EUTIROX PILLS 112MKG

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 surgical treatment);

- diffuse toxic goiter after reaching the euthyroid state of thyreostatics (as a combination therapy or monotherapy);

- as a diagnostic tool when conducting a thyroid suppression test.

Dosage and administration

The daily dose is determined individually depending on the evidence.

Eutirox® in a daily dose taken orally in the morning on an empty stomach, at least 30 minutes before a meal, drinking a pill with a small amount of liquid (half a glass of water) and not chewing.

When conducting hypothyroidism replacement therapy at patients under the age of 55 in the absence of cardiovascular diseases Eutirox ® prescribed in a daily dose of 1.6-1.8 mg / kg of body weight; at patients over the age of 55 or with concomitant cardiovascular diseases - 0.9 mcg / kg body weight.

At hypothyroidism replacement therapy initial dose for patients under the age of 55 years (in the absence of cardiovascular diseases) for women it is 75-100 mcg / day, for men - 100-150 mcg / day. For patients older than 55 years or with concomitant cardiovascular diseases the initial dose is 25 mcg / day; increase the dose should be 25 mcg with an interval of 2 months to normalize the level of TSH in the blood; If the symptoms of the cardiovascular system appear or worsen, it is necessary to correct the treatment of cardiovascular diseases.

At severe long-existing hypothyroidism treatment should begin with extreme caution with small doses - 12.5 mg / day. The dose is increased to maintenance at longer intervals - at 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 doses of the drug depend on age.

Breast children and children under 3 years old daily dose of eutirox® give 1 reception for 30 minutes before the first feeding. The pill is dissolved in water to a thin suspension immediately before taking the drug.

At treatment of euthyroid goiter appoint 75-200 mcg / day.

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

AT complex therapy of thyrotoxicosis - 50-100 mcg / day.

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

At performing a thyroid suppression test use the following dosing regimen of the drug:

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

Adverse effects

With proper use of the drug Eutirox® under the supervision of a physician, no side effects are observed.

In case of hypersensitivity to the drug, allergic reactions may occur.

Contraindications

- increased individual sensitivity to the drug;

- untreated thyrotoxicosis;

- Untreated pituitary insufficiency;

- Untreated adrenal insufficiency;

- use during pregnancy in combination with antithyroid agents.

Treatment should not be started 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 formulation).

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

Use during pregnancy and lactation

During pregnancy and during breastfeeding, therapy with a drug prescribed for hypothyroidism should continue. During pregnancy, you may need to increase the dose of the drug due to increased levels of thyroxin-binding globulin.

There is no evidence of 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 during pregnancy in combination with thyreostatics is contraindicated, because taking levothyroxine sodium may require an increase in thyrostatic doses. Since thyreostatics, unlike levothyroxine sodium, can penetrate the placental barrier, hypothyroidism can develop in the fetus.

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

Use in children

At treatment of congenital hypothyroidism at children doses of the drug depend on age.

Use in elderly patients

When conducting hypothyroidism replacement therapy at patients under the age of 55 in the absence of cardiovascular diseases, Eutirox is prescribed in a daily dose of 1.6–1.8 mcg / kg of body weight; at patients over the age of 55 or with concomitant cardiovascular diseases - 0.9 mcg / kg body weight.

At hypothyroidism replacement therapy initial dose for patients under the age of 55 years (in the absence of cardiovascular diseases) for women it is 75-100 mcg / day, for men - 100-150 mcg / day. For patients older than 55 years or with concomitant cardiovascular diseases the initial dose is 25 mcg / day; increase the dose should be 25 mcg with an interval of 2 months to normalize the level of TSH in the blood; when symptoms or deterioration of the cardiovascular system occur, correct the appropriate therapy.

Special notes

Prior to the initiation of thyroid hormone replacement therapy or before performing the 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 or adrenal insufficiency. Also, prior to the initiation of therapy with thyroid hormones, one 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 thyroid hormone concentrations is necessary.

Before the replacement therapy with thyroid hormones, it is necessary to determine the etiology of secondary hypothyroidism. If necessary, substitution therapy should be initiated to compensate for adrenal insufficiency.

