L-Thyroxin 50 Berlin-Chemie tablets 50 mcg №25X2

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L-Thyroxine 50 Berlin-Chemie tab 50mcg in bl. in pack. №25×2
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: Round, slightly convex tablets from almost white to slightly beige color with a notch for division on one side and embossed “50” on the other. Tablets can be divided into two equal parts with the same dosage. Release form The original package contains 2 blisters of laminated aluminum foil (OPA 25 µm / aluminum 45 µm / PVC 60 µm) and rigid aluminum foil with a sealing coating (20 µm), 25 tablets each, with a leaflet in each package. Special instructions Before starting therapy with thyroid hormones, the presence or treatment of the following diseases or conditions should be excluded or carried out: – Ischemic heart disease – Angina pectoris – Atherosclerosis – Hypertension – Pituitary insufficiency and / or insufficiency of the adrenal cortex – Autonomy of the thyroid gland In ischemic heart disease, heart failure, tachyarrhythmias, non-flare phase myocarditis, chronic hypothyroidism, or in patients with a history of myocardial infarction, it is essential to avoid pharmacologically induced hyperthyroidism, even if mild. During therapy with thyroid hormones, these patients should be subject to more frequent monitoring of thyroid hormone levels (see section “Dosage and method of application”). In secondary hypothyroidism, the presence of concomitant adrenocortical insufficiency should be checked. In the presence of this disease, substitution therapy (hydrocortisone) should be carried out first. If thyroid autonomy is suspected, a TRH test or thyroid scintigraphy with suppression is recommended. In postmenopausal women who are at increased risk of developing osteoporosis, thyroid function should be checked more frequently while using levothyroxine to avoid an increase in the concentration of levothyroxine in the blood to above physiological levels. Thyroid hormones should not be used to reduce body weight. In euthyroid patients, normal doses do not result in weight loss. Higher doses can lead to serious or even life-threatening adverse events, especially when combined with certain weight loss agents. If a regimen of levothyroxine therapy is established, switching to another medicinal product containing thyroid hormones should be carried out only under the control of laboratory tests and clinical data. For patients with diabetes and patients receiving anticoagulants, see section “Interaction with other medicinal products and other types of interaction” In very rare cases, there have been reports of hypothyroidism that occurred during the simultaneous use of sevelamer and levothyroxine. Therefore, in patients receiving both drugs, it is recommended to carefully monitor the level of TSH (see also the section “Interaction with other drugs and other forms of interaction”). Pharmacodynamics Mechanism of action Synthetic levothyroxine, which is part of L-Thyroxine 50 Berlin-Chemie, is identical in its action to the natural thyroid hormone produced mainly by the thyroid gland. There are no differences between endogenous and exogenous levothyroxine for the body. Pharmacodynamic action After partial conversion to liothyronine (T3), mainly in the liver and kidneys, and after entering the cells of the body, thyroid hormones cause specific effects, influencing development, growth and metabolism through the activation of T3 receptors. Clinical efficacy and safety Substitution of thyroid hormones leads to the normalization of metabolic processes. For example, taking levothyroxine leads to a significant reduction in elevated cholesterol levels due to hypothyroidism. Pharmacokinetics Absorption When levothyroxine is taken orally on an empty stomach, the drug is absorbed mainly in the upper small intestine, and the degree of absorption depends mainly on the dosage form and can be up to 80%. Tmax is approximately 5-6 hours. In the case of taking levothyroxine with food intake, absorption is significantly reduced. After the first oral administration, the effect usually occurs after 3-5 days. Distribution The volume of distribution is approximately 10-12 liters. Approximately 99.97% of levothyroxine is associated with specific transport proteins. The binding of proteins to the hormone is not covalent, and therefore there is a constant and very rapid exchange between the free and bound hormone. Withdrawal Metabolic clearance of levothyroxine is approximately 1.2 liters of plasma / day. Breakdown occurs mainly in the liver, kidneys, brain and muscles. Metabolites are excreted in urine and feces. The half-life of levothyroxine is approximately 7 days; with hypothyroidism, it can increase (approximately up to 9-10 days), and with hyperthyroidism, it can decrease (up to 3-4 days). Pregnancy and lactation Levothyroxine crosses the placenta only in small amounts. When taking the drug in normal doses, levothyroxine passes into breast milk only in small quantities. Renal impairment Due to the high degree of protein binding, neither hemodialysis nor hemoperfusion has an effect on the level of levothyroxine. Preclinical Safety Data Acute Toxicity Levothyroxine has very low acute toxicity. Chronic Toxicity Chronic toxicity studies have been