L-thyroxine pills 100mcg N50 Berlin-Chemie
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Active ingredients
Levothyroxine sodium
Release form
Pills
Composition
1 tablet contains: Active substance: levothyroxine sodium 100 mcg.; Excipients: calcium hydrophosphate dihydrate - 31.9 mg, microcrystalline cellulose - 32 mg, sodium carboxymethyl starch (type A) - 24 mg, dextrin - 13.6 mg, long-chain partial glycerides - 2.4 mg ;
Pharmacological effect
Synthetic preparation of thyroid hormone, levorotatory isomer thyroxine. After partial conversion to triiodothyronine (in the liver and kidneys) and transfer to the cells of the body, it affects the development and growth of tissues and metabolism. In low doses, it has an anabolic effect on protein and fat metabolism. In medium doses, it stimulates growth and development, increases the tissue's need for oxygen, stimulates the metabolism of proteins, fats and carbohydrates, and increases the functional activity of the cardiovascular system and the central nervous system. In high doses it inhibits the production of TTRG 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 discontinuation of the drug. The clinical effect in hypothyroidism appears after 3-5 days. Diffuse goiter decreases or disappears within 3-6 months.
Pharmacokinetics
After oral administration, levothyroxine is absorbed almost exclusively from the upper small intestine. Absorbed up to 80% of the dose. A simultaneous meal reduces the absorption of levothyroxine. Cmax in serum is reached approximately 5-6 hours after ingestion.; Distribution; Associates with serum proteins (thyroxin-binding globulin, thyroxin-binding prealbumin and albumin) by more than 99%. In various tissues, about 80% of levothyroxine is monodeiodinated to form triiodothyronine (T3) and inactive products. Metabolism; 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) .; Excretion; Metabolites are excreted in urine and bile.; T1 / 2 is 6-7 days.; Pharmacokinetics in special clinical cases; When thyrotoxicosis T1 / 2 is shortened to 3-4 days, and with hypothyroidism is extended to 9-10 days.
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 with thyreostatics (as a combination or monotherapy); - as a diagnostic tool when conducting a thyroid suppression test.
Contraindications
- hypersensitivity to the drug; - untreated thyrotoxicosis; - acute myocardial infarction, acute myocarditis; - untreated adrenal insufficiency.; The drug should be prescribed with caution in IHD (atherosclerosis, angina pectoris, history of myocardial infarction), arterial hypertension, arrhythmia, diabetes mellitus, severe long-term hypothyroidism, malabsorption syndrome (dose adjustment may be required)
Use during pregnancy and lactation
During pregnancy and lactation (breastfeeding) therapy with a drug prescribed for hypothyroidism should continue. When pregnancy requires an increase in the dose of the drug due to increased levels of thyroxin-binding globulin. The amount of thyroid hormone secreted in breast milk during lactation (even during treatment with high doses of the drug) is not enough to cause any abnormalities in the baby.; Use of the drug in combination with thyrostatic drugs during pregnancy is contraindicated taking levothyroxine may require an increase in thyrostatic doses. Since thyreostatics, unlike levothyroxine, can penetrate the placental barrier, hypothyroidism may develop in the fetus. During the breastfeeding period, the drug should be taken with caution, strictly in recommended doses under medical supervision.
Dosage and administration
The daily dose is determined individually depending on the evidence.; L-Thyroxin Berlin-Chemie is taken orally daily 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. hypothyroidism replacement therapy in patients younger than 55 years old in the absence of cardiovascular diseases L-Thyroxin Berlin-Chemie is prescribed in a daily dose of 1.6-1.8 mcg / kg body weight; patients older than 55 years or with cardiovascular diseases - 0.9 mcg / kg body weight.For significant obesity, the calculation should be done on "ideal body weight."; For the exact dosage of the drug, the most appropriate dosage of L-thyroxin Berlin-Chemie should be used (50, 75, 100, 125 or 150 mcg) .; It should be started with extreme caution, with small doses - from 25 mcg / day, the dose is increased to supporting at longer intervals of time - by 25 mcg / day every 2 weeks and more often determine the level of TSH in the blood. In hypothyroidism, L-Thyroxine Berlin-Chemie is usually taken throughout life. In Thyrotoxicosis, L-Thyroxin Berlin-Chemie is used in combination therapy with thyrostatics after reaching the euthyroid state. In all cases, the duration of drug treatment is determined by the doctor.; Infants and children up to 3 years of age receive a daily dose of L-Thyroxin Berlin-Chemie at one time 30 minutes before the first feeding. The tablet is dissolved in water to a thin suspension, which is prepared immediately before taking the drug.
Side effects
When using the drug according to the indications in recommended doses under the supervision of a physician, no side effects are observed.; In case of hypersensitivity to the drug, allergic reactions may occur.
Overdose
Symptoms characteristic of thyrotoxicosis: palpitations, heart rhythm disturbances, heart pain, anxiety, tremor, sleep disturbances, excessive sweating, loss of appetite, weight loss, diarrhea. Treatment: a reduction in the daily dose of the drug can be recommended a few days, the appointment of beta-blockers. After the disappearance of side effects, treatment should begin with caution with a lower dose. Antithyroid drugs are not recommended.
Interaction with other drugs
Levothyroxine enhances the effect of indirect anticoagulants, which may require a reduction in their dose.; The use of tricyclic antidepressants with levothyroxine may lead to an increase in the action of antidepressants. More frequent monitoring of blood glucose levels is recommended during periods of initiation of treatment with levothyroxine, as well as when changing the dose of the drug.; Levothyroxine reduces the effect of cardiac glycosides.With simultaneous use of colestyramine, colestipol and aluminum hydroxide, they decrease the plasma concentration of levothyroxine by inhibiting its absorption in the intestine. If used simultaneously with anabolic steroids, asparaginase, tamoxifen, pharmacokinetic interaction is possible at the level of protein binding. Clofibrate, furosemide in high doses increases the content of levothyroxine and T4 not bound to plasma proteins; Somatotropin, while application with levothyroxine can accelerate the closure of the epiphyseal growth zones.; Acceptance of phenobarbital, carbamazepine and rifampicin may increase the clearance of levothyroxine and require an increase in dose.; Estrogens increase the concentration of thyroglobulin fraction, which may lead to a decrease in the effectiveness of the drug. , ethionamide, antithyroid drugs, beta-blockers, carbamazepine, chloral hydrate, diazepam, levodopa, dopamine, metoclopramide, lovastatin, somatostatin have iyanie synthesis, secretion, distribution and metabolism of the drug.
special instructions
In hypothyroidism, caused by damage to the pituitary gland, it is necessary to find out whether there is at the same time an insufficiency of the adrenal cortex. In this case, GCS replacement therapy should be started before the treatment of 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 does not affect the ability to drive vehicles and work requiring increased concentration of attention.