Release form, composition and packing Bagothyrox
Pill yellow, rectangular, with three notches on each side, on each of four equal parts tablets impression "T4" on both sides. 1 tab. levothyroxine sodium 50 mg. Inactive ingredients: microcrystalline cellulose, powdered cellulose, lactose monohydrate, magnesium stearate, sodium croscarmellose, Quinoline yellow dye.
Tablets white, rectangular, with three notches on each side, on each of four equal parts tablets impression "T4" on both sides. 1 tab. levothyroxine sodium 100 mcg. Inactive ingredients: microcrystalline cellulose, powdered cellulose, lactose monohydrate, magnesium stearate, sodium croscarmellose.
Pill blue, rectangular, with three notches on each side, on each of four equal parts tablets impression "T4" on both sides. 1 tab. levothyroxine sodium 150 mcg. Inactive ingredients: microcrystalline cellulose, powdered cellulose, lactose monohydrate, magnesium stearate, sodium croscarmellose, brilliant blue dye.
Clinico-pharmacological group: preparation of thyroid hormones.
Pharmacological action
The preparation of thyroid hormones, synthetic levogyrate isomer of thyroxine. After partial conversion to triiodothyronine (in the liver and kidneys) and the transition to the body's cells, influences the growth and development of tissue metabolism.
When used in low doses has anabolic effects on protein and fat metabolism.
When used in moderate doses stimulate the growth and development of the organism, increases in oxygen demand of tissues, stimulates the metabolism of proteins, fats and carbohydrates, increases the functional activity of the cardiovascular system and central nervous system. When used in high doses inhibits the production of thyrotropin-releasing hormone, hypothalamus and pituitary thyroid stimulating hormone. Therapeutic effect observed after 7-12 days, during the same time preserves the action after the drug. Clinical effect of hypothyroidism is manifested in 3-5 days. Basedow's disease is reduced or disappears within 3-6 months.
Statement
hypothyroidism;
euthyroid goiter;
as replacement therapy for prevention of recurrence of goiter after thyroid gland resection;
thyroid cancer (after surgery);
toxic goiter after reaching the euthyroid state thyreostatics (as a combination therapy or monotherapy);
as a diagnostic tool during the test thyroid suppression.
Dosing regimen
The daily dose is determined individually depending on the evidence. Bagotiroks take 1 time per day in the morning on an empty stomach, at least 30 minutes before meals. Wash down the pill a little liquid (half a cup of water) and do not chew.
During replacement therapy of hypothyroidism in patients under the age of 55 years in the absence of cardiovascular disease drug is prescribed a daily dose of 1.6-1.8 mg / kg body weight in patients older than 55 years or concomitant cardiovascular diseases - 0.9 mg / kg body. With significant obesity dose calculation should be done on an "ideal weight".
Babies Bagotiroksa daily dose given in 1 reception for 30 minutes before the first feeding. Tablet dissolved in water to a fine mist just before taking this medication. In severe, long-existing hypothyroidism, treatment should be started with caution at low doses - 12.5 mg / day. Increase the dose to maintenance at longer intervals - 12.5 mg / day every 2 weeks - and often determine the level of TSH.
Hypothyroid Bagotiroks usually take in a lifetime. When thyrotoxicosis take medication in the treatment of thyreostatics after reaching the euthyroid state. In all cases, the duration of drug treatment is determined individually.
Side effect
Using the drug in recommended doses and under the supervision of a doctor side effects are not observed. Hypersensitivity to the drug may experience allergic reactions.
Contraindications
untreated hyperthyroidism;
Acute myocardial infarction;
acute myocarditis;
untreated adrenal insufficiency;
increased individual sensitivity to the drug.
Precautions should be prescribed the drug for coronary heart disease (including atherosclerosis, angina pectoris, history of myocardial infarction), hypertension, arrhythmia, diabetes, severe long-existing hypothyroidism, malabsorption syndrome (may require dose adjustment).
Pregnancy and lactation
During pregnancy and lactation (breastfeeding) should continue therapy with drugs prescribed at the hypothyroidism.
During pregnancy require increased doses of the drug because of elevated levels of thyroxine-binding globulin. Number of thyroid hormone secreted in breast milk during lactation (even during treatment with high-dose) is insufficient to cause any disturbances in the child.
Use of the drug during pregnancy in combination with thyreostatics contraindicated because receiving levothyroxine may require increased doses thyreostatics. Since thyreostatics, unlike levothyroxine, can cross the placenta, the fetus may develop hypothyroidism.