conducted in various animal species (rats, dogs). Against the background of the use of the drug in high doses in rats, there were signs of toxic effects on the liver, an increased frequency of spontaneous nephrosis, as well as changes in organ weight. No significant side effects were observed in dogs. Mutagenicity There are no studies on the mutagenic potential of levothyroxine. To date, no data have been obtained that would indicate the occurrence of disorders in the offspring caused by changes in the genome. Carcinogenicity Long-term studies of the carcinogenic effect of levothyroxine in animals have not been conducted. Reproductive toxicity Thyroid hormones cross the placenta only in very small amounts. There is no scientific evidence of fertility problems in men or women. There is no suspicion or indication of this. Indications for use – Replacement of thyroid hormones in hypothyroidism of any etiology – Prevention of relapse of goiter after removal of euthyroid goiter – Euthyroid benign goiter – Adjuvant therapy against the background of hyperthyroidism therapy with thyreostatics after reaching the state of euthyroidism – Suppressive and replacement therapy for malignant neoplasms of the thyroid gland, mainly after thyroidectomy L-Thyroxin 50 Berlin-Chemie is indicated for use in all age groups. Route of administration and doses Dosage Dosage instructions are considered as a guide. The individual daily dose should be determined based on the results of laboratory and clinical studies. Thyroid hormone therapy should be initiated at low doses and gradually increased every 2 to 4 weeks until the full replacement dose is reached. If residual thyroid function is preserved, a lower dose may be sufficient for replacement therapy. In elderly patients, in patients with coronary artery disease, and in patients with severe or chronic hypothyroidism, thyroid hormone treatment should be started with extreme caution – for example, it is recommended to start treatment at a lower dose (eg, 12.5 micrograms of levothyroxine per day), and increase it slowly at significant intervals (eg, gradually increase the dose of 12.5 micrograms of levothyroxine per day every 14 days), often checking the level of thyroid hormones. The dose of levothyroxine should be below the dose required for complete replacement; therefore, not be sufficient to completely normalize the level of TSH. Experience has shown that both in patients with low body weight and in patients with large nodular goiter, lower doses of the drug are sufficient. Because T4 or fT4 levels may be elevated in some patients, serum TSH concentrations are better suited to monitor treatment. Children and adolescents with congenital and acquired hypothyroidism The maintenance dose is usually 100-150 micrograms of levothyroxine per m2 of body surface area per day. For newborns and infants with congenital hypothyroidism who require rapid replacement of the missing hormones with levothyroxine, the recommended initial dose of levothyroxine for use in the first 3 months is 10-15 micrograms per kg of body weight per day. In the future, the dose should be adjusted individually, based on clinical data, as well as the level of thyroid hormones and TSH. For children with acquired hypothyroidism, the recommended initial dose of levothyroxine is 12.5-50 micrograms per day. Based on clinical data, as well as the level of thyroid hormones and TSH, the dose should be increased gradually at intervals of 2 to 4 weeks until the full dose required for replacement therapy is reached. Dosage in elderly patients In some cases in elderly patients, for example in patients with heart disease, a gradual reduction in the dose of levothyroxine sodium with regular determination of TSH levels should be preferred. Dosage The full daily dose is taken orally on an empty stomach with a liquid; the drug is taken in the morning, at least half an hour before breakfast. Infants are given the full daily dose at least half an hour before their first meal of the day. The tablets should first be dissolved in a small amount of water (10-15 ml), and the resulting suspension, which should only be freshly prepared, should be given to the baby, adding some more liquid (5-10 ml) to it. Duration of use In hypothyroidism and after thyroidectomy due to a malignant neoplasm of the thyroid gland – as a rule, throughout life; with euthyroid goiter and for the prevention of relapse of goiter – from several months or years to use throughout life; in adjuvant therapy for hyperthyroidism – depending on the duration of thyreostatic therapy. The duration of treatment for euthyroid goiter should be from 6 months to two years. If during this time therapy with L-Thyroxin 50 Berlin-Chemie has not brought the desired result, other treatment options should be considered. When you miss the next dose of the drug In case of taking too small a dose or missing a dose of the drug, you should not take a double dose to compensate for the missed one. The next tablet should be taken at the usual time, following the prescribed frequency of administration. Use during pregnancy and lactation Pregnancy During pregnancy, thyroid hormone therapy should not be interrupted. Despite widespread use during pregnancy, there is still no evidence of undesirable effects of