L-Thyroxin 150 tablets Berlin-Chemie 150mkg, No. 100

L-Thyroxin 150 tablets Berlin-Chemie 150mkg, No. 100

• 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 (in the form of combined or monotherapy);

• as a diagnostic tool when performing a thyroid suppression test.

The daily dose is determined individually, depending on the indications. L-thyroxine in a daily dose is taken orally in the morning on an empty stomach, at least 30 minutes before a meal, with a pill 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, L-thyroxine is prescribed in a daily dose of 1.6-1.8 ?g / kg of body weight; in patients over 55 years old or with cardiovascular diseases - 0.9 ?g / kg body weight.

For infants and children under 3 years of age, the daily dose of L-thyroxine 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 hypothyroidism, L-thyroxine is usually taken throughout life. In case of thyrotoxicosis, L-thyroxine 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.

Tablets 1 tab.

levothyroxine sodium 125mkg; 100 mcg; 75 ?g; 50?g

Excipients: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium carboxymethyl starch (type A), dextrin, long-chain partial glycerides.

• Increased individual sensitivity to the drug;

• untreated thyrotoxicosis;

• acute myocardial infarction, acute myocarditis;

• untreated adrenal insufficiency;

• hereditary galactose intolerance, lactase deficiency or impaired absorption of glucose and lactose.

  With caution: the drug should be prescribed for diseases of the cardiovascular system: ischemic heart disease (atherosclerosis, angina pectoris, a history of myocardial infarction), arterial hypertension, arrhythmias; with diabetes mellitus, severe long-term hypothyroidism, malabsorption syndrome (dose adjustment may be required).

pharmachologic effect

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 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 is manifested after 3-5 days.Diffuse goiter decreases or disappears within 3-6 months.

Pharmacokinetics

When taken orally, levothyroxine sodium is absorbed almost exclusively in the upper part of the small intestine. Up to 80% of the taken dose of the drug is absorbed. Food intake reduces the absorption of levothyroxine sodium. Cmax is achieved approximately 5-6 hours after oral administration. After absorption, more than 99% of the drug binds to serum proteins (thyroxine-binding globulin, thyroxine-binding prealbumin and albumin). In various tissues, approximately 80% of sodium 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 by the kidneys and through the intestines.The half-life of the drug is 6-7 days. With thyrotoxicosis, the half-life is shortened to 3-4 days, and with hypothyroidism it is extended to 9-10 days.

Side effect

With the correct use of L-thyroxine under the supervision of a physician, side effects are not observed. With hypersensitivity to the drug, allergic reactions may occur. The development of other side effects is due to an overdose of the drug (see the 'Overdose' section).

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 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 disturbance in the child. The use of the drug in combination with antithyroid drugs during pregnancy is contraindicated, since taking levothyroxine sodium may require an increase in the dose of antithyroid drugs. Since antithyroid drugs, unlike levothyroxine sodium, can penetrate the placenta, the fetus may develop hypothyroidism.During the period of breastfeeding, the drug should be taken with caution, strictly in the recommended doses under the supervision of a doctor.

Application in children

Application is possible according to the dosage regimen.

Use in elderly patients

Application is possible according to the dosage regimen.

special instructions

In hypothyroidism caused by damage to the pituitary gland, it is necessary to find out whether there is simultaneously an adrenal cortex insufficiency. In this case, glucocorticosteroid replacement therapy should be started before starting treatment for hypothyroidism with thyroid hormones in order to avoid the development of acute adrenal insufficiency. It is recommended to periodically determine the concentration of thyroid-stimulating hormone (TSH) in the blood, an increase in which indicates an insufficient dose. The drug has no effect on activities related to driving vehicles and operating mechanisms.

Overdose

In case of an overdose of the drug, symptoms characteristic of thyrotoxicosis are observed: palpitations, heart rhythm disturbances, heart pain, anxiety, tremors, sleep disturbances, excessive sweating, increased appetite, weight loss, diarrhea. 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. After the disappearance of side effects, treatment should be started with caution with a lower dose.

Drug interactions

Levothyroxine sodium enhances the effect of indirect anticoagulants, which may require a reduction in their dose. The use of tricyclic antidepressants with levothyroxine sodium can lead to an increase in the effect of antidepressants. Thyroid hormones can increase the need for insulin and oral hypoglycemic drugs. More frequent monitoring of the concentration of glucose in the blood is recommended during the periods of initiation of treatment with levothyroxine sodium, as well as when changing its dosage regimen. Levothyroxine sodium reduces the action of cardiac glycosides. With the simultaneous use of cholestyramine, colestipol and aluminum hydroxide, the plasma concentration of levothyroxine sodium decreases by inhibiting its absorption in the intestine. With simultaneous use with anabolic steroids, asparaginase,tamoxifen, a pharmacokinetic interaction is possible at the level of protein binding. With simultaneous use with phenytoin, salicylates, clofibrate, furosemide in high doses, the content of levothyroxine sodium and thyroxine (T4) not associated with blood plasma proteins increases. Taking estrogen-containing drugs increases the content of thyroxine-binding globulin, which may increase the need for sodium levothyroxine in some patients. Growth hormone, when used simultaneously with sodium levothyroxine, can accelerate the closure of the epiphyseal growth zones. Taking phenobarbital, carbamazepine and rifampicin may increase the clearance of sodium levothyroxine and require an increase in the dose. The distribution and metabolism of the drug is influenced by amiodarone, aminoglutethimide, PASK, ethionamide, antithyroid drugs, beta-blockers,carbamazepine, chloral hydrate, diazepam, levodopa, dopamine, metoclopramide, lovastatin, somatostatin. With simultaneous use with phenytoin, salicylates, furosemide (in high doses), clofibrate, the concentration of the drug in the blood increases. Phenytoin reduces the amount of protein-bound levothyroxine and the concentration of T4 by 15 and 25%, respectively.

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