Iodadin

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT IODADINE (IODADINE)

Composition:

Active substance: povidone-iodine;

1 g of ointment contains povidone-iodine 100 mg;

Excipients: macrogol 1450, macrogol 4000, poloxamer 338, sodium phosphate dodecahydrate, purified water, macrogol 400.

Pharmaceutical form. Ointment.

Main physicochemical properties: homogeneous brown-colored ointment with a characteristic odor.

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 after application to the skin. Free iodine exerts a bactericidal effect and has a broad spectrum of antimicrobial activity against bacteria, viruses, fungi, and protozoa.

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

Upon contact with skin and mucous membranes, significant amounts of iodine are released from the polymer.

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; therefore, a change in the intensity of the brown color serves as an indicator of its effectiveness.

The active ingredient of the medicinal product Iodadin ointment has a broad antimicrobial spectrum of activity: it acts against Gram-positive and Gram-negative bacteria (bactericidal), viruses (virucidal), fungi (fungicidal), fungal spores (sporicidal), as well as certain protozoa.

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

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

Prolonged application of the preparation on large wound surfaces or severe burns, as well as on mucous membranes, may lead to the absorption of a significant amount of iodine. Usually, prolonged use of the preparation results in a rapid increase in blood iodine levels, which return to baseline 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. Since the molecular weight ranges between 35,000–50,000, substance retention is possible.

Absorption of povidone-iodine or iodide is the same as that of iodine from other sources.

The volume of distribution is 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, while the level of inorganic iodine is 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 (normally 100–300 µg iodine per 1 g creatinine).

Clinical characteristics.

Indications.

Prevention of infections in minor cuts and abrasions, minor burns, and minor surgical procedures.

Treatment of fungal and bacterial skin infections, as well as infections of pressure sores and trophic ulcers.

Contraindications.

• Hypersensitivity to iodine or suspected hypersensitivity, or to any of the excipients.
• Thyroid dysfunction (nodular colloid goiter, endemic goiter, Hashimoto's thyroiditis).
• Hyperthyroidism or other acute thyroid disorders.
• Period before and after treatment and scintigraphy with radioactive iodine in patients with carcinoma of the thyroid gland. At least 1–2 weeks must elapse between scintigraphy with radioactive iodine or radioactive iodine therapy for thyroid tumors and the last administration of povidone-iodine.
• Dermatitis herpetiformis Duhring.
• Renal insufficiency.
• Concomitant use with mercury-containing preparations, as their combination may form a substance that can damage the skin.
• Children under 1 year of age.

Interaction with other medicinal products and other forms of interaction.

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

Proteins and other organic compounds reduce its activity.

Concomitant use of Iodadin and enzymatic ointments for wound treatment reduces the efficacy of both agents. Medicinal products containing mercury, silver, hydrogen peroxide, taurolidine, or chlorhexidine may interact with the povidone-iodine complex; therefore, their combined use is not recommended.

Tincture of benzoin reduces pH, which may cause a burning sensation, especially if the wound is bandaged.

When used concomitantly with lithium preparations, a synergistic hypothyroid effect may occur.

Application of povidone-iodine simultaneously with or immediately after antiseptics containing octenidine may result in temporary dark discoloration of the skin at the site of application.

Caution!

Due to its oxidizing properties, povidone-iodine may interfere with 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, which may affect the results of certain diagnostic tests (e.g., thyroid scintigraphy, determination of protein-bound iodine, and measurement of radioactive iodine). Interaction with iodine used for thyroid therapy is also possible.

Thyroid scintigraphy should be performed 1–2 weeks after discontinuation of prolonged treatment with the product to ensure reliable results.

The dark brown color of the ointment indicates its activity; decolorization caused by exposure to light and temperatures above 40 °C is accompanied by a reduction in antimicrobial efficacy.

Special precautions for use.

The product is intended for topical use only.

Prolonged use may cause irritation and occasionally severe skin reactions. If signs of irritation or hypersensitivity occur, application of the product should be discontinued.

The use of povidone-iodine may reduce iodine uptake by the thyroid gland, which may affect the results of certain diagnostic tests and procedures (thyroid scintigraphy, protein-bound iodine determination, diagnostic procedures using radioactive iodine), making it impossible to plan treatment of thyroid disorders with iodine-containing drugs. An interval of at least 1–4 weeks should be maintained between courses of povidone-iodine treatment.

Povidone-iodine should be used in patients with latent hyperthyroidism or other thyroid disorders (especially elderly patients) only under medical supervision.

