Eutirox: instructions for use and what it is for, price, reviews, analogues. How to take the drug Eutirox for weight loss - instructions for use, composition and side effects Drug interaction Eutirox

19.07.2020

Release form

Pills

Composition

Active ingredient: Levothyroxine sodium (Levothyroxine sodium) Concentration of active ingredient (mg): 0.075

Pharmacological effect

Thyroid hormone preparation. Synthetic levorotatory isomer of thyroxine. After partial transformation into triiodothyronine (in the liver and kidneys) and transition into the cells of the body, it affects the development and growth of tissues, and metabolism. In small doses, it has an anabolic effect on protein and fat metabolism. In medium doses, it stimulates growth and development, increases the tissue oxygen demand, stimulates the metabolism of proteins, fats and carbohydrates, increases the functional activity of the cardiovascular system and the central nervous system. In large doses, it inhibits the production of thyrotropin-releasing hormone of the hypothalamus and thyroid-stimulating hormone of the pituitary gland. The therapeutic effect is observed after 7-12 days, during the same time the effect persists after the drug is discontinued. The clinical effect in hypothyroidism appears after 3-5 days. Diffuse goiter decreases or disappears within 3-6 months.

Pharmacokinetics

Absorption and distribution When administered orally, levothyroxine sodium is absorbed mainly in the upper part of the small intestine. Up to 80% of the dose taken is absorbed. Food intake reduces the absorption of levothyroxine sodium. Cmax in serum is reached approximately 5-6 hours after ingestion. More than 99% of the absorbed drug binds to serum proteins (thyroxine-binding globulin, thyroxine-binding prealbumin and albumin). Metabolism and excretion in various tissues. monodeiodination of about 80% of levothyroxine occurs with the formation of triiodothyronine (T3) and inactive products. Thyroid hormones are metabolized primarily in the liver, kidneys, brain and muscles. A small amount of the drug undergoes deamination and decarboxylation, as well as conjugation with sulfuric and glucuronic acids (in the liver). Metabolites are excreted by the kidneys and through the intestines. T1 / 2 is 6-7 days. Pharmacokinetics in special clinical cases With thyrotoxicosis, T1 / 2 is shortened to 3-4 days, and with hypothyroidism it is extended to 9-10 days.

Indications

Hypothyroidism; euthyroid goiter; as a replacement therapy and for the prevention of recurrence of goiter after resection of the thyroid gland; thyroid cancer (after surgery); diffuse toxic goiter after reaching the euthyroid state with thyreostatics (as combination therapy or monotherapy); as a diagnostic tool for conducting a thyroid suppression test.

Contraindications

Increased individual sensitivity to the drug; untreated thyrotoxicosis; untreated pituitary insufficiency; untreated adrenal insufficiency; use during pregnancy in combination with antithyroid drugs. Do not start treatment for acute myocardial infarction, acute myocarditis, acute pancarditis. Not recommended for patients with rare hereditary diseases associated with galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome (due to the presence of as part of a lactose preparation) .With caution, the drug should be prescribed for coronary artery disease (atherosclerosis, angina pectoris, myocardial infarction in history), arterial hypertension, arrhythmias, with diabetes mellitus, with severe long-term hypothyroidism, malabsorption syndrome (dose adjustment may be required).

Precautions

With caution, the drug should be prescribed for ischemic heart disease (atherosclerosis, angina pectoris, myocardial infarction in history), arterial hypertension, arrhythmias, diabetes mellitus, with severe long-term hypothyroidism, malabsorption syndrome (dose adjustment may be required), in patients with a predisposition to psychotic reactions.

Application during pregnancy and lactation

During pregnancy and during breastfeeding, therapy with a drug prescribed for hypothyroidism should be continued. During pregnancy, an increase in the dose of the drug may be required due to an increase in the level of thyroxine-binding globulin. There is no data on the occurrence of teratogenic and fetotoxic effects when using the drug at the recommended therapeutic doses. The use of the drug during pregnancy in excessively high doses can negatively affect the fetus and postnatal development. The use of the drug in combination with thyreostatics during pregnancy is contraindicated, because taking levothyroxine sodium may require an increase in thyreostatics doses. Since thyrostatics, unlike levothyroxine sodium, can penetrate the placental barrier, the fetus may develop hypothyroidism. During breastfeeding, the drug should be taken strictly in the recommended doses under the supervision of a doctor. When using the drug in the recommended therapeutic doses, the concentration of thyroid hormone secreted in breast milk is insufficient to cause hyperthyroidism and suppression of TSH secretion in a child.

Method of administration and dosage

The daily dose is determined individually depending on the indications. Eutirox in a daily dose is taken orally in the morning on an empty stomach, at least 30 minutes before a meal, with a small amount of liquid (half a glass of water) and without chewing. When carrying out replacement therapy for hypothyroidism in for patients under the age of 55 in the absence of cardiovascular diseases, Eutirox is prescribed in a daily dose of 1.6-1.8 μg / kg of body weight; in patients over the age of 55 or with concomitant cardiovascular diseases - 0.9 μg / kg of body weight In case of replacement therapy for hypothyroidism, the initial dose for patients under the age of 55 (in the absence of cardiovascular diseases) is 75-100 for women mcg / day, for men - 100-150 mcg / day. For patients over 55 years of age or with concomitant cardiovascular diseases, the initial dose is 25 μg / day; the dose should be increased by 25 mcg with an interval of 2 months until the TSH level in the blood normalizes; with the onset or worsening of symptoms from the cardiovascular system, it is necessary to correct the therapy of cardiovascular diseases.In severe long-term hypothyroidism, treatment should be started with extreme caution with low doses - 12.5 μg / day. The dose is increased to a maintenance dose at longer intervals - by 12.5 μg / day every 2 weeks - and the level of TSH in the blood is determined more often. In the treatment of congenital hypothyroidism in children, the dose of the drug depends on age. For infants and children under 3 years of age, the daily dose of Eutirox give in 1 dose 30 minutes before the first feeding. The tablet is dissolved in water to a fine suspension immediately before taking the drug. In the treatment of euthyroid goiter, 75-200 mcg / day is prescribed. For the prevention of relapse after surgical treatment of euthyroid goiter - 75-200 mcg / day. In the complex therapy of thyrotoxicosis - 50-100 mcg / day. days For suppressive therapy of thyroid cancer - 150-300 mcg / day When conducting a thyroid suppression test, the following dosage regimen is used: Doses of Eutiroxza 4 weeks before the test 3 weeks before the test 2 weeks before the test 1 week before the test 75 mcg / day 75 mcg / day 150-200 mcg / day 150-200 mcg / day In case of hypothyroidism, Eutirox is taken, as a rule, throughout life. In case of thyrotoxicosis, Eutirox is used in complex therapy with thyreostatics after reaching the euthyroid state. In all cases, the duration of drug treatment is determined individually.

