Description of the dosage form
Release form, composition and packaging
Pills white, round, flat on both sides, with beveled edges and embossed signs (on one side - “EM 25”, on the other - a cross-shaped mark).
Excipients:
Pills white, round, flat on both sides, with beveled edges and with embossed signs (on one side - “EM 50”, on the other - a cross-shaped mark).
Excipients: lactose monohydrate, corn starch, gelatin, croscarmellose sodium, magnesium stearate.
25 pcs. - blisters (2) - cardboard packs.
25 pcs. - blisters (4) - cardboard packs.
Pills white, round, flat on both sides, with beveled edges and embossed signs (on one side - “EM 75”, on the other - a cross-shaped mark).
Excipients: lactose monohydrate, corn starch, gelatin, croscarmellose sodium, magnesium stearate.
25 pcs. - blisters (2) - cardboard packs.
25 pcs. - blisters (4) - cardboard packs.
Pills white, round, flat on both sides, with beveled edges and with embossed signs (on one side - “EM 100”, on the other - a cross-shaped mark).
Excipients: lactose monohydrate, corn starch, gelatin, croscarmellose sodium, magnesium stearate.
25 pcs. - blisters (2) - cardboard packs.
25 pcs. - blisters (4) - cardboard packs.
Pills white, round, flat on both sides, with beveled edges and with embossed signs (on one side - “EM 125”, on the other - a cross-shaped mark).
Excipients: lactose monohydrate, corn starch, gelatin, croscarmellose sodium, magnesium stearate.
25 pcs. - blisters (2) - cardboard packs.
25 pcs. - blisters (4) - cardboard packs.
Pills white, round, flat on both sides, with beveled edges and embossed signs (on one side - “EM 150”, on the other - a cross-shaped mark).
Excipients: lactose monohydrate, corn starch, gelatin, croscarmellose sodium, magnesium stearate.
25 pcs. - blisters (2) - cardboard packs.
25 pcs. - blisters (4) - cardboard packs.
Clinical and pharmacological group
Thyroid hormone drugpharmachologic effect
Thyroid hormone preparation. Synthetic levorotatory isomer of thyroxine. After partial conversion into triiodothyronine (in the liver and kidneys) and passage 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 tissue oxygen demand, stimulates the metabolism of proteins, fats and carbohydrates, and increases the functional activity of the cardiovascular system and 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 discontinuation of the drug. The clinical effect for hypothyroidism appears after 3-5 days. Diffuse goiter decreases or disappears within 3-6 months.
Pharmacokinetics
When taken orally, levothyroxine is absorbed almost exclusively in the upper small intestine. Up to 80% of the dose taken is absorbed. Eating reduces the absorption of levothyroxine.
Cmax in blood serum is reached approximately 5-6 hours after oral administration.
More than 99% of the absorbed drug is bound to serum proteins (thyroxine-binding globulin, thyroxine-binding prealbumin and albumin).
In various tissues, approximately 80% of levothyroxine is monodeiodinated to form triiodothyronine (T 3) and inactive products. Thyroid hormones are metabolized mainly 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 in urine and bile.
T 1/2 is 6-7 days.
With thiotoxicosis, T1/2 is shortened to 3-4 days, and with hypothyroidism it is extended to 9-10 days.
Indications for use of the drug
- euthyroid goiter;
- hypothyroidism;
— after resection of the thyroid gland as replacement therapy and to prevent goiter recurrence;
— thyroid cancer (after surgical treatment);
— diffuse toxic goiter after achieving a euthyroid state with thyreostatics (as combination therapy or monotherapy);
- as a diagnostic tool when performing a thyroid suppression test.
Dosage regimen
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 the tablet.
When conducting at patients under 55 years of age in the absence of cardiovascular diseases, Eutirox ® is prescribed in a daily dose of 1.6-1.8 mcg/kg body weight; at patients over 55 years old or with concomitant cardiovascular diseases - 0.9 mcg/kg body weight.
In case of significant obesity, the dose calculation should be done based on the “ideal weight”.
At replacement therapy for hypothyroidism starting dose for patients under 55 years of age (in the absence of cardiovascular diseases) is 75-100 mcg/day for women, 100-150 mcg/day for men. For patients over 55 years of age or with concomitant cardiovascular diseases the initial dose is 25 mcg/day; the dose should be increased by 25 mcg at intervals of 2 months until the TSH level in the blood normalizes; If symptoms from the cardiovascular system appear or worsen, adjust appropriate therapy.
At severe long-term hypothyroidism treatment should be started with extreme caution with small doses - 12.5 mcg/day. The dose is increased to maintenance at longer intervals - by 12.5 mcg / day every 2 weeks - and the level of TSH in the blood is determined more often.