Since the development of hyperthyroidism cannot be excluded, prolonged use of povidone-iodine (more than 14 days) or its application in large amounts over extensive areas (more than 10% of body surface) in patients (particularly elderly) with latent thyroid dysfunction should be permitted only after careful assessment of expected benefits versus potential risks. Such patients should be monitored for early signs of hyperthyroidism and appropriate evaluation of thyroid function should be performed, even after discontinuation of the product (up to 3 months).

Iodine absorption varies individually in each patient; therefore, no exact recommendations can be given. Thyroid function tests and physicians' recommendations are decisive in such cases.

If symptoms of hyperthyroidism occur during treatment, thyroid function should be evaluated.

Particular attention should be paid to patients with pre-existing renal insufficiency when using the ointment regularly.

Regular use of the ointment should be avoided in patients receiving lithium therapy.

The oxidizing effect of povidone-iodine may cause corrosion of metals, whereas plastics and synthetic materials are generally resistant. In individual cases, discoloration may occur, which is usually reversible. Povidone-iodine can be easily removed from textiles and other materials with warm soapy water. Stubborn stains should be treated with ammonia solution or sodium thiosulfate.

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).

Do not heat before use. Keep out of reach of children.

Use during pregnancy or breastfeeding.

During pregnancy or breastfeeding, povidone-iodine should be used strictly on medical advice and only in the smallest possible doses. Iodine crosses the placental barrier and may pass into breast milk, thus posing a risk of iodine hypersensitivity in the fetus or newborn. Povidone-iodine levels in breast milk are higher than in blood serum. Cases of thyroid disorders, including congenital hypothyroidism, have been reported in infants whose mothers received iodine therapy. The product may also cause hyperthyroidism or elevated thyroid hormone levels in the fetus or newborn. Evaluation of thyroid function in infants is necessary.

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 speed when driving vehicles or operating machinery.

Iodadin, ointment, does not affect reaction speed when driving vehicles or operating machinery.

Method of Administration and Dosage

The medication is intended for topical use.

For the treatment of infections, apply the ointment once or twice daily. The duration of treatment should not exceed 14 days.

For infection prophylaxis, apply the ointment once or twice weekly, as long as necessary.

The affected skin should be cleaned and dried. Apply a thin layer of ointment to the affected skin area. A dressing may be applied over the treated area.

Children

The medication should not be used in children under 1 year of age. High doses of iodine should be avoided in children, as pediatric skin is more permeable and children are more prone to hypersensitivity to iodine, increasing the risk of developing hyperthyroidism. Povidone-iodine should be used in small amounts in pediatric 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;
• Kidney dysfunction and anuria;
• Circulatory failure;
• Laryngeal edema with secondary asphyxia, pulmonary edema, metabolic acidosis, hypernatremia.

Hyperthyroidism or hypothyroidism may also occur. In case of thyroid dysfunction, povidone-iodine treatment should be discontinued.

Treatment

Symptomatic and supportive therapy should be administered.

In cases of severe arterial hypotension, intravenous fluids should be administered and, if necessary, vasopressor agents.

Endotracheal intubation may be required if corrosive injury to the upper respiratory tract causes significant swelling.

Do not induce vomiting. The patient should be placed in a position that ensures airway patency and prevents aspiration of gastric contents (in case of vomiting).

If the patient has not vomited and is able to tolerate oral intake, ingestion of starchy foods (potatoes, flour, starch, bread) may be considered, as they help convert iodine into less toxic iodides.

If there are no signs of intestinal perforation, gastric lavage with a starch solution via a nasogastric tube may be performed (the fluid drained from the stomach turns blue or purple, and the color may indicate when lavage can be stopped).

Iodine is effectively removed by hemodialysis, which should be used in severe cases of iodine intoxication, especially in the presence of renal failure. Continuous veno-venous hemodiafiltration is less effective than hemodialysis.

Side effects.

Immune system disorders: hypersensitivity, anaphylactic reactions.

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

Skin and subcutaneous tissue disorders: local hypersensitivity skin reactions such as contact dermatitis with formation of psoriasiform red small bullous lesions; 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.

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 respiratory distress (anaphylactic reactions) may occur.

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

Reporting of adverse reactions after drug registration is of great importance. It allows continuous monitoring of the benefit-risk ratio of the drug. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of drug efficacy via the Automated Pharmacovigilance Information System at: 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. 20 g or 40 g in a tube; 1 tube per pack.

Availability. Over-the-counter.

Manufacturer. LLC "DKP "Pharmaceutical Factory".

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