Euthyrox 25 mcg tablets 100, L-Thyroxine
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Active substance: levothyroxine sodium 25 μg.
Excipients: corn starch - 25.00 mg, gelatin - 5.00 mg, croscarmellose sodium - 3.50 mg, magnesium stearate - 0.50 mg, lactose monohydrate - 65.975 mg.
The drug of thyroid hormones. 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, on metabolism. In small doses, it has an anabolic effect on protein and fat metabolism. In medium doses stimulates growth and development, increases the need for tissues in oxygen, stimulates 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 remains after discontinuation of the drug. The clinical effect of hypothyroidism is manifested after 3-5 days. Diffuse goiter decreases or disappears within 3-6 months.
Indications for use
- euthyroid goiter;
- as a replacement therapy and for the prevention of recurrence of goiter after surgical interventions on the thyroid gland;
- as suppressive and replacement therapy for malignant neoplasms of the thyroid gland, mainly after surgical treatment;
- diffuse toxic goiter: after reaching euthyroid conditions with antithyroid drugs (in the form of combined or monotherapy);
- as a diagnostic tool for the thyroid suppression test.
- 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 lactose in the composition of the drug).
Caution should be exercised the drug for coronary artery disease (atherosclerosis, angina pectoris, myocardial infarction in the anamnesis), arterial hypertension, arrhythmia, diabetes mellitus, severe long-existing hypothyroidism, malabsorption syndrome (dose adjustment may be required).
Use in pregnancy and lactation
During pregnancy and during breastfeeding, therapy with a drug prescribed for hypothyroidism should continue. During pregnancy, it may be necessary to increase the dose of the drug 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 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 thyrostatics during pregnancy is contraindicated, because taking levothyroxine sodium can require an increase in the dose of thyrostatics. Since thyrostatics, unlike levothyroxine sodium, can penetrate the placental barrier, the fetus may develop hypothyroidism.
During breastfeeding, the drug should be taken strictly in recommended doses under the supervision of a doctor. When using the drug in recommended therapeutic doses, the concentration of thyroid hormone secreted with breast milk is insufficient to cause hyperthyroidism and suppression of TSH secretion in a child.
Before starting thyroid hormone replacement therapy or before performing a thyroid suppression test, the following diseases or pathological conditions should be excluded or treated: acute coronary insufficiency, angina pectoris, atherosclerosis, arterial hypertension, pituitary insufficiency or adrenal insufficiency. Also, before starting thyroid hormone therapy, you should exclude or treat the functional autonomy of the thyroid gland.
It is necessary to exclude the possibility of even minor drug-induced 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 thyroid hormone replacement therapy, it is necessary to find out the etiology of secondary hypothyroidism. If necessary, replacement therapy should be started to compensate for adrenal insufficiency.
If the development of functional autonomy of the thyroid gland is suspected before the start of therapy, it is recommended to perform a TRG test or suppressive scintigraphy.
In postmenopausal women with diagnosed hypothyroidism and having an increased risk of osteoporosis, it is necessary to exclude the presence of exceeding physiological concentrations of levothyroxine sodium in whey. 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 treatment of hyperthyroidism with antithyroid drugs.
From the moment of initiation of therapy with levothyroxine sodium, in the case of a transition 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 research.
Influence on the ability to drive vehicles and control 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.
Usage and Dose
The daily dose is determined individually depending on the indications.
Eutirox ® in a daily dose, take it orally in the morning on an empty stomach, at least 30 minutes before meals, washing down the tablet with a small amount of liquid (half a glass of water) and not chewing.
When conducting replacement therapy for hypothyroidism in patients under the age of 55 years in the absence of cardiovascular diseases Eutirox ® prescribed in a daily dose of 1.6-1.8 μg / kg of body weight; in patients over the age of 55 years or with concomitant cardiovascular diseases - 0.9 μg / kg body weight.
With replacement therapy for hypothyroidism, the initial dose for patients under the age of 55 years (in the absence of cardiovascular diseases) is 75-100 μg / day for women, for men - 100-150 μg / day. For patients older than 55 years or with concomitant cardiovascular diseases, the initial dose is 25 μg / day; increase the dose should be 25 μg at intervals of 2 months until the level of TSH in the blood is normalized; with the appearance or worsening of symptoms from the cardiovascular system, it is necessary to correct the therapy for cardiovascular diseases.
In severe long-existing hypothyroidism, treatment should be started with extreme caution with small doses - 12.5 μg / day. The dose is increased to maintenance at longer intervals - by 12.5 μg / day every 2 weeks - and more often determine the level of TSH in the blood.
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 based on body weight (μg/ kg)|
|over 12 years old||100-200||2-3|
Infants and children under 3 years of age daily dose of Eutirox ® give in 1 reception 30 minutes before the first feeding. The tablet is dissolved in water to a thin suspension immediately before taking the drug.
In the treatment of euthyroid goiter, 75-200 μg / day is prescribed.
For the prevention of relapse after surgery treatment of euthyroid goiter - 75-200 μg / day.
In the complex therapy of thyrotoxicosis - 50-100 μg / day.
For suppressive therapy of thyroid cancer - 150-300 μg / day.
When conducting a thyroid suppression test, the following dosage regimen of the drug is used:
|Doses of Eutirox ®|
|4 weeks before the test||3 weeks before the test||2 weeks before the test||1 week before the test|
|75 μg/day||75 μg/day||150-200 μg/day||150-200 μg/day|
In hypothyroidism, Eutirox ® taken, as a rule, throughout life. With thyrotoxicosis Eutirox ® used in complex therapy with thyrostatics after reaching a euthyroid state. In all cases, the duration of treatment with the drug is determined individually.
In case of an overdose of the drug, a significant increase in the metabolic rate is observed. Clinical signs of hyperthyroidism may occur in the event of an overdose, if the individual threshold of tolerability of levothyroxine sodium is exceeded, or if the dose of the drug from the start of therapy increases too quickly.
Symptoms characteristic of hyperthyroidism: heart rhythm disturbance, tachycardia, palpitations, angina pectoris, headache, muscle weakness and muscle cramps, hyperemia (especially of the skin of the face), fever, vomiting, menstrual irregularities, benign internuriceranous hypertension, tremor, anxiety, insomnia, excessive sweating, weight loss, diarrhea. There have been reported cases of sudden cardiac arrest in patients who have taken excessively high doses of levothyroxine sodium for many years. In predisposed patients, there were isolated cases of seizures when the individual tolerability threshold was exceeded.
Treatment: depending on the severity of the symptoms, a decrease in the daily dose of the drug, a break in treatment for several days, the appointment of beta-blockers is indicated. 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.
With the correct use of the drug Eutirox ® under the supervision of a doctor, side effects are not observed.
With hypersensitivity to the drug can be observed allergic reactions.
The drug should be stored out of the reach of children, protected from light at a temperature not exceeding 25 ° C.
Do not use after the expiration date.
Shelf life -3 years.
- Merck Sharp & Dohme
- Dosage form
- 25 mcg
- levothyroxine sodium
- Number of tablets
- INN Russian
- Левотироксин натрия
- Russian title