If you suspect the development of functional autonomy of the thyroid gland prior to treatment, 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 serum levothyroxine sodium in excess of physiological concentrations in serum. 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 of antithyroid drugs during the treatment of hyperthyroidism.

Since the start of levothyroxine sodium therapy 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 research.

Influence on ability to drive motor transport and control mechanisms

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

Overdose

With an overdose of the drug, a significant increase in metabolic rate is observed.Clinical signs of hyperthyroidism may occur in case of overdose, if the individual tolerance threshold of levothyroxine sodium is exceeded, or if the dose of the drug since the start of therapy rises too quickly.

Symptomscharacteristic of hyperthyroidism: cardiac arrhythmias, tachycardia, palpitations, angina pectoris, headache, muscle weakness and muscle cramps, hyperemia (especially facial skin), fever, vomiting, menstrual disorder, benign intracranial skull hypertension, tremor, anxiety, insomnia, benign intracranial cranial hypertension, tremor, anxiety, insomnia, benign intracranial cranial hypertension, tremor, anxiety, insomnia, benign intracranial cranial hypertension, tremor, anxiety, insomnia, benign intracranial cranial hypertension, tremor, anxiety, rash, benign lesion, benign intracranial hypertension, tremor, menstrual disorders excessive sweating, weight loss, diarrhea. Cases of sudden cardiac arrest have been reported 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 tolerance threshold was exceeded.

Treatment: depending on the severity of symptoms, a decrease in the daily dose of the drug, 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 begin with caution with a lower dose.

Drug interaction

The use of tricyclic antidepressants with levothyroxine sodium can lead to an increased effect of antidepressants.

Levothyroxine sodium reduces the action of cardiac glycosides.

With simultaneous use of colestyramine and colestipol (ion exchange resin), as well as aluminum hydroxide, the plasma concentration of levothyroxine sodium is reduced due to inhibition of its absorption in the intestine. In this regard, levothyroxine sodium should be applied for 4-5 hours before taking these drugs.

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

Protease inhibitors (eg, ritonavir, indinavir, lopinavir) may influence the effectiveness of levothyroxine sodium. Thorough monitoring of thyroid hormone concentrations is recommended. If necessary, adjust the dose of levothyroxine sodium.

Phenytoin may affect the effectiveness of levothyroxine sodium due to the displacement of levothyroxine sodium from its association with plasma proteins, which may 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. Thorough monitoring of thyroid hormone concentrations is recommended.

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

Levothyroxine sodium may enhance the effect of anticoagulants (coumarin derivatives) by displacing them from their association with
plasma proteins, which may increase the risk of bleeding, for example, hemorrhages in the CNS or Gastrointestinal bleeding , especially in elderly patients. Therefore, regular monitoring of coagulation parameters is necessary both at the beginning and during the combination therapy with these drugs. If necessary, the dose of anticoagulant should be adjusted.

Salicylates, dicumarol, Furosemide in high doses (250 mg), clofibrate and other drugs can displace levothyroxine sodium from the association with plasma proteins, which leads to an increase in the concentration of the fraction of free T4.

Sevelamer may decrease absorption of levothyroxine sodium. Tyrosine kinase inhibitors (for example, 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 has been described in the literature as potentially reducing the efficacy of levothyroxine sodium. Therefore, it is recommended to take levothyroxine sodium at least 2 hours before the use of such drugs.

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

Propylthiouracil, GCS, beta-sympatholytics, iodine-containing contrast agents, Amiodarone inhibit peripheral T conversion4 in 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 the nodular goiter with the possible development of unrecognized functional autonomy.

Sertralin, chloroquine / proguanil reduce the effectiveness of levothyroxine sodium and increase serum TSH levels.

Drugs that promote the induction of hepatic enzymes (for example, barbiturates, carbamazepine) may contribute to the hepatic clearance of levothyroxine sodium.

In women who use estrogen-containing contraceptives, or in postmenopausal women who receive hormone replacement therapy, the need for levothyroxine sodium may increase.

Consumption of co-containing foods may reduce intestinal absorption of levothyroxine sodium. Therefore, dose adjustment may be necessary, especially at the beginning or after cessation of the use of products containing soy.

Terms and conditions of storage

The drug should be stored out of the reach of children, protected from light at a temperature not higher than 25 ° C.