At treatment of congenital hypothyroidism at children The dose of the drug depends on age.
Infants The daily dose of Eutirox is given in 1 dose 30 minutes before the first feeding. The tablet is dissolved in water to a thin suspension immediately before taking the drug.
At treatment of euthyroid goiter 75-200 mcg/day is prescribed.
For prevention of relapse after surgical treatment of euthyroid goiter- 75-200 mcg/day.
IN complex therapy of thyrotoxicosis- 50-100 mcg/day.
For suppressive therapy for thyroid cancer- 50-300 mcg/day.
At performing a thyroid suppression test use the following dosage regimen:
For hypothyroidism, Eutirox ® is usually taken throughout life. For thyrotoxicosis, Euthyrox ® is used in complex therapy with thyreostatics after achieving a euthyroid state. In all cases, the duration of treatment with the drug is determined individually.
Side effect
When Eutirox is used correctly under medical supervision, no side effects are observed.
If you are hypersensitive to the drug, allergic reactions may occur.
Contraindications to the use of the drug
- untreated thyrotoxicosis;
- untreated pituitary insufficiency;
- untreated adrenal insufficiency;
- acute myocardial infarction;
- acute myocarditis;
- acute pancarditis;
- increased individual sensitivity to the drug.
WITH caution the drug should be prescribed for ischemic heart disease (atherosclerosis, angina pectoris, history of myocardial infarction), arterial hypertension, arrhythmia, diabetes mellitus, severe long-term hypothyroidism, malabsorption syndrome (dose adjustment may be required).
Use of the drug during pregnancy and lactation
During pregnancy and breastfeeding, therapy with the drug prescribed for hypothyroidism should be continued. During pregnancy, an increase in the dose of the drug is required due to an increase in the level of thyroxine-binding globulin. The amount of thyroid hormone secreted in breast milk during lactation (even when treated with high doses of the drug) is not enough to cause any problems in the child.
The use of the drug in combination with thyreostatics during pregnancy is contraindicated, because taking levothyroxine may require increasing doses of thyreostatics. Since thyreostatics, unlike levothyroxine, can cross the placenta, the fetus may develop hypothyroidism.
During breastfeeding, the drug should be taken with caution, strictly in recommended doses under medical supervision.
special instructions
In case of hypothyroidism caused by damage to the pituitary gland, it is necessary to find out whether there is simultaneous insufficiency of the adrenal cortex. In this case, glucocorticoid replacement therapy should be started before treatment of hypothyroidism with thyroid hormones is started in order to avoid the development of acute adrenal insufficiency.
Impact on the ability to drive vehicles and operate machinery
The drug does not affect professional activities related to driving vehicles and operating machinery.
Overdose
In case of drug overdose there are observed symptoms, characteristic of thyrotoxicosis: palpitations, cardiac arrhythmias, heart pain, anxiety, tremor, sleep disturbance, increased sweating, loss of appetite, weight loss, diarrhea.
Treatment: depending on the severity of symptoms, a reduction in the daily dose of the drug, a break in treatment for several days, and the prescription of beta-blockers are indicated. After side effects disappear, treatment should be started with caution at a lower dose.
Drug interactions
Levothyroxine enhances the effect of indirect anticoagulants, which may require a reduction in their dose.
The use of tricyclic antidepressants with levothyroxine may result in increased antidepressant effects.
Thyroid hormones may increase the need for insulin and oral hypoglycemic agents. More frequent monitoring of blood glucose levels is recommended during periods of initiation of treatment with levothyroxine, as well as when changing the dose of the drug.
Levothyroxine reduces the effect of cardiac glycosides.
With simultaneous use of cholestyramine, colestipol and aluminum hydroxide, they reduce the plasma concentration of levothyroxine by inhibiting its absorption in the intestine. In this regard, levothyroxine should 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 protein binding.
When used simultaneously with phenytoin, dicumarol, salicylates, clofibrate, furosemide in high doses, the content of levothyroxine not bound to proteins in the blood plasma increases.
Taking estrogen-containing medications increases thyroxine-binding globulin levels, which may increase the need for levothyroxine in some patients.
Somatotropin, when used simultaneously with levothyroxine, can accelerate the closure of epiphyseal growth plates.
Taking phenobarbital, carbamazepine and rifampicin may increase the clearance of levothyroxine and require an increase in dose.
Conditions for dispensing from pharmacies
The drug is available with a prescription.
Storage conditions and periods
The drug should be stored in a place protected from light, out of reach of children, at a temperature not exceeding 25°C. Shelf life - 3 years.
