Active substancePovidone-iodinePovidone-iodine
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  • Dosage form: & nbspsolution for external and local use
    Composition:

    100 g of solution contain:

    active substance: Povidone-iodine (with an active iodine content of 10%) 7.5 g;

    Excipients: sodium dihydrogen phosphate dihydrate, lauromacrogol-400, sodium iodate, sodium hydroxide, water purified to 100 g.

    Description:Transparent solution of brown color with a characteristic odor of iodine.
    Pharmacotherapeutic group:Antiseptic
    ATX: & nbsp

    D.08.A.G.02   Povidone-iodine

    Pharmacodynamics:

    An antiseptic that represents a complex of iodine and povidone, effective at a pH of 2 to 7. The bactericidal action is due to free active iodine, which is released from the povidone-iodine complex. Compared with alcoholneighing iodine solutions, the aqueous solution of povidone-iodine has a significantly less irritating effect.

    Free iodine as a strong oxidant reacts at the molecular level with insoluble fatty acids and practically not oxidizing SH- and OH-groups of amino acids in the composition of enzymes and basic structural components of bacteria, both gram-positive and gram-negative, mycobacteria, fungi, especially the genus Candida (Candida), various viruses and some protozoa. However, in order to completely inactivate some viruses and bacterial spores, a sufficiently long period of drug exposure is necessary.

    There are no known cases of development of resistance in microorganisms with long-term use of povidone-iodine.

    Pharmacokinetics:After the application of povidone-iodine, some absorption of iodine is possible, which must be taken into account depending on the location, amount and duration of the drug. If small amounts of the drug are applied to undamaged skin, then the absorption of iodine is negligible. The increase in absorption may be the result of prolonged use of drugs containing povidone-iodine, mucous membranes, extensive wounds and burns, and especially after washing the cavities. As a result, a temporary increase in the iodine content in the blood is observed. In people with a healthy thyroid gland, a higher iodine content does not entail a clinically relevant changethe in the state of the thyroid gland. In normal iodine metabolism processes, excess iodine is removed through the kidneys.
    Indications:

    Post-traumatic and postoperative wounds of various locations, burns, trophic ulcers, pressure ulcers, diabetic foot.

    Damage to the skin of various origins, maceration, abrasions, bruises. Infections of the skin with different etiologies, including infectious dermatitis and eczema. Treatment of the mucous membranes and skin of the patient before and after the operation, biopsy, puncture, including the skin around the drainage, catheters and probes.

    Hygienic treatment of the hands of medical personnel, treatment of the hands of surgeons.

    Infections of the mucosa of the mouth and nasopharynx.

    Infections of the mucous membranes in women. Conducting "small" gynecological operations (artificialsnortingthe introduction of an intrauterine device, coagulation of erosion and polyp).

    Contraindications:

    Hypersensitivity to the components of the drug.

    Thyroid dysfunction (thyrotoxicosis).

    Thyroid adenoma.

    Herpetiform dermatitis of Dühring.

    Simultaneous use of radioactive iodine.

    Preterm, newborns and children under 6 months.

    Carefully:

    Chronic renal failure.

    Pregnancy and lactation:

    The drug is not recommended to use from the third month of pregnancy and during breastfeeding.

    It is possible to use the solution in pregnant women before the ninth week of pregnancy, when the expected benefit from treatment with the drug exceeds the possible risk of complications.

    Dosing and Administration:

    Outer, local.

    The preparation is used in the form of 7.5% solution or in a diluted form. To dilute the drug can be used 0.9% solution of sodium chloride, Ringer's solution, phosphate buffer solution.

    Povidone-iodine is applied to the surface by lubrication using a tampon moistened in solution, sprinkling with a mechanical sprayer, and the napkins impregnated with the solution are left on the surface.

    The preparation in the form of a 7.5% solution is used for antiseptic treatment of shallow wounds, burns, skin lesions: abrasions, bruises; for the treatment of the skin and mucous membranes of the patient before and after the operation, biopsy or puncture, skin around drains, catheters and probes.

    When treating the skin before the operation, it is necessary to use the solution, avoiding its "accumulation" under the patient, as this can cause skin irritation.

    For the treatment of the hands of surgical personnel, 5 ml of the preparation in the form of 7.5% solution is applied to the skin of the hands and treated for 2.5 minutes. The procedure is repeated twice. For the hygienic treatment of the hands, 3 ml are applied to the skin and processed for 1 minute. Then carefully rinse with water.

