Betadine solution for external and local use 10% bottle with dropper 1000 ml

Instructions Betadine solution for external and local use 10% bottle with dropper 1000 ml

Composition

active ingredient: povidone-iodine;

1 ml of solution contains 100 mg of povidone-iodine;

excipients: glycerin (85%), nonoxynol 9, citric acid anhydrous, sodium hydrogen phosphate anhydrous, sodium hydroxide, purified water.

Dosage form

Solution for external and local use.

Main physicochemical properties: dark brown solution with an iodine odor, does not contain suspended and precipitated particles.

Pharmacotherapeutic group

Antiseptics and disinfectants. Povidone-iodine.

ATX code D08A G02.

Pharmacological properties

Pharmacodynamics

Povidone-iodine is a complex of iodine and polyvinylpyrrolidone polymer, which releases iodine over a period of time after application to the skin. Elemental iodine exhibits a strong bactericidal effect, has a broad spectrum of antimicrobial activity against bacteria, viruses, fungi and protozoa.

Mechanism of action: free iodine has a rapid bactericidal effect, and the polymer is a depot for iodine.

Upon contact with skin and mucous membranes, a significant amount of iodine is released from the polymer.

When forming a complex with PVP, iodine largely loses the local irritant effect inherent in alcoholic iodine solutions, and is therefore well tolerated by the skin, mucous membranes, and affected surfaces.

Iodine reacts with oxidative-sulfide (SH) and hydroxyl (OH) groups of amino acids that are part of enzymes and structural proteins of microorganisms, inactivating or destroying these proteins. Most microorganisms are destroyed by in vitro action in less than a minute, and the main destructive effect occurs in the first 15-30 seconds. In this case, iodine is discolored, and therefore a change in the saturation of the brown color is an indicator of its effectiveness.

The active ingredient of Betadine® cutaneous solution has a broad antimicrobial spectrum of action, namely, it acts on gram-positive and gram-negative bacteria (bactericidal), on viruses (virulicidal), on fungi (fungicidal) and fungal spores (sporicidal), as well as on some simpler microorganisms (protozoal).

Due to the mechanism of action, resistance to the drug, including secondary resistance, is not expected with long-term use.

The drug dissolves in water and is easily washed off with water.

Prolonged application of the drug to large wound surfaces or severe burns, as well as mucous membranes, can lead to the absorption of a significant amount of iodine. As a rule, as a result of long-term use of the drug, the iodine content in the blood increases rapidly. The concentration returns to the initial level 7-14 days after the last use of the drug.

In patients with normal thyroid function, increasing iodine stores does not cause clinically significant changes in thyroid hormonal status.

Pharmacokinetics

The absorption and renal excretion of povidone-iodine depends on its molecular weight, and since it varies between 35,000-50,000, retention of the substance is possible.

The volume of distribution corresponds to approximately 38% of body weight, the biological half-life after vaginal administration is about 2 days. The normal total plasma iodine level is approximately 3.8-6 μg/dl, and the inorganic iodine level is 0.01-0.5 μg/dl.

The drug is excreted from the body mainly through the kidneys with a clearance of 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).

Indication

Hand disinfection and antiseptic treatment of mucous membranes, e.g. before surgical operations, gynecological and obstetric procedures, bladder catheterization, biopsy, injections, punctures, blood sampling, as well as as first aid for accidental contamination of the skin with infected material. Antiseptic treatment of wounds and burns. Hygienic and surgical hand disinfection.

Contraindication

Hypersensitivity to iodine or suspected of it or to other components of the drug. Patients with thyroid dysfunction (nodular colloid goiter, endemic goiter and Hashimoto's thyroiditis). Patients with hyperthyroidism or other acute thyroid disorders. Before and after treatment and radioactive iodine scintigraphy in patients with thyroid carcinoma. Dermatitis herpetiformis of Dühring. Renal failure.

Interaction with other medicinal products and other types of interactions

The povidone-iodine complex is active against microorganisms at pH 2-7.

The use of povidone-iodine simultaneously with or immediately after use with antiseptics containing octenidine may lead to the appearance of dark necrosis at the site of application of the drug.

The drug can react with proteins and unsaturated organic complexes, so the effect of povidone-iodine can be compensated by increasing its dose.

Long-term use, especially on large surfaces, should be avoided in patients receiving lithium preparations.

Application features

The use of povidone-iodine may reduce the uptake of iodine by the thyroid gland, which may affect the results of some examinations and procedures (thyroid scintigraphy, determination of protein-binding iodine, diagnostic procedures using radioactive iodine), and therefore planning the treatment of thyroid disease with iodine preparations may not be possible. After stopping treatment with povidone-iodine, a break of at least 1-4 weeks is required.

The drug should not be used in patients before or after treatment of thyroid cancer with radioactive iodine or radioactive iodine scintigraphy.

Significant amounts of iodine can cause hyperthyroidism in patients with thyroid dysfunction (e.g., nodular colloid goiter, endemic goiter). Therefore, they should limit the time and area of skin treated with the ointment.

Even after treatment is completed, it is necessary to monitor for the appearance of early symptoms of hyperthyroidism and monitor thyroid function.