"INN: Levothyroxine sodium
Manufacturer: Merck KGaA
Anatomical-therapeutic-chemical classification: Levothyroxine sodium
Registration number in the Republic of Kazakhstan: No. RK-LS-5 No. 014665
Registration period: 08.12.2014 - 08.12.2019
Instructions
Tradename
Euthyrox®
International nonproprietary name
Levothyroxine sodium
Dosage form
Tablets 25, 50, 75, 100, 125 and 150 mcg
Cleaving
One tablet contains:
active substance - levothyroxine sodium* 0.026, 0.053, 0.079, 0.105, 0.131 and 0.158 mg.
Excipients: lactose monohydrate** (65.974 mg, 65.948 mg, 65.921 mg, 65.895 mg, 65.869 mg, 65.843 mg), corn starch 25.0 mg, gelatin 5.0 mg, croscarmellose sodium 3.5 mg, magnesium stearate 0.5 mg ,
* - for stability add 5% excess of levothyroxine sodium
** - the amount is indicated according to the dosages of 25, 50, 75, 100, 125 and 150 mcg
Description
White, round tablets, flat on both sides, with beveled edges. On both sides of the tablet there is a separating line, on one side of the tablet there is an engraving “EM 25”, “EM 50”, “EM 75”, “EM 100”, “EM 125”, “EM 150” (for each dosage).
Pharmacotherapeutic group
Drugs for the treatment of thyroid diseases. Thyroid hormones. Levothyroxine sodium.
ATX code N03AA01
Pharmacological properties
Pharmacokinetics
When taken orally, levothyroxine is absorbed primarily in the upper small intestine. Depending on the galenic composition, up to 80% of the drug is absorbed. tmax is approximately 5-6 hours.
The onset of action of the drug is observed 3-5 days after oral administration. Levothyroxine is 99.97% bound to special transport proteins. This bond is not covalent, so there is a constant and very rapid exchange of hormones bound to plasma proteins and free hormone fractions. Due to its protein binding, levothyroxine is not subject to hemodialysis or hemoperfusion. The half-life of levothyroxine is 7 days. With hyperthyroidism, the half-life is reduced to 3-4 days, and with hypothyroidism it increases to 9-10 days. The volume of distribution is about 10-12 l. The liver contains 1/3 of all extrathyroidal levothyroxine, which is subject to rapid exchange with levothyroxine in 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.
Pharmacodynamics
Synthetic levothyroxine, which is contained in the drug Euthyrox®, is identical in its action to the natural main hormone produced by the thyroid gland. It is converted to T3 in peripheral organs and, like the endogenous hormone, has a specific effect on T3 receptors. The body is unable to distinguish between endogenous and exogenous levothyroxine.
Indications for use
Eutirox® 25 - 150 mcg:
Treatment of benign euthyroid goiter
Prevention of relapse after surgical treatment of euthyroid goiter depending on postoperative hormonal status
Replacement therapy for hypothyroidism
Thyroid cancer therapy
Eutirox® 25 - 100 mcg:
Concomitant therapy in the treatment of hyperthyroidism with antithyroid drugs
Eutirox® 100/150 µg:
As a diagnostic tool when performing a thyroid suppression test
Directions for use and doses
Daily doses can be taken in one dose.
Oral administration: one daily dose in the morning on an empty stomach, 30 minutes before breakfast, preferably with a small amount of water (half a glass of water).
For infants, the daily dose is given in one dose 30 minutes before the first morning feeding. The tablets are dissolved in water, and the resulting suspension is taken with some more water. The suspension must be freshly prepared for each dose.
Levothyroxine sodium tablets are available in varying strengths from 25 to 150 mcg to treat patients based on their individual needs. Therefore, patients usually need to take only one tablet per day.
The daily dose is determined individually depending on laboratory tests and clinical examination. Because most patients have elevated T4 and FT4 concentrations, basal serum thyroid-stimulating hormone (TSH) concentrations provide a more reliable basis for determining 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 newborns and children with congenital hypothyroidism, when rapid replacement therapy is important, the initial recommended dose is 10-15 mcg/kg body weight per day for the first 3 months. The dose should then be adjusted on an individual basis depending on clinical results, TSH and thyroid hormone levels.
In elderly patients, patients with coronary artery disease, and patients with severe or long-standing hypothyroidism, treatment should be started with low doses (eg, 12.5 mcg/day) and slowly increased over long intervals (eg, dose increases every two weeks). at 12.5 mcg/day) with frequent monitoring of thyroid hormones. Therefore, in such patients, it may be possible to consider prescribing a lower dose that does not provide complete replacement therapy, which will not lead to complete correction of TSH levels.
Experience with the drug shows that a lower dosage is sufficient for patients with low weight and patients with large nodular goiter.
