Iodadin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT IODADINE

Composition:

Active substance: povidone-iodine;

1 ml of solution contains povidone-iodine (calculated as 10% active iodine content) 100 mg;

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

Pharmaceutical form. Solution for external and local use.

Main physicochemical properties: dark brown liquid with a characteristic odor.

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 period of time 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 reservoir.

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 properties typical of alcoholic iodine solutions, thus being well tolerated by the skin, mucous membranes, and affected surfaces.

Iodine reacts with oxidative 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 ingredient of the drug, Iodadin, has a broad antimicrobial spectrum of activity, including action 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 is water-soluble and 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 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 hormonal status.

Pharmacokinetics.

Absorption and renal excretion of povidone-iodine depend on its molecular weight. Since the molecular weight ranges between 35,000 and 50,000, the substance may be retained in the body.

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 by 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, injection, puncture, 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 any of the excipients.

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 interactions.

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

Particular attention should be paid to the fact that 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 necrosis at the application sites.

Povidone-iodine may react with proteins and unsaturated organic compounds; therefore, the effect of povidone-iodine may be reduced, which may necessitate an increase in dose.

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

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), thereby making it impossible to plan treatment of thyroid disorders with iodine-containing drugs. After discontinuation of povidone-iodine therapy, an interval of at least 1–4 weeks should be observed.

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

Significant amounts of iodine may cause hyperthyroidism in patients with thyroid dysfunction (e.g., nodular colloid goiter, endemic goiter). Therefore, 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 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 possible skin irritation).

Since the development of hyperthyroidism cannot be excluded, prolonged use of povidone-iodine (more than 14 days) or its application in large quantities over extensive areas (exceeding 10% of body surface) in patients (particularly elderly patients) with latent thyroid dysfunction should only be permitted after careful assessment of the expected benefit versus potential risk. Such patients should be monitored for early signs of hyperthyroidism and undergo 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 may pass into breast milk, thus posing a potential risk of increased sensitivity of the fetus or newborn to iodine. The concentration of povidone-iodine in breast milk is higher than in blood serum. Therefore, the drug may induce hyperthyroidism or elevated thyroid hormone levels in the fetus or newborn. Monitoring of thyroid function in infants is required.

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

Ability to affect reaction speed when driving or operating machinery.

Unknown.

Method of Administration and Dosage

The product is intended for topical use in both diluted and undiluted form.

The product must not be mixed with hot water. Only short-term warming to body temperature is permissible.

Dosing

Undiluted Iodadin solution is used for disinfection of hands and skin prior to surgical procedures, urinary bladder catheterization, injections, and punctures.

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 after application.

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, 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 may be used in neonates and children under 1 year of age only under strict indications.

High doses of iodine should be avoided in neonates and young children, as their skin has higher permeability and they more frequently exhibit increased sensitivity to iodine, which increases the risk of developing hyperthyroidism. Povidone-iodine should be administered in small doses to such patients. If necessary, thyroid function should be monitored 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;
• impaired kidney function 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, kidney function, and thyroid function.

Additionally, immediate administration of starch- and protein-containing substances (e.g., starch solution in water or milk) is recommended. Gastric lavage using a 5% solution of sodium thiosulfate (or intravenous administration of a 10% solution of sodium thiosulfate) at 3-hour intervals, if necessary. Clinical monitoring of thyroid function is also required to exclude or detect symptoms of early onset iodine-induced hyperthyroidism.

Side effects.

Immune system: Hypersensitivity, anaphylactic reactions.

Renal and urinary system: Renal function impairment, acute renal failure.

Skin and subcutaneous tissue: Localized hypersensitivity skin 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 large 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 gland disorders.

In rare cases, generalized acute reactions with decreased blood pressure and/or breathing difficulties (anaphylactic reactions) may occur.

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

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 or 120 ml in bottles; 30 ml or 120 ml in bottles, 1 bottle per carton.

Prescription status. Over-the-counter.

Manufacturer: LLC "DKP "Pharmaceutical Factory".

Manufacturer's address and place of business: 4 Korolova St., Stanishivka village, Zhytomyr district, Zhytomyr region, 12430, Ukraine.