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Euthyrox®

The use of tricyclic antidepressants with levothyroxine sodium may lead to increased effects of the antidepressants.

Levothyroxine sodium reduces the effect of cardiac glycosides.

With simultaneous use of cholestyramine and colestipol (ion exchange resins), as well as aluminum hydroxide, they reduce the plasma concentration of levothyroxine sodium by inhibiting its absorption in the intestine. In this regard, levothyroxine sodium must be used 4-5 hours before taking these drugs.

When used simultaneously with anabolic steroids, asparaginase, tamoxifen, pharmacokinetic interaction is possible at the level of binding to plasma proteins.

Protease inhibitors (eg, ritonavir, indinavir, lopinavir) may affect the effectiveness of levothyroxine sodium. Close monitoring of thyroid hormone concentrations is recommended. If necessary, the dose of levothyroxine sodium should be adjusted. Phenytoin may affect the effectiveness of levothyroxine sodium due to the displacement of levothyroxine sodium from plasma proteins, which can lead to increased concentrations of free T4 and T3. On the other hand, phenytoin increases the rate of metabolism of levothyroxine sodium in the liver. Close monitoring of thyroid hormone concentrations is recommended.

Levothyroxine sodium may reduce the effectiveness of hypoglycemic drugs. Therefore, frequent monitoring of blood glucose concentrations is necessary from the start of thyroid hormone replacement therapy. If necessary, the dose of the hypoglycemic drug should be adjusted.

Levothyroxine sodium may enhance the effect of anticoagulants (coumarin derivatives) by displacing them from plasma proteins, which may increase the risk of bleeding, such as hemorrhage in the central nervous system or gastrointestinal bleeding, especially in elderly patients. Therefore, regular monitoring of coagulation parameters is necessary both at the beginning and during combination therapy with these drugs. If necessary, the dose of the anticoagulant should be adjusted. Salicylates, dicumarol, furosemide in high doses (250 mg), clofibrate and other drugs can displace levothyroxine sodium from binding to plasma proteins, which leads to an increase in the concentration of the free T4 fraction.

Orlistat: When orlistat is taken concomitantly with levothyroxine sodium, hypothyroidism may develop and/or decreased control of hypothyroidism may occur. The reason for this may be decreased absorption of iodine salts and/or levothyroxine sodium.

Sevelamer may reduce the absorption of levothyroxine sodium. Tyrosine kinase inhibitors (eg, imatinib, sunitinib) may reduce the effectiveness of levothyroxine sodium. Therefore, at the beginning or at the end of a course of concomitant therapy with these drugs, it is recommended to monitor changes in thyroid function in patients. If necessary, the dose of levothyroxine sodium is adjusted. Aluminum-containing drugs (antacids, sucralfate), iron-containing drugs, calcium carbonate are described in the literature as potentially reducing the effectiveness of levothyroxine sodium. Therefore, it is recommended to take levothyroxine sodium at least 2 hours before using such medications.

Somatropin, when used simultaneously with levothyroxine sodium, can accelerate the closure of epiphyseal growth plates.

Propylthiouracil, glucocorticosteroids, beta-sympatholytics, iodinated contrast agents and amiodarone inhibit the peripheral conversion of T4 to T3. Due to the high iodine content, the use of amiodarone may be accompanied by 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 reduce the effectiveness of levothyroxine sodium and increase serum TSH concentrations. Drugs that induce hepatic enzymes (eg, barbiturates, carbamazepine) may enhance the hepatic clearance of levothyroxine sodium.

In women using estrogen-containing contraceptives or in postmenopausal women receiving hormone replacement therapy, the need for levothyroxine sodium may be increased.

Consumption of soy-containing products may reduce the intestinal absorption of levothyroxine sodium. Therefore, dosage adjustments may be necessary, especially when starting or stopping consumption of soy-containing products.

Eutirox tablets 25mkg No. 25x4

Name

Eutirox tablet 25 µg in blister pack. No. 25x4

Description

White, round tablets, flat on both sides, with a bevel. On both sides of the tablet there is a separating line, on one side of the tablet there is an engraving “EAT + dosage”.

Main active ingredient

Levothyroxine sodium

Release form

Pills

Dosages

25mcg

pharmachologic effect

Pharmacodynamics

The synthetic levothyroxine contained in the drug Eutirox is identical in effect to the natural main hormone secreted by the thyroid gland. In peripheral organs, it is converted into T3, and, like the endogenous hormone, has specific effects on T3 receptors. The body is not able to distinguish endogenous levothyroxine from exogenous.