Side effects

With the correct use of the drug Eutirox under the supervision of a physician, side effects are not observed.In case of hypersensitivity to the drug, allergic reactions may occur.

Overdose

With an overdose of the drug, a significant increase in the metabolic rate is observed. Clinical signs of hyperthyroidism may occur in case of an overdose, if the individual tolerance threshold for levothyroxine sodium is exceeded, or if the dose of the drug rises too quickly since the start of therapy. Symptoms characteristic of hyperthyroidism: heart rhythm disturbances, tachycardia, palpitations, angina pectoris, headache, muscle weakness and muscle cramps, hyperemia (especially of the facial skin), fever, vomiting, menstrual irregularities, benign intracranial hypertension, tremor, anxiety, insomnia, excessive sweating, weight loss, diarrhea. Cases of sudden cardiac arrest have been reported in patients who have been taking excessively high doses of levothyroxine sodium for many years. In predisposed patients, there were isolated cases of seizures when the individual tolerance threshold was exceeded. An overdose of levothyroxine sodium can lead to the appearance of symptoms of acute psychosis, especially in patients with a predisposition to psychotic disorders. Treatment: depending on the severity of symptoms, a decrease in the daily dose of the drug is indicated, a break in treatment for several days, the appointment of beta-blockers. When using the drug in extremely high doses, plasmapheresis can be prescribed. After the disappearance of side effects, treatment should be started with caution with a lower dose.

Interaction with other drugs

The use of tricyclic antidepressants with levothyroxine sodium can lead to an increase in the effect of antidepressants. Levothyroxine sodium reduces the action of cardiac glycosides. With the simultaneous use of colestyramine and colestipol (ion exchange resins), as well as aluminum hydroxide, the plasma concentration of sodium levothyroxine is reduced 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 (for example, ritonavir, indinavir, lopinavir) can influence the effectiveness of levothyroxine sodium. Careful monitoring of thyroid hormone concentrations is recommended. If necessary, the dose of levothyroxine sodium should be adjusted. Phenytoin may affect the efficacy of levothyroxine sodium due to the displacement of levothyroxine sodium from its bond with plasma proteins, which can lead to an increase in the concentration of free T4 and T3. On the other hand, phenytoin increases the metabolic rate of levothyroxine sodium in the liver. It is recommended to carefully monitor the concentration of thyroid hormones. Levothyroxine sodium may reduce the effectiveness of hypoglycemic drugs. Therefore, frequent monitoring of blood glucose concentration is necessary since the start of thyroid hormone replacement therapy. If necessary, the dose of the hypoglycemic drug should be adjusted. Levothyroxine sodium can enhance the effect of anticoagulants (coumarin derivatives) by displacing them from the connection with plasma proteins, which can increase the risk of bleeding, for example, 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 the connection with plasma proteins, which leads to an increase in the concentration of the free T4 fraction. With the simultaneous administration of orlistat and levothyroxine sodium hypothyroidism may develop and / or decreased control of hypothyroidism may occur. The reason for this may be a decrease in the absorption of iodine salts and / or sodium levothyroxine. Sevelamer may decrease the absorption of levothyroxine sodium. Tyrosine kinase inhibitors (eg, imatinib, sunitinib) can reduce the effectiveness of levothyroxine sodium. 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 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 the use of such drugs. Somatropin, when used simultaneously with levothyroxine sodium, can accelerate the closure of the epiphyseal growth zones. Propylthiouracil, GCS, beta-sympatholytics, iodine-containing contrast agents, amiodarone inhibit peripheral transformation 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 levels. Medicines that promote the induction of hepatic enzymes (eg, barbiturates, carbamazepine) can contribute to hepatic sodium clearance of levothyroxine. In women using estrogen-containing contraceptives, or in postmenopausal women receiving hormone replacement therapy, the need for levothyroxine sodium may increase. The consumption of soy-containing products can reduce the intestinal absorption of levothyroxine sodium. Therefore, dose adjustment may be required, especially at the beginning or after stopping the use of foods containing soy.

special instructions

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: acute coronary insufficiency, angina pectoris, atherosclerosis, arterial hypertension, pituitary insufficiency or adrenal insufficiency. Also, prior to initiation of thyroid hormone therapy, functional thyroid autonomy should be excluded or treated, and even minor drug-related hyperthyroidism should be excluded in patients with coronary insufficiency, heart failure, or tachyarrhythmias. Therefore, in these cases, regular monitoring of the concentration of thyroid hormones is necessary. Before carrying out replacement therapy with thyroid hormones, it is necessary to find out the etiology of secondary hypothyroidism. If necessary, substitution therapy should be initiated to compensate for adrenal insufficiency. serum levothyroxine sodium concentrations. In this case, careful monitoring of thyroid function is recommended. The use of levothyroxine sodium is not recommended in the presence of metabolic disorders accompanied by hyperthyroidism. An exception is the use during the therapy of hyperthyroidism with antithyroid drugs. From the moment of initiation of therapy with levothyroxine sodium, in case of switching from one drug to another, it is recommended to adjust the dose depending on the patient's clinical response to therapy and the results of laboratory tests. Effect on the ability to drive vehicles and control mechanisms. the drug on the ability to drive vehicles and mechanisms was not carried out. However, since levothyroxine sodium is identical to the natural thyroid hormone, no effect on the ability to drive vehicles and mechanisms is expected.

