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Iodine balance tablets 200 µg No. 25x4

Name

Iodine balance tablet 200 mcg per blister. in pack No. 25x4

Main active ingredient

Potassium iodide

Description

Iodine balance, tablets 200 mcg: almost white to yellowish-gray round tablets, flat on both sides, with beveled edges. On both sides of the tablet there is a separating line, on one side of the tablet there is an engraving “EM 33”.

Dosage

200mcg

pharmachologic effect

Pharmacodynamics

Iodine is one of the vital microelements. Without iodine, normal functioning of the thyroid gland is impossible, since it is a component of thyroxine and triiodothyronine. Thyroid hormones are involved in the development of all organs and systems, in the regulation of metabolic processes in the body: protein, fat, carbohydrate and energy; they also regulate the activity of the brain, nervous and cardiovascular systems, reproductive and mammary glands, the growth and development of the child, the formation of his intellectual abilities abilities. Iodine deficiency is especially dangerous for children, adolescents, pregnant and lactating women. Iodine balance®, being a source of iodine, replenishes its deficiency in the body, prevents the development of iodine deficiency diseases, and prevents the development of goiter associated with a lack of iodine in food; normalizes the size of the thyroid gland in newborns, children, adolescents and adults.

Pharmacokinetics

When taken orally, the drug is almost completely absorbed in the small intestine. The average volume of distribution for healthy individuals is approximately 23 liters (38% of body weight). The normal plasma iodine concentration ranges from 0.001 to 0.005 μg/ml. Accumulates in the thyroid gland, salivary glands, mammary glands and stomach tissues. The concentration in saliva, gastric juice and breast milk is approximately 30 times higher than in blood plasma. It is excreted in the urine; the concentration of iodine in urine relative to creatinine (µg/g) is an indicator of its intake into the body.

Indications for use

— prevention of iodine deficiency diseases, incl. endemic goiter (especially in pregnant and lactating women); - prevention of goiter recurrence after its surgical removal, as well as upon completion of goiter treatment with thyroid hormone preparations; - treatment of diffuse euthyroid goiter in newborns, children, adolescents and young adult patients.

Use during pregnancy and lactation

During pregnancy and breastfeeding, the need for iodine increases, so it is especially important to use Iodine Balance in sufficient doses to ensure adequate iodine intake into the body (the recommended iodine intake is 250 mcg per day). The drug crosses the placenta and is excreted in breast milk. If a nursing woman takes Iodbalance®, additional administration of the drug to breastfed infants is not required. The use of the drug during pregnancy and breastfeeding is possible only in recommended doses. When carrying out therapy, it is necessary to take into account the amount of iodine supplied with food.

Precautionary measures

Iodine deficiency increases, and its excess reduces, the response to thyreostatic therapy in patients with hyperfunction of the thyroid gland. Therefore, in the period preceding this therapy and during the treatment of hyperfunction of the thyroid gland, it is necessary, if possible, to avoid prescribing any iodine preparations. The use of the drug should be avoided before diagnostics and during therapy with radioactive iodine, the presence or suspicion of thyroid cancer. The drug should not be used for hypothyroidism, unless hypothyroidism is caused by iodine deficiency. The drug penetrates the placenta well and can cause the development of hypothyroidism and goiter in the fetus if potassium iodide is taken in large doses. The drug passes into breast milk. Therefore, the use of potassium iodide preparations during pregnancy and lactation is possible only in recommended doses. When using the drug, it is necessary to take into account the amount of iodine coming from other sources (iodized salt, food fortified with iodine, vitamin and mineral complexes, etc.). If a nursing woman takes Iodine Balance, additional use of the drug is not required for breastfed infants. It should be taken into account that during drug therapy in patients with renal failure, hyperkalemia may develop. Iodine balance does not affect the ability to drive vehicles or operate machinery.

Interaction with other drugs

Thyrostatic drugs inhibit the conversion of iodine to organic matter within the thyroid gland and can therefore cause goiter formation. Substances that are absorbed by the thyroid gland through the same “uptake” mechanism as iodide can inhibit iodine uptake by the thyroid gland through a competitive mechanism (for example, perchlorate, which also inhibits the recycling of iodide within the thyroid gland). Inhibition is also possible by drugs that are not themselves absorbed, such as thiocyanate, at concentrations exceeding 5 mg/dL. Taking high doses of iodine and simultaneous administration of potassium-sparing diuretics can lead to the development of hyperkalemia. Simultaneous administration of iodine therapy in high doses with lithium preparations promotes the development of goiter and hypothyroidism. The uptake of iodine by the thyroid gland and its metabolism are stimulated by thyroid-stimulating hormone. Quinidine: with simultaneous use, the effect of quinidine on the heart is enhanced due to an increase in the concentration of potassium in the blood plasma. Plant alkaloids and heavy metal salts: simultaneous use may lead to the formation of insoluble sediment and complicate the absorption of iodine.

