Euthyrox tablets 25mcg №25×4

Name:
Eutiroks tabl 25mkg in a blister. No. 25×4
Description:
White, round tablets, flat on both sides, with a bevel. On both sides of the tablet there is a dividing line, on one side of the tablet there is an engraving “I eat + dosage”. The main active ingredient Levothyroxine sodium Release form Tablets Dosage 25 μg Pharmacological action Pharmacodynamics Synthetic levothyroxine contained in the drug Eutiroks is identical in effect to the natural main hormone secreted by the thyroid gland. In peripheral organs, it is converted into TK, and, like the endogenous hormone, it has specific effects on TK receptors. The body is not able to distinguish endogenous levothyroxine from exogenous. Pharmacokinetics When administered orally, levothyroxine is absorbed primarily in the upper small intestine. Absorbed up to 80% of the dose taken, the maximum concentration in the blood is reached approximately 5-6 hours after ingestion. When taken orally, the onset of action of the drug is observed after 3-5 days. Levothyroxine exhibits an extremely high binding to specific transport proteins of about 99.97%. This protein-hormone binding is not covalent, so the bound hormone in plasma is in a state of continuous and very rapid exchange with the free hormone fraction. Due to the high degree of protein binding, levothyroxine does not undergo either hemodialysis or hemoperfusion. The half-life of the drug is on average 7 days. With thyrotoxicosis, the half-life is shortened (3-4 days), and with hypothyroidism it is lengthened (about 9-10 days). The volume of distribution is about 10-12 liters. The liver contains 1/3 of all levothyroxine located outside the thyroid gland, which can quickly exchange with levothyroxine in the blood serum. Thyroid hormones are metabolized primarily in the liver, kidneys, brain, and muscles. Metabolites are excreted in urine and feces. The total metabolic clearance of levothyroxine is approximately 1.2 liters of plasma per day. Indications for use Eutiroks 25-150 mcg: Treatment of euthyroid goiter; Prevention of relapse after surgical treatment of euthyroid goiter, depending on the postoperative hormonal status; Replacement therapy for hypothyroidism; Suppressive therapy for thyroid cancer. antithyroid agents. Euthyrox 100/150 mcg: As a diagnostic tool for the thyroid suppression test. Use during pregnancy and lactation During pregnancy and especially breastfeeding, levothyroxine therapy should continue. During pregnancy, even an increase in dosage may be required. Pregnancy There are no data on the occurrence of teratogenic and fetotoxic effects when taking the drug at recommended therapeutic doses. Taking the drug during pregnancy in excessively high doses can adversely affect the fetus and postnatal development. The use of levothyroxine during pregnancy in combination with antithyroid drugs is not indicated. This combination may require increased doses of antithyroid agents known to cross the placenta and cause fetal hypothyroidism. Diagnostic tests for thyroid suppression should not be performed during pregnancy, as the use of radioactive substances in pregnant women is contraindicated. Breastfeeding Levothyroxine is excreted in breast milk during lactation, but at the recommended therapeutic doses, the concentration of thyroid hormone is insufficient to cause hyperthyroidism and suppression of thyroid-stimulating hormone (TSH) secretion in a child. Precautions Before starting thyroid hormone replacement therapy or before performing a thyroid suppression test, it is necessary to exclude or treat the following diseases or pathological conditions: coronary insufficiency, angina pectoris, atherosclerosis, arterial hypertension, pituitary insufficiency, adrenal insufficiency. Also, before starting therapy with thyroid hormones, functional autonomy of the thyroid gland should be excluded or treated. In patients at risk of developing psychiatric disorders, levothyroxine therapy should be started at a low dose and then gradually increased. It is recommended to monitor the condition of patients. If symptoms of mental disorders occur, it is necessary to consider the possibility of changing the dose. Even mild drug-induced hyperthyroidism should be excluded in patients with coronary insufficiency, heart failure, or tachyarrhythmias. In this regard, in such cases, frequent monitoring of the concentration of thyroid hormones is necessary. Before replacement therapy with thyroid hormones, it is necessary to find out the etiology of secondary hypothyroidism. If