During breastfeeding the drug should be taken with caution, under medical supervision, is strictly at the recommended doses.
Cautions
In hypothyroidism, caused the defeat of the pituitary gland, it is necessary to determine whether there is a simultaneous failure of the adrenal cortex. In this case, substitution therapy, corticosteroids should begin before the treatment of hypothyroidism with thyroid hormone in order to avoid the development of acute adrenal insufficiency.
Overdose
Symptoms associated with hyperthyroidism: palpitations, cardiac arrhythmias, heart pain, anxiety, tremor, sleep disturbance, increased sweating, decreased appetite, weight loss, diarrhea.
Treatment: Depending on the severity of symptoms showed reduction of daily dose, treatment interruption for several days, the appointment of beta-blockers. After the disappearance of side effects of treatment should be started cautiously with lower doses.
Drug Interactions
Together, levothyroxine sodium enhances the effect of indirect anticoagulants, which may require reduction of their dose. The use of tricyclic antidepressants with levothyroxine sodium may lead to increased action of antidepressants. Thyroid hormones may increase the need for insulin and oral hypoglycemic agents (when using this combination is recommended more frequent monitoring of blood glucose, especially in the early appointment of levothyroxine sodium, as well as its dose).
Together, levothyroxine sodium reduces the effect of cardiac glycosides. While the application kolestiramin, colestipol, and aluminum hydroxide, reducing the concentration of levothyroxine sodium in the blood plasma due to inhibition of its absorption from the gastrointestinal tract.
With the simultaneous application of levothyroxine sodium with anabolic steroids, asparaginase, tamoxifen might pharmacokinetic interaction at the level of binding protein.
In an application with phenytoin, salicylates, clofibrate, furosemide in high doses increases the content of unbound to plasma proteins of levothyroxine sodium and T4.
Receiving estrogenosoderzhaschih drugs increases the content of thyroxine-binding globulin (may increase the need for levothyroxine sodium in some patients).
Growth hormone, while the application of levothyroxine sodium may speed up the closure of the epiphyseal growth zones. Acceptance of phenobarbital, carbamazepine and rifampin may increase the clearance of levothyroxine sodium (which will require increased doses).
Conditions and terms of
List B. The drug should be kept in the dark and inaccessible to children at or above 25 ° C. Shelf life - 2 years.
Pill yellow, rectangular, with three notches on each side, on each of four equal parts tablets impression "T4" on both sides. 1 tab. levothyroxine sodium 50 mg. Inactive ingredients: microcrystalline cellulose, powdered cellulose, lactose monohydrate, magnesium stearate, sodium croscarmellose, Quinoline yellow dye.
Tablets white, rectangular, with three notches on each side, on each of four equal parts tablets impression "T4" on both sides. 1 tab. levothyroxine sodium 100 mcg. Inactive ingredients: microcrystalline cellulose, powdered cellulose, lactose monohydrate, magnesium stearate, sodium croscarmellose.
Pill blue, rectangular, with three notches on each side, on each of four equal parts tablets impression "T4" on both sides. 1 tab. levothyroxine sodium 150 mcg. Inactive ingredients: microcrystalline cellulose, powdered cellulose, lactose monohydrate, magnesium stearate, sodium croscarmellose, brilliant blue dye.
Clinico-pharmacological group: preparation of thyroid hormones.
Pharmacological action
The preparation of thyroid hormones, synthetic levogyrate isomer of thyroxine. After partial conversion to triiodothyronine (in the liver and kidneys) and the transition to the body's cells, influences the growth and development of tissue metabolism.
When used in low doses has anabolic effects on protein and fat metabolism.
When used in moderate doses stimulate the growth and development of the organism, increases in oxygen demand of tissues, stimulates the metabolism of proteins, fats and carbohydrates, increases the functional activity of the cardiovascular system and central nervous system. When used in high doses inhibits the production of thyrotropin-releasing hormone, hypothalamus and pituitary thyroid stimulating hormone. Therapeutic effect observed after 7-12 days, during the same time preserves the action after the drug. Clinical effect of hypothyroidism is manifested in 3-5 days. Basedow's disease is reduced or disappears within 3-6 months.
Statement
hypothyroidism;
euthyroid goiter;
as replacement therapy for prevention of recurrence of goiter after thyroid gland resection;
thyroid cancer (after surgery);
toxic goiter after reaching the euthyroid state thyreostatics (as a combination therapy or monotherapy);
as a diagnostic tool during the test thyroid suppression.
