision.

    In connection with 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 stool,as well as blood or glucose in the urine.

    During the application of povidone iodine, iodine uptake 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 also interaction 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.

    If symptoms of hyperthyroidism occur during the course of treatment, the function of the thyroid gland should be checked.

    Caution should be observed with the regular use of the drug Yodasept, patients with previously diagnosed kidney failure.

    Regular use of the drug in patients receiving lithium preparations should be avoided.

    It is recommended to be careful when introducing vaginal suppositories to virgins.

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

    During the application of suppositories it is recommended to use sanitary napkins.

    After contact with the drug, avoid contact with the product in the eyes.

    Read the instructions carefully before using the product. Keep the manual, it may be needed again. If you have any questions, consult a doctor. The medicine you are treating is intended for you personally and should not be passed on to others, as it can harm them even if you have the same symptoms as you.

    Effect on the ability to drive transp. cf. and fur:Does not affect the ability to drive a vehicle and other mechanisms.
    Form release / dosage:

    Vaginal suppositories, 200 mg.

    Packaging:

    For 5 suppositories in a contour cell box made of a PVC / PE polymer film.

    Two contour squares with five suppositories are placed together with instructions for medical use of the drug in a pack of cardboard box A or chrome-ersatz. Packs are packed in boxes of cardboard corrugated.

    Storage conditions:

    In the dark place at a temperature of no higher than 25 FROM.

    Keep out of the reach of children.

    Shelf life:

    3 years.

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

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-003963
    Date of registration:15.11.2016
    Expiration Date:15.11.2021
    The owner of the registration certificate:YUZHFARM, LLC YUZHFARM, LLC Russia
    Manufacturer: & nbsp
    Representation: & nbspYUZHFARM, LLCYUZHFARM, LLC
    Information update date: & nbsp18.11.2017
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