necessary, replacement therapy should be started to compensate for adrenal insufficiency. If the development of functional thyroid autonomy is suspected, a TRH test or suppressive scintigraphy is recommended before the start of therapy. In postmenopausal women with hypothyroidism and an increased risk of osteoporosis, serum levels of levothyroxine sodium in excess of physiological levels should be avoided. Therefore, careful monitoring of thyroid function is recommended. The use of levothyroxine is not recommended in the presence of conditions accompanied by hyperthyroidism. An exception is the concomitant use during drug therapy of hyperthyroidism with antithyroid drugs. Thyroid hormones are not suitable for weight loss. Physiological doses do not result in any weight loss in euthyroid patients. Doses that are significantly higher than physiological can lead to the development of serious and even life-threatening adverse reactions (see section “Overdose”). With the selected therapy with levothyroxine, in the case of switching to a drug from another manufacturer, it is recommended to adjust the dose depending on the patient’s clinical response to therapy and the results of laboratory examination. When taking orlistat and levothyroxine together, hypothyroidism and / or decreased control of the state of hypothyroidism may develop (see section “Interaction with other drugs”). Patients taking levothyroxine should consult a physician before starting, ending or changing the regimen of orlistat treatment, due to the need to take orlistat and levothyroxine at different times and possible adjustment of the dose of levothyroxine. In addition, in such patients, it is recommended to monitor the level of hormones in the blood serum. The drug contains lactose, so its use is not recommended for patients with rare hereditary diseases associated with galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome. For information regarding diabetic patients and patients receiving anticoagulants, please refer to the section “Interaction with other medicinal products”. Interaction with other drugs Antidiabetic drugs: Levothyroxine may weaken the effect of antidiabetic drugs. Therefore, in patients with diabetes mellitus, at the beginning of thyroid hormone therapy, blood glucose levels should be checked frequently and, if necessary, the dose of the antidiabetic drug should be adjusted. Coumarin derivatives: Levothyroxine sodium may enhance the effect of anticoagulants by displacing them from plasma proteins, which may increase the risk of bleeding, such as CNS or gastrointestinal bleeding, especially in elderly patients. Therefore, regular monitoring of coagulation parameters is necessary both at the beginning and during combined therapy with these drugs. If necessary, the dose of the anticoagulant should be adjusted. Protease inhibitors: Protease inhibitors (eg, ritonavir, indinavir, lopinavir) may interfere with the effectiveness of levothyroxine. Careful monitoring of thyroid hormone levels is recommended. If necessary, the dose of levothyroxine sodium should be adjusted. Phenytoin: Phenytoin may interfere with the efficacy of levothyroxine by displacing levothyroxine from plasma protein binding, which may lead to an increase in fT4 and T3 concentrations. On the other hand, phenytoin increases the intensity of the metabolism of levothyroxine sodium in the liver. Careful monitoring of thyroid hormone levels is recommended. Cholestyramine and cholestipol: Ion exchange resins such as cholestyramine and cholestipol inhibit the absorption of levothyroxine sodium. In this regard, levothyroxine sodium should be used 4-5 hours before taking these drugs. Medicines containing aluminum, iron, calcium carbonate: There are reports in the literature of a potential decrease in the effectiveness of levothyroxine when used simultaneously with medicines containing aluminum (antacids, sucralfate). In this regard, drugs containing levothyroxine should be taken at least two hours before taking aluminum-containing drugs. The same rule applies in the case of iron preparations and calcium carbonate. Salicylates, dicoumarol, furosemide, clofibrate: Salicylates, dicoumarol, furosemide in high doses (250 mg), clofibrate and other drugs can displace levothyroxine sodium from plasma protein binding, which leads to an increase in the concentration of the fT4 fraction. Orlistat: When taking orlistat and levothyroxine together, hypothyroidism and / or decreased control of the state of hypothyroidism may develop. The mechanism