Dosing regimen
The daily dose is determined individually depending on the evidence. Bagotiroks take 1 time per day in the morning on an empty stomach, at least 30 minutes before meals. Wash down the pill a little liquid (half a cup of water) and do not chew.
During replacement therapy of hypothyroidism in patients under the age of 55 years in the absence of cardiovascular disease drug is prescribed a daily dose of 1.6-1.8 mg / kg body weight in patients older than 55 years or concomitant cardiovascular diseases - 0.9 mg / kg body. With significant obesity dose calculation should be done on an "ideal weight".
Babies Bagotiroksa daily dose given in 1 reception for 30 minutes before the first feeding. Tablet dissolved in water to a fine mist just before taking this medication. In severe, long-existing hypothyroidism, treatment should be started with caution at low doses - 12.5 mg / day. Increase the dose to maintenance at longer intervals - 12.5 mg / day every 2 weeks - and often determine the level of TSH.
Hypothyroid Bagotiroks usually take in a lifetime. When thyrotoxicosis take medication in the treatment of thyreostatics after reaching the euthyroid state. In all cases, the duration of drug treatment is determined individually.
Side effect
Using the drug in recommended doses and under the supervision of a doctor side effects are not observed. Hypersensitivity to the drug may experience allergic reactions.
Contraindications
untreated hyperthyroidism;
Acute myocardial infarction;
acute myocarditis;
untreated adrenal insufficiency;
increased individual sensitivity to the drug.
Precautions should be prescribed the drug for coronary heart disease (including atherosclerosis, angina pectoris, history of myocardial infarction), hypertension, arrhythmia, diabetes, severe long-existing hypothyroidism, malabsorption syndrome (may require dose adjustment).
Pregnancy and lactation
During pregnancy and lactation (breastfeeding) should continue therapy with drugs prescribed at the hypothyroidism.
During pregnancy require increased doses of the drug because of elevated levels of thyroxine-binding globulin. Number of thyroid hormone secreted in breast milk during lactation (even during treatment with high-dose) is insufficient to cause any disturbances in the child.
Use of the drug during pregnancy in combination with thyreostatics contraindicated because receiving levothyroxine may require increased doses thyreostatics. Since thyreostatics, unlike levothyroxine, can cross the placenta, the fetus may develop hypothyroidism.
During breastfeeding the drug should be taken with caution, under medical supervision, is strictly at the recommended doses.
Cautions
In hypothyroidism, caused the defeat of the pituitary gland, it is necessary to determine whether there is a simultaneous failure of the adrenal cortex. In this case, substitution therapy, corticosteroids should begin before the treatment of hypothyroidism with thyroid hormone in order to avoid the development of acute adrenal insufficiency.
Overdose
Symptoms associated with hyperthyroidism: palpitations, cardiac arrhythmias, heart pain, anxiety, tremor, sleep disturbance, increased sweating, decreased appetite, weight loss, diarrhea.
Treatment: Depending on the severity of symptoms showed reduction of daily dose, treatment interruption for several days, the appointment of beta-blockers. After the disappearance of side effects of treatment should be started cautiously with lower doses.
Drug Interactions
Together, levothyroxine sodium enhances the effect of indirect anticoagulants, which may require reduction of their dose. The use of tricyclic antidepressants with levothyroxine sodium may lead to increased action of antidepressants. Thyroid hormones may increase the need for insulin and oral hypoglycemic agents (when using this combination is recommended more frequent monitoring of blood glucose, especially in the early appointment of levothyroxine sodium, as well as its dose).
Together, levothyroxine sodium reduces the effect of cardiac glycosides. While the application kolestiramin, colestipol, and aluminum hydroxide, reducing the concentration of levothyroxine sodium in the blood plasma due to inhibition of its absorption from the gastrointestinal tract.
With the simultaneous application of levothyroxine sodium with anabolic steroids, asparaginase, tamoxifen might pharmacokinetic interaction at the level of binding protein.
In an application with phenytoin, salicylates, clofibrate, furosemide in high doses increases the content of unbound to plasma proteins of levothyroxine sodium and T4.
Receiving estrogenosoderzhaschih drugs increases the content of thyroxine-binding globulin (may increase the need for levothyroxine sodium in some patients).
Growth hormone, while the application of levothyroxine sodium may speed up the closure of the epiphyseal growth zones. Acceptance of phenobarbital, carbamazepine and rifampin may increase the clearance of levothyroxine sodium (which will require increased doses).
Conditions and terms of
List B. The drug should be kept in the dark and inaccessible to children at or above 25 ° C. Shelf life - 2 years.
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