Eutirox (levothyroxine sodium) is a thyroid drug used as a substitute for thyroid hormones. Diseases of the thyroid gland and, in particular, hypothyroidism are one of the most common endocrine pathologies today, especially in areas with traditionally low iodine content in the environment. Hypothyroidism requires hormone replacement therapy. It is necessary to start a medication course at the earliest stage of the disease, when its consequences for the body are minimal. The main task of an endocrinologist at this stage is to normalize and maintain a stable level of thyroid hormones. For the treatment of hypothyroidism, complete artificially reconstituted analogs of human thyroid hormones - levothyroxine and triiodothyronine - are widely used. One of these drugs is Eutirox - sodium levothyroxine. When taken orally, about 80% of levothyroxine sodium is absorbed in the gastrointestinal tract. The peak concentration in the blood is noted after 5-6 hours from the moment of administration. The half-life of Eutirox is 6-7 days (with hypothyroidism, it increases to 9-10 days). The daily dose of the drug is determined on an individual basis, depending on the clinical situation. The effectiveness of the treatment is determined by the concentration of thyroid-stimulating hormone and free thyroxine. Pregnancy doubles the need for thyroxine. Hormone replacement therapy in the treatment of hypothyroidism is lifelong. For patients of this profile, daily intake of levothyroxine is a vital necessity.

If the drug is produced in a limited (1-2) number of dosages, then compliance (patient adherence to treatment) decreases, because in this case, it is necessary to divide the tablet in two, into four or eight parts, which can also lead to inaccurate dosing and a decrease in the quality of the pharmacotherapy carried out. Eutirox is one of the few levothyroxine preparations on the Russian market, which is produced in a wide range of dosages: from 25 to 150 mcg. The convenience of taking the drug increases compliance, which is especially important in lifelong pharmacotherapy, and improves the patient's quality of life. Normalization of metabolism when taking Eutirox eliminates the deficiency of thyroid hormones, brings the concentration of thyroid-stimulating hormone in the blood into line with the physiological level, restores physical and mental performance. In small doses, Eutirox exhibits an anabolic effect on the metabolism of proteins and lipids. Before starting treatment, it is necessary to conduct a deep medical examination and exclude the presence of diseases such as angina pectoris, atherosclerosis, hypertension, pituitary insufficiency. In patients with an unstable psyche, treatment is started with minimal doses and gradually increased under regular medical supervision. With the consumption of foods containing soy, absorption of levothyroxine sodium in the intestine may deteriorate, which requires a slight increase in the dose taken.

Pharmacology

The therapeutic effect is observed after 7-12 days, during the same time the effect persists after the drug is discontinued. The clinical effect in hypothyroidism appears after 3-5 days. Diffuse goiter decreases or disappears within 3-6 months.

Pharmacokinetics

Absorption and distribution

When taken orally, levothyroxine sodium is absorbed mainly in the upper part of the small intestine. Up to 80% of the dose taken is absorbed. Food intake reduces the absorption of levothyroxine sodium.

C max in serum is reached approximately 5-6 hours after oral administration.

More than 99% of the absorbed drug binds to serum proteins (thyroxine-binding globulin, thyroxine-binding prealbumin and albumin).

Metabolism and excretion

In various tissues, about 80% of levothyroxine is monodeiodinated with the formation of triiodothyronine (T 3) and inactive products. Thyroid hormones are metabolized primarily in the liver, kidneys, brain and muscles. A small amount of the drug undergoes deamination and decarboxylation, as well as conjugation with sulfuric and glucuronic acids (in the liver). Metabolites are excreted by the kidneys and through the intestines.

T 1/2 is 6-7 days.

Pharmacokinetics in special clinical situations

With thyrotoxicosis, T 1/2 is shortened to 3-4 days, and with hypothyroidism, it is extended to 9-10 days.

Release form

The tablets are white, round, 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 "EM + dosage".

Excipients: corn starch - 25.00 mg, gelatin - 5.00 mg, croscarmellose sodium - 3.50 mg, magnesium stearate - 0.50 mg, lactose monohydrate - 65.95 mg.

25 pcs. - blisters (2) - cardboard packs.
25 pcs. - blisters (4) - cardboard packs.

Dosage

The daily dose is determined individually, depending on the indications.

Eutirox ® in a daily dose is taken orally in the morning on an empty stomach, at least 30 minutes before a meal, with a small amount of liquid (half a glass of water) and without chewing.

When carrying out replacement therapy for hypothyroidism in patients under the age of 55 in the absence of cardiovascular diseases, Eutirox ® is prescribed in a daily dose of 1.6-1.8 μg / kg of body weight; in patients over the age of 55 or with concomitant cardiovascular diseases - 0.9 μg / kg of body weight.

With replacement therapy for hypothyroidism, the initial dose for patients under the age of 55 (in the absence of cardiovascular diseases) is 75-100 mcg / day for women, and 100-150 mcg / day for men. For patients over 55 years old or with concomitant cardiovascular diseases, the initial dose is 25 μg / day; the dose should be increased by 25 mcg with an interval of 2 months until the TSH level in the blood normalizes; when symptoms of the cardiovascular system appear or worsen, it is necessary to correct the therapy of cardiovascular diseases.

In severe long-term hypothyroidism, treatment should be started with extreme caution with low doses of 12.5 mcg / day. The dose is increased to a maintenance dose at longer intervals - by 12.5 μg / day every 2 weeks - and the level of TSH in the blood is often determined.

For infants and children under 3 years of age, the daily dose of Eutirox ® is given in 1 dose 30 minutes before the first feeding. The tablet is dissolved in water to a fine suspension immediately before taking the drug.

When treating euthyroid goiter, 75-200 μg / day is prescribed.

For the prevention of relapse after surgical treatment of euthyroid goiter - 75-200 μg / day.

In the complex therapy of thyrotoxicosis - 50-100 mcg / day.

For suppressive therapy of thyroid cancer - 150-300 mcg / day.