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Indications |
(levothyroxine sodium mcg/day) |
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Treatment of benign euthyroid goiter |
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Prevention of relapse after surgical treatment of euthyroid goiter |
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Replacement therapy for hypothyroidism in adults initial dose maintenance dose |
Adults |
100 - 150 μg/m2 body surface |
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Concomitant therapy during treatment of hyperthyroidism with antithyroid drugs |
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Suppressive therapy for thyroid cancer |
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Use for diagnostic purposes when performing a thyroid suppression test |
In 4 weeks |
In 3 weeks |
In 2 weeks |
In 1 week |
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In the case of replacement maintenance therapy for hypothyroidism, as well as after strumectomy or thyroidectomy and in the prevention of relapse after removal of euthyroid goiter, the drug is usually taken throughout life. Concomitant treatment of hyperthyroidism after achieving euthyroid status is indicated for the period during which the antithyroid drug is used.
For benign euthyroid goiter, the duration of treatment ranges from 6 months to 2 years. If treatment within this period is not sufficient, surgery or radioactive iodine treatment of the goiter should be considered.
Side effects
cardiac arrhythmia (eg, atrial fibrillation and extrasystoles), tachycardia, palpitations, angina pectoris
headache
muscle weakness and cramps
hyperemia, fever
vomiting, diarrhea
menstrual irregularities
intracranial hypertension, tremor, anxiety, sleep disturbance
excessive sweating
weight loss
hypersensitivity reactions (angioedema, etc.)
Contraindications
Hypersensitivity to the active substance or any excipient
Untreated adrenal insufficiency
Untreated pituitary insufficiency
Untreated thyrotoxicosis
Use during pregnancy in combination with antithyroid drugs
You should not start treatment with Eutirox® in case 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, Lapp lactase deficiency or glucose-galactose malabsorption.
Drug interactions
Antidiabetic drugs
Levothyroxine may reduce the effectiveness of antidiabetic medications. Therefore, it is recommended to frequently check your blood glucose levels when starting treatment with thyroid hormones. If necessary, the dose of antidiabetic agents should be adjusted.
Coumarin derivatives
Levothyroxine may enhance the effect of anticoagulant therapy because it displaces anticoagulants from plasma protein binding, which may increase the risk of bleeding, such as central nervous system or gastrointestinal hemorrhage.
intestinal bleeding, especially in elderly patients. Therefore, regular monitoring of coagulation parameters is necessary at the beginning and during concomitant therapy. If necessary, the dose of anticoagulants should be adjusted.
Protease inhibitors
Protease inhibitors, such as ritonavir, indinavir, lopinavir, may affect the effectiveness of levothyroxine. Close monitoring of thyroid hormone levels is recommended. If necessary, the dose of levothyroxine should be adjusted.
Phenytoin
Phenytoin may affect the effectiveness of levothyroxine by displacing it from plasma proteins, which may lead to increased levels of free T4 and T3. On the other hand, phenytoin increases the rate of metabolism of levothyroxine in the liver. Close monitoring of thyroid hormone levels is recommended.
Cholestyramine, colestipol
Taking ion exchange resins such as cholestyramine and colestipol inhibits the absorption of levothyroxine sodium. Therefore, levothyroxine sodium should be taken 4-5 hours before taking these medications.
Aluminum-containing preparations, iron-containing preparations, calcium carbonate
Salicylates, dicumarol, furosemide, clofibrate
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 level of the free T4 fraction.
Orlistat
When levothyroxine and orlistat are used together, hypothyroidism and/or decreased control of hypothyroidism may occur. This is possible due to decreased absorption of iodized salt and/or levothyroxine.
Sevelamer
Sevelamer may reduce the absorption of levothyroxine. Therefore, it is recommended that patients be monitored for changes in thyroid function at the beginning and end of concomitant therapy. If necessary, the dose of levothyroxine should be adjusted.
Tyrosine kinase inhibitors
Tyrosine kinase inhibitors such as imatinib, sunitinib may reduce the effectiveness of levothyroxine.
Propylthiouracil, glucocorticoids, beta-sympatholytics, amiodarone and iodinated contrast agents
These substances inhibit the peripheral conversion of T4 to T3.
Due to its high iodine content, amiodarone can initiate both hyperthyroidism and hypothyroidism. Particular attention should be paid to nodular goiter with possible unrecognized functional autonomy.
Sertraline, chloroquine/proguanil
These substances reduce the effectiveness of levothyroxine and increase serum TSH levels.
Drugs with enzyme-inducing effects
Drugs with enzyme-inducing effects, such as barbiturates or carbamazepine, may increase the hepatic clearance of levothyroxine.
Estrogens
In women using estrogen-containing contraceptives or in postmenopausal women receiving hormone replacement therapy, the need for levothyroxine may be increased.
Consumption of soy-containing products may reduce the intestinal absorption of levothyroxine. Therefore, a dose adjustment of Eutirox® may be required, especially at the beginning or after stopping the consumption of products containing soy.
