Iodadine pessaries

Composition:

active ingredient: povidone-iodine; 1 pessary contains povidone-iodine 200 mg;

excipient: macrogol 1000.

Dosage form. Pessaries.

Main physical and chemical properties: pessaries are dark brown in color, torpedo-shaped with the smell of iodine. Pessaries must be uniform, no inclusions are allowed on the cut. An air core or funnel-shaped depression on the longitudinal cut is allowed.

Pharmacotherapeutic group: Antimicrobials and antiseptics used in gynecology. ATC code: G01A X11.

Pharmacological properties.

Pharmacodynamics.

Povidone-iodine is a complex of iodine and polyvinylpyrrolidone polymer, which releases iodine over a period of time after application to the skin. Elemental iodine has a bactericidal effect, has a broad spectrum of antimicrobial activity against bacteria, viruses, fungi and protozoa.

Mechanism of action: free iodine demonstrates a rapid bactericidal effect, and the polymer is a depot for iodine.

Upon contact with skin and mucous membranes, a significant amount of iodine is released from the polymer.

Iodine reacts with oxidative sulfide (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 by in vitro action in less than a minute, and the main destructive effect occurs in the first 15-30 seconds . In this case, iodine is discolored, and therefore a change in the saturation of the brown color is an indicator of its effectiveness.

The active substance of the drug IODADIN, pessaries, has a broad antimicrobial spectrum of action: it acts on gram-positive and gram-negative bacteria (bactericidal), on viruses (virulicidal), on fungi (fungicidal) and fungal spores (sporicidal), as well as on some simpler microorganisms (protozoal).

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

The medicine dissolves in water and is easily washed off with water.

Prolonged use of the drug on mucous membranes may lead to the absorption of significant amounts of iodine. Usually, as a result of prolonged use of the drug, the iodine content in the blood increases rapidly and returns to the initial level 7–14 days after the last use of the drug.

In patients with normal thyroid function , increasing iodine stores does not cause clinically significant changes in thyroid hormonal status.

Pharmacokinetics.

The absorption and renal excretion of povidone-iodine depend on its molecular weight, and since it varies between 35,000 and 50,000, retention of the substance is possible.

The absorption of povidone-iodine or iodide is the same as that of regular iodine from other sources.

The volume of distribution corresponds to 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, and the inorganic iodine level is 0.01–0.5 μg/dL. The drug is excreted from the body mainly by the kidneys with a clearance of 15 to 60 ml/min depending on the plasma iodine level and creatinine clearance (normal 100–300 μg iodine per 1 g creatinine).

Clinical characteristics.

Indication.

Acute and chronic vaginal infections (colpitis):

• mixed infections;
• nonspecific infections (bacterial vaginosis caused by Cardnerella vaginalis );
• fungal infections (Candida albicans );
• vaginal infections due to treatment with antibiotics and steroid drugs;
• trichomoniasis (if necessary, combined systemic treatment should be carried out).

Preoperative prophylaxis for vaginal surgery or diagnostic procedures .

Contraindication.

• Hypersensitivity to iodine or suspected hypersensitivity to other components of the drug.
• Thyroid dysfunction (nodular colloid goiter, endemic goiter and Hashimoto’s thyroiditis).
• Hyperthyroidism or other acute thyroid disorders.
• Period before and after treatment and radioactive iodine scintigraphy in patients with thyroid carcinoma. At least 1–2 weeks should elapse between radioactive iodine scintigraphy or radioactive iodine treatment of thyroid tumors and the last exposure to povidone-iodine.
• During’s dermatitis herpetiformis.
• Kidney failure.
• Simultaneous use with drugs containing mercury, as a substance is formed that can damage the skin.

Interaction with other drugs and other types of interactions.

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

Proteins and other organic compounds reduce its activity.

The simultaneous use of Iodadin and enzyme preparations reduces the effectiveness of both agents. Preparations containing mercury, silver, hydrogen peroxide, taurolidine or chlorhexidine may interact with the povidone-iodine complex, therefore their combined use is not recommended.

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

Long-term use of the drug should be avoided in patients receiving lithium preparations, since their simultaneous use may cause a synergistic hypothyroid effect.

WARNING!

The oxidative action 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 using povidone-iodine, iodine uptake by the thyroid gland may be reduced, which may affect the results of some diagnostic tests (such as thyroid scintigraphy , protein-bound iodine determination, and radioactive iodine measurement). Interactions with iodine used for thyroid therapy are also possible.

Application features.