The oxidizing effect of povidone-iodine may lead to false-positive results in diagnostic tests (e.g. toluidine and guaiac tests for hemoglobin and glucose in feces and urine).

The oxidizing action of povidone-iodine may cause corrosion of metals, while plastic and synthetic materials are generally not sensitive to povidone-iodine. In isolated cases, discoloration may occur, which is usually reversible.

Povidone-iodine is easily removed from textiles and other materials with warm soapy water. Stains that are difficult to remove should be treated with ammonia solution or sodium thiosulfate.

The solution is not intended for internal use.

When preoperatively disinfecting the skin, care should be taken to ensure that no solution remains under the patient (due to the possibility of skin irritation).

Since the development of hyperthyroidism cannot be excluded, long-term (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 the elderly) with latent thyroid dysfunction should only be considered after careful consideration of the expected benefit and possible risk. Such patients should be monitored for early signs of hyperthyroidism and appropriate thyroid function testing should be performed, even after discontinuation of the drug (for up to 3 months).

In case of oropharyngeal use, pneumonitis may occur.

Ability to influence reaction speed when driving vehicles or other mechanisms

Unknown.

Use during pregnancy or breastfeeding

Povidone-iodine should be used only in cases strictly prescribed by a doctor, but in the smallest doses. Iodine crosses the placental barrier and can penetrate into breast milk, so there may be a risk of hypersensitivity of the fetus or newborns to iodine. The level of povidone-iodine is higher in breast milk than in blood serum. Therefore, the drug may cause hyperthyroidism or increased levels of thyroid hormone in the fetus or newborn. There is a need to check the function of the thyroid gland in children.

The drug is contraindicated for use after the 2nd month of pregnancy and during breastfeeding. Breastfeeding should be discontinued during treatment.

Method of administration and doses

The drug is intended for external use in dissolved and undiluted form.

Do not mix the drug with hot water. Only brief heating to body temperature is permissible.

Dosage

Undiluted Betadine® solution is used to treat hands and skin before surgery, bladder catheterization, injections, punctures, etc.

Solutions can be used 2-3 times a day.

Hygienic hand disinfection: 2 times 3 ml of undiluted solution - each dose of 3 ml remains on the skin for 30 seconds.

Surgical hand disinfection: 2 times 5 ml of undiluted solution - each dose of 5 ml remains on the skin for 5 minutes.

To disinfect the skin, the undiluted solution is left to dry after application.

According to the above indications, the solution can be used after dilution with tap water. During operations, as well as for antiseptic treatment of wounds and burns, 0.9% sodium chloride solution or Ringer's solution should be used for dilution.

The following dilutions are recommended:

Table 1.

The solution should be diluted immediately before use.

Children

Povidone-iodine can be used in newborns and children under 1 year of age only under strict indications.

High doses of iodine should be avoided in neonates and young children because their skin is more permeable and they are more likely to be hypersensitive to iodine, which increases the risk of developing hyperthyroidism. Povidone-iodine should be used in small doses in such patients. If necessary, monitor thyroid function in children.

Overdose

The following symptoms are characteristic of acute iodine intoxication:

metallic taste in the mouth, increased salivation, a burning sensation or pain in the mouth or throat; irritation and swelling in the eyes; skin reactions; gastrointestinal disorders and diarrhea; renal dysfunction and anuria; circulatory failure; laryngeal edema with secondary asphyxia, pulmonary edema, metabolic acidosis, hypernatremia.

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

As well as immediate use of starch- and protein-containing products (e.g. starch solution in water or milk). Gastric lavage with 5% sodium thiosulfate solution (or 10% sodium thiosulfate solution intravenously) at 3-hour intervals, as necessary. Also clinical monitoring of thyroid function to exclude or detect symptoms of early iodine-induced hyperthyroidism.

Adverse reactions

Immune system disorders: hypersensitivity, anaphylactic reactions.

Renal and urinary disorders: renal dysfunction, acute renal failure.

Skin and subcutaneous tissue disorders: local skin hypersensitivity reactions such as contact dermatitis with the formation of psoriasis-like red small bullous lesions; allergic reactions including itching, redness, rash, angioedema, exfoliative dermatitis, dry skin, chemical and thermal skin burns.

Endocrine system: hyperthyroidism (sometimes with symptoms such as tachycardia or anxiety); hypothyroidism.

Metabolism and nutrition disorders: electrolyte imbalance; metabolic acidosis.

Prolonged use of povidone-iodine may result in the absorption of large amounts of iodine.

In some cases, iodine-induced hyperthyroidism resulting from long-term use of the drug has been described, mainly in patients with existing thyroid disease.

In some cases, generalized acute reactions with a decrease in blood pressure and/or difficulty breathing (anaphylactic reactions) are possible.

Investigations: changes in serum electrolyte levels (hypernatremia) and osmolarity, metabolic acidosis.

Expiration date

3 years.

Storage conditions

Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.

Packaging

1000 ml of solution in a green plastic bottle.

Vacation category

Without a prescription.

Producer

CJSC Pharmaceutical Plant EGIS, Hungary.

Location of the manufacturer and its business address

9900, Kermend, Matyas Kirai Street 65, Hungary.