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: coronary insufficiency, angina pectoris, arteriosclerosis, hypertension, pituitary insufficiency and adrenal insufficiency. Also, before starting thyroid hormone therapy, functional autonomy of the thyroid gland should be excluded or treated.
When initiating treatment with levothyroxine in patients at risk of mental disorders, it is recommended to begin therapy with small doses of levothyroxine with a gradual increase in the dose during the initial stage of therapy. It is recommended to monitor melon patients. If mental disturbances occur, the dose of levothyroxine should be adjusted.
It is necessary to exclude the possibility of even minor drug-induced hypothyroidism in patients with coronary insufficiency, heart failure or tachyarrhythmias. Therefore, in these cases, regular monitoring of thyroid hormone levels is necessary.
Before starting replacement therapy, it is necessary to determine the cause of secondary hypothyroidism, since thyroid-stimulating hormone deficiency in secondary hypothyroidism rarely occurs in isolation. If concomitant pathology is confirmed, treatment with Eutirox® should be started only after compensation for adrenal insufficiency.
If the development of functional autonomy of the thyroid gland is suspected, it is recommended to perform a stimulation test with thyrotropin-releasing hormone (TRH test) or suppressive scintigraphy before starting therapy.
Postmenopausal women with hypothyroidism and an increased risk of osteoporosis should avoid increasing the physiological concentration of levothyroxine in the blood serum. In this case, careful monitoring of thyroid function is recommended.
Thyroid hormones are not intended for weight loss. Physiological doses do not lead to weight loss in euthyroid patients. Supraphysiological doses may cause serious or even life-threatening adverse effects (see overdose section).
From the moment of initiation of levothyroxine therapy, if switching from one drug to another, it is recommended to adjust the dose depending on the patient's clinical response to therapy and laboratory results.
When levothyroxine and orlistat are used together (see drug interactions), hypothyroidism and/or decreased control of hypothyroidism may occur. Patients taking levothyroxine should consult their physician before starting, stopping, or changing their treatment regimen with orlistat. Orlistat and levothyroxine should be taken at different times and the dose of levothyroxine should be adjusted if necessary. In the future, it is necessary 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 problems such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
Information for patients with diabetes mellitus and patients undergoing anticoagulant therapy is presented in the drug interactions section.
Pregnancy and lactation
During pregnancy and especially during lactation, levothyroxine should be continued. During pregnancy, you may even need to increase the dose. 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 the drug in combination with antithyroid drugs during pregnancy is contraindicated, since taking levothyroxine sodium may require an increase in doses of antithyroid drugs. Since antithyroid drugs, unlike levothyroxine sodium, can cross the placenta, the fetus may develop hypothyroidism.
Levothyroxine is secreted into breast milk during lactation, but the concentrations of Eutirox® when taking recommended therapeutic doses are insufficient to cause the development of hyperthyroidism or suppression of TSH secretion in the infant.
Features of the effect of the drug on the ability to drive a vehicle or potentially dangerous mechanisms.
Studies of the effect of the drug on the ability to drive vehicles and machines have not been conducted. However, since levothyroxine sodium is identical to natural thyroid hormone, no effect on the ability to drive vehicles or use machinery is expected.
Overdose
In case of an overdose of the drug, a significant increase in metabolic rate is observed.
Clinical signs of hyperthyroidism may occur in case of overdose or exceeding the individual threshold of tolerance of levothyroxine sodium, especially if the dose is increased too quickly at the beginning of therapy. If such symptoms appear, you should reduce the daily dose or stop taking the drug for several days. After side effects disappear, treatment should be resumed with caution.
Symptoms: increased heart rate (tachycardia), restlessness, agitation, or unintentional movements (hyperkinesis). Cases of sudden cardiac arrest have been reported in patients who have taken excessively high doses of levothyroxine sodium for many years.
In patients predisposed to disorders, isolated cases of seizures developing when the individual tolerance threshold was exceeded.
An overdose of levothyroxine may present with symptoms of hypothyroidism and may lead to acute psychosis, especially in patients at risk of psychiatric disorders.
Treatment: elevated T3 levels are an indicator of overdose. Depending on the degree of overdose, it is recommended to suspend treatment with Eutirox® and conduct a laboratory examination. Beta blockers may be prescribed. When taking extremely high doses, plasmapheresis may be prescribed.
Release form and packaging
Some facts about the product:
Price in online pharmacy website: from 125
Pharmacological properties
The drug Eutirox is a synthetic drug whose action is aimed at combating diseases of the thyroid gland. The drug has a positive effect on tissues and metabolism, is able to stimulate protein synthesis in the body, increases the need to supply tissues with oxygen, stimulates the metabolism of proteins, fats and carbohydrates in the body, promotes active activity of the heart and blood vessels and the functioning of the nervous system. With increased dosages, the drug can reduce the production of thyroid-stimulating hormone.
