Betayod-zdorovya

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT BETAID-ZDOROVYE (BETAID-ZDOROVYE)

Composition:

Active substance: povidone-iodine;

1 ml of the preparation contains 100 mg of povidone-iodine;

Excipients: nonoxinol 9, glycerin, citric acid anhydrous, sodium hydrogen phosphate anhydrous, sodium hydroxide, purified water.

Pharmaceutical form. Topical solution.

Main physico-chemical properties: dark brown solution with an iodine odor, free from suspended particles and sediment.

Pharmacotherapeutic group. Antiseptics and disinfectants. Povidone-iodine.

ATC code D08AG02.

Pharmacological Properties.

Pharmacodynamics.

Povidone-iodine is a complex of iodine and the polymer polyvinylpyrrolidone (PVP), which releases iodine gradually over a certain period after application to the skin. Free iodine exerts a strong bactericidal effect and has a broad spectrum of antimicrobial activity against bacteria, viruses, fungi, and protozoa.

Mechanism of action: free iodine provides a rapid bactericidal effect, while the polymer acts as an iodine depot.

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

When complexed with PVP, iodine largely loses the local irritant properties characteristic of alcoholic iodine solutions, thus being well tolerated by the skin, mucous membranes, and affected surfaces.

Iodine reacts with oxidizable sulfhydryl (SH–) and hydroxyl (OH–) groups of amino acids present in enzymes and structural proteins of microorganisms, inactivating or destroying these proteins. Most microorganisms are destroyed in vitro within less than one minute, with the primary destructive effect occurring within the first 15–30 seconds. During this process, iodine is decolorized, so a change in the intensity of the brown color serves as an indicator of its effectiveness.

The active substance of the drug BETAID-Zdorovya, topical solution, has a broad antimicrobial spectrum of activity, namely: it acts against Gram-positive and Gram-negative bacteria (bactericidal), viruses (virucidal), fungi (fungicidal) and fungal spores (sporicidal), as well as certain protozoa (antiprotozoal).

Due to its mechanism of action, resistance to the drug, including secondary resistance during prolonged use, is not expected.

The drug is water-soluble and is easily washed off with water.

Pharmacokinetics.

Prolonged application of the drug to large wound surfaces or severe burns, as well as to mucous membranes, may result in the absorption of a significant amount of iodine. Usually, prolonged use leads to a rapid increase in blood iodine levels. Concentrations return to baseline levels within 7–14 days after the last application.

In patients with normal thyroid gland function, increased iodine stores do not cause clinically significant changes in thyroid hormone status.

Absorption and renal excretion of povidone-iodine depend on its molecular weight. Since the molecular weight ranges between 35,000–50,000, retention of the substance is possible.

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

The drug is primarily excreted via the kidneys with a clearance rate of 15 to 60 mL/min, depending on plasma iodine levels and creatinine clearance (normal: 100–300 µg iodine per 1 g creatinine).

Clinical characteristics.

Indications.

Disinfection of hands and antiseptic treatment of mucous membranes, for example prior to surgical procedures, gynecological and obstetric procedures, urinary bladder catheterization, biopsy, injections, punctures, blood collection, as well as first aid in case of accidental skin contamination with infectious material.

Antiseptic treatment of wounds and burns.

Hygienic and surgical hand disinfection.

Contraindications.

Hypersensitivity to iodine or suspected hypersensitivity to iodine, or hypersensitivity to other components of the medicinal product.

Thyroid gland dysfunction (nodular colloid goiter, endemic goiter, Hashimoto's thyroiditis).

Hyperthyroidism or other acute thyroid disorders.

The medicinal product is contraindicated before and after treatment and scintigraphy with radioactive iodine in patients with thyroid carcinoma.

Dermatitis herpetiformis Duhring.

Renal insufficiency.

Interaction with other medicinal products and other forms of interaction.

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

Caution! Due to its oxidizing properties, povidone-iodine may affect the results of certain diagnostic tests, such as tests for occult blood in feces or urine, or glucose in urine. When povidone-iodine is used, iodine uptake by the thyroid gland may be reduced – this may affect the results of certain diagnostic tests (e.g., thyroid scintigraphy, determination of protein-bound iodine, measurement of radioactive iodine) or povidone-iodine may interfere with iodine used for thyroid therapy. Medicinal products containing mercury, silver, hydrogen peroxide, or taurolidine may interact with the povidone-iodine complex – therefore, their concomitant use is not recommended.

Simultaneous or immediate sequential use of povidone-iodine with antiseptics containing octenidine may lead to the development of dark necrosis at the application sites.

The medicinal product may react with proteins and unsaturated organic compounds; therefore, the effect of povidone-iodine may be reduced, necessitating an increase in dose.

Prolonged use of the medicinal product, especially over large surface areas, should be avoided in patients receiving lithium therapy.

Special precautions for use.

The use of povidone-iodine may reduce iodine uptake by the thyroid gland, which can affect the results of certain diagnostic tests and procedures (thyroid scintigraphy, protein-bound iodine determination, diagnostic procedures involving radioactive iodine), making it impossible to plan treatment of thyroid disorders with iodine-containing medications. After discontinuation of povidone-iodine therapy, an interval of at least 1–4 weeks should be observed.

The product should not be used in patients before or after radioactive iodine treatment for thyroid cancer, nor should radioactive iodine scintigraphy be performed in such patients.

