active substance:1 tablet contains levothyroxine 125 µg
other ingredients:calcium hydrogen phosphate, microcrystalline cellulose, dextrin, sodium starch (type a), long chain partial glycerides.The
Thyroid hormones. PBX code N0ZA A01.
hypersensitivity to the active substance or to any of the excipients. Untreated hyperthyroidism of any origin. 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.
dosage Data should be considered as recommendations. The individual dose should be determined based on the results of laboratory tests and clinical examination. In case you maintain the minimum function of the thyroid gland should apply the lowest dose substitution.
for Adult patients.
Hypothyroidism.the Initial dose is 25-50 µg/day, for which the drug is used in accordance with the lower content of the active substance, supporting - 100-200 µg/day (increasing the dose by 25-50 µg is carried out at intervals of 2-4 weeks).
prevention of recurrence of goiter.75-200 µg/day
Benign goiter with euthyroid state function.75-200 µg/day
After thyroidectomy for a malignant tumor.150-300 µg/day
Children over 3 years of age.
for children older than 3 years with acquired hypothyroidism, the recommended dose is 12.5-50 mcg per day, for which drugs with an appropriate content of the active substance are used. It is also necessary to increase the dose gradually, every 2-4 weeks, according to the results of clinical examination, as well as taking into account the indicators of thyroid hormone levels and thyroid-stimulating hormone (TTG) levels in the blood until the dose is fully provides a replacement effect.
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 care, using a small dose-12.5 mcg per day. 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. 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 form 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 treatmentThe
if the dose is tolerated by a patient, it is very rare, or in the case of an overdose, especially if the dose increases too quickly at the beginning of treatment, symptoms such as tachycardia, palpitations, arrhythmia, angina pectoris, tremor, feeling of internal anxiety, insomnia, hyperhidrosis, feeling hot, fever, fever, weight loss, vomiting, diarrhea, headache, weakness and cramping, muscle cycle, pseudonym of the brain. 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 in the form of urticaria, bronchospasm and larynx edema, and in some cases - anaphylactic shock. In this case, the use of the drug should be abolished.
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. It is recommended to stop taking the drug and conduct control tests. In the case of severe tachycardia, it can be weakened by beta-adrenoreceptor blockers. 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.
Treatment with thyroid hormones is necessary to carry out 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, patients with hypothyroidism may increase the need for levothyroxine, due to changes in estrogen levels, so the function of the thyroid gland should be monitored 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. During pregnancy it is forbidden to perform a test for suppression of thyroid function.The
this dosage form is intended for use in children over 3 years of age. 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, it is necessary to exclude such diseases: ischemic heart 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 secondary hypothyroidism, it is necessary to find out whether there is simultaneous insufficiency of the adrenal cortex. 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 TSH. Compliance with the dose and frequency of the drug should be monitored by a doctor in elderly people. If you suspect autoimmune thyroiditis should determine the level of TTH or conduct thyroscintigraphy 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.
when levothyroxine is used simultaneously with cholesterol, colestipol or chariot, which inhibit the absorption of levothyroxine, it is necessary to adhere to the interval of 4-5 hours between their reception. Levothyroxine absorption may decrease with the simultaneous use of aluminous antacids, calcium carbonate or iron preparations, so it should be taken no later than 2:00 before taking these funds. Sevelamer and lanthanum carbonate may inhibit the bioavailability of levothyroxine, so l-thyroxine 150 Berlin-Hemi should be used 1:00 before or 3:00 after their application. Propylthiouracil, glucocorticoids, beta-blockers and iodinated contrast agents inhibit the conversion of T4to T3. Amiodarone, for the high iodine content in it, can cause both hypothyroidism and hyperthyroidism. Particular caution should be exercised when nodular goiter with possible unrecognized functional autonomy of the thyroid gland. The rapid introduction of phenytoin can lead to increased plasma concentrations of free levothyroxine, which in some cases can contribute to the emergence of arrhythmias. Under the influence of salicylates, furosemide (dose 250 mg), clofibrate may occur displacement of levothyroxine from binding sites with plasma proteins and, as a consequence, - strengthening its action. Sertraline and chloroquine/proguanil reduce the effectiveness of levothyroxine and increase the level of TSH in serum. Barbiturates and other drugs with garmentindustry effect on liver can increase hepatic clearance of levothyroxine. During the period of use of contraceptives containing estrogen, or hormone therapy in the postmenopause may increase the need for levothyroxine. Products containing soy may reduce the absorption of levothyroxine in the intestine, so at the beginning and especially at the end of the soy diet may require dose adjustment. Under the influence of levothyroxine, there may be an insufficiency of the hypoglycemic action of insulin and oral antidiabetic drugs. Therefore, patients with diabetes mellitus, who are prescribed levothyroxine, need regular monitoring of blood sugar levels (especially at the beginning of therapy), and if necessary - dose correction antidiabetic drugs. Levothyroxine can enhance the effect of indirect anticoagulants, so you need to regularly monitor blood clotting, and if necessary, to reduce the dose of anticoagulants drugs.The
Pharmacodynamics.the Synthetic levothyroxine contained in l-thyroxine 125 Berlin-Hemi is identical in action 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 of the interior of 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%. Metabolic clearance is about 1.2 liters of plasma per day, the breakdown occurs mainly in the liver, brain and muscles. Due to the high degree of plasma protein binding, thyroid hormones are detected in hemodialysate in small amounts.
round, slightly convex tablets from white to slightly beige, with a notch for division on the one hand and a embossed "125" - on the other. The tablet can be divided into 2 equal parts.The
do not use after the expiry date indicated on the package.
do not Store above 25 ° C. keep out of reach of children.The
25 tablets in a blister, 1 or 2 or 4 blisters in a carton.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 in pill form for 125 micrograms of the active ingredient levothyroxine sodium. It is used to treat diseases associated with the thyroid gland.
L-Thyroxine is prescribed by the attending physician based on clinical symptoms and laboratory tests. The medicine is effective to combat:
with the daily use of the drug is replenished in the body lack of thyroid hormones. The expected effect can be observed in 2 weeks after the first application of the drug. The doctor prescribes an individual therapeutic scheme, in compliance with which diffuse goiter may become smaller in size or disappear completely.
L-Thyroxine is used on an empty stomach for quick absorption. Each appointment comes at a time half an hour before meals. The average daily dosage per adult is up to 100 µg. If necessary, you can raise the rate by another 25 mcg. For the treatment of children, a dosage of 50 µg is provided.