Pharmacokinetics

When taken orally, levothyroxine is absorbed primarily in the upper small intestine. Up to 80% of the dose taken is absorbed, the maximum concentration in the blood is reached approximately 5-6 hours after administration. When taken orally, the onset of action of the drug is observed after 3-5 days. Levothyroxine exhibits extremely high binding to specific transport proteins, approximately 99.97%. This binding of protein and hormone is not covalent, so the bound hormone in the plasma is in a state of continuous and very rapid exchange with the free hormone fraction. Due to its high degree of protein binding, levothyroxine is not subject to hemodialysis or hemoperfusion. The half-life of the drug averages 7 days. With thyrotoxicosis, the half-life is shortened (3-4 days), and with hypothyroidism, it is longer (approximately 9-10 days). The volume of distribution is about 10-12 l. 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 L of plasma per day.

Indications for use

Eutirox 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.

Eutirox 25-100 mcg: Concomitant replacement therapy during the treatment of hyperthyroidism with antithyroid drugs. Eutirox 100/150 mcg: As a diagnostic tool when performing a thyroid suppression test.

Use during pregnancy and lactation

During pregnancy and especially breastfeeding, levothyroxine therapy should be continued. During pregnancy, you may even need to increase the dosage. Pregnancy There is no data on the occurrence of teratogenic and fetotoxic effects when taking the drug in recommended therapeutic doses. Taking the drug during pregnancy in excessively high doses can negatively affect the fetus and postnatal development. The use of levothyroxine in combination with antithyroid drugs during pregnancy is not indicated. This combination may require increased doses of antithyroid drugs, which are known to cross the placenta and cause the development of hypothyroidism in the fetus. 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 when taking recommended therapeutic doses, the concentration of thyroid hormone is insufficient to cause hyperthyroidism and suppression of thyroid-stimulating hormone (TSH) secretion in the child.

Precautionary measures

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 thyroid hormone therapy, 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 patient's condition. If symptoms of mental disorders occur, dosage changes should be considered. It is necessary to exclude the possibility of even minor drug-induced hyperthyroidism 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 carrying out replacement therapy with thyroid hormones, it is necessary to determine the etiology of secondary hypothyroidism. If necessary, replacement therapy should be started to compensate for adrenal insufficiency. If the development of functional autonomy of the thyroid gland is suspected, a TRH test or suppressive scintigraphy is recommended before starting therapy. In postmenopausal women with hypothyroidism and an increased risk of osteoporosis, serum concentrations of levothyroxine sodium exceeding 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 of antithyroid drugs during drug therapy for hyperthyroidism. Thyroid hormones are not suitable for weight loss. Physiological doses do not result in any weight loss in euthyroid patients. Doses significantly higher than physiological ones can lead to the development of serious and even life-threatening adverse reactions (see section “Overdose”). With selected levothyroxine therapy, in 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 hypothyroidism may develop (see section “Interaction with other drugs”). Patients taking levothyroxine should consult their physician before starting, stopping, or changing their treatment regimen with orlistat, due to the need to take orlistat and levothyroxine at different times and possible adjustments in the dose of levothyroxine. In addition, in such patients it is recommended to monitor serum hormone levels. 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 patients with diabetes and patients receiving anticoagulants, see the section "Interactions with other drugs."

Interaction with other drugs

Antidiabetic drugs: Levothyroxine may reduce the effect of antidiabetic drugs. Therefore, in patients with diabetes mellitus, blood glucose levels should be checked frequently when initiating thyroid hormone therapy and the dose of the antidiabetic drug should be adjusted if necessary. 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 central nervous system hemorrhage or gastrointestinal bleeding, especially in elderly patients. Therefore, regular monitoring of coagulation parameters is necessary both at the beginning and during combination 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. Close monitoring of thyroid hormone concentrations is recommended. If necessary, the dose of levothyroxine sodium should be adjusted. Phenytoin: Phenytoin may affect the effectiveness of levothyroxine due to the displacement of levothyroxine from plasma proteins, which can lead to increased concentrations of fT4 and T3. On the other hand, phenytoin increases the rate of metabolism of levothyroxine sodium in the liver. Close monitoring of thyroid hormone concentrations is recommended. Cholestyramine and cholestipol: Ion exchange resins such as cholestyramine and cholestipol inhibit the absorption of levothyroxine sodium. In this regard, levothyroxine sodium must 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, medications containing levothyroxine should be taken at least two hours before taking aluminum-containing medications. The same rule applies in the case of iron-containing 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 binding to plasma proteins, which leads to an increase in the concentration of the fT4 fraction. Orlistat: When orlistat is taken together with levothyroxine, hypothyroidism and/or decreased control of hypothyroidism may occur. The mechanism of the phenomenon may be associated with decreased absorption of iodine salts and/or levothyroxine. Sevelamer: Sevelamer may reduce the absorption of levothyroxine. Therefore, at the beginning or at the end of a course of concomitant therapy with this drug, monitoring changes in thyroid function in patients is recommended. 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 a 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 iodinated contrast agents: Propylthiouracil, glucocorticosteroids, beta-sympatholytics and iodinated 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 concentrations. 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 be increased. Soy-containing products: Consumption of soy-containing products may reduce the intestinal absorption of levothyroxine sodium. Therefore, dosage adjustments may be necessary, especially when starting or stopping consumption of soy-containing products.