With constant use and compliance with dosage recommendations prescribed by your doctor, the positive therapeutic effect appears within a week. After stopping the medication, its therapeutic effect continues to operate for another 7-12 days.
Composition and release form
The drug Eutirox is available in the form of tablets, which are sold in packs of 25 pieces. Instructions for use are included. The drug contains the following components:
Indications for use
The drug Eutirox is prescribed to patients with:
In addition, the medicine is used to prevent the re-formation of goiter and to diagnose diseases of the endocrine system.
International Classification of Diseases (ICD-10)
Side effects
Taking Eutirox does not cause side symptoms. Failure to comply with the recommendations of the attending physician and hypersensitivity to the components of the drug may result in allergies or signs of intoxication of the body.
Contraindications
The medication should not be taken if the patient has the following health problems:
Use during pregnancy
The drug can be taken by patients who are pregnant or breastfeeding. Moreover, it is recommended to increase the dosage of the medication during pregnancy, as the concentration of TSH in the body increases. If you follow the recommendations prescribed by your doctor, there is no negative impact on the development of the fetus. An overdose of the drug may have a negative effect on the fetus developing in the womb.
The drug Eutirox should not be prescribed during pregnancy when taken simultaneously with thyreostatic drugs, since the components of the latter tend to penetrate the placenta and can cause a decrease in the function of the thyroid gland and insufficient production of hormones in the fetus. It is recommended to stop breastfeeding for the duration of therapy or to do so only if absolutely necessary and under the supervision of the attending physician.
Method and features of application
The drug Eutirox is intended for internal oral administration. The recommended dosage, as well as the duration of therapy, are determined by the attending physician after conducting an examination, collecting tests, establishing the exact clinical picture of the disease and taking into account the individual characteristics of the patient. The tablets must be taken in the morning, before meals. The tablets should not be chewed, cut, broken or crushed; they should be swallowed whole with plenty of water. Children under three years of age should be prescribed the drug thirty minutes before the first feeding. Children are given the tablet in dissolved form. The instructions contain detailed information on recommended dosages and duration of therapy.
Alcohol compatibility
The drug Eutirox cannot be combined with drinking alcohol-containing drinks, as this can reduce the pharmacological properties of the drug and also place increased stress on the functioning of internal organs.
Interaction with other drugs
The drug Eutirox cannot be taken simultaneously with a number of other drugs, as this can change the pharmacokinetic and pharmacodynamic properties on both sides. Increased pharmacological effects of drugs: tricyclics. Reducing the effects of medications: cardiac glycosides; antidiabetic drugs. Reduced effectiveness of Eutirox:
Overdose
An overdose of Eutirox can cause intoxication of the body, which is expressed in the manifestation of a number of symptomatic signs:
Analogs
The drug Eutirox has several analogues in terms of pharmacological effects and composition:
Terms of sale
The drug Eutirox is sold in pharmacies as prescribed by the attending physician and with a prescription from a medical institution.
Storage conditions
It is recommended to store the medication out of reach of children and away from any light sources at a temperature not exceeding 25 °C. The shelf life of the medicine is three years from the date of manufacture. After the expiration date, the medication cannot be used and must be disposed of in accordance with sanitary standards. The instructions contain detailed information about storage rules and regulations.
"Eutirox" is a synthetic analogue of thyroxine, a thyroid hormone, used to treat hypothyroidism. Due to the hormonal effect, if the dosage is exceeded, there is a risk of getting an overdose of Eutirox with unpleasant consequences for the body.
Description of the drug
The drug "Eutirox" is available in the form of tablets, each of which contains from 25 to 150 mg of the active substance - levothyroxine sodium, which is a synthetic analogue of the thyroid hormone, as well as additional components. Recommended doses of Eutirox vary depending on the expected therapeutic effect:
- a high dosage is prescribed to reduce the concentration of the hormone produced by the pituitary gland;
- medium – increases the activity of the nervous and cardiovascular systems, regulates growth processes and improves tissue respiration;
- a low dose of Eutirox is prescribed to stimulate protein and lipid metabolism.
Only a doctor can select the dosage and determine the period of treatment, depending on the individual characteristics of the patient’s body and the nature of the course of the disease.
The human body absorbs the drug well. Reviews about the drug are positive: a noticeable therapeutic effect (if used regularly) is achieved within 3-14 days, depending on the disease, and patients observe persistent improvements in serious pathologies several months after starting to take the drug. After stopping the pills, they stop working after one to two weeks.
