L-Tyroxin 50 tablets Berlin-Chemie 50mkg, No. 50

• Hypothyroidism (hypothyroidism) of any genesis: primary and secondary hypothyroidism, after surgery for struma, as a result of radioactive iodine therapy (as replacement therapy).

• Prevention of recurrence (re-formation) of nodular goiter after surgery for goiter with normal thyroid function.

• Diffuse goiter with normal function.

• As part of combination therapy for the treatment of hyperfunction of the thyroid gland with thyreostatics after reaching its normal function.

• Malignant tumor of the thyroid gland, mainly after surgery to suppress tumor recurrence and as replacement therapy.

Inside, on an empty stomach, at least 30 minutes before breakfast. The daily dose of the drug is set and controlled individually on the basis of laboratory and clinical examination data.

Experience has shown that with a small body weight and in the presence of a large nodular struma, a low dose is sufficient.

Unless otherwise prescribed, the following dosage recommendations apply:

with hypofunction of the thyroid gland, the initial daily dose, for adults - 25-100 mcg, then the dose is increased as prescribed by the doctor every 2-4 weeks by 25-50 mcg until a maintenance daily dose of 125-250 mcg is reached; children - 12.5-50 mcg, with a long course of treatment, the dose is determined by the body weight and height of the child (based on an approximate calculation of 100 to 150 mcg of sodium levothyroxine per 1 m2 of body surface);

to prevent recurrence of goiter and with diffuse goiter in adults - 75-200 mcg / day;

as part of combination therapy for the treatment of hyperfunction of the thyroid gland with thyreostatics - 50Ц100 mcg / day;

in the treatment of malignant tumors, the daily dose is 150Ц300 mcg.

Estimated maintenance daily dose of levothyroxine sodium

The daily dose of the drug is set individually, depending on the indications.

During pregnancy, the need for thyroid hormones increases, therefore, it is necessary to inform the doctor about the existing or occurring pregnancy during the course of treatment so that, if necessary, the dose of the drug can be adjusted.

The tablets are white or white with a slightly yellowish tinge, round, slightly convex, with a line on one side and embossing '50' on the other.

1 tab.

levothyroxine sodium 50 mcg

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

• Increased individual sensitivity to the drug,

• acute myocardial infarction,

• untreated adrenal cortex insufficiency,

• hyperfunction of the thyroid gland.

  With care: in case of 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 is possible).

pharmachologic effect

Synthetic preparation of thyroid hormone, 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 high doses, it inhibits the production of TSHR of the hypothalamus and TSH 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

Suction

After oral administration, levothyroxine is absorbed almost exclusively from the upper small intestine. Up to 80% of the dose taken is absorbed. Simultaneous food intake reduces the absorption of levothyroxine. Cmax in serum is reached approximately 5-6 hours after oral administration.

Distribution

Binds to serum proteins (thyroxine-binding globulin, thyroxine-binding prealbumin and albumin) by more than 99%. In various tissues, monodeiodination of approximately 80% of levothyroxine occurs with the formation of triiodothyronine (T3) and inactive products.

Metabolism

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).

Withdrawal

Metabolites are excreted in the urine and bile.

T1 / 2 is 6-7 days.

Pharmacokinetics in special clinical situations

With thyrotoxicosis, T1 / 2 is shortened to 3-4 days, and with hypothyroidism it is extended to 9-10 days.

Side effect

When using the drug according to indications in recommended doses under the supervision of a physician, side effects are not observed.

With hypersensitivity to the drug, allergic reactions may occur.

Application during pregnancy and lactation

During pregnancy and lactation (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 thyrostatic drugs during pregnancy is contraindicated, because taking levothyroxine may require an increase in thyreostatics doses. Since thyrostatics, unlike levothyroxine, can penetrate the placental barrier, hypothyroidism may develop in the fetus.

During breastfeeding, the drug should be taken with caution, strictly in recommended doses under medical supervision.

Application in children

In children, the initial daily dose is 12.5-50 mcg. With a long course of treatment, the dose of the drug is determined from an approximate calculation of 100-150 ?g / m2 of body surface area.

For infants and children under 3 years of age, the daily dose of L-Tyroxin Berlin-Chemie 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.

Use in elderly patients

With extreme caution and under regular medical supervision, the drug should be prescribed to elderly patients.

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, GCS replacement therapy should be started before starting treatment for hypothyroidism with thyroid hormones in order to avoid the development of acute adrenal insufficiency.

Influence on the ability to drive vehicles and mechanisms

The drug does not affect the ability to drive vehicles and work that requires increased concentration.

Overdose

Symptoms characteristic of thyrotoxicosis: palpitations, heart rhythm disturbances, heart pain, anxiety, tremors, sleep disturbances, excessive sweating, decreased appetite, weight loss, diarrhea.

Treatment: a decrease in the daily dose of the drug, a break in treatment for several days, the appointment of beta-blockers may be recommended. After the disappearance of side effects, treatment should be started with caution with a lower dose. Antithyroid drugs are not recommended.

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 increase the effect of antidepressants.

Thyroid hormones may increase the need for insulin and oral hypoglycemic drugs. More frequent monitoring of blood glucose levels is recommended during the periods of initiation of treatment with levothyroxine, as well as when the dose of the drug is changed.

Levothyroxine reduces the action of cardiac glycosides. With the simultaneous use of colestyramine, colestipol and aluminum hydroxide, the plasma concentration of levothyroxine is reduced by inhibiting its absorption in the intestine.

With simultaneous use with anabolic steroids, asparaginase, tamoxifen, 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 and T4, unbound to plasma proteins, increases.

Growth hormone, when used simultaneously with levothyroxine, can accelerate the closure of the epiphyseal growth zones.

Taking phenobarbital, carbamazepine and rifampicin may increase the clearance of levothyroxine and require an increase in the dose.

Estrogens increase the concentration of the thyroglobulin-related fraction, which can lead to a decrease in the effectiveness of the drug.

Amiodarone, aminoglutethimide, PASK, ethionamide, antithyroid drugs, beta-blockers, carbamazepine, chloral hydrate, diazepam, levodopa, dopamine, metoclopramide, lovastatin, somatostatin affect the synthesis, secretion, distribution and metabolism of the drug.