L-Thyroxin 100 Berlin Chemi table No. 100
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Active ingredient: sodium levothyroxine 100 mg.
Excipients: hydrous calcium phosphate; MCC; carboxymethyl starch sodium salt (type A); dextrin; long-chain partial glycerides.
Synthetic preparation of thyroid hormone, 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, 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.
Indications for use
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.
- Increased individual sensitivity to the drug;
- untreated thyrotoxicosis;
- acute myocardial infarction;
- acute myocarditis;
- untreated adrenal insufficiency.
Care should be taken to prescribe the drug for coronary artery disease (atherosclerosis, angina pectoris, a history of myocardial infarction), arterial hypertension, arrhythmias, diabetes mellitus, severe long-term hypothyroidism, malabsorption syndrome (dose adjustment may be required).
Pregnancy and lactation use
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 thyroxin-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 baby.
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.
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 control mechanisms
The drug has no effect on the ability to drive vehicles and work that requires increased concentration.
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 can 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 decreases by inhibiting its absorption in the intestine.
When used simultaneously with anabolic steroids, asparaginase, tamoxifen, pharmacokinetic interaction is possible at the level of protein binding.
When used simultaneously 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 a dose increase.
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.
Symptoms typical for 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.
Method of administration and dosage
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 low body weight and in the presence of a large nodular struma, a low dose is sufficient.
Unless otherwise indicated, 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 child's body weight and height (based on an approximate calculation of 100 to 150 mcg sodium levothyroxine per 1 m 2 body surface);
to prevent recurrence of goiter and with diffuse goiter in adults - 75-200 mcg / day;
as part of combination therapy in the treatment of hyperfunction of the thyroid gland with thyreostatics - 50-100 mcg / day;
in the treatment of malignant tumors, the daily dose is 150-300 mcg.
Allergic reactions (skin rash, itchy skin).
When used in excessively high doses, hyperthyroidism (changes in appetite, dysmenorrhea, chest pain, diarrhea, tachycardia, arrhythmia, fever, tremors, headache, irritability, muscle cramps in the lower extremities, nervousness, sweating, difficulty falling asleep, vomiting , weight loss).
When used in insufficiently effective doses, hypothyroidism (dysmenorrhea, constipation, dryness, puffiness of the skin, headache, lethargy, myalgia, drowsiness, weakness, apathy, weight gain).
Store at a temperature not exceeding 25 ° C.
Keep out of the reach of children.
Shelf life 3 years.
- Dosage form
- 100 mcg
- Levothyroxine sodium
- Number of tablets
- INN Russian
- Левотироксин натрия
- Russian title