of the phenomenon may be associated with a decrease in the absorption of iodine and / or levothyroxine salts. Sevelamer: Sevelamer may reduce the absorption of levothyroxine. Therefore, at the beginning or at the end of the course of concomitant therapy with this drug, it is recommended to monitor changes in thyroid function in patients. If necessary, the dose of levothyroxine is adjusted. Tyrosine kinase inhibitors: Tyrosine kinase inhibitors (eg, imatinib, sunitinib) may reduce the effectiveness of levothyroxine. Therefore, at the beginning or at the end of the course of concomitant therapy with these drugs, it is recommended to monitor changes in thyroid function in patients. If necessary, the dose of levothyroxine is adjusted. Propylthiouracil, glucocorticosteroids, beta-sympatholytics and iodine-containing contrast agents: Propylthiouracil, glucocorticosteroids, beta-sympatholytics and iodine-containing contrast agents, amiodarone inhibit the peripheral conversion of T4 to T3. Due to the high iodine content, the use of amiodarone can lead to the development of both hyperthyroidism and hypothyroidism. Particular attention should be paid to nodular goiter with the possible development of unrecognized functional autonomy. Sertraline, chloroquine/proguanil: Sertraline, chloroquine/proguanil reduce the effectiveness of levothyroxine and increase serum TSH levels. Enzyme-inducing drugs: Drugs that induce hepatic enzymes (eg, barbiturates, carbamazepine) may increase the hepatic clearance of levothyroxine sodium. Estrogens: In women using estrogen-containing contraceptives, or in postmenopausal women receiving hormone replacement therapy, the need for levothyroxine may increase. Soy-containing foods: Eating soy-containing foods may help reduce intestinal absorption of levothyroxine sodium. Therefore, dose adjustment may be required, especially at the beginning or after the cessation of the use of products containing soy. Contraindications Hypersensitivity to the active ingredient or any of the excipients of the drug; untreated adrenal insufficiency, untreated pituitary insufficiency and untreated thyrotoxicosis; drug treatment should not be started in the presence of acute myocardial infarction, acute myocarditis and acute pancarditis; the use of levothyroxine and an antithyroid agent for the treatment of hyperthyroidism in the period of pregnancy is not shown (see section “Use during pregnancy and during breastfeeding”) Composition 1 film-coated tablet, 25 mcg contains: Active ingredient: levothyroxine sodium – 25 mcg. Excipients: corn starch – 25.00 mg, gelatin – 5.00 mg, croscarmellose sodium – 3.50 mg, magnesium stearate – 0.50 mg, lactose monohydrate – 65.975 mg. Route of administration and doses For the treatment of each patient according to his/her individual needs, tablets with a content of sodium levothyroxine in the range from 25 to 150 micrograms are available. Therefore, patients usually only need to take one tablet per day. Dosing recommendations are provided as a guide only. The individual daily dose should be determined based on the results of laboratory tests and clinical studies. Since a certain number of patients have elevated T4 and fT4 concentrations, basal serum TSH levels provide a more reliable basis for choosing a course of treatment. Thyroid hormone therapy should be started at a low dose and gradually increased every 2 to 4 weeks until the full replacement dose is reached. For newborns and children with congenital hypothyroidism in whom rapid replacement therapy is important, the recommended starting dose is 10 to 15 micrograms per kilogram of body weight per day for the first 3 months. Thereafter, the dose should be individually adjusted depending on the clinical findings, and the level of thyroid hormones and TSH. In elderly patients, in patients with ischemic heart disease, and in patients with severe or long-term hypothyroidism, special care is required when initiating thyroid hormone therapy, that is, it is recommended to start therapy with a low initial dose (for example, 12.5 mcg / day), which should be gradually increased at extended intervals, and over a long period of time (for example, a gradual increase of 12.5 mcg / day every two weeks) with frequent monitoring of thyroid hormone levels. Therefore, it may be necessary to use a dose lower than the optimal dose that provides complete replacement therapy, and therefore does not lead to a complete correction of the TSH level. Experience shows that low doses are sufficient for patients with low body