    The preparation in the diluted form is used:

    - in the dilution 1: 2 - 1:20 for washing deep wounds, pressure sores, trophic ulcers, with intraoperative treatment of wounds;

    - in the dilution 1:25 with preoperative preparation of patients: limb washing;

    - in the dilution 1: 100 with preoperative preparation of patients: washing the body;

    - in the form of 1% solution when diluted with a phosphate buffer solution: application to the mucosa of the eyes.

    All solutions of the drug are used only freshly prepared.

    Povidone-iodine solutions should be applied to the damaged surface until it is completely moistened.

    On the seams of wounds, napkins impregnated with povidone-iodine solution are applied. Antiseptic film, formed when the povidone-iodine is drying, is easily washed off with water.

    The use of povidone-iodine solutions should continue until the signs of infection disappear or until the obvious risk of infection disappears.

    Povidone-iodine solutions are not irritant and do not slow the healing of wounds, even with prolonged use.

    Side effects:

    Hypersensitivity reactions to the drug are possible: allergic reactions of delayed type (itching, redness of the skin, blisters) or allergic reactions of immediate type (anaphylactoid reactions).

    Prolonged use of the drug (more than 7-10 days) and application on large skin surfaces, extensive wounds due to absorption can cause phenomena of iodine ("metallic" taste in the mouth,increased salivation and lachrymation, swelling of the mucous membranes) and systemic reactions (metabolic acidosis, hyponatremia, impaired renal and thyroid function), at the appearance of which it is necessary to stop using the drug and consult a doctor.

    Overdose:

    After an extremely intense absorption of iodine over a prolonged period, symptoms of hyperthyroidism such as tachycardia, an excited state, a tremor, and a headache may be noted. Mild forms of hyperthyroidism sometimes do not require intervention, and severe forms may require thyreostatic therapy.

    Interaction:

    The drug is incompatible with the salts of alkaloids (celandine), tannic acid (tannin), salicylic acid, silver salts, bismuth, taurolidine and hydrogen peroxide.

    In the presence of blood and pus, the drug binds to proteins and other organic compounds, so that its bactericidal activity may decrease. In this case, it is recommended to increase the frequency / frequency of application of the drug.

    The simultaneous use of povidone iodine and topical preparations containing enzymes can promote oxidation and inhibition of their enzymatic activity.Povidone-iodine has a synergistic effect with lithium preparations, as a result of which, with their long-term joint application, reversible oppression of thyroid function is possible. Therefore, patients who constantly take lithium drugs should avoid prolonged application of povidone-iodine on large surfaces.

    The drug can lead to false-positive results in some diagnostic tests: the determination of hemoglobin or sugar in the urine and stool, the study of thyroid function. Examination of the thyroid gland in this case should be done no earlier than 1-2 weeks after the end of treatment with povidone-iodine.
    Special instructions:

    Avoid getting undiluted drug in the eyes.

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

    Not found.

    Form release / dosage:

    Solution for external and local use, 7,5%.

    Packaging:

    To 30 ml in a vial of polyethylene with a nozzle-dropper and with a screwed cover.

    100 ml, 500 ml and 1000 ml in a polyethylene bottle with a screw cap, equipped with a snap-in device and a first-opening control device.

    250 ml each in a polyethylene bottle equipped with a mechanical nebulizer and a cap protecting the nebulizer.

    For 5 liters in a can of polyethylene with a screw cap and instructions for use (for hospitals). Additionally, a label is attached to the canister containing the text of the instructions for use.

    A bottle of 30 ml, 100 ml or 250 ml together with instructions for use in a cardboard bundle.

    For 20 bottles of 100 ml, 250 ml and 500 ml, 10 bottles of 1000 ml each with the appropriate number of instructions for use in a cardboard box (for hospitals).

    Storage conditions:

    Store the temperature from 2 to 25 ° C in the dark place.

    Keep out of the reach of children.

    Shelf life:

    3 years in vials of 30 ml, 100 ml and 250 ml.

    5 years in vials of 500 ml and 1000 ml, in canister of 5 liters.

    Do not apply at the end of the periodspecified on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-001229
    Date of registration:17.11.2011 / 17.09.2013
    Expiration Date:17.11.2016
    The owner of the registration certificate:B. Brown Mehlungen AGB. Brown Mehlungen AG Germany
    Manufacturer: & nbsp
    Representation: & nbspB. Brown Medikal, Open CompanyB. Brown Medikal, Open Company
    Information update date: & nbsp23.02.2017
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