Povidone-iodine

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT Povidone-Iodine (POVIDONE-IODINE)

Composition:

Active ingredient: povidone-iodine;

1 g of the preparation contains povidone-iodine (calculated with respect to 10 % active iodine and dry substance) – 100 mg;

Excipients: propylene glycol, polyethylene glycol 400, proxitane 268, emulsifier No. 1, sodium hydrogen phosphate dodecahydrate, purified water.

Pharmaceutical form. Liniment.

Main physicochemical properties: brown-colored liniment of uniform consistency with a faint specific odor; the presence of air bubbles is permissible.

Pharmacotherapeutic group. Antiseptics and disinfectants. ATC code D08AG02.

Pharmacological properties.

Pharmacodynamics.

The antiseptic effect of the drug is due to the ability of active iodine to oxidize intracellular and membrane structures of microbial cells, free sulfhydryl groups in enzymes and other proteins of microorganisms. Povidone-iodine liniment has a broad spectrum of activity. It is active against bacteria, fungi, protozoa, and viruses. The iodine in the preparation is in a bound form as a complex with polyvinylpyrrolidone, therefore it is gradually and evenly released upon contact with the affected surface.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

• Prevention of infections in wounds, cuts, burns, and minor surgical procedures.
• Treatment of fungal and bacterial skin infections, pressure ulcers, and trophic ulcers.

Contraindications.

• Individual intolerance or hypersensitivity to iodine and other components of the drug;
• regular use in patients with thyroid dysfunction (particularly with nodular colloid goiter, endemic goiter, and Hashimoto's thyroiditis);
• dermatitis herpetiformis;
• renal insufficiency;
• period before and after treatment and scintigraphy with radioactive iodine in patients with thyroid carcinoma.

Interaction with other medicinal products and other forms of interaction.

The antimicrobial activity of povidone-iodine complex is effective within a pH range of 2 to 7.

Proteins and other organic compounds reduce its activity.

The drug should not be used concomitantly with other disinfectants containing oxidizing agents (e.g., silver, hydrogen peroxide), alkalis, or cationic surfactants, as well as with topical agents containing enzymes, chlorhexidine, or taurolidine, due to mutual reduction in efficacy and possible interactions with the povidone-iodine complex.

Mercury-containing preparations: should not be used due to the risk of forming mercuric iodide.

Benzoic tincture: reduces pH, which may cause a burning sensation, especially if the wound is covered.

Lithium preparations: a synergistic hypothyroid effect is possible.

Due to its oxidizing properties, povidone-iodine may lead to false-positive results in certain laboratory tests, such as occult blood detection in feces or urine, or glucose in urine.

The use of povidone-iodine may reduce iodine uptake by the thyroid gland and may affect the results of certain diagnostic tests and procedures (thyroid scintigraphy, determination of protein-bound iodine, diagnostic procedures using radioactive iodine), or may interfere with iodine used for therapy of thyroid disorders. To obtain reliable scintigraphy results, the procedure should be performed 1–2 weeks after discontinuation of prolonged povidone-iodine treatment.

Iodine absorbed through intact skin or wound surfaces may influence the results of thyroid function tests.

The dark brown color of the liniment indicates its activity; decolorization caused by light or 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.

Povidone-iodine use may reduce iodine uptake by the thyroid gland, which can affect the results of certain diagnostic tests and procedures (thyroid scintigraphy, determination of protein-bound iodine, diagnostic procedures using radioactive iodine). Therefore, planning of iodine-based treatment for thyroid disorders may become impossible. A break of at least 1-4 weeks should be made between courses of povidone-iodine treatment.

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

Since the development of hyperthyroidism cannot be ruled out, prolonged use (more than 14 days) or use in large quantities over extensive body surface areas (more than 10% of total body surface) in patients (particularly elderly) with latent thyroid dysfunction should be allowed 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, even after discontinuation of the product (up to 3 months).

Thyroid function should be monitored in all patients during prolonged use.

Repeated use of the liniment 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 some cases, discoloration of such materials may occur, which is usually reversible.

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

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

If symptoms do not begin to improve, or if the condition worsens, or if adverse effects occur, use of the product should be discontinued and medical advice should be sought regarding further use.

Use during pregnancy or breastfeeding.

Povidone-iodine has no teratogenic effects. However, the product is contraindicated after the second month of pregnancy.

Iodine crosses the placental barrier and may pass into breast milk; therefore, breastfeeding should be discontinued during treatment.

Ability to affect reaction rate when driving or operating machinery.

The product does not affect reaction speed when driving or operating machinery.

Method of administration and dosage.

Apply the liniment topically.

After treating (cleaning and drying) the affected skin area, apply the preparation as a thin layer:

• for treatment of infections – 1–2 times daily;
• for prevention of infection – 1–2 times per week, as long as necessary.

A dressing may be applied over the treated skin.

The duration of treatment should not exceed 14 days.

The preparation should not be used longer than the specified period without consulting a physician.

Children.

Povidone-iodine may be used in children under 1 year of age only under strict indications.

High doses of iodine should be avoided in newborns and infants due to their increased skin permeability and higher incidence of hypersensitivity to iodine, which increases the risk of developing hyperthyroidism. In such patients, povidone-iodine should be used in small amounts. If necessary, monitor thyroid function in children.

Overdose.

Symptoms. Due to the low absorption of the drug following topical application, overdose is unlikely. However, considering the possibility of prolonged use and application over large skin areas, overdose cannot be excluded. Symptoms may include metallic taste in the mouth, increased salivation, burning sensation and pain in the mouth or throat, eye irritation and swelling, skin reactions, gastrointestinal disturbances and diarrhea, breathing difficulties, pulmonary edema, metabolic disturbances (metabolic acidosis and increased blood sodium levels), circulatory insufficiency, renal dysfunction, and anuria.

Treatment. In case of intentional or accidental ingestion of a large amount of the drug, symptomatic and supportive therapy is required, including careful monitoring of electrolyte balance, renal function, and thyroid function.

At the first signs of overdose, remove or wash off any remaining liniment from the skin and seek immediate medical attention.

Side effects.

Povidone-iodine ointment is generally well tolerated by patients, as its irritant effect is less than that of iodine.

Immune system, skin and subcutaneous tissue: allergic reactions, including burning sensation, itching, redness, rash, angioneurotic edema (these symptoms require discontinuation of the drug); local skin hypersensitivity reactions such as contact dermatitis with development of fine red, psoriasis-like, bullous rashes; acute generalized reactions with hypotension and/or respiratory distress (anaphylactic reactions) are possible.

Urinary system: impaired kidney function, acute renal failure (with prolonged use of the drug on large wound surfaces or in severe burns).

Endocrine system: excess iodine may cause disorders such as goiter, hypothyroidism or hyperthyroidism. Iodine-induced hyperthyroidism has been reported in some cases following prolonged use of the drug, mainly in patients with pre-existing thyroid disease.

Investigations: hypernatremia, changes in blood osmolarity, metabolic acidosis.

In case of any adverse reactions, it is essential to consult a physician regarding further use of the drug.

Shelf life. 2 years.

Do not use the drug after the expiry date stated on the packaging.

Storage conditions.

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

Keep out of reach of children.

Packaging. 30 g in a tube and a carton.

Availability. Over-the-counter (without prescription).

Manufacturer.

Public Joint-Stock Company "Scientific-Production Center "Borshchahivskyy Chemical-Pharmaceutical Plant".

Manufacturer's address and place of business.

17 Myru Street, Kyiv, 03134, Ukraine.