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POTASSIUM IODIDE
Release form
Tablets
For children
From 13 years old
For pregnant women
For a doctor's recommendation
For nursing mothers
Not recommended
For drivers
Not specified
Storage temperature
to 25 °C
INSTRUCTION
storage
active substance: Potassium iodide; 1 tablet contains potassium iodide 250 mg (0.25 g); excipients: basic magnesium carbonate, sodium thiosulfate, calcium stearate, colloidal anhydrous silicon dioxide.
Medicinal form
Tablets. Main physico-chemical properties: white tablets with a flat surface, beveled edges and a line; the presence of inclusions and marbling is allowed.
Pharmacotherapeutic group
Antidotes. ATX code V03АB21.
Pharmacological properties
Pharmacodynamics. When iodides enter the epithelial cells of the thyroid follicle under the influence of the iodide-peroxidase enzyme, iodine is oxidized to form elemental iodine, which is incorporated into the tyrosine molecule. At the same time, one part of the tyrosine radicals in thyroglobulin is iodinated. Iodized tyrosine radicals condense into thyrotrons, the main of which are thyroxine (T4) and triiodothyronine (T3). The formed complex of thyronine and thyroglobulin is released as a deposited form of thyroid hormone in the colloid of the follicle and remains in this state for several days or weeks. With iodine deficiency, this process is disrupted. Potassium iodide compensates for its deficiency, helps to restore the disturbed synthesis of thyroid hormones. The important properties of potassium iodide are its ability to prevent the accumulation of radioactive iodine in the thyroid gland and to protect it from radiation. Pharmacokinetics. When taken internally, it is quickly absorbed from the gastrointestinal tract. Widely distributed throughout all body tissues and fluids. It is excreted mainly by the kidneys.
Indication
For iodine prophylaxis during nuclear accidents in order to prevent exposure
Contraindication
`- individual hypersensitivity to the components of the medicinal product; - hypocomplementary urticarial vasculitis (McDuffie syndrome); - pronounced hyperthyroidism; - furunculosis; - increased sensitivity to iodine; - latent hyperthyroidism; - hyperfunction of the thyroid gland; - toxic adenoma, nodular or diffuse toxic goiter; - dermatitis herpetiformis (Dühring's disease); - hemorrhagic diathesis; - urticaria, pulmonary tuberculosis, nephritis, nephrosis, pyoderma; - children under 12 years of age.
Interaction with other medicinal products and other forms of interaction
With simultaneous high-dose therapy with iodine and potassium-sparing diuretics, the development of hyperkalemia is possible, with lithium preparations - the development of goiter and hypothyroidism. With the simultaneous use of the medicinal product "Potassium iodide" with angiotensin-converting enzyme (ACE) inhibitors, hyperkalemia, cardiac arrhythmias, or cardiac arrest may develop. If such combined use is considered appropriate, it is recommended to monitor the level of potassium in the blood plasma. Perchlorate and thiocyanate competitively inhibit the absorption of iodine by the thyroid gland, and thyroid-stimulating hormone (TSH) stimulates it. The simultaneous use of the drug "Potassium iodide" with water-containing drugs (for example, amiodarone) is not recommended due to the risk of unwanted effects. The combined use of quinidine and the drug "Potassium iodide" may be accompanied by an increase in the effect of quinidine on the heart due to an increase in the concentration of potassium in the blood plasma. The combination of the drug with plant alkaloids and salts of heavy metals can lead to the formation of an insoluble precipitate and complicate the absorption of iodine.
Features of use
It is necessary to consider the need to use the medicine "Potassium iodide" for different age groups at risk. Pregnant women, nursing mothers and children should first receive iodine prophylaxis. Iodine prophylaxis is used against inhalation exposure to radioactive iodine isotopes, but should not be considered exclusive, in particular in the case of ingestion of radioactive iodine through the digestive tract. The optimal effect is possible if the drug is taken in advance (preventive) 6 hours or less before irradiation. The permissible period for taking "Potassium iodide" is 24 hours before and 6 hours after the expected start of exposure to radiation. It is also advisable to take a medicine to block the thyroid gland within eight hours after the start of exposure to radiation. Starting iodine prophylaxis later than 24 hours after exposure to radioactive iodine may cause more harm than good, as it will contribute to prolonging the biological half-life of radioactive iodine isotopes in the thyroid gland. A single use of the medicine "Potassium iodide" provides protection of the thyroid gland for about 24 hours. Evacuation of the population (if justified) is a more effective measure of radiation protection than repeated administration of the drug. If evacuation is delayed or impossible for some reason, multiple (repeated) use of the medicinal product "Potassium iodide" should be carried out no earlier than 24 hours after the first administration and under the condition of prolonged release of radioactivity into the external environment. Against the background of therapy, patients with renal failure may develop hyperkalemia. "Potassium iodide" should be used with caution at the same time as potassium-containing medicinal products in patients with adrenal insufficiency, acute dehydration or heat convulsions. Prophylaxis with the drug "Potassium iodide" is not indicated for adults over 40 years of age, except in cases where inhalation doses of radiation increase to the level of 5 Gy, i.e., those that disrupt the functions of the thyroid gland. The risk of developing thyroid cancer in patients over 40 years old is low, but the frequency of the disease is higher, so taking potassium iodide can cause complications from the thyroid gland. Iodine-induced hyperthyroidism may occur in patients with asymptomatic nodular goiter or occult Graves' disease (Based's disease) who are not under medical care. Use during pregnancy or breastfeeding. Pregnancy. Teratogenic effects such as congenital goiter and hypothyroidism have been reported during the use of iodides in pregnant women. Prophylactic administration of potassium iodide to pregnant women should also be effective for the fetus. During pregnancy, the number of doses of potassium iodide should be minimal, repeated doses should be avoided. In regions with low soil iodine, long-term use may result in loss of thyroid function in the mother or fetus with potential consequences for fetal development. If potassium iodide is used late in pregnancy, the newborn's thyroid function should be monitored. In general, the usual screening tests in the newborn period are sufficient. In newborns who received potassium iodide in the first weeks of life, the levels of thyroid-stimulating hormone (TSH) and, if necessary, T4 should be monitored, and if necessary, appropriate replacement therapy should be carried out. Pregnant women with active hyperthyroidism should not take potassium iodide due to the risk of decreased thyroid function in the fetus. Breast-feeding. "Potassium iodide" penetrates into breast milk, however, women who are breastfeeding do not need a dose adjustment. Such women should take the medicine for their own protection and to potentially reduce the content of radioactive iodine in breast milk, but repeated use of the medicine "Potassium iodide" is not recommended.