Contraindications

manifest (or obvious) hyperthyroidism;
hidden (or latent) hyperthyroidism (when using doses exceeding 150 mcg/day);
Dühring's dermatitis herpetiformis;
solitary toxic adenomas of the thyroid gland and functional autonomy of the thyroid gland (focal and diffuse), nodular toxic goiter (with the exception of preoperative therapy for the purpose of blocking the thyroid gland);
hypersensitivity to the active substance or auxiliary components of the drug;
pulmonary tuberculosis;
hemorrhagic diathesis.
Iodine balance should not be taken for hypothyroidism, except in cases where the development of the latter is caused by severe iodine deficiency.
Prescription of the drug should be avoided during therapy with radioactive iodine, the presence or suspicion of thyroid cancer.
Since the drug contains lactose monohydrate, it is not recommended for use in patients with rare hereditary diseases associated with galactose intolerance, lactase deficiency or glucose-galactose malabsorption.

Compound

Each tablet contains: Active ingredient: potassium iodide 216.6 mcg (corresponds to 200 mcg iodine). Excipients: magnesium stearate (E470), microcrystalline cellulose (E460), colloidal silicon dioxide (E551), corn starch, cellulose powder, lactose monohydrate.

Directions for use and doses

Prevention of the development of iodine deficiency diseases, incl. endemic goiter: During pregnancy and breastfeeding: 200 mct of iodine per day (1 tablet of Iodine Balance, 200 mcg). Prevention of goiter relapse after its surgical removal or upon completion of a course of treatment with thyroid hormones: 100-200 mcg of iodine daily (1 tablet of Iodine Balance 200 mcg). Treatment of euthyroid goiter: Newborns, children, adolescents: 100-200 mcg of iodine per day (1 tablet of Iodine Balance 200 mcg). Young adult patients (up to 40 years): 300-500 mcg of iodine per day (2 tablets of Iodine Balance 200 mcg). The daily dose of the drug should be taken in one dose, after meals, with a sufficient amount of liquid. When prescribing the drug to newborns and children under 3 years of age, it is recommended to dissolve the tablet in a small amount (1 tablespoon) of boiled water at room temperature. The use of the drug for prophylactic purposes is carried out for, as a rule, several months or years, and often throughout life. For the treatment of goiter in newborns, in most cases, 2-4 weeks are sufficient; in children, adolescents and adults it usually takes 6-12 months or more. The duration of treatment is determined by the doctor. When determining the dose of the drug, it is necessary to take into account national guidelines for the appropriate use of the drug for the prevention and treatment of diseases caused by iodine deficiency. If you forget to take Iodbalance on time, continue taking the drug as usual. Do not take a double dose to make up for a separate missed dose.

Overdose

Symptoms of intoxication: Brown discoloration of mucous membranes, vomiting, abdominal pain and diarrhea. This can lead to dehydration and shock. In rare cases, esophageal stenosis. Fatalities have been reported when large amounts of iodine were taken (from 30 to 250 ml of iodine, which corresponds to 0.75-6.25 g E). Chronic overdose can lead to the phenomenon of “iodism”: metallic taste in the mouth, swelling and inflammation of the mucous membranes (rhinitis, conjunctivitis, gastroenteritis, bronchitis); bullous or tuberous iododerma, ecfoliative dermatitis and angioedema. Rare cases of fever and acne, as well as swelling of the salivary glands, have been reported. Treatment of acute intoxication: Gastric lavage, symptomatic treatment of water and electrolyte disturbances and shock. Treatment of chronic intoxication: Cancellation of iodine preparations. Hypothyroidism caused by iodine intake: it is recommended to stop using the drug and begin thyroid hormone replacement therapy. Hyperthyroidism caused by iodine intake: In this case, we cannot talk about an overdose as such, since hyperthyroidism can be caused by an amount of iodine that is normal in other countries. Treatment according to the form of the disease: with a mild form, treatment is usually not required; in severe forms, thyreostatic therapy is indicated (the effect, however, occurs somewhat later). In the most severe cases (thyrotoxic crisis): intensive care, plasmapheresis or thyroidectomy.

Side effect

With the prophylactic use of Iodine Balance, as well as with therapeutic use in newborns, children and adolescents, as a rule, no adverse reactions are observed. From the immune system: with unknown frequency - hypersensitivity reactions (rhinitis, exfoliative dermatitis, rash, Quincke's edema, bullous or tuberous iododerma, fever, acne, swelling of the salivary glands). Patients with a predisposition to autoimmune thyroiditis may develop antibodies to TPO. From the blood: very rarely - eosinophilia. From the cardiovascular system: in isolated cases - tachycardia, tremor. From the central nervous system: in isolated cases - irritability, sleep disturbance, increased sweating. From the gastrointestinal tract: discomfort in the epigastric region, in isolated cases - diarrhea (in patients over 40 years of age). From the endocrine system: With long-term administration of high doses of the drug (more than 300 mcg per day), iodine-induced hyperthyroidism may develop (especially in elderly patients, in the presence of nodular goiter or toxic adenoma). When treated with high doses of iodine (more than 1,000 mcg per day), iodine-induced goiter and hypothyroidism may develop in some cases. If the listed adverse reactions occur, as well as reactions not listed in the instructions for use, you should consult a doctor.

Storage conditions

At a temperature not exceeding 30 °C. Keep out of the reach of children.