levothyroxine on the course of pregnancy or on the health of the fetus / newborn. Thanks to estrogen, the need for levothyroxine during pregnancy may increase. For this reason, during pregnancy, thyroid function should be monitored, and, if necessary, the dose of thyroid hormone should be adjusted. The use of levothyroxine as adjuvant therapy in the treatment of hyperthyroidism with thyreostatics during pregnancy is contraindicated. With the additional intake of levothyroxine, an increase in the dose of thyreostatics may be required. Unlike levothyroxine, thyreostatics can cross the placental barrier at effective doses. This can lead to hypothyroidism in the fetus. For this reason, in pregnant women with hyperthyroidism, antithyroid drugs should always be used as monotherapy and at low doses. During pregnancy, a thyroid suppression test should not be performed. Breast-feeding During lactation, thyroid hormone therapy should not be interrupted. At present, there is no information about the presence of undesirable effects of levothyroxine on the health of the newborn. Even with the use of high doses of levothyroxine, thyroid hormones pass into breast milk in amounts that are not sufficient to develop hyperthyroidism in infants or to suppress TSH secretion. Thanks to estrogen, the need for levothyroxine during pregnancy may increase. For this reason, after pregnancy, thyroid function should also be monitored, and, if necessary, the dose of thyroid hormone should be adjusted. During lactation, a thyroid suppression test should not be performed. Fertility There is no scientific evidence of impaired fertility in men or women. There is no suspicion or indication of this. Interactions with other drugs Antidiabetic drugs: Levothyroxine may weaken the effect of antidiabetic drugs, which consists in lowering blood glucose levels. Therefore, in persons with diabetes, blood glucose levels should be checked regularly – mainly at the beginning of thyroid hormone therapy. If necessary, it is necessary to adjust the dose of the sugar-lowering drug. Coumarin derivatives: Levothyroxine may enhance the effect of coumarin derivatives by displacing them from plasma protein binding sites. For this reason, people who simultaneously take levothyroxine and coumarin derivatives should regularly check blood clotting and, if necessary, adjust the dose of the anticoagulant (dose reduction). Ion exchange resins: Ion exchange resins such as cholestyramine, colestipol, colesevelam, or the calcium and sodium salts of polystyrene sulfonic acid inhibit the absorption of levothyroxine; therefore, they should not be used earlier than 4-5 hours after taking L-Thyroxine 50 Berlin-Chemie. Aluminum-containing antacids, as well as iron-containing and calcium-containing drugs: Absorption of levothyroxine may decrease in case of simultaneous use of aluminum-containing antacids (antacids, sucralfate), iron-containing drugs and calcium-containing drugs. Therefore, L-Thyroxin 50 Berlin-Chemie should be taken at least two hours before taking these funds. Sevelamer and lanthanum carbonate: Sevelamer and lanthanum carbonate are expected to reduce the bioavailability of levothyroxine (see also section “Interaction with other medicinal products and other forms of interaction”). Therefore, in patients taking sevelamer and levothyroxine at the same time, careful monitoring of TSH levels is recommended. The dose of levothyroxine can be adjusted if necessary. Tyrosine kinase inhibitors: Tyrosine kinase inhibitors (imatinib and sunitinib) may reduce the effectiveness of levothyroxine. Therefore, it is recommended that patients be monitored for changes in thyroid function at the start and end of combination therapy. If necessary, the dose of levothyroxine should be adjusted. Propylthiouracil, glucocorticoids and beta-blockers: These substances inhibit the conversion of T4 to T3 Amiodarone and iodinated radiopaque agents due to their high iodine content can cause both hyperthyroidism and hypothyroidism. Particular care is required for nodular goiter with possibly existing but undiagnosed autonomy. Due to the effect of amiodarone on thyroid function, it may be necessary to adjust the dose of L-Thyroxine 50 Berlin-Chemie. Phenytoin Phenytoin may displace levothyroxine from plasma protein binding sites. This leads to an increase in the level of free thyroxine (fT4) in blood plasma and free triiodothyronine (fT3). On the other hand, the metabolism of phenytoin in the liver is enhanced. Close monitoring of thyroid hormone levels is recommended. Salicylates, dicoumarol, furosemide, clofibrate: Salicylates, dicoumarol, high doses of furosemide (250 mg), clofibrate, and other agents may displace levothyroxine from plasma protein binding sites. This leads to an increase in the level of free thyroxine (fT4) in the blood plasma. Estrogen-containing contraceptives, postmenopausal hormone replacement therapy drugs: The need for levothyroxine may increase with the use of estrogen-containing contraceptives or postmenopausal hormone replacement therapy. Sertraline, chloroquine/proguanil: These substances reduce the effectiveness of levothyroxine and increase plasma TSH levels. Enzyme-inducing drugs: Barbiturates, rifampicin, carbamazepine and other drugs that can activate hepatic enzymes may increase