Indications for use
"Eutirox", acting as natural thyroxine, affects the replenishment of thyroid hormones in various pathological conditions. Indications for use of the drug are a number of functional disorders of the endocrine system, including:
- long-term deficiency of thyroid hormones (Eutirox is mainly prescribed for hypothyroidism);
- chronic negative effect of antibodies produced by the human body itself (autoimmune diseases);
- an increase in the volume and weight of the gland without disrupting its functions;
- recovery after surgical interventions (including surgical treatment of cancer);
- delayed mental and physical development, which is caused by hormonal reasons (cretinism);
- increased tissue metabolism and pathological activity of the nervous system;
- concomitant diseases that are treated with drugs that block the functioning of the thyroid gland.
"Eutirox", the indications for use of which are quite extensive, is almost a universal drug that treats pathologies of the endocrine system and is used as part of complex therapy for autoimmune diseases and some conditions of the cardiovascular and nervous systems. It is sometimes necessary to start using the drug during the recovery period after surgery, for preventive and diagnostic purposes (thyroid function test).
How to correctly calculate the dose and how to take the drug in each specific case? The answer to this question can only be given by the attending physician, based on the results of a comprehensive diagnosis of the patient’s condition. How long the course of treatment will last and whether there are contraindications is also decided by the specialist - some patients take the drug throughout their lives, while others only need a certain course.
Side effects of Eutirox
Unpleasant side effects can occur, first of all, if the required dose of Eutirox is incorrectly selected.
Side effects also appear in case of increased individual sensitivity to one of the elements in the composition of the drug (allergic reaction), non-compliance with the dosage regimen, or interaction with certain other drugs.
If the dosage is not high enough, the side effects of the medication are manifested by symptoms of hypothyroidism:
- weakening of concentration and memory, decreased ability to work;
- drowsiness, fatigue and slowness;
- disorders of the digestive system, constipation and nausea;
- swelling of the face, mucous membranes of the nose and auditory tube (as a result, a decrease in hearing and visual acuity occurs).
A patient taking too much dosage may experience the following:
- pain in the heart and sternum;
- disturbances in the frequency and rhythm of contractions of the heart muscle;
- restlessness, sweating, insomnia, increased anxiety;
- convulsions and idiopathic tremor (trembling of the trunk or limbs of unknown origin);
- loss of appetite, weight loss, digestive disorders such as diarrhea and vomiting;
- menstrual cycle disorders in women.
Usually the body reacts quickly to an incorrect dosage, which allows you to change the course of therapy in time. Any negative consequences of taking the drug require repeated consultation with a specialist to adjust the treatment regimen and dosage of the drug.
Contraindications to taking the medicine
The main contraindications are hypersensitivity to the components of the drug, untreated hypothyroidism, thyrotoxicosis and adrenal insufficiency, acute inflammation of the membranes of the heart or cardiac muscle, as well as myocardial infarction.
Pregnancy and lactation are not a serious limitation: if a woman starts using Eutirox before pregnancy, she can continue taking the drug while she is expecting a child.
You should take the tablets with caution if you have diabetes, arrhythmia, high blood pressure or coronary heart disease. The use of Eutirox in acceptable doses is approved for the treatment of congenital hypothyroidism in children from birth.
Drug overdose
"Eutirox" is a hormonal drug, therefore, taken in an excessive dosage, it causes a state of hyperfunction of the thyroid gland. The human body usually reacts to hyperthyroidism as follows:
In addition, with hyperthyroidism, which is caused by an overdose of Eutirox, metabolic processes are disrupted. This provokes weight loss, frequent urination, hair loss, and thinning of the skin or nails.
An incorrectly selected period of treatment and an excessive dosage (or too rapid an increase) threaten to compress the optic nerve, which can result in complete loss of vision.
Instructions for use
Eutirox instructions for use
Dosage form
The tablets are white, round, flat on both sides, with beveled edges and embossed characters (on one side - “EM 25”, on the other - a cross-shaped line).
Compound
levothyroxine sodium 50 mcg
Excipients: lactose monohydrate, corn starch, gelatin, croscarmellose sodium, magnesium stearate
Pharmacodynamics
Thyroid hormone preparation. Synthetic levorotatory isomer of thyroxine. After partial conversion into triiodothyronine (in the liver and kidneys) and passage 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 tissue oxygen demand, stimulates the metabolism of proteins, fats and carbohydrates, and increases the functional activity of the cardiovascular system and 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 discontinuation of the drug. The clinical effect of hypothyroidism appears after 3-5. Diffuse goiter decreases or disappears within 3-6 months.
Pharmacokinetics
When taken orally, levothyroxine is absorbed almost exclusively in the upper small intestine. Up to 80% of the dose taken is absorbed. Eating reduces the absorption of levothyroxine.
Cmax in serum is achieved approximately 5-6 hours after oral administration.