When conducting a thyroid suppression test, the following dosage regimen is used:

In hypothyroidism, Eutirox ® is taken, as a rule, throughout life. In case of thyrotoxicosis, Eutirox ® is used in complex therapy with thyrostatics after reaching the euthyroid state. In all cases, the duration of drug treatment is determined individually.

Overdose

Symptoms characteristic of hyperthyroidism: heart rhythm disturbance, tachycardia, palpitations, angina pectoris, headache, muscle weakness and muscle cramps, hyperemia (especially of the facial skin), fever, vomiting, menstrual irregularities, benign intracranial hypertension, insanity, tremor, , increased sweating, weight loss, diarrhea. Cases of sudden cardiac arrest have been reported in patients who have been taking excessively high doses of levothyroxine sodium for many years. In predisposed patients, there were isolated cases of seizures when the individual threshold of tolerance was exceeded.

Treatment: depending on the severity of the symptoms, a decrease in the daily dose of the drug is shown, a break in treatment for several days, the appointment of beta-blockers. When using the drug in extremely high doses, plasmapheresis can be prescribed. After the disappearance of side effects, treatment should be started with caution with a lower dose.

Interaction

The use of tricyclic antidepressants with levothyroxine sodium can lead to an increase in the effect of antidepressants.

Levothyroxine sodium reduces the action of cardiac glycosides.

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

With simultaneous use with anabolic steroids, asparaginase, tamoxifen, pharmacokinetic interaction is possible at the level of binding to plasma proteins.

Protease inhibitors (eg, ritonavir, indinavir, lopinavir) can interfere with the effectiveness of levothyroxine sodium. Careful monitoring of thyroid hormone concentrations is recommended. If necessary, the dose of levothyroxine sodium should be adjusted.

Phenytoin can affect the effectiveness of levothyroxine sodium due to the displacement of levothyroxine sodium from the bond with plasma proteins, which can lead to an increase in the concentration of free T 4 and T 3. On the other hand, phenytoin increases the metabolic rate of levothyroxine sodium in the liver. Careful monitoring of thyroid hormone concentrations is recommended.

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

Levothyroxine sodium can enhance the effect of anticoagulants (coumarin derivatives) by displacing them from association with
plasma proteins, which can increase the risk of bleeding, for example, 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 its connection with plasma proteins, which leads to an increase in the concentration of the free T 4 fraction.

Sevelamer may decrease the absorption of levothyroxine sodium. Tyrosine kinase inhibitors (eg, imatinib, sunitinib) can reduce the effectiveness of levothyroxine sodium. 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 sodium is adjusted.

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

Propylthiouracil, GCS, beta-sympatholytics, iodine-containing contrast agents, amiodarone inhibit the peripheral transformation of T 4 into T 3. 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 the nodular goiter with the possible development of unrecognized functional autonomy.

Sertraline, chloroquine / proguanil reduce the efficacy of levothyroxine sodium and increase serum TSH levels.

Medicines that promote the induction of hepatic enzymes (eg, barbiturates, carbamazepine) may promote 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 increase.

The use of soy-containing products can help reduce the absorption of levothyroxine sodium in the intestine. Therefore, dose adjustment may be required, especially at the beginning or after stopping the use of foods containing soy.

Side effects

With the correct use of Eutirox ® under the supervision of a physician, side effects are not observed.

With increased sensitivity to the drug, allergic reactions may occur.

Indications

hypothyroidism;
euthyroid goiter;
as replacement therapy and for the prevention of recurrence of goiter after resection of the thyroid gland;
thyroid cancer (after surgery);
diffuse toxic goiter after reaching the euthyroid state with thyreostatics (as combination therapy or monotherapy);
as a diagnostic tool for a thyroid suppression test.

Contraindications

increased individual sensitivity to the drug;
untreated thyrotoxicosis;
untreated pituitary insufficiency;
untreated adrenal insufficiency;
use during pregnancy in combination with antithyroid drugs.

You should not start treatment for acute myocardial infarction, acute myocarditis, acute pancarditis.

Not recommended for patients with rare hereditary diseases associated with galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome (due to the presence of lactose in the preparation).

Care should be taken to prescribe the drug for coronary artery disease (atherosclerosis, angina pectoris, myocardial infarction in history), arterial hypertension, arrhythmias, diabetes mellitus, with severe long-term hypothyroidism, malabsorption syndrome (dose adjustment may be required).

Application features

Application during pregnancy and lactation

There is no data on the occurrence of teratogenic and fetotoxic effects when using the drug in the recommended therapeutic doses. The use of the drug during pregnancy in excessively high doses can adversely affect the fetus and postnatal development.

The use of the drug in combination with thyreostatics during pregnancy is contraindicated, because taking levothyroxine sodium may require an increase in thyreostatics doses. Since thyreostatics, unlike levothyroxine sodium, can penetrate the placental barrier, hypothyroidism may develop in the fetus.

During the period of breastfeeding, the drug should be taken strictly in the recommended doses under the supervision of a doctor. When using the drug in the recommended therapeutic doses, the concentration of thyroid hormone secreted in breast milk is insufficient to cause hyperthyroidism and suppression of TSH secretion in a child.

Application in children

In the treatment of congenital hypothyroidism in children, the dose of the drug depends on age.

special instructions

Before starting thyroid hormone replacement therapy or before performing a thyroid suppression test, the following diseases or pathological conditions must be excluded or treated: acute coronary insufficiency, angina pectoris, atherosclerosis, arterial hypertension, pituitary insufficiency or adrenal insufficiency. Also, prior to initiation of thyroid hormone therapy, functional thyroid autonomy should be excluded or treated.

Before carrying out replacement therapy with thyroid hormones, it is necessary to find out the etiology of secondary hypothyroidism. If necessary, you should start replacement therapy 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 diagnosed hypothyroidism and an increased risk of osteoporosis, it is necessary to exclude the presence of higher physiological concentrations of levothyroxine sodium in serum. In this case, careful monitoring of thyroid function is recommended.

Since the start of therapy with levothyroxine sodium, in the case of switching from one drug to another, it is recommended to adjust the dose depending on the patient's clinical response to therapy and the results of laboratory tests.

