L-thyroxine pills 100mcg N100 Berlin-Chemie
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Active ingredients
Levothyroxine sodium
Release form
Pills
Composition
1 tablet contains: Active substance: levothyroxine sodium 100 mcg. Adjuvants: calcium hydrogen phosphate 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 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 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, the production of TTRG of the hypothalamus and TSH of the pituitary gland is inhibited. 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
AbsorptionAfter ingestion, 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 Associated with serum proteins (thyroxin-binding globulin, thyroxin-binding prealbumin and albumin) by more than 99%. In various tissues, approximately 80% of levothyroxine is mono-deiodinated 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). ExcretionMetabolites are excreted in the urine and in the bile. T1 / 2 is 6-7 days. -4 days, and with hypothyroidism is extended to 9-10 days.
Indications
hypothyroidism; euthyroid goiter - as a diagnostic tool when conducting a thyroid suppression test.
Contraindications
- hypersensitivity to the components of the drug; - untreated thyrotoxicosis; - acute myocardial infarction, acute myocarditis; - untreated adrenal function failure. diabetes, severe long-existing 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 disorders in the child. Use of the drug in combination with thyrostatic drugs during pregnancy is contraindicated because 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 breastfeeding, 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 daily by mouth inside 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. therapy of hypothyroidism 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.With significant obesity, the calculation should be made on the ideal body weight. For accurate dosing of the drug, you should use the most suitable dosage of L-thyroxin Berlin-Chemie (50, 75, 100, 125 or 150 mcg). For severe long-term hypothyroidism, treatment should caution, with small doses - from 25 mcg / day, the dose is increased to maintenance at longer intervals - at 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 for a lifetime. With 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. For infants and children up to 3 years of age, the daily dose of L-Thyroxin Berlin-Chemie is given 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 the recommended doses under the supervision of a physician, no side effects are observed. Allergic reactions may be observed in case of hypersensitivity to the drug.
Overdose
Symptoms characteristic of thyrotoxicosis: heartbeat, heart rhythm disturbance, heart pain, anxiety, tremor, sleep disturbance, increased sweating, loss of appetite, weight loss, diarrhea. Treatment: a reduction in the daily dose of the drug can be recommended, a break in treatment by several 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 increased 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 periods of starting 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, the plasma concentration of levothyroxine is reduced due to inhibition of its absorption in the intestine. When used simultaneously with anabolic steroids, asparaginase, tamoxifen, pharmacokinetic interaction at the level of protein binding is possible. in high doses of furosemide, the content of levothyroxine and T4 not bound to plasma proteins increases. Somatotropin When used with levothyroxine, it 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 the thyroglobulin fraction associated with it, which can lead to a decrease in the effectiveness of the drug. antithyroid drugs, beta-blockers, carbamazepine, chloral hydrate, diazepam, levodopa, dopamine, metoclopramide, lovastatin, somatostatin have an effect s on the 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. Effect 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.