Pechayevsky iodine

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT IODINE PECHAYEVSKIY (IODINE PECHAYEVSKIY)

Composition:

Active substance: povidone-iodine; 1 ml of solution contains 100 mg of povidone-iodine, corresponding to 10 mg of active iodine;

Excipients: glycerol; nonoxynol 9; citric acid, monohydrate; sodium hydrogen phosphate; sodium hydroxide; purified water.

Pharmaceutical form. Topical solution.

Main physicochemical properties: dark brown solution with a characteristic odour of iodine, free from precipitate.

Pharmacotherapeutic group. Antiseptics and disinfectants. Iodine preparations. Povidone-iodine.

ATC code D08AG02.

Pharmacological properties.

Pharmacodynamics.

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

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

Upon contact with the 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 characteristic of alcoholic iodine solutions, and therefore is well tolerated by the skin, mucous membranes, and affected surfaces.

Iodine reacts with oxidative-sulfhydryl (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 in vitro within less than a minute, with the primary destructive effect occurring within the first 15–30 seconds. During this process, iodine is decolorized, and thus the fading of the brown color serves as an indicator of its effectiveness.

The active ingredient of Pechayevsky's Iodine has a broad antimicrobial spectrum of activity, being effective against Gram-positive and Gram-negative bacteria (bactericidal), viruses (virucidal), fungi (fungicidal), fungal spores (sporicidal), and certain protozoa.

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

The preparation 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 to mucous membranes, may lead to the absorption of a significant amount of iodine. Usually, prolonged use of the drug results in 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.

Pharmacokinetics.

Absorption and renal excretion of povidone-iodine depend on its molecular weight, which ranges between 35,000 and 50,000, potentially leading to substance retention.

The volume of distribution is approximately 38% of body weight. The biological half-life after vaginal administration is about 2 days. Normal total plasma iodine levels are approximately 3.8–6 µg/dL, while inorganic iodine levels range from 0.01–0.5 µg/dL.

The drug is primarily excreted from the body 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 of iodine per 1 g of creatinine).

Clinical characteristics.

Indications.

Hand disinfection and antiseptic treatment of mucous membranes, e.g. prior to surgical procedures, gynecological and obstetric procedures, urinary bladder catheterization, biopsy, injections, punctures, blood sampling, as well as first aid in case of accidental skin contamination with infected material.

Antiseptic treatment of wounds and burns.

Hygienic and surgical hand disinfection.

Contraindications.

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

Patients with thyroid gland dysfunction (nodular colloid goiter, endemic goiter, Hashimoto's thyroiditis).

Patients with hyperthyroidism or other acute thyroid disorders.

Before and after radioactive iodine therapy and scintigraphy 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 interfere with the results of certain diagnostic tests, such as occult blood detection in feces or urine, or glucose detection in urine. When povidone-iodine is used, iodine uptake by the thyroid gland may be reduced, which may affect the results of certain diagnostic tests (e.g. thyroid scintigraphy, determination of protein-bound iodine, measurement of radioactive iodine), or 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 necroses at the application sites.

The medicinal product may react with proteins and unsaturated organic compounds; therefore, the effect of povidone-iodine may be counteracted, requiring an increased dose.

Prolonged use, especially over large surfaces, should be avoided in patients receiving lithium medications.

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). Therefore, treatment of thyroid disorders with iodine-containing medications may not be feasible. After discontinuation of povidone-iodine therapy, a break of at least 1–4 weeks should be observed.

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

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

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 individual 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 the risk of skin irritation).

Since the development of hyperthyroidism cannot be completely ruled out, prolonged use of povidone-iodine (more than 14 days) or its use in large quantities over extensive areas (more than 10% of body surface) in patients (especially elderly patients) with latent thyroid dysfunction should only be considered after careful assessment of the expected benefit versus potential risk. Such patients should be monitored for early signs of hyperthyroidism and appropriate evaluation of thyroid function, even after discontinuation of the drug (for up to 3 months).

When used in the oropharynx, pneumonitis may occur.

Use during pregnancy or breastfeeding.

Povidone-iodine should be used only when strictly prescribed by a physician and in the smallest possible doses. Iodine crosses the placental barrier and can pass into breast milk, thus posing a risk of hypersensitivity to iodine in the fetus or newborn. 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. Evaluation of thyroid function in infants is necessary.

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

Ability to affect reaction speed when driving or operating machinery.

Unknown.

Method of Administration and Dosage.

The product is intended for external use, either diluted or undiluted.

The product must not be mixed with hot water. Only brief warming up to body temperature is permitted.

Dosing.

The undiluted 10% solution is used for disinfection of hands and skin prior to surgical procedures, urinary catheterization, injections, and punctures. The solution 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 diluted with tap water. However, for surgical procedures and for antiseptic treatment of wounds and burns, physiological saline 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 may be used in newborns and children under 1 year of age only under strict indications.

High doses of iodine should be avoided in newborns and infants due to increased skin permeability and a higher incidence of hypersensitivity 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.

Symptoms of acute iodine intoxication include:

• metallic taste in the mouth, increased salivation, burning sensation or pain in the mouth or throat;
• eye irritation and swelling;
• skin reactions;
• gastrointestinal disturbances 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.

Also immediately administer starch- and protein-containing substances (e.g., starch solution in water or milk). Gastric lavage using a 5% solution of sodium thiosulfate (or intravenous administration of a 10% solution of sodium thiosulfate) every 3 hours, if necessary. Clinical monitoring of thyroid function should also be performed to exclude or detect symptoms of early iodine-induced hyperthyroidism.

Side effects.

Immune system: hypersensitivity, anaphylactic reactions.

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

Skin and subcutaneous tissues: local skin hypersensitivity reactions such as contact dermatitis with formation of psoriasis-like red, small, bullous lesions; allergic reactions including pruritus, erythema, rash, angioneurotic edema, exfoliative dermatitis, dry skin, chemical and thermal skin burns.

Endocrine system: 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 significant amount of iodine.

In some cases, iodine-induced hyperthyroidism has been reported following prolonged use of the product, primarily in patients with pre-existing thyroid disease.

In rare cases, generalized acute reactions with hypotension and/or respiratory distress (anaphylactic reactions) are possible.

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

Reporting of suspected adverse reactions after drug registration is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmacy professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy via the automated pharmacovigilance information system at the following link: https://aisf.dec.gov.ua

Shelf life. 3 years.

Storage conditions.

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

Keep out of reach of children.

Packaging.

30 ml of solution in a bottle with dropper cap; 1 bottle per cardboard box.

50 ml or 100 ml of solution in a bottle with a nozzle; 1 bottle per cardboard box.

120 ml of solution in a jar with dropper cap; 1 jar per cardboard box.

1000 ml in plastic containers.

Dispensing category. Over-the-counter.

Manufacturer.

JSC "Tekhnolohiya".

Manufacturer's location and address of business activity.

8 Staroprizhna Street, Uman, Cherkasy region, 20300, Ukraine.