Influence on the ability to drive vehicles and use mechanisms

Studies of the effect of the drug on the ability to drive vehicles and mechanisms have not been conducted. However, since levothyroxine sodium is identical to the natural thyroid hormone, no effect on the ability to drive vehicles and mechanisms is expected.

Composition

Each tablet contains:

Active ingredient: levothyroxine sodium - 25 mcg, 50 mcg, 75 mcg, 100 mcg, 125 mcg or 150 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 / 65.95 / 65.925 / 65.90 / 65.875 / 65, 85 mg.

Description

White, round tablets, flat on both sides, beveled. On both sides of the tablet there is a dividing line, on one side of the tablet there is an engraving "EM + dosage".

Pharmacotherapeutic group

Means for the treatment of thyroid diseases. Funds with the activity of thyroid hormones. CodeATX: H03AA01.

Pharmacotherapeutic properties

Pharmacodynamics

The synthetic levothyroxine contained in the Eutirox drug 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, has specific effects on TK receptors. The body is unable to distinguish between endogenous and exogenous levothyroxine.

Pharmacokinetics

When taken orally, levothyroxine is absorbed mainly in the upper part of the 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, amounting to about 99.97%. This binding of protein and hormone is not covalent; therefore, 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 is not subjected to either hemodialysis or hemoperfusion.

The half-life of the drug is 7 days on average. With thyrotoxicosis, the half-life is shortened (3-4 days), and with hypothyroidism, it is lengthened (approximately 9-10 days). The volume of distribution is about 10-12 liters. The liver contains 1/3 of all levothyroxine outside the thyroid gland, which can be rapidly exchanged 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

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 against the background of treatment of hyperthyroidism with antithyroid drugs.

Eutirox 100/150 mcg:

As a diagnostic tool for thyroid suppression test.

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 drug for the treatment of hyperthyroidism during pregnancy is not indicated (see section "Use during pregnancy and during breastfeeding").

Application during pregnancy and during breastfeeding

During pregnancy and especially breastfeeding, levothyroxine therapy should be continued. Even an increase in dosage may be required during pregnancy.

Pregnancy

There is no data on the occurrence of teratogenic and fetotoxic effects when taking the drug in the 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 increasing doses of antithyroid drugs, which are known to cross the placenta and cause 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.

Breast-feeding

Levothyroxine is excreted in breast milk during lactation, but when taking the recommended therapeutic doses, the concentration of thyroid hormone is insufficient to cause hyperthyroidism and suppression of the secretion of thyroid-stimulating hormone (TSH) in a child.

Method of administration and dosage

Tablets containing levothyroxine sodium in the range of 25 to 150 μg are available to treat each patient according to his / her individual needs. Therefore, patients usually only need to take one tablet a 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, the basal serum TSH concentration provides a more reliable basis for choosing a course of treatment.

Thyroid hormone therapy should be started at a low dose and gradually increased every 2–4 weeks until the full replacement dose is reached.

For infants 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 data, and the level of thyroid hormones and TSH.

In elderly patients, in patients with ischemic heart disease, as well as in patients with severe or long-term hypothyroidism, special caution is required when initiating thyroid hormone therapy, that is, it is recommended to start therapy with a low initial dose (for example, 12.5 μg / 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 TSH levels.

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 recurrence of goiter after surgery	75-200
Substitution therapy for hypothyroidism in adults initial dose maintenance dose	25- 50100-200
Substitution therapy for hypothyroidism in children initial dose maintenance dose	12.5-50 100 - 150 μg / m2 body surface
Concomitant therapy against the background of therapy for hyperthyroidism with antithyroid drugs	50- 100
Suppressive therapy for thyroid cancer	150-300
As a diagnostic tool for a thyroid suppression test		4 weeks before the test	3 weeks before the test	42 weeks before the test	1 week before the test
	Eutirox 100 mcg			2 tablets / day	2 tablets / day
	Eutirox 150 mcg	1/2 tab. / Day	1/2 tab. / Day	1 table / day	1 table / day

Mode of application

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 (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 just before taking, should be taken with a small amount of water.

The duration of treatment, as a rule, is lifelong in the case of replacement therapy for hypothyroidism and after strumectomy or thyroidectomy for the prevention of recurrence after removal of euthyroid goiter. Concomitant therapy of hyperthyroidism after reaching euthyroidism is indicated for the period in which the antithyroid drug is prescribed.

With 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 pill dose is missed, you should not increase the dose with subsequent pills.

Side effect

If the individual tolerance limit for levothyroxine sodium is exceeded or after an overdose, the following clinical symptoms characteristic of hyperthyroidism may appear, 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, menstrual irregularities, brain pseudotumors, tremors, anxiety, insomnia, sweating, weight loss, diarrhea.

In such cases, the daily dose should be reduced or the 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 Eutirox, 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 registration of a medicinal product. This will ensure continuous monitoring of the relationship of benefit and risk of the drug.

Patients are advised to consult their doctor in the event of an adverse reaction specified in these instructions for medical use or not mentioned in it.

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 the 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 treated with beta-blockers. When extremely high doses are taken, plasmapheresis may be helpful.

In predisposed patients, there were isolated cases of seizures when the individual threshold of tolerance 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 inadequate doses of levothyroxine sodium for many years.

Interaction with other medicinal products

Antidiabetic drugs:

Levothyroxine can 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 can enhance the effect of anticoagulants by displacing them from the connection with plasma proteins, which can increase the risk of bleeding, for example, hemorrhage in the central nervous system or gastrointestinal bleeding, especially in elderly patients. Therefore, it is necessary to regularly monitor the coagulation parameters both at the beginning and during the combined therapy with these drugs. If necessary, the dose of the anticoagulant should be adjusted.

Protease inhibitors:

Protease inhibitors (eg, ritonavir, indinavir, lopinavir) can interfere with the effectiveness of levothyroxine. Careful monitoring of thyroid hormone concentrations is recommended. If necessary, the dose of levothyroxine sodium should be adjusted.