weight and in patients with large nodular goiter. Indication for use Recommended dose (micrograms of levothyroxine sodium / day) Treatment of euthyroid goiter – 75-200 Prevention of relapse of goiter after surgical interventions – 75-200 children initial dose maintenance dose 12.5-50, 100-150 mcg/m2 body surface Concomitant therapy against the background of hyperthyroidism therapy with antithyroid drugs – 50-100 Suppressive therapy for thyroid cancer – 150-300 As a diagnostic agent during the thyroid suppression test: 4 weeks before the test Eutirox 100 mcg – Eutirox 150 mcg – 1/2 tab. / day. 3 weeks before the test Eutiroks 100 mcg – Eutiroks 150 mcg – 1/2 tab. / day. 42 weeks before the test Eutiroks 100 mcg – 2 tablets / day. Eutiroks 150 mcg – 1 tab./day. 1 week before the test Eutiroks 100 mcg – 2 tablets / day. Eutiroks 150 mcg – 1 tab./day. Method of administration The daily dose can be taken in one dose. Ingestion: as a single daily dose in the morning on an empty stomach, half an hour before breakfast, preferably with a small amount of liquid (eg half a glass of water). Children should receive the entire dose at once, at least 30 minutes before their first meal of the day. The tablets must be dissolved in a small amount of water and the resulting suspension, which should be prepared right before taking, should be taken with a small amount of water. The duration of treatment is usually lifelong in the case of hypothyroidism replacement therapy and after strumectomy or thyroidectomy to prevent recurrence after removal of a euthyroid goiter. Concomitant therapy for hyperthyroidism after reaching a euthyroid state is indicated for the period in which the antithyroid drug is administered. With euthyroid goiter, the required duration of treatment is from 6 months to 2 years. If treatment is not sufficient during this time, surgical treatment or radioactive iodine therapy should be considered. If one tablet is missed, the dose should not be increased for the next tablet. Overdose An increase in T3 levels is a reliable indicator of overdose, more accurate than an increase in T4 or fT4 levels. In case of an overdose of the drug, a significant increase in the metabolic rate is observed (see section “Side effects”). Depending on the degree of overdose, it is recommended to stop taking the drug and undergo a follow-up examination. Symptoms consisting of pronounced beta-sympathomimetic effects, such as tachycardia, anxiety, agitation, and hyperkinesia, may be treated with beta-blockers. When taking extremely high doses, plasmapheresis may be useful. In predisposed patients, isolated cases of seizures have been noted when the individual tolerance threshold is exceeded. An overdose of levothyroxine can cause symptoms of hyperthyroidism and lead to acute psychosis, especially in patients at risk of developing psychiatric disorders. Cases of sudden cardiac arrest have been reported in patients who have taken inadequate doses of levothyroxine sodium for many years. Side effects If the individual tolerance limit of levothyroxine sodium is exceeded or after an overdose, the following clinical symptoms characteristic of hyperthyroidism may occur, especially if the dose is increased too quickly at the beginning of treatment: arrhythmias (for example, atrial fibrillation and extrasystole), tachycardia, palpitations, angina pectoris, cephalalgia , muscle weakness and convulsions, flushing, fever, vomiting, menstrual disorders, brain pseudotumors, tremors, anxiety, insomnia, sweating, weight loss, diarrhea. In such cases, the daily dose should be reduced or treatment canceled for several days. Therapy can be resumed after the disappearance of unwanted reactions. In case of hypersensitivity to any of the components of the drug Euthyrox, allergic reactions may develop, especially from the skin and respiratory tract. There have been reports of cases of Quincke’s edema. Reporting Suspected Adverse Reactions It is important to report suspected adverse reactions after drug registration. This will allow continuous monitoring of the benefit-risk ratio of the medicinal product. If an adverse reaction occurs that is indicated in this package leaflet or not mentioned in it, patients are advised to contact their doctor. Medical professionals are encouraged to report any suspected adverse drug reactions to the Republican Unitary Enterprise Center for Expertise and Testing in Healthcare. Storage conditions At a temperature not higher than 25 °C. Keep out of the reach of children. Buy Eutiroks tablets 25mcg No. 25×4