active substance:1 tablet contains 50 µg levothyroxine or 100 µg respectively;
other ingredients:calcium hydrogen phosphate dihydrate, microcrystalline cellulose, dextrin, sodium starch (type a), long chain partial glycerides.The
Thyroid hormones. PBX code N0ZA A01.
L-thyroxine 50 BERLIN-Chemie L-thyroxine 100 BERLIN-ChemieThe
Additional reading For l-thyroxine 100 BERLIN-HemiThe
hypersensitivity to the active substance or to any of the auxiliary substances of the preparation. Untreated hyperthyroidism of any origin (for example untreated thyrotoxicosis). Untreated adrenal cortex insufficiency. Untreated pituitary insufficiency. Acute myocardial infarction. Acute myocarditis. Acute pancreatitis. During pregnancy, the simultaneous use of levothyroxine and any thyrostatic agent is contraindicated.
Data on the dosage should be considered as recommendations. For the treatment of each individual patient, depending on his/her individual needs, the drug exists in the form of tablets containing 50 µg and 100 µg of levothyroxine. The tablets can be divided into two equal parts. The individual daily dose of the drug is determined based on the results of laboratory tests and clinical examination. Therapy with thyroid hormones should begin with a low dose and gradually increase (every 2-4 weeks) to the required therapeutic dose. In case you maintain the minimum function of the thyroid gland should apply the lowest dose substitution.
for Adult patients.
treatment of benign thyroid disease 75-200 µg/day
prevention of recurrence of goiter 75-200 µg/day.
Replacement therapy for hypothyroidism initial dose is 25-50 µg/day, supporting-100-200 µg/day.
Concomitant therapy in the treatment of hyperthyroidism thyreostatics means: 50-100 mg/day.
Suppressive and replacement therapy for thyroid cancer: 150-300 µg/day.
in a test of thyroid suppression: 200 mg/day (14 days before the test).
Children with congenital and acquired hypothyroidism.
for infants and children with congenital hypothyroidism who receive immediate levothyroxine substitution therapy, the recommended starting dose for the first 3 months is 10-15 µg levothyroxine per kilogram of body weight per day. Further correction of a dose is carried out individually according to results of clinical researches taking into account indicators of level of hormone of a thyroid gland, and also level of TTG. For children with acquired hypothyroidism, the recommended dose is 12.5-50 µg of levothyroxine per day, for which the drug should be used at the appropriate dosage. Based on clinical data on thyroid hormone as well as TTG levels, the dose should be increased gradually at intervals of 2-4 weeks until the full dose required for substitution therapy is achieved. Infants and children under 3 years of age are given a full daily dose at least 30 minutes before the first day of feeding. The tablets should be dissolved in a small amount of water (10-15 ml), and the resulting freshly prepared suspension should be given to the child, adding to it a small amount of water (5-10 ml). Maintenance dose is usually 100 to 150 µg of levothyroxine per 1 m2of the body surface area per day.
take particular care at the beginning of treatment with thyroid hormones elderly patients, patients with ischemic heart disease, patients with severe hypothyroidism or in the case where reduction of thyroid function is observed for a long time. In these cases, treatment should be started with careful caution, using a small dose-12.5 mcg per day, using the drug at the appropriate dosage. To increase the dose to the level of support should be gradually, over a long period of time, adding the 12.5 mcg of the drug per day every 2 weeks. For this it is necessary to use other preparations of levothyroxine with the possibility of this dosing. In addition, it is necessary to increase the frequency of monitoring the level of TTG in the blood. It should be noted that the appointment of doses, less optimal, providing full replacement therapy, does not lead to a complete correction of TTG. Experience shows that the use of the minimum dose is the best solution for low body weight and large nodular goiter.
the entire daily dose should be swallowed without chewing tablets, drink a small amount of liquid, such as ? Cup water. Take the drug on an empty stomach, at least 30 minutes before Breakfast. Due to the special shape of the tablet, it can be divided as follows: tablet on a hard surface cut to divide up and pressing it with your finger on top perpendicular to the direction.
