Vitadin

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

Composition:

Active substance: povidone-iodine;

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

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

Pharmaceutical form. Topical solution 100 mg/ml.

Main physicochemical properties: dark brown solution with the odor of iodine, free from suspended and precipitated particles.

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 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 characteristic of alcoholic iodine solutions, thus being well tolerated by the skin, mucous membranes, and injured surfaces.

Iodine reacts with oxidative sulfhydryl (SH–) and hydroxyl (OH–) groups of amino acids that are part of microbial enzymes and structural proteins, thereby inactivating or destroying these proteins. Most microorganisms are killed 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 VITADIN topical solution has a broad antimicrobial spectrum of activity: it acts against Gram-positive and Gram-negative bacteria (bactericidal), viruses (virucidal), fungi (fungicidal), fungal spores (sporicidal), and certain protozoa (antiprotozoal).

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.

Pharmacokinetics

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. Typically, prolonged use of the drug results in a rapid increase in blood iodine levels. Concentrations 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.

Absorption and renal excretion of povidone-iodine depend on its molecular weight. Since the molecular weight ranges between 35,000 and 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. Normal total plasma iodine levels are approximately 3.8–6 µg/dL, while inorganic iodine levels range from 0.01 to 0.5 µg/dL.

The drug is primarily eliminated 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 iodine per 1 g 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 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 carcinoma of the thyroid gland.

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. Due to its oxidizing properties, povidone-iodine may affect the results of certain diagnostic tests, such as occult blood testing in feces or urine, or glucose testing 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). Povidone-iodine may also 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. The product may react with proteins and unsaturated organic compounds, so the effect of povidone-iodine may be counteracted by increasing its dose.

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 should not be used simultaneously with disinfectants containing chlorhexidine, hydrogen peroxide, taurolidine, silver sulfadiazine, mercury, or alkalis, due to the possibility of partial reduction in the product's activity.

Concurrent topical application of povidone-iodine and benzoic tincture leads to a decrease in pH, which may cause a burning sensation, especially if the wound is bandaged.

Concomitant use of povidone-iodine and lithium preparations may result in a synergistic hypothyroid effect.

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 drugs. 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 treatment of thyroid cancer with radioactive iodine or during radioactive iodine scintigraphy.

Significant amounts of iodine may induce hyperthyroidism in patients with thyroid dysfunction (e.g., nodular colloid goiter, endemic goiter).

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 amounts over extensive body surfaces (over 10% of body surface area) in patients (especially 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 appropriate evaluation of thyroid function, even after discontinuation of the drug (up to 3 months).

Oropharyngeal administration may lead to the development of pneumonitis.

Discoloration of the solution indicates reduced efficacy of the medicinal product. Light and temperatures above 40°C accelerate the decomposition of the active substance. The solution is intended for external use only.

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; therefore, there is a risk of fetal or neonatal hypersensitivity to iodine. The concentration of povidone-iodine in breast milk is higher than in blood serum. Thus, 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 vehicles or operating machinery.

Unknown.

Method of application and dosage.

The product is intended for external use in both undiluted and diluted forms. The product should not be mixed with hot water. Only brief warming to body temperature is permitted.

Dosing

Undiluted VITADIN 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 remaining on the skin for 30 seconds.

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

For skin disinfection, the undiluted solution is left on the skin until dry after application.

For the indications listed 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 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 is more permeable and they more frequently exhibit increased sensitivity to iodine, increasing the risk of developing hyperthyroidism. Povidone-iodine should be administered in small doses to such patients. Thyroid function should be monitored in children if necessary.

Overdose.

Symptoms characteristic 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 insufficiency;
• laryngeal edema with secondary asphyxia, pulmonary edema, metabolic acidosis, hypernatremia.

Prolonged treatment of burn wounds with significant amounts of povidone-iodine may provoke disturbances in electrolyte balance or serum osmolality, leading to renal dysfunction or metabolic acidosis.

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

In cases of intoxication due to accidental oral ingestion of the medicinal product, immediate administration of food products containing starch or protein (such as a starch solution in water or milk) is indicated, followed by gastric lavage with a 5% sodium thiosulfate solution. If necessary, intravenous administration of 10 ml of 10% sodium thiosulfate solution at 3-hour intervals may be performed. Monitoring of thyroid function is recommended for early detection 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 hypersensitivity skin reactions such as contact dermatitis with formation of psoriasis-like red, fine 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 anxiety); 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 osmolality, metabolic acidosis.

Reporting of adverse reactions after drug registration is of great importance. It enables continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare and pharmaceutical professionals, as well as patients or their legal representatives, should report all suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

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.

30 ml in a bottle, 1 bottle stoppered with a dropper cap, in a carton;

100 ml in a bottle, 1 bottle stoppered with a nozzle and cap, in a carton;

1000 ml in a bottle, stoppered with a cap or dropper and cap.

Prescription status. Over-the-counter.

Manufacturer.

JSC PF "Viola".

Manufacturer's address and location of its business activities.

75 Amosova St., Zaporizhzhia, Ukraine, 69063.