Methods of application
After an official notification of a radiation accident and when there is a threat of radioactive iodine entering the body to protect the thyroid gland from radiation, "Potassium iodide" should be prescribed to adults and children over 12 years of age at 125 mg (1/2 tablet) once a day. Half a tablet can be taken after a meal with a small amount of water. For children, crush the tablet and take it, having previously dissolved it in a small amount of sweet tea or milk. The optimal effect of taking the medicine "Potassium iodide" is possible if it is taken in advance (preventive) 6 hours or less before irradiation. The permissible period for taking the drug is 24 hours before and 6 hours after the expected start of exposure to radiation (see the section "Peculiarities of use"). A single dose of the medicine "Potassium iodide" is sufficient. In case of long-term or repeated negative effects, repeated administration of the drug is possible. Multiple (repeated) use of "Potassium iodide" should be carried out no earlier than 24 hours after the first administration of the medicinal product (see the section "Peculiarities of use"). Special groups of patients. It is not recommended to use a repeated dose in patients older than 40 years (see the section "Particulars of use"). Children. Potassium iodide in this dosage form is not recommended for children under 12 years of age.
Overdose
In acute iodine intoxication, reflex vomiting, abdominal pain, diarrhea (sometimes with blood), and brown discoloration of the mucous membranes are observed. Dehydration and shock may occur. Esophageal stenosis is rarely noted. Chronic overdose leads to a phenomenon called iodism: a metallic taste in the mouth, swelling and inflammation of the mucous membranes (rhinitis, conjunctivitis, gastroenteritis, bronchitis); acne rash; dermatitis; swelling and pain of salivary glands; hemorrhages, increased body temperature; irritability. With long-term use of high doses of the drug (more than 300 mcg per day), the development of iodine-induced hyperthyroidism is possible (especially in elderly patients with nodular goiter or toxic adenoma). During therapy with high doses of iodine (more than 1 mg/day), goiter and hypothyroidism may develop in some cases. Treatment. First aid consists in washing the stomach, taking activated charcoal. When using hemodialysis, it is possible to reduce the level of iodine in the blood plasma.
Side effects
Adverse reactions are listed below by MedDRA system organ class, namely: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1) /100), rare (≥ 1/10,000 — < 1/1,000), very rare (< 1/10,000), frequency unknown (cannot be estimated from available data). From the side of the immune system: Unknown: manifestations of iodism: hypersensitivity reactions, swelling of the nasal mucosa, urticaria, Quincke's edema, anaphylactic shock, skin rashes, itching. From the blood system: Not known: eosinophilia. From the cardiovascular system: Not known: tachycardia. From the side of the central nervous system: Not known: irritability, sleep disturbances, increased sweating. From the gastrointestinal tract: Not known: diarrhea (in patients over 40 years old), gastrointestinal disorders (including nausea), taste disturbances (including a metallic taste). On the part of the endocrine system: Unknown: with high-dose therapy, goiter and hypothyroidism, iodine-induced autoimmune diseases (such as Grace's and Hashimoto's disease) may develop in some cases. Not known: Hyperthyroidism, thyroiditis, and thyroid enlargement with or without myxedema have also been reported. In the event of the appearance of any undesirable phenomena, the patient must consult a doctor! Reporting of suspected adverse reactions. The reporting of suspected adverse reactions after the registration of a medicinal product is of great importance. This makes it possible to monitor the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical workers, as well as patients or their legal representatives should be notified of all cases of suspected adverse reactions and/or lack of effectiveness of the medicinal product through the Automated Pharmacovigilance Information System at the link: https://aisf.dec.gov.ua.
Expiration date
4 years.
Storage conditions
Store in the original packaging at a temperature not higher than 25 ºС. Keep out of the reach of children.
Packaging
10 tablets in strips, No. 150 (15x10) in strips.
Leave category
By prescription.
Producer
Monfarm PJSC.
Address
Ukraine, 19161, Cherkasy region, Uman district, village Avramivka, str. Zavodska, 8.