the clearance of levothyroxine through the liver. Protease inhibitors: There is a decrease in the therapeutic effect of levothyroxine when used together with lopinavir, ritonavir and indinavir. Therefore, patients simultaneously taking levothyroxine and protease inhibitors need to carefully monitor clinical symptoms and thyroid function. If necessary, the dose of levothyroxine should be adjusted. Soy products may reduce intestinal absorption of levothyroxine. An increase in plasma TSH levels has been reported in children on a soy diet and taking levothyroxine for congenital hypothyroidism. Unusually high doses of levothyroxine may be required to achieve normal plasma T4 and TSH levels. Plasma T4 and TSH levels should be carefully monitored during and after discontinuation of the soy diet; dose adjustment of levothyroxine may be necessary. Contraindications – Hypersensitivity to the active substance or any of the excipients listed in the “List of excipients” section. – Untreated hyperthyroidism – Untreated adrenal insufficiency – Untreated pituitary insufficiency (resulting in adrenal insufficiency, which requires treatment) – Acute myocardial infarction – Acute myocarditis – Acute pancarditis During pregnancy, taking levothyroxine concomitantly with antithyroid drugs is contraindicated. Composition One tablet of L-Thyroxine 50 Berlin-Chemie contains 53.2 – 56.8 µg of levothyroxine-sodium x H2O (which corresponds to 50 µg of levothyroxine-sodium). For a complete list of excipients, see the “List of excipients” section. Overdose As an indicator of overdose, an increase in T3 levels is more reliable than an increase in T4 or fT4 levels. In case of overdose and intoxication, symptoms occur that are characteristic of a moderate or significant acceleration of metabolism (see section “Side Effects”). Depending on the degree of overdose, it is recommended to stop taking the drug and undergo a follow-up examination. In cases of intoxication in humans (suicide attempts), levothyroxine in doses up to 10 mg is tolerated without complications. The development of such serious complications as a violation of vital functions (respiration and blood circulation) is unlikely, provided that there is no history of coronary heart disease. Despite this, there are reports of the development of a thyrotoxic crisis, seizures, heart failure and coma. There are isolated reports of sudden cardiac death in patients with a history of long-term abuse of levothyroxine. In cases of acute overdose, the absorption of the drug from the gastrointestinal tract can be reduced by taking activated charcoal. Treatment is usually symptomatic and supportive. Severe beta-sympathomimetic symptoms such as tachycardia, anxiety, agitation, or hyperkinesia can be alleviated by the use of beta-blockers. The use of thyreostatics is not indicated, since the function of the thyroid gland is already completely suppressed. In the case of taking the drug in a very high dose (suicide attempt), it is advisable to perform plasmapheresis. With an overdose of levothyroxine, long-term monitoring is necessary. Due to the gradual conversion of levothyroxine to liothyronine, the development of symptoms may occur with a delay of up to 6 days. Side effects In the case of proper use and provided that clinical and laboratory parameters are under observation, the occurrence of side effects in the treatment of L-Thyroxin 50 Berlin-Chemie is unlikely. In some cases, with intolerance to the drug at a certain dose or in cases of overdose, especially as a result of too rapid increase in dose at the beginning of treatment, symptoms of hyperthyroidism such as palpitations, arrhythmias, especially tachycardia, angina pectoris, muscle weakness and muscle cramps, sensation fever, sweating, tremors, restlessness, insomnia, weight loss, diarrhea, headache, menstrual irregularities. As atypical symptoms, fever, vomiting, as well as idiopathic intracranial hypertension (especially in children) can be observed. In such cases, you should either reduce the daily dose of the drug, or cancel it for several days. Immediately after the disappearance of an undesirable effect, treatment can be resumed with careful dose selection. In case of hypersensitivity to levothyroxine or to any of the excipients of the drug L-Thyroxine 50 Berlin-Chemie, allergic reactions from the skin and respiratory tract are possible. There are separate reports of the development of anaphylactic shock. There are separate reports of the development of angioedema (Quincke’s edema). In such a case, the tablets should be discontinued. Reported adverse reactions If the listed adverse reactions occur, as well as reactions not listed in the instructions for use, you should consult a doctor. Reporting side effects after drug registration is important. This allows continued monitoring of the benefit/risk ratio of the medicinal product. Health care workers are required to report any adverse events through the national reporting system. Storage conditionsStore at a temperature not exceeding 25°C. Keep out of the reach of children. Do not use this medicine after the expiration date which is stated on the folding carton and blister. The expiration date is the last day of the specified month. Buy L-Thyroxin 50 Berlin-Chemie tablets 50 mcg No. 25X2 №25Х2