Phenytoin:

Phenytoin can affect the effectiveness of levothyroxine due to the displacement of levothyroxine from the plasma protein binding, which can lead to an increase in the concentration of fT4 and T3. On the other hand, phenytoin increases the metabolic rate of levothyroxine sodium in the liver. Careful 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 should be used 4-5 hours before taking these drugs.

Medicines containing aluminum, iron, calcium carbonate:

The literature describes reports of a potential decrease in the effectiveness of levothyroxine when used simultaneously with medicinal products containing aluminum (antacids, sucralfate). In this regard, medicines containing levothyroxine should be taken at least two hours before taking aluminum-containing products.

The same rule applies in the case of iron-containing preparations and calcium carbonate.

Salicylates, dicumarol, furosemide,clofibrate:

Salicylates, dicumarol, 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:

With the combined administration of orlistat and levothyroxine, hypothyroidism and / or decreased control of the hypothyroidism state 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 decrease 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. Adjust the dose of levothyroxine if necessary.

Tyrosine kinase inhibitors:

Tyrosine kinase inhibitors (eg, imatinib, sunitinib) can 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. Adjust the dose of levothyroxine if necessary.

Propylthiouracil, glucocorticosteroids, beta-sympatholytics andiodine-containing contrast drugs:

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 the nodular goiter with the possible development of unrecognized functional autonomy.

Sertraline, Chloroquine / Proguanil:

Sertraline, chloroquine / proguanil reduce the efficacy of levothyroxine and increase serum TSH concentration.

Enzyme-inducing drugs:

Medicines that promote the induction of hepatic enzymes (eg, barbiturates, carbamazepine) can 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.

Precautions

Before starting replacement therapy with thyroid hormones 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, prior to initiation of thyroid hormone therapy, functional thyroid autonomy should be excluded or treated.

In patients at risk of developing mental disorders, therapy with levothyroxine 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, the possibility of changing the dose should be considered.

It is necessary to exclude the possibility of even minor drug-related 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.

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 in excess of physiological should be avoided. Therefore, careful monitoring of thyroid function is recommended.

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 selected therapy with levothyroxine, 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 orlistat and levothyroxine are taken together, hypothyroidism and / or a decrease in the control of the hypothyroidism state may develop (see the section "Interaction with other medicinal products"). Patients taking levothyroxine, before starting, ending or changing the treatment regimen with orlistat, should consult a doctor, because of the need to take orlistat and levothyroxine at different times and the possible dose adjustment 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 on patients with diabetes and patients receiving anticoagulants, see the section "Interaction with other medicinal products".

Influence on the ability to drive vehicles and mechanisms

Manufacturer / Marketing Authorization Holder

Merck KGaA, Frankfurter Strasse 250, 64293 Darmstadt, Germany.

Release form

Pills

Composition

Active ingredient: Levothyroxine sodium (levothyroxine sodium) Concentration of active ingredient (mg): 50

Pharmacological effect

Pharmacokinetics

Indications

Hypothyroidism; - euthyroid goiter; - as replacement therapy and for the prevention of recurrence of goiter after resection of the thyroid gland; - thyroid cancer (after surgery); - diffuse toxic goiter after reaching the euthyroid state with thyreostatics (as combination therapy or monotherapy); - as a diagnostic tool for a thyroid suppression test.

Contraindications

Increased individual sensitivity to the drug; - untreated thyrotoxicosis; - untreated pituitary insufficiency; - untreated adrenal insufficiency; - use during pregnancy in combination with antithyroid drugs. Treatment should not be started in acute myocardial infarction, acute myocarditis, acute pancarditis. Not recommended. hereditary diseases associated with galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome (due to the presence of lactose in the preparation).

Precautions

Application during pregnancy and lactation

Method of administration and dosage

The daily dose is determined individually depending on the indications. Eutirox in a daily dose is taken orally in the morning on an empty stomach, at least 30 minutes before a meal, with a small amount of liquid (half a glass of water) and without chewing. When carrying out replacement therapy for hypothyroidism in for patients under the age of 55 in the absence of cardiovascular diseases, Eutirox is prescribed in a daily dose of 1.6-1.8 μg / kg of body weight; in patients over the age of 55 or with concomitant cardiovascular diseases - 0.9 μg / kg of body weight In case of replacement therapy for hypothyroidism, the initial dose for patients under the age of 55 (in the absence of cardiovascular diseases) is 75-100 for women mcg / day, for men - 100-150 mcg / day. For patients over 55 years old or with concomitant cardiovascular diseases, the initial dose is 25 μg / day; the dose should be increased by 25 mcg with an interval of 2 months until the TSH level in the blood normalizes; with the onset or worsening of symptoms from the cardiovascular system, it is necessary to correct the therapy of cardiovascular diseases.In severe long-term hypothyroidism, treatment should be started with extreme caution with low doses - 12.5 μg / day. The dose is increased to a maintenance dose at longer intervals - by 12.5 μg / day every 2 weeks - and more often the level of TSH in the blood is determined. In the treatment of congenital hypothyroidism in children, the doses of the drug depend on age. Age Daily dose of levothyroxine (μg) Dose of levothyroxine in the calculation per body weight (μg / kg) 0-6 months 25-50 10-156-12 months 50-75 6-81-5 years old 75-100 5-66-12 years old 100-150 4-5 older than 12 years 100-200 2-3 For infants and children under 3 years of age, the daily dose of Eutirox is given in 1 dose 30 minutes before the first feeding. The tablet is dissolved in water to a fine suspension immediately before taking the drug. In the treatment of euthyroid goiter, 75-200 mcg / day is prescribed. To prevent relapse after surgical treatment of euthyroid goiter - 75-200 mcg / day. In the complex therapy of thyrotoxicosis - 50-100 mcg / day. days For suppressive therapy of thyroid cancer - 150-300 mcg / day When conducting a thyroid suppression test, the following dosage regimen is used: Doses of Eutiroxza 4 weeks before the test 3 weeks before the test 2 weeks before the test 1 week before the test 75 mcg / day 75 mcg / day 150-200 mcg / day 150-200 mcg / day In case of hypothyroidism, Eutirox is taken, as a rule, throughout life. In case of thyrotoxicosis, Eutirox is used in complex therapy with thyreostatics after reaching the euthyroid state. In all cases, the duration of drug treatment is determined individually.