Contraindications

Hypersensitivity to the active component or any of the excipients of the drug;
untreated adrenal insufficiency, untreated pituitary insufficiency and untreated thyrotoxicosis;
treatment with the drug should not be started in the presence of acute myocardial infarction, acute myocarditis and acute pancarditis;
the use of levothyroxine and an antithyroid drug for the treatment of hyperthyroidism during pregnancy is not indicated (see section “Use during pregnancy and breastfeeding”).

Compound

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.

Directions for use and doses

Levothyroxine sodium tablets ranging from 25 to 150 mcg are available to treat each patient according to his/her individual needs. 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 concentrations provide a more reliable basis for treatment decisions. 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 neonates 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. After this, the dose should be individually adjusted depending on clinical data and the level of thyroid hormones and TSH. In elderly patients, in patients with coronary artery disease, and in patients with severe or long-standing hypothyroidism, special caution is required when initiating thyroid hormone therapy, i.e., it is recommended to begin therapy with a low initial dose (for example, 12.5 mcg/day). daily), which should be gradually increased at extended intervals and over a long period of time (eg, 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 complete correction of TSH levels. Experience shows that low doses are sufficient for patients with low body weight and in patients with large nodular goiter. Indications for use Recommended dose (micrograms of levothyroxine sodium/day) Treatment of euthyroid goiter - 75-200 Prevention of goiter relapse after surgery - 75-200 Replacement therapy for hypothyroidism in adults initial dose maintenance dose 25-50, 100-200 Replacement therapy for hypothyroidism in adults children initial dose maintenance dose 12.5-50, 100 - 150 mcg/m2 of body surface Concomitant therapy during the treatment of hyperthyroidism with antithyroid drugs - 50-100 Suppressive therapy for thyroid cancer - 150-300 As a diagnostic tool when performing a thyroid suppression test: 4 weeks before the test Eutirox 100 mcg - Eutirox 150 mcg - 1/2 tablet / day. 3 weeks before the test Eutirox 100 mcg - Eutirox 150 mcg - 1/2 tablet / day. 42 weeks before the test Eutirox 100 mcg - 2 tablets/day. Eutirox 150 mcg - 1 tablet/day. 1 week before the test Eutirox 100 mcg - 2 tablets/day. Eutirox 150 mcg - 1 tablet/day. Method of administration The daily dose can be taken in one dose. Oral administration: as a single daily dose in the morning on an empty stomach, half an hour before breakfast, preferably with a small amount of liquid (for example, half a glass of water). Children should receive the entire dose at once, at least 30 minutes before the first meal of the day. The tablets must be diluted in a small amount of water and the resulting suspension, which should be prepared immediately before use, should be taken with a small amount of water. The duration of treatment is usually lifelong in the case of replacement therapy for hypothyroidism and after strumectomy or thyroidectomy to prevent relapses after removal of euthyroid goiter. Concomitant therapy for hyperthyroidism after achieving a euthyroid state is indicated for the period during which an antithyroid drug is prescribed. For euthyroid goiter, the required duration of treatment is from 6 months to 2 years. If treatment is not sufficient during this time, surgery or radioactive iodine therapy should be considered. If one dose of tablets is missed, you should not increase the dose the next time you take the tablets.

Overdose

An increase in T3 levels is a reliable indicator of overdose, more clearly 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 can be relieved by taking beta blockers. When taking extremely high doses, plasmapheresis may be useful. In predisposed patients, isolated cases of seizures occurring when the individual tolerance threshold was exceeded. An overdose of levothyroxine can cause symptoms of hyperthyroidism and lead to acute psychosis, especially in patients at risk of developing mental disorders. Cases of sudden cardiac arrest have been reported in patients who have been taking inappropriate doses of levothyroxine sodium for many years.

Side effect

If the individual tolerance limit for 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 cramps, hyperemia, fever, vomiting, menstruation irregularities, pseudotumor cerebri, tremor, anxiety, insomnia, sweating, weight loss, diarrhea. In such cases, the daily dose should be reduced or treatment should be canceled for several days. Therapy can be resumed after the disappearance of adverse reactions. In case of hypersensitivity to any of the components of the drug Eutirox, allergic reactions may develop, especially from the skin and respiratory tract. Case reports of angioedema have been reported. Reporting Suspected Adverse Reactions It is important to report suspected adverse reactions after marketing authorization of a medicinal product. This will ensure continuous monitoring of the benefit-risk ratio of the drug. If an undesirable reaction occurs, either listed or not mentioned in these instructions for medical use, patients are advised to consult their doctor. Medical professionals are advised 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 exceeding 25 °C. Keep out of the reach of children.