1 ml of 100 mg povidone-iodine
excipients:glycerin (85%), nonoxinol 9, citric acid, sodium phosphate anhydrous, sodium hydroxide, purified water.
Dosage form. Solution for external and local application.
the Solution is dark brown in color with a smell of iodine, does not contain suspended and deposited particles.
the Name and location of manufacturer.
ZAO Pharmaceutical factory EGIS, Hungary under license of MUNDIPHARMA A. T., Switzerland/EGIS Pharmaceuticals PLC, Hungary under license from MUNDIFARMA A. G., Switzerland
9900, G.. Kormend, Matyas Kiraly St. 65, Hungary/9900, Kormend, Matyas kiraly ut 65, Hungary.
Pharmacological group. Antiseptic and disinfectant. Povidone-iodine.
ATC Code D08A G02.
Povidone-iodine is a complex of iodine and polyvinylpyrrolidone polymer that gives off iodine for a certain time after application to the skin. Elementary iodine has a strong bactericidal effect, has a wide range of antimicrobial action against bacteria, viruses, fungi and protozoa.
Mechanism of action: free iodine provides a rapid bactericidal effect, and the polymer is a depot for iodine.
when in contact with skin and mucous membranes, a significant amount of iodine is released from the polymer.
in the formation of a complex with PVP iodine largely loses the local effect inherent in an alcoholic solution of iodine, and therefore well tolerated by the skin, mucous membranes and affected surfaces.
Iodine reacts with the oxidation of sulfide (SH) and hydroxyl (OH) group of amino acids included in the composition of enzymes and structural proteins of micro-organisms, destroying or inactivating these proteins. Most microorganisms are destroyed inin vitroin less than a minute, and the main destructive action takes place in the first 15-30 seconds. In this case, iodine is discolored, in connection with which the change in the saturation of brown color is an indicator of its effectiveness.
Active substance of the drug Betadinecutaneous solution has a broad antimicrobial spectrum of action, namely acts on gram-positive and gram-negative bacteria (bactericidal), viruses (virulizin), fungi (fungicides) and fungal spores (sporicide) and some simple organisms (protozoa).
resistance to the drug, including secondary resistance in long-term use is not expected due to the mechanism of action.
the Preparation dissolves in water and is easily washed off with water.
Prolonged application of the drug to extensive wound surfaces or severe burns, as well as mucous membranes can lead to the absorption of a significant amount of iodine. Typically, as a result of prolonged use of the drug iodine content in the blood increases rapidly. The concentration returns to the initial level 7-14 days after the last administration of the drug.
in patients with normal thyroid function, an increase in iodine stores does not cause clinically significant changes in thyroid hormone status.
Absorption and renal excretion of povidone-iodine depends on its molecular weight, and because it ranges is 35000-50000, there can be a delay of substance.
the volume of distribution corresponds to about 38% of body weight, the half-life after vaginal use is about 2 days. The normal total level of iodine in the blood plasma is about 3.8-6 µg/DL, and the level of inorganic iodine-0.01-0.5 µg/DL.
the drug is Excreted mainly through the kidneys with clearance from 15 to 60 ml/min depending on the level of iodine in the blood plasma and creatinine clearance (normal: 100-300 mcg of iodine per 1 g of creatinine).The
the Use of povidone-iodine can prevent the uptake of iodine by the thyroid gland, can affect the results of certain tests and procedures (scintigraphy of the thyroid gland, the definition of belkovosvazavatei iodine diagnostic procedures using radioactive iodine), therefore planning the treatment of thyroid disease with iodine may not be possible. After the termination of treatment povidone iodine should take a break of at least 1-4 weeks.
Oxidative action of povidone-iodine can lead to false-positive results of diagnostic tests (e.g. Toluidine and guaiac test for hemoglobin and glucose in the stool and urine).
the Oxidizing effect of povidone iodine can cause corrosion of metals, whereas plastic and synthetic materials are usually not sensitive to povidone iodine. In some cases, there may be a change in color, usually restored.
Povidone-iodine can be easily removed from textiles and other materials with warm water and soap. Stains difficult to remove, should be treated with a solution of ammonia or sodium thiosulfate.
the Solution is intended for internal use.
in preoperative skin disinfection, care should be taken to ensure that no residual solution remains in the patient (due to the possibility of skin irritation).
Since it is impossible to exclude the development of hyperthyroidism, prolonged (more than 14 days) use of povidone iodine or its use in large quantities on large surfaces (more than 10% of the body surface) in patients (especially elderly) with latent disorders of thyroid function is permissible only after a careful ratio of the expected benefit and possible risk. Such patients should be monitored to detect early signs of hyperthyroidism and proper examination of thyroid function, even after discontinuation of the drug (for up to 3 months).The
use during pregnancy or lactation.
Povidone-iodine has no teratogenic effect. The drug is contraindicated to apply after the 2nd month of pregnancy and during lactation. Iodine penetrates the placental barrier and can penetrate into breast milk. At the time of treatment should stop breast-feeding.
Ability to influence the reaction rate when driving motor transport or operating other mechanisms.is Unknown.The
newborns and children under 1 year of age should use povidone iodine only on strict indications. If necessary, the function of the thyroid gland should be monitored.
Method of application and doses.
the Preparation is intended for external use in dissolved and insoluble form.
you should Not mix the drug with hot water. Only short-term heating to body temperature is allowed.The
Undiluted solution Betadineused for treatment of hands and skin before surgery, catheterization of the bladder, injections, puncture, etc.
Solutions can be used 2-3 times a day.
Hygienic hand disinfection:2 times 3 ml undiluted solution - each dose of 3 ml remains on the skin for 30 seconds.
Surgical hand disinfection:2 times 5 ml undiluted solution - each dose of 5 ml remains