More than 99% of the absorbed drug is bound to serum proteins (thyroxine-binding globulin, thyroxine-binding prealbumin and albumin).
In various tissues, approximately 80% of levothyroxine is monodeiodinated to form triiodothyronine (T3) and inactive products. Thyroid hormones are metabolized mainly 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 in urine and bile. T1/2 is 6-7 days.
With thiotoxicosis, T1/2 is shortened to 3-4, and with hypothyroidism it is lengthened to 9-10
Side effects
When Eutirox is used correctly under medical supervision, no side effects are observed.
If you are hypersensitive to the drug, allergic reactions may occur.
Selling Features
prescription
Special conditions
In case of hypothyroidism caused by damage to the pituitary gland, it is necessary to find out whether there is simultaneous insufficiency of the adrenal cortex. In this case, glucocorticoid replacement therapy should be started before treatment of hypothyroidism with thyroid hormones is started in order to avoid the development of acute adrenal insufficiency.
Impact on the ability to drive vehicles and operate machinery
The drug does not affect professional activities related to driving vehicles and operating machinery.
Indications
euthyroid goiter;
Hypothyroidism;
After resection of the thyroid gland as replacement therapy and to prevent goiter recurrence;
Thyroid cancer (after surgical treatment);
Diffuse toxic goiter after achieving a euthyroid state with thyreostatics (as combination therapy or monotherapy);
As a diagnostic tool when performing a thyroid suppression test.
Contraindications
Untreated thyrotoxicosis;
Untreated pituitary insufficiency;
Untreated adrenal insufficiency;
Acute myocardial infarction;
Acute myocarditis;
Acute pancarditis;
Increased individual sensitivity to the drug.
The drug should be prescribed with caution in case of coronary artery disease (atherosclerosis, angina pectoris, history of myocardial infarction), arterial hypertension, arrhythmia, diabetes mellitus, severe long-term hypothyroidism, malabsorption syndrome (dose adjustment may be required).
Drug interactions
Levothyroxine enhances the effect of indirect anticoagulants, which may require a reduction in their dose.
The use of tricyclic antidepressants with levothyroxine may result in increased antidepressant effects.
Thyroid hormones may increase the need for insulin and oral hypoglycemic agents. More frequent monitoring of blood glucose levels is recommended during periods of initiation of treatment with levothyroxine, as well as when changing the dose of the drug.
Levothyroxine reduces the effect of cardiac glycosides.
With simultaneous use of cholestyramine, colestipol and aluminum hydroxide, they reduce the plasma concentration of levothyroxine by inhibiting its absorption in the intestine. In this regard, levothyroxine should 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 protein binding.
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Dosage
The daily dose is determined individually depending on the indications.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 mcg/kg body weight; in patients over 55 years of age or with concomitant cardiovascular diseases - 0.9 mcg/kg body weight.
In case of significant obesity, the dose calculation should be made for the “ideal weight”.
For replacement therapy for hypothyroidism, the initial dose for patients under 55 years of age (in the absence of cardiovascular diseases) is 75-100 mcg/for women, for men - 100-150 mcg/ For patients over 55 years of age or with concomitant cardiovascular diseases diseases, the initial dose is 25 mcg/; the dose should be increased by 25 mcg at intervals of 2 months until the TSH level in the blood normalizes; If symptoms from the cardiovascular system appear or worsen, adjust appropriate therapy.
In case of severe long-term hypothyroidism, treatment should be started with extreme caution with small doses - 12.5 mcg / dose, increased to maintenance at longer intervals - by 12.5 mcg / every 2 weeks - and the TSH level in the blood is determined more often.
When treating congenital hypothyroidism in children, the dose of the drug depends on age.
Age Daily dose of levothyroxine (mcg) Dose of levothyroxine per body weight (mcg/kg)
0-6 months 25-50 10-15
6-12 months 50-75 6-8
1-5 years 75-100 5-6
For infants, the daily dose of Eutirox is given in one dose, 30 minutes before the first feeding. The tablet is dissolved in water to a thin suspension immediately before taking the drug.
When treating euthyroid goiter, 75-200 mcg/day is prescribed.
To prevent relapse after surgical treatment of euthyroid goiter - 75-200 mcg/
In complex therapy of thyrotoxicosis - 50-100 mcg/
For suppressive therapy of thyroid cancer - 50-300 mcg/
When performing a thyroid suppression test, use the following dosage regimen:
Doses of Euthyrox
4 weeks before the test 3 weeks before the test 2 weeks before the test 1 week before the test
75 mcg 75 mcg 150-200 mcg 150-200 mcg
For hypothyroidism, Eutirox® is usually taken throughout life. For thyrotoxicosis, Euthyrox® is used in complex therapy with thyreostatics after achieving a euthyroid state.