the Duration of treatment.Drug use throughout life hypothyroid, after surgery of strumectomy or thyroidectomy and for relapse prevention after the removal of euthyroid goiter. The duration of the drug in an adjuvant for treatment of hyperthyroidism after reaching the euthyroid functional state corresponds to the period thyreostatics therapy. With a mild form of euthyroid goiter, the duration of treatment ranges from 6 months to 2 years. If the patient's condition does not improve after treatment, surgical intervention or therapy with radioactive iodine is prescribed.
if the dose is transferred to patients, it is very rare, or in the case of an overdose, especially if the dose increases too quickly at the beginning of treatment, the following symptoms may occur.
from the nervous system.Tremor, pseudotumor of the brain, a sense of inner anxiety, insomnia, and headache.
from the heart.Tachycardia, rapid heartbeat, arrhythmia, angina development, atrial fibrillation, extrasystole.
from the digestive tract.Vomiting, diarrhea.
on the part of the skin and subcutaneous tissue.skin rashes, itching, angioedema.
on the part of the reproductive system.disruption of the menstrual cycle.
General violations.Hyperhidrosis, feeling hot, increased body temperature, loss of body weight, weakness and muscle cramps.
when these symptoms occur, the daily dose is recommended to reduce or discontinue the use of the drug for several days. There have been reports of cases of sudden death, which was caused by cardiac disorders in patients who have long been applied higher doses of levothyroxine. With the disappearance of side effects resume treatment by gently swiping the selection of doses of the drug. There may be allergic reactions, including urticaria, bronchospasm and swelling of the larynx, and in some cases - anaphylactic shock. In this case, stop using the drug.
In case of overdose observed rapid pulse, palpitations, anxiety, sensation of heat, increased body temperature, sweating, heart palpitations, insomnia, tremor, increased frequency of angina, anxiety, weight loss, vomiting, diarrhea, headache, weakness and cramps m of the muscles, menstrual irregularities, pseudotumor of the brain. There have been reports of individual cases of epileptic seizures in the appropriate category of patients when the individual dose limit was exceeded. It is recommended to stop taking the drug and conduct control tests. Increased levels of T3(triiodothyronine) is a reliable indicator of overdose, more than increased levels of T4and ft4(free) in serum. In case of severe tachycardia, anxiety, agitation or hyperkinesia these can be mitigated with the help of beta-adrenoceptor. Thyrostatic agents are not used, because the function of the thyroid gland is already completely suppressed. Under extreme doses (attempts suicide) can help plazmaferez. There have been reports of cases of sudden death associated with heart disorder patients, long used higher doses of levothyroxine.
thyroid hormones Should be treated consistently and correctly, especially during pregnancy and lactation. Despite the widespread use of the drug during pregnancy, the fact that there is a danger to the fetus is still unknown. The amount of thyroid hormones released into milk during breast-feeding, even in the treatment of thyroid hormones in high doses is not enough for the development of infants hyperthyroidism or suppression of TTH secretion. During pregnancy in patients with hypothyroidism can increase the need for levothyroxine, due to changes in estrogen levels, so the function of the thyroid gland to monitor both during and after pregnancy, and if necessary, to adjust the replacement dose.
During pregnancy is contraindicated the use of levothyroxine as a support tool in the treatment of hyperthyroidism thyreostatics drugs. Thyreostatics drugs that unlike levothyroxine, significant doses penetrates through placental barrier, could lead to development of hypothyroidism of the fetus. Taking very high doses of levothyroxine during pregnancy can adversely affect the postnatal development of the child. During pregnancy, it is forbidden to perform a test for the suppression of thyroid function as well as to use radioactive substances.The
the Drug is used in pediatric practice. Detailed information about the recommended doses and the method of application of the drug is given in the section "Method of application and doses".
