Instructions for Iodadin ointment 10% tube 20 g
Composition
active ingredient: 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.
Dosage form
Ointment.
Main physicochemical properties: homogeneous brown ointment with a specific odor.
Pharmacotherapeutic group
Antiseptics and disinfectants. Iodine preparations. Povidone-iodine. ATX code D08A G02.
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, significant amounts of iodine are released from the polymer.
Iodine reacts with the oxidizing 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, ointment, 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 drug dissolves in water and is easily washed off with water.
Prolonged application of the drug to large wound surfaces or severe burns, as well as mucous membranes, may lead to the absorption of a significant amount of iodine. Usually, as a result of long-term use of the drug, the iodine content in the blood increases rapidly and returns to the initial level 7–14 days after the last application 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 level of iodine in the blood plasma and creatinine clearance (normally 100–300 mcg of iodine per 1 g of creatinine).
Indication
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 bedsores and trophic ulcers.
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.
- Children's age up to 1 year.
Interaction with other medicinal products 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 ointments for wound treatment reduces the effectiveness of both drugs. Drugs containing mercury, silver, hydrogen peroxide, taurolidine or chlorhexidine may interact with the povidone-iodine complex, therefore their combined use is not recommended.
Benzoin tincture causes a decrease in pH, which can cause a burning sensation, especially if the wound is bandaged.
In case of concomitant use with lithium preparations, a synergistic hypothyroid effect is possible.
The use of povidone-iodine simultaneously with antiseptics containing octenidine or immediately after them may result in temporary darkening of the skin at the application site.
Due to its oxidizing properties, povidone-iodine may affect the results of some diagnostic tests, such as the detection of occult blood in stool or urine or glucose in 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.
Thyroid scintigraphy should be performed 1–2 weeks after discontinuation of long-term drug therapy to obtain reliable results.
The dark brown color of the ointment indicates its activity; discoloration, which occurs under the influence of light and temperatures above 40 °C, is accompanied by a weakening of the antimicrobial effect.
Application features
The drug is intended for topical use only.
Prolonged use may cause irritation and sometimes severe skin reactions. If signs of irritation or hypersensitivity appear, application should be discontinued.
The use of povidone-iodine may reduce the uptake of iodine by the thyroid gland, which may affect the results of some examinations and procedures (thyroid scintigraphy, determination of protein-bound iodine, diagnostic procedures using radioactive iodine), and therefore planning the treatment of thyroid disease with iodine preparations may be impossible. A break of at least 1–4 weeks should be taken between courses of treatment with povidone-iodine.
In cases of latent hyperthyroidism or other thyroid diseases (especially in patients of the older age group), the drug is used only under the supervision of a physician.
Since the development of hyperthyroidism cannot be excluded, long-term (more than 14 days) use of povidone-iodine or its application in significant quantities to large surfaces (more than 10% of the body surface) in patients (especially the elderly) with latent thyroid dysfunction should be considered only after careful assessment of the expected benefit and possible risk. Such patients should be monitored for early signs of hyperthyroidism and appropriate thyroid function testing should be performed, even after discontinuation of the drug (up to 3 months).
Iodine absorption is individual for each patient, so there are no exact recommendations. Thyroid function tests, as well as doctor's recommendations, are crucial 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 failure when using the ointment regularly.
Regular use of the ointment should be avoided in patients receiving lithium medications.
The oxidizing effect of povidone-iodine can 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.
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).
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 as prescribed by a doctor, but in the smallest doses. Iodine crosses the placental barrier and can penetrate into 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 diseases, including congenital hypothyroidism, have been reported in children whose mothers were treated with iodine. The drug can also cause hyperthyroidism or increased levels of thyroid hormones in the fetus or newborn. It is necessary to check thyroid function in children.
The drug is contraindicated for use after the 2nd month of pregnancy and during breastfeeding. Breastfeeding should be discontinued during treatment.
Ability to influence reaction speed when driving vehicles or other mechanisms
Iodadin, ointment, does not affect the reaction speed when driving vehicles and working with other mechanisms.
Method of administration and doses
The drug is applied topically.
For the treatment of infections, the ointment is applied 1 or 2 times a day. The duration of treatment is no more than 14 days.
To prevent infections, the ointment is applied 1 or 2 times a week as long as necessary.
The affected skin should be cleaned and dried. Apply a thin layer of ointment to the affected skin surface. A bandage can be applied to the treated skin.
The drug is not used in children under 1 year of age. The use of high doses of iodine in children should be avoided, since children's skin is more permeable and children are more likely to have increased sensitivity to iodine, which increases the risk of developing hyperthyroidism. Povidone-iodine should be used in small doses in pediatric patients. If necessary, monitor thyroid function 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 provided.
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 swelling.
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.
Side effects
Immune system disorders: hypersensitivity, anaphylactic reactions.
Renal and urinary disorders: renal dysfunction, acute renal failure.
Skin and subcutaneous tissue disorders: local skin hypersensitivity reactions such as contact dermatitis with the formation of psoriasis-like red small bullous lesions; allergic reactions including itching, redness, rash, angioedema, exfoliative dermatitis, dry skin, chemical and thermal skin burns.
Endocrine system: hyperthyroidism (sometimes with symptoms such as tachycardia or anxiety); hypothyroidism.
Metabolism and nutrition disorders: electrolyte imbalance; metabolic acidosis.
Prolonged use of povidone-iodine may result in the absorption of large amounts of iodine.
In some cases, iodine-induced hyperthyroidism resulting from long-term use of the drug has been described, mainly in patients with existing thyroid disease.
In some cases, generalized acute reactions with a decrease in blood pressure and/or difficulty breathing (anaphylactic reactions) are possible.
Investigations: changes in serum electrolyte levels (hypernatremia) and osmolarity, metabolic acidosis.
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio of the 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
3 years.
Storage conditions
Store in original packaging at a temperature not exceeding 25 ° C. Keep out of the reach of children.
Packaging
20 g or 40 g in a tube; 1 tube in a pack.
Vacation category
Without a prescription.
Producer
LLC "SKP "Pharmaceutical Factory".
Location of the manufacturer and address of the place of its activity. Ukraine, 12430, Zhytomyr region, Zhytomyr district, village Stanyshivka, Koroleva st., b. 4.