Do not use the drug in patients before or after radioactive iodine treatment for thyroid cancer or radioactive iodine scintigraphy. At least 1-2 weeks should elapse between radioactive iodine scintigraphy or radioactive iodine treatment for thyroid tumors and the last exposure to povidone-iodine.

Since the development of hyperthyroidism cannot be excluded, long-term (more than 14 days) use of povidone-iodine in patients (especially the elderly) with latent thyroid dysfunction is permissible only after careful assessment of the expected benefit and possible risk. The condition of such patients should be monitored for early signs of hyperthyroidism and appropriate examination of thyroid function, even after discontinuation of the drug (up to 3 months). The absorption of iodine in each patient is individual, therefore there are no precise recommendations. Thyroid function tests, as well as the recommendations of doctors, are of decisive importance in this case.

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

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

Regular use of pessaries should be avoided in patients receiving lithium medications.

The oxidizing action of povidone-iodine may cause corrosion of metals, while plastic and synthetic materials are generally insensitive to povidone-iodine. In isolated cases, discoloration may occur, which is usually reversible.

Povidone-iodine is easily removed from textiles and other materials with warm soapy water. Stains that are difficult to remove should be treated with ammonia solution or sodium thiosulfate.

Use during pregnancy or breastfeeding.

Povidone-iodine should be used strictly as prescribed by a doctor, but in the smallest doses. Iodine crosses the placental barrier and can enter breast milk, so there is a risk of hypersensitivity to iodine in the fetus or newborn. The level of povidone-iodine is higher in breast milk than in serum. Thyroid disorders, including congenital hypothyroidism, have been reported in infants born to mothers treated with iodine. The drug may also cause hyperthyroidism or elevated thyroid hormone levels in the fetus or newborn. Thyroid function should be monitored in infants.

The drug is contraindicated for use after the 2nd month of pregnancy and during breastfeeding. Breastfeeding should be discontinued during treatment.

Fertility.

The drug has a spermicidal effect, so it is not recommended for use by women planning a pregnancy.

The ability to influence the reaction speed when driving vehicles or other mechanisms.

IODADIN, pessaries, does not affect the reaction speed when driving vehicles and working with other mechanisms.

Method of administration and doses.

The medicine should be applied vaginally.

It is recommended to use the drug once a day for 7 days.

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

In case of more severe infections, it is recommended to use for another 7 days. In case of persistent infections, the drug is prescribed 2 times a day (after consultation with a doctor).

Remove the pessary from the sheath and, after moistening it with water, insert it deep into the vagina.

During treatment with the drug, the use of sanitary pads is recommended. (tampons cannot be used).

Method of administration: 1 pessary should be inserted deep into the vagina in the evening before going to bed. The drug should be used daily (even during menstruation).

Children.

IODADIN , pessaries, are not used in children.

Overdose.

The following symptoms are characteristic of acute iodine intoxication:

– metallic taste in the mouth, increased salivation, heartburn or pain in the mouth or throat;

– eye irritation and swelling;

– skin reactions;

– gastrointestinal disorders and diarrhea;

– renal 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, treatment with povidone-iodine should be discontinued.

Treatment.

Symptomatic and supportive treatment should be administered.

In case of severe hypotension, intravenous fluids and, if necessary, vasopressors should be administered.

Tracheal intubation may be required if there is corrosive damage to the upper airway causing significant edema.

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

If the patient is not vomiting and is able to tolerate oral feeding, starchy foods (potatoes, flour, starch, bread) may be given, which will help convert iodine into less toxic iodides.

Provided there are no signs of intestinal perforation, the stomach can be lavaged with a starch solution via a nasogastric tube (the fluid obtained 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.

Adverse reactions.

Immune system disorders: hypersensitivity, anaphylactic reactions (including decreased blood pressure and/or difficulty breathing) .

From the kidneys and urinary system: renal dysfunction , acute renal failure.

Skin and subcutaneous tissue disorders: hypersensitivity reactions such as contact dermatitis with the formation of psoriatic-like red small bullous lesions, itching, redness, rash, angioedema, exfoliative dermatitis; dryness, chemical and thermal burns.

If the above symptoms occur, you should immediately stop using the medicine and consult a doctor.

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

In some cases, iodine-induced hyperthyroidism has been described, resulting from prolonged use of the drug, mainly in patients with existing thyroid disease.

Metabolism and nutrition disorders: electrolyte imbalance; metabolic acidosis.

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

Side effects from other organs and systems were only occasionally reported.

Pessaries have a spermicidal effect, so their use is not recommended for those planning a pregnancy.

Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua

Expiration date. 2 years.

Storage conditions.

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

Packaging .

7 pessaries in a blister; 2 blisters in a pack.

Release category: Over-the-counter.