Significant amounts of iodine may induce hyperthyroidism in patients with thyroid dysfunction (e.g. nodular colloid goiter, endemic goiter). In such patients, the duration of application and the skin surface area treated should be limited.

Even after completion of treatment, patients should be monitored for early symptoms of hyperthyroidism and thyroid function should be controlled.

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

The oxidizing effect of povidone-iodine may cause corrosion of metals, whereas plastic and synthetic materials are generally resistant to povidone-iodine. In some cases, discoloration may occur, which is usually reversible.

Povidone-iodine can be easily removed from textiles and other materials with warm water and soap. Stubborn stains should be treated with ammonia solution or sodium thiosulfate.

The solution is not intended for internal use.

During preoperative skin disinfection, care should be taken to ensure that no residual solution remains under the patient (due to possible skin irritation).

Since the development of hyperthyroidism cannot be ruled out, prolonged use (more than 14 days) or application in large amounts over extensive skin areas (exceeding 10% of body surface area) in patients (particularly elderly patients) with latent thyroid dysfunction should only be considered after careful assessment of expected benefits versus potential risks. Such patients should be monitored for early signs of hyperthyroidism and appropriate thyroid function tests should be performed, even after discontinuation of the drug (up to 3 months).

With oropharyngeal use, pneumonitis may occur.

Use during pregnancy or breastfeeding.

Povidone-iodine should be used during pregnancy and breastfeeding only on medical advice and at the lowest possible doses. Iodine crosses the placental barrier and may pass into breast milk, thus posing a risk of fetal or neonatal hypersensitivity to iodine. The concentration of povidone-iodine in breast milk is higher than in blood serum. Therefore, the drug may cause hyperthyroidism or elevated thyroid hormone levels in the fetus or newborn. Thyroid function in infants should be monitored.

The product is contraindicated after the second month of pregnancy and during breastfeeding. Breastfeeding must be discontinued for the duration of treatment.

Ability to affect reaction rate while driving or operating machinery.

Unknown.

Method of Administration and Dosage

The product is intended for topical use in both diluted and undiluted forms. The product must not be mixed with hot water. Only brief warming up to body temperature is permissible.

Dosing.

Undiluted BETAIOD-Zdorovya solution is used for disinfection of hands and skin prior to surgical procedures, urinary catheterization, injections, punctures, etc.

Solutions may be applied 2–3 times daily.

Hygienic hand disinfection: 2 applications of 3 mL of undiluted solution – each 3 mL dose remains on the skin for 30 seconds.

Surgical hand disinfection: 2 applications of 5 mL of undiluted solution – each 5 mL dose remains on the skin for 5 minutes.

For skin disinfection, the undiluted solution is left on the skin until it dries.

For the indications specified above, the solution may also be used after dilution with tap water. However, for surgical procedures and 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:

The solution should be diluted immediately before use.

Children.

Povidone-iodine should be used in neonates and children under 1 year of age only when strictly indicated.

High doses of iodine should be avoided in neonates and young children, as their skin is more permeable and hypersensitivity to iodine occurs more frequently, increasing the risk of hyperthyroidism. Povidone-iodine should be used in small doses in such patients. If necessary, thyroid function should be monitored.

Overdose.

Symptoms characteristic of acute iodine intoxication include:

• metallic taste in the mouth, increased salivation, sensation of burning or pain in the mouth or throat;
• eye irritation and swelling;
• skin reactions;
• gastrointestinal disturbances and diarrhea;
• impaired kidney function and anuria;
• circulatory insufficiency;
• laryngeal edema with secondary asphyxia, pulmonary edema, metabolic acidosis, hypernatremia.

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

Starch- and protein-containing products (e.g., starch solution in water or milk) should also be administered immediately. Gastric lavage with 5% sodium thiosulfate solution (or intravenous administration of 10% sodium thiosulfate solution) at 3-hour intervals, if necessary. Clinical monitoring of thyroid function is also required to exclude or detect early symptoms of iodine-induced hyperthyroidism.

Side effects.

Immune system disorders: hypersensitivity, anaphylactic reactions.

Renal and urinary disorders: impaired kidney function, acute renal failure.

Skin and subcutaneous tissue disorders: local skin hypersensitivity reactions such as contact dermatitis with psoriasis-like erythematous small bullous formations; allergic reactions including pruritus, erythema, rash, angioneurotic edema, exfoliative dermatitis, dry skin, chemical and thermal skin burns.

Endocrine disorders: hyperthyroidism (sometimes with symptoms such as tachycardia or restlessness); hypothyroidism.

Metabolism and nutrition disorders: electrolyte imbalance, metabolic acidosis.

Prolonged use of povidone-iodine may lead to absorption of a large amount of iodine.

Iodine-induced hyperthyroidism has been observed in some cases following prolonged use of the product, primarily in patients with thyroid gland disorders.

In rare cases, generalized acute reactions with decreased arterial pressure and/or respiratory distress (anaphylactic reactions) may occur.

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

Shelf life. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

50 ml or 100 ml in a bottle sealed with a nozzle and cap, in a carton; 100 ml in a container sealed with a nozzle and cap, in a carton; 1000 ml in a bottle sealed with a dropper stopper and cap.

Availability. Over-the-counter.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROV'YA".

Manufacturer's address and location of business activity.

22, Shevchenka Street, Kharkiv, Kharkiv region, 61013, Ukraine.