Side effects

With the correct use of the drug Eutirox under the supervision of a physician, side effects are not observed.In case of hypersensitivity to the drug, allergic reactions may occur.

Overdose

Interaction with other drugs

special instructions

Description of the dosage form

White, round tablets, flat on both sides, beveled. On both sides of the tablet there is a dividing line, on one side of the tablet there is an engraving "EM + dosage".

Pharmacodynamics

Synthetic levorotatory isomer of thyroxine. After partial conversion to triiodothyronine (in the liver and kidneys) and transition to the cells of the body, it affects the development and growth of tissues, metabolism. In small doses, it has an anabolic effect on protein and fat metabolism, in medium doses it stimulates growth and development, increases tissue oxygen demand, stimulates the metabolism of proteins, fats and carbohydrates, increases the functional activity of the CVS and the central nervous system, in large doses it inhibits the production of thyrotropin-releasing hypothalamic hormone and pituitary TSH.

The therapeutic effect develops in 7-12 days and lasts for the same time after drug withdrawal. The clinical effect in hypothyroidism is manifested in 3-5 days. Diffuse goiter decreases or disappears within 3-6 months.

Pharmacokinetics

When administered orally, levothyroxine sodium is absorbed mainly in the upper part of the small intestine (up to 80% of the dose taken). Food intake reduces the absorption of levothyroxine. C max in blood plasma is reached approximately 5-6 hours after administration. After absorption, more than 99% of the drug binds to serum proteins (thyroxine-binding globulin, thyroxine-binding prealbumin and albumin). In various tissues, monodeiodination of approximately 80% of levothyroxine occurs with the formation of triiodothyronine (T 3) and inactive products. Thyroid hormones are metabolized primarily in the liver, kidneys, brain and muscles. A small amount of the drug undergoes deamination and decarboxylation, as well as conjugation with sulfuric and glucuronic acids (in the liver). Metabolites are excreted by the kidneys and through the intestines.

T 1/2 - 6-7 days, with thyrotoxicosis - 3-4 days, with hypothyroidism - 9-10 days.

Eutirox: Indications

hypothyroidism;

euthyroid goiter;

replacement therapy and prevention of goiter recurrence after surgery on the thyroid gland;

thyroid cancer (after surgery);

diffuse toxic goiter, after reaching the euthyroid state against the background of antithyroid therapy (in the form of combination or monotherapy);

as a diagnostic tool for performing a thyroid suppression test.

Eutirox: Contraindications

increased individual sensitivity to the drug;

untreated thyrotoxicosis;

untreated pituitary insufficiency;

untreated adrenal insufficiency;

use during pregnancy in combination with antithyroid drugs.

Do not start treatment with the drug in the presence of acute myocardial infarction, acute myocarditis and acute pancarditis. 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.

Carefully: ischemic heart disease (atherosclerosis, angina pectoris, myocardial infarction in history), arterial hypertension, arrhythmia, diabetes mellitus, severe long-term hypothyroidism, malabsorption syndrome (dose adjustment may be required), patients with a predisposition to psychotic reactions.

Application during pregnancy and lactation

During pregnancy and breastfeeding, therapy with a drug prescribed for hypothyroidism should be continued. During pregnancy, an increase in the dose of the drug may be required due to an increase in the content of thyroxine-binding globulin.

During the period of breastfeeding, the drug should be taken strictly in the recommended doses, under the supervision of a doctor. When taking the recommended therapeutic doses, the concentration of thyroid hormone secreted in breast milk during lactation is insufficient to cause hyperthyroidism and suppression of TSH secretion in a child. There is no data on the occurrence of teratogenic and fetotoxic effects when taking the drug in the recommended therapeutic doses. Taking the drug during pregnancy in excessively high doses can negatively affect the fetus and postnatal development.

The use of the drug during pregnancy in combination with antithyroid drugs is contraindicated, because taking levothyroxine sodium may require an increase in the dose of antithyroid drugs. Since antithyroid drugs, unlike levothyroxine sodium, can cross the placenta, the fetus may develop hypothyroidism.

Method of administration and dosage

Inside.

The daily dose is determined individually, depending on the indications.

Eutirox ® in a daily dose is taken in the morning on an empty stomach, at least 30 minutes before a meal, with a small amount of liquid (half a glass of water) and without chewing.

When carrying out replacement therapy for hypothyroidism in patients under 55 years of age in the absence of cardiovascular diseases, Eutirox ® is prescribed in a daily dose of 1.6–1.8 μg / kg / day; in patients over 55 years of age or with cardiovascular diseases - 0.9 μg / kg / day.

For infants and children under 3 years of age, the daily dose of Eutirox ® is given in one dose 30 minutes before the first feeding. The tablet is dissolved in water to a fine suspension, which is prepared immediately before taking the drug.

In patients with severe long-term hypothyroidism, treatment should be started with extreme caution with low doses - from 12.5 μg / day, the dose is increased to a maintenance dose of 12.5 μg / day every 2 weeks, and the concentration of TSH in the blood is often determined.

In hypothyroidism, Eutirox ® is taken, as a rule, throughout life. In case of thyrotoxicosis, Eutirox ® is used in complex therapy with antithyroid drugs after reaching the euthyroid state. In all cases, the duration of drug treatment is determined by the doctor.

For accurate dosing, it is necessary to use the most appropriate dosage of Eutirox ®.

Eutirox: Side effects

With the correct use of Eutirox ® under the supervision of a physician, side effects are not observed. Cases of allergic reactions in the form of angioedema have been reported.

Overdose

Symptoms characteristic of hyperthyroidism: cardiac arrhythmias, tachycardia, palpitations, angina pectoris, headache, muscle weakness and muscle twitching, hyperemia (especially of the face), fever, vomiting, menstrual irregularities, benign intracranial hypertension, tremor, anxiety, insomnia, hyperhidrosis, weight loss, weight loss, body weight loss.