Thyroid hormones do not help reducing body weight. The appointment of the physiological doses does not reduce body mass in patients with normally functioning thyroid glands (euthyroid state). When exceeding the recommended doses, adverse reactions may occur (see"Overdose"). Before starting therapy with thyroid hormones or conducting tests for thyroidin suppressions, it is necessary to exclude such diseases: coronary artery disease (angina pectoris), arterial hypertension, pituitary insufficiency, adrenal cortex insufficiency, functional autonomy of the thyroid gland or normalize the patient's condition.
it is necessary to avoid the development of even the most States of hyperthyroidism caused by the action of the drug, with ischemic disease, heart failure or tachyarrhythmias. In such cases, you should frequently check the level of thyroid hormone.
in the case of secondary thyrotoxicosis, the cause should be determined before the appointment of substitution therapy, if necessary, a course of replacement therapy to compensate for adrenal cortex insufficiency.
if you suspect Autonomous thyroiditis, you should determine the level of TTH or conduct thyroscintigraphy before treatment.
do Not assign the drug to patients with hyperthyroidsim condition when the treatment antithyroid remedies to treat hyperthyroidism.
at secondary hypothyroidism it is necessary to find out, simultaneous insufficiency of an adrenal cortex is observed. If this is confirmed, it is necessary to first carry out substitution therapy (hydrocortisone). When using levothyroxine for the treatment of hypothyroidism in women during menopause, with an increased risk of osteoporosis, in order to avoid increasing the level of levothyroxine in the blood above the physiological content, frequent control of thyroid function should be carried out. There were reports of cases of hypothyroidism in patients, at the same time received sevelamer and levothyroxine, so in such patients it is necessary to carefully monitor the level of TTH. Compliance with the dose and frequency of taking the drug should be controlled by an elderly doctor. In cases of suspected autoimmune thyroiditis should determine the level of TSH or clean tireostatikami before treatment. When exceeding the recommended doses, side effects may occur (see"Overdose"). After starting the use of levothyroxine or when changing the drug is recommended to adjust the dose in accordance with the individual patient's reaction to this drug and laboratory data. The drug should be used with caution in patients with diabetes mellitus (see "Interactions with other medicinal products and other forms of interaction").The
Appropriate studies have not been conducted.
Antidiabetic agents.Levothyroxine can reduce the effect of antidiabetic drugs. More frequent monitoring of blood glucose levels is recommended at the beginning of treatment with levothyroxine, as well as when the dose changes.
coumarin Derivatives:levothyroxine increases the effect of anticoagulant drugs increases the risk of hemorrhage, such as bleeding in the brain and spinal cord, or gastrointestinal bleeding, especially in people of advanced age. Therefore, it is necessary to carry out laboratory monitoring of coagulation parameters and, if necessary, to reduce the dose of anticoagulants.
protease Inhibitors(e.g. ritonavir, indinavir, lopinavir) may affect the action of levothyroxine. Careful monitoring of thyroid hormones is necessary. If necessary, the dose of levothyroxine should be corrected.
Phenytoincan affect the action of levothyroxine, expelling it from plasma proteins, thereby increasing the level of fractions of free thyroxine (fT4) and free triiodothyronine (fT3). On the other hand, phenytoin increases liver metabolism of levothyroxine. It is recommended that careful monitoring of the level of thyroid hormones.
Cholestyramine, colestipolinhibit the absorption of levothyroxine. Therefore, levothyroxine sodium should be taken for 4-5:00 before taking such products.
preparations containing aluminium (antacids, sucralfat), iron and calcium carbonatemay reduce the effect of levothyroxine. Therefore, drugs containing levothyroxine should be taken at least 2:00 before taking drugs containing aluminum, iron or calcium carbonate.
Salicylates, dicumarol, furosemide in high doses (250 mg), clofibrateand other substances can expel sodium levothyroxine from plasma proteins, which leads to an increase in the FT4 fraction.
the Sevelamercan reduce the absorption of levothyroxine. In this regard, it is recommended to monitor changes in thyroid function at the beginning and end of co-treatment. If necessary, the dose of levothyroxine is corrected.
tyrosine kinase Inhibitors(e.g. imatinib, sunitinib) may reduce the effectiveness of levothyroxine. In this regard, it is recommended to monitor changes in thyroid function at the beginning and end of co-treatment. If necessary, the dose of levothyroxine is corrected.
