Iodadin

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

Composition:

Active substance: povidone-iodine; 1 suppository contains 200 mg of povidone-iodine;

Excipient: macrogol 1000.

Pharmaceutical form. Suppositories.

Main physico-chemical properties: dark brown, torpedo-shaped suppositories with an odor of iodine. Suppositories must be homogeneous; inclusions in the cross-section are not permitted. Presence of an air channel or funnel-shaped depression in the longitudinal cross-section is acceptable.

Pharmacotherapeutic group. Antimicrobial and antiseptic agents used in gynecology. ATC code G01AX11.

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, a significant amount of iodine is released from the polymer.

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 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 substance of the medicinal product IODADIN, vaginal suppositories, has a broad antimicrobial spectrum of action: it acts against Gram-positive and Gram-negative bacteria (bactericidal), viruses (virucidal), fungi (fungicidal) and 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 medicinal product dissolves in water and is easily washed off with water.

Prolonged use of the product on mucous membranes may lead to absorption of a significant amount of iodine. Usually, as a result of prolonged use, iodine levels in the blood rise rapidly and return to baseline within 7–14 days after the last administration.

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 this varies between 35,000–50,000, substance retention is possible.

Absorption of povidone-iodine or iodide is the same as that of ordinary 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. Normal total plasma iodine levels are approximately 3.8–6 µg/dL, while inorganic iodine levels are 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 (normally 100–300 µg of iodine per 1 g of creatinine).

Clinical characteristics.

Indications.

Acute and chronic vaginal infections (colpitis):

• mixed infections;
• non-specific infections (bacterial vaginosis caused by Gardnerella vaginalis);
• fungal infections (Candida albicans);
• vaginal infections following antibiotic and steroid therapy;
• trichomoniasis (combined systemic treatment should be administered if necessary).

Preoperative prophylaxis in surgical procedures in the vagina or diagnostic procedures.

Contraindications.

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

Interaction with other medicinal products and other forms of interaction.

The povidone-iodine complex is active against microorganisms within a pH range of 2–7.

Proteins and other organic compounds reduce its activity.

Concomitant use of Iodadin and enzymatic preparations 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.

Simultaneous use of povidone-iodine with antiseptics containing octenidine, or immediately after their use, may lead to temporary dark discoloration at the site of application.

Prolonged use of the medicinal product should be avoided in patients receiving lithium preparations, as their concomitant use may cause a synergistic hypothyroid effect.

Caution!

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).

When povidone-iodine is used, iodine uptake by the thyroid gland may be reduced, which may affect the results of certain diagnostic tests (such as thyroid scintigraphy, determination of protein-bound iodine, and measurement of radioactive iodine). Interaction with iodine used for thyroid therapy is also possible.

Special precautions for use.

Do not use the medicinal product in patients before or after radioactive iodine treatment of thyroid cancer or radioactive iodine scintigraphy. At least 1–2 weeks should elapse between radioactive iodine scintigraphy or radioactive iodine therapy for thyroid tumor and the last exposure to povidone-iodine.

Since the development of hyperthyroidism cannot be excluded, prolonged use (more than 14 days) of povidone-iodine in patients (especially elderly patients) with latent thyroid dysfunction is permissible only after careful assessment of the expected benefit and potential risk. The condition of such patients should be monitored for early signs of hyperthyroidism and appropriate thyroid function evaluation, even after discontinuation of the medicinal product (up to 3 months). Iodine uptake varies individually in each patient; therefore, no precise recommendations can be given. Thyroid function tests, as well as physicians' recommendations, are crucial 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 povidone-iodine lozenges regularly.

Regular use of lozenges should be avoided in patients receiving lithium preparations.

The oxidizing effect of povidone-iodine may cause corrosion of metals, whereas plastics 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.

Use during pregnancy or breastfeeding.

Povidone-iodine should be used strictly according to physician's instructions and only in the smallest possible doses. Iodine crosses the placental barrier and can pass into breast milk; therefore, there is a risk of iodine hypersensitivity in the fetus or newborn. The concentration of povidone-iodine in breast milk is higher than in blood serum. Cases of thyroid disorders, including congenital hypothyroidism, have been reported in infants whose mothers received iodine therapy. The medicinal product may also cause hyperthyroidism or elevated thyroid hormone levels in the fetus or newborn. Evaluation of thyroid function in infants is necessary.

The medicinal product is contraindicated after the 2nd month of pregnancy and during breastfeeding. Breastfeeding must be discontinued during treatment.

Fertility.

The medicinal product has a spermicidal effect and therefore is not recommended for women planning pregnancy.

Ability to affect reaction speed when driving or operating machinery.

YO-DADIN, lozenges, does not affect reaction speed when driving vehicles or operating other machinery.

Administration and Dosage.

The medicinal product is intended for vaginal use.

It is recommended to use the drug once daily for 7 consecutive days.

The drug should be used daily (even during menstruation).

In cases of more severe infections, treatment for an additional 7 days is recommended. For persistent infections, the drug may be prescribed twice daily (after consultation with a physician).

Suppositories should be removed from the packaging, moistened with water, and inserted deeply into the vagina.

During treatment with this medicinal product, hygienic pads are recommended (tampons must not be used).

Method of administration: Insert 1 suppository deeply into the vagina in the evening before bedtime. The drug should be used daily (even during menstruation).

Children.

YOIDADIN suppositories are not intended for use 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 insufficiency;

‒ laryngeal edema with secondary asphyxia, pulmonary edema, metabolic acidosis, hypernatremia.

Hyperthyroidism or hypothyroidism may also occur. If thyroid gland function is impaired, treatment with povidone-iodine should be discontinued.

Treatment.

Symptomatic and supportive therapy should be administered.

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

Endotracheal intubation may be necessary if there is corrosive damage to the upper respiratory tract causing 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 is not vomiting 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.

Provided 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; the color may indicate when lavage can be discontinued).

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 (including decreased blood pressure and/or breathing difficulties).

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

Skin and subcutaneous tissue disorders: hypersensitivity reactions such as contact dermatitis with psoriasis-like red papulovesicular eruptions, pruritus, erythema, rash, angioneurotic edema, exfoliative dermatitis; dryness, chemical and thermal burns.

If any of the above symptoms occur, the use of the medicinal product should be discontinued immediately and medical advice sought.

Endocrine system disorders: hyperthyroidism (sometimes with symptoms such as tachycardia or anxiety), hypothyroidism.

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

Metabolism and nutrition disorders: electrolyte imbalance; metabolic acidosis.

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

Adverse effects related to other organs and systems have been reported only occasionally.

Suppositories have a spermicidal effect; therefore, their use is not recommended for individuals planning pregnancy.

Reporting suspected adverse reactions after authorization of the medicinal product is of great importance. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients, as well as their legal representatives, are encouraged to 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. 2 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 20 °C. Keep out of reach of children.

Packaging.

7 suppositories in a blister; 2 blisters per carton.

Availability. Over-the-counter.

Manufacturer. LLC "DKP "Pharmaceutical Factory".

Manufacturer's address and location of operations. 4, Korolyova St., village Stanishivka, Zhytomyr district, Zhytomyr region, 12430, Ukraine.