Treatment: depending on the severity of symptoms, the doctor may recommend a decrease in the daily dose of the drug, a break in treatment for several days, the appointment of beta-blockers. When taking extremely high doses, plasmapheresis may be prescribed. After the disappearance of side effects, treatment should be started with caution, with a lower dose. An overdose of levothyrxine sodium can lead to symptoms of acute psychosis, especially in patients with a predisposition to psychotic disorders. Cases of sudden cardiac arrest have been reported in patients who have been taking excessively high doses of levothyroxine sodium for many years. In predisposed patients, there were isolated cases of seizures when the individual threshold of tolerance was exceeded.

Interaction

The use of tricyclic antidepressants with levothyroxine sodium can lead to an increase in the effect of antidepressants.

Levothyroxine sodium reduces the action of cardiac glycosides.

With simultaneous use with anabolic steroids, asparaginase, tamoxifen, pharmacokinetic interaction is possible at the level of binding to plasma proteins. Protease inhibitors (eg ritonavir, indinavir, lopinavir) can interfere with the effectiveness of levothyroxine sodium. Careful monitoring of thyroid hormone concentrations is recommended. If necessary, the dose of levothyroxine sodium should be adjusted.

Phenytoin can interfere with the effectiveness of levothyroxine sodium due to the displacement of levothyroxine sodium from the plasma protein binding, which can lead to an increase in the concentration of free T 4 and T 3. On the other hand, phenytoin increases the metabolic rate of levothyroxine sodium in the liver. Careful monitoring of thyroid hormone concentrations is recommended.

Levothyroxine sodium can enhance the effect of anticoagulants (coumarin derivatives) by displacing them from the connection with plasma proteins, which can increase the risk of bleeding, for example, 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 its binding to plasma proteins, which leads to an increase in the concentration of the free T 4 fraction.

Orlistat: while taking orlistat and levothyroxine sodium, hypothyroidism may develop and / or a decrease in hypothyroidism control may occur. The reason for this may be a decrease in the absorption of iodine salts and / or sodium levothyroxine.

Sevelamer may decrease the absorption of levothyroxine sodium.

Tyrosine kinase inhibitors (eg, imatinib, sunitinib) can reduce the effectiveness of levothyroxine sodium. 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 sodium is adjusted.

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

Propylthiouracil, GCS, beta-sympatholytics and iodine-containing contrast agents, amiodarone inhibit the peripheral transformation of T 4 into T 3. 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 the nodular goiter with the possible development of unrecognized functional autonomy.

Sertraline, chloroquine / proguanil decrease the effectiveness of levothyroxine sodium and increase serum TSH concentration.

Medicines that promote the induction of hepatic enzymes (eg, barbiturates, carbamazepine) can promote hepatic clearance of levothyroxine sodium.

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

Eating foods containing soy may help reduce intestinal absorption of levothyroxine sodium. Therefore, dose adjustment may be required, especially at the beginning or after stopping the use of foods containing soy.

special instructions

In patients at risk of developing psychotic disorders, it is recommended to start therapy with a low dose of levothyroxine sodium, followed by a slow increase at the beginning of therapy. Monitoring of patients is recommended. If signs of psychotic disorders are found, the dose of levothyroxine sodium taken should be adjusted.

It is necessary to exclude the possibility of even minor drug-related hyperthyroidism in patients with coronary insufficiency, heart failure, or tachyarrhythmias. Therefore, in these cases, regular monitoring of the concentration of thyroid hormones is necessary. Before carrying out replacement therapy with thyroid hormones, it is necessary to find out the etiology of secondary hypothyroidism.

If necessary, you should start replacement therapy 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, it is necessary to exclude the presence of higher physiological serum levothyroxine sodium concentrations. In this case, careful monitoring of thyroid function is recommended.

The use of levothyroxine sodium is not recommended in the presence of metabolic disorders accompanied by hyperthyroidism. An exception is the concomitant use of antithyroid drugs during drug therapy of hyperthyroidism. Since the start of therapy with levothyroxine sodium, in the case of switching from one drug to another, it is recommended to adjust the dose depending on the patient's clinical response to therapy and the results of laboratory tests.

With the simultaneous use of orlistat and levothyroxine sodium, hypothyroidism may develop and / or a decrease in the control of hypothyroidism may occur (see the section "Interaction with other medicinal products"). Patients taking levothyroxine sodium should consult a physician before using orlistat, as it may be necessary to take orlistat and levothyroxine sodium at different times of the day and adjust the dose of levothyroxine sodium. Further monitoring of thyroid function is recommended.

Influence on the ability to drive vehicles and mechanisms. Studies of the drug on the effect on the ability to drive vehicles and mechanisms have not been conducted. However, since levothyroxine sodium is identical to the natural thyroid hormone, the effect on the ability to drive vehicles and mechanisms is not expected.

Consumer claims and information on adverse events should be sent to the address of OOO Merck: 115054, Moscow, st. Gross, 35.

Release form

Composition

Pharmacological effect

Pharmacokinetics

Indications

Contraindications

Precautions

Application during pregnancy and lactation

Method of administration and dosage

Side effects

Overdose

Interaction with other drugs

special instructions

Pharmacology

Pharmacokinetics

Release form

Dosage

Overdose

Interaction

Side effects

Indications

Contraindications

Application features

Application during pregnancy and lactation

Application in children

special instructions

Composition

Description

Pharmacotherapeutic group

Indications for use

Contraindications

Method of administration and dosage

Side effect

Overdose

Interaction with other medicinal products

Precautions

Release form

Composition

Pharmacological effect

Pharmacokinetics

Indications

Contraindications

Precautions

Application during pregnancy and lactation

Method of administration and dosage

Side effects

Overdose

Interaction with other drugs

special instructions

Description of the dosage form

Pharmacodynamics

Pharmacokinetics

Eutirox: Indications

Eutirox: Contraindications

Application during pregnancy and lactation

Method of administration and dosage

Eutirox: Side effects

Overdose

Interaction

special instructions

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