Propylthiouracil, glucocorticoids, beta-Simpatolitiki, amiodarone and drugs that contain iodine, inhibit peripheral conversion of T4 to TK.
for its high iodine content, amiodarone can promote both hyperthyroidism and hypothyroidism. With caution should appoint patients vuzlovyi the goiter of unknown etiology.
Sertraline, chloroquine/proguanilreduce the effectiveness of levothyroxine and increase the level of serum TSH.
Enzymes induced by drugs(barbiturates, carbamazepine) may increase liver clearance of levothyroxine.
Estrogens.Women who take contraceptive drugs containing estrogens, as well as women of post-menopausal age taking hormone replacement drugs, may require higher doses of levothyroxine.
products containing soy,can inhibit the intestinal absorption of levothyroxine. First, and especially at the end of the soy diet may be necessary to adjust the dose.The
Pharmacodynamics.Synthetic levothyroxine, which is found in preparations l-thyroxine 50 Berlin-Chemie, L-thyroxine 100 Berlin-Chemie in its action identical to the natural hormone produced by the thyroid gland. After partial transformation into a liotironina (T3), mainly in the liver and kidneys, and the transition to the body's cells, it affects the development, growth and metabolism.
Pharmacokinetics.Suction a received oral levothyroxine occurs mainly in the small intestine and is highly dependent on galanovoj forms of the drug - up to a maximum of 80% in the fasting. The maximum concentration in the blood plasma is reached after 6: 00 after administration. The effect of the drug is observed 3-5 days after the start of oral therapy. The volume of distribution in the body determine the rate of ? liter/kg of Levothyroxine is associated with plasma proteins is more than 99%. The connection with the protein is not covalent, thus, is associated hormone, which is plasma, capable of continuous and rapid exchange with the free fractions of the hormone. Due to the high level of protein binding, levothyroxine is not amenable to hemodialysis or hemoperfusion. The half-life period is 7 days. In thyrotoxicosis, this period is reduced to 3-4 days, and hypothyroidism is extended to 9-10 days. The liver accumulates about 1/3 of the total amount of levothyroxine injected, quickly enters into interaction with levothyroxine, which is in the blood plasma. Metabolic clearance is about 1.2 liters of plasma per day, splitting occurs mainly in the liver, kidneys, brain and muscles. Metabolites are excreted in urine and feces.
50 µg tablets: round, slightly convex tablets, white to slightly beige, with an incision for division on one side and a embossed "50" on the other;
100 mcg tablets: round, slightly convex tablets from white to slightly beige, with a notch for division on one side and a embossed "100" on the other.
the tablet can be divided into 2 equal Parts.The
do not use after the expiry date indicated on the package.
Store at a temperature not higher than 25 ° C. the Drug should be stored out of reach of children.The
Blister of 25 tablets, 1 or 2 or 4 blisters in a cardboard box.The
According to the recipe.The
the Production of tablets "in bulk" and control series:
Tempelhofer Weg 83, 12347 Berlin, Germany.
series Packaging, inspection and release:
Glienicker Weg 125, 12489 Berlin, Germany.
L-Thyroxine is a synthetic medicine with the main active ingredient levothyroxine sodium weighing 50 µg. The main effect is aimed at activating the growth and development of tissues, metabolism.
the agent is the anabolic effect, promotes body fat metabolism. After two weeks of therapy one can observe the expected treatment outcome. Within six months of regular use of medication is gradually disappearing diffuse goiter.
L-Thyroxine is administered after diagnosis.
the Drug may be used in the form of replacement therapy. Among the contraindications-acute heart disease.
the average daily rate is determined by the doctor individually. The drug is used on an empty stomach, washed down with liquid in small quantities. Dosage for adult patients is calculated at 1.8 µg/kg body weight. For men, the initial rate is set at 150 µg (3 tablets).
in order to dose the medicine correctly, taking into account the therapeutic scheme, tablets should be selected with a suitable portion. The drug can be prescribed to children up to three years of age inclusive.