Pharmacotherapeutic group: Thyroid therapy, thyroid hormones. ATX code H03A A01.
Composition:
active substance: levothyroxine sodium;
Excipients: calcium hydrogen phosphate dihydrate, microcrystalline cellulose, dextrin, sodium starch (type A), long-chain partial glycerides.
Indications:
L-thyroxin 50 BERLIN-Chemi, L-thyroxin 100 BERLIN-Chemi: benign goiter with euthyroid state of thyroid function; prevention of recurrence of goiter after resection of goiter with euthyroid state of thyroid function; replacement therapy for hypothyroidism of various etiologies, an auxiliary agent for thyreostatic therapy of hyperthyroidism after reaching the euthyroid functional state; suppressive and replacement therapy for thyroid cancer, mainly after thyroidectomy.For L-thyroxin 100 BERLIN-Chemie: as a diagnostic tool for thyroid suppression test.
Contraindications:
Hypersensitivity to the active substance or to any of the excipients of the drug. Untreated hyperthyroidism of any origin. Untreated adrenal insufficiency. Untreated pituitary insufficiency (this leads to insufficiency of the adrenal cortex, requires treatment). Acute myocardial infarction. Acute myocarditis. Acute pancarditis. During pregnancy, the simultaneous use of levothyroxine and any thyrostatic agent is contraindicated (for more information on use during pregnancy and lactation, see the section “Use during pregnancy or lactation”).
Method of administration and dosage:
Dosage data should be considered as guidelines. The individual daily dose should be determined based on the results of laboratory tests and clinical examination. Thyroid hormone therapy should be started at a low dose and gradually increased (every 2-4 weeks) to the required therapeutic dose. Since the level of T4 or free thyroxine (fT4) may be elevated in some patients, the determination of the serum TSH concentration is better for monitoring the treatment regimen.
Adult patients. Benign goiter treatment: 75-200 mcg / day. Prevention of recurrent goiter: 75-200 mcg / day. Substitution therapy for hypothyroidism, the initial dose is 25-50 mcg / day, maintenance – 100-200 mcg / day. Concomitant therapy in the treatment of hyperthyroidism with thyreostatic agents: 50-100 mcg / day. Suppressive and replacement therapy for thyroid cancer: 150-300 mcg / day. When conducting a thyroid suppression test (only for L-thyroxin 100 Berlin-Chemie): 200 μg (equivalent to 2 tablets) / day (14 days before the test).
Children with congenital and acquired hypothyroidism. The maintenance dose is usually 100-150 mcg of levothyroxine per 1 m2 of body surface area per day. For infants and children with congenital hypothyroidism who are indicated for immediate replacement therapy with levothyroxine, the recommended initial dose in the first 3 months is 10-15 μg of levothyroxine per kilogram of body weight per day. In the future, dose adjustment should be carried out individually according to the results of clinical studies, taking into account the indicators of the level of the thyroid hormone, as well as the level of TSH. For children with acquired hypothyroidism, the recommended starting dose is 12.5-50 mcg of levothyroxine per day, for which the drug should be used in an appropriate dosage. Based on clinical data on thyroid hormone, as well as TSH levels, the dose should be increased gradually at intervals of 2-4 weeks until the full dose required for replacement therapy is reached. For infants and children under 3 years of age, use the full daily dose at least 30 minutes before the first feed of that day. The tablets can be taken as a suspension. The tablets must first be dissolved in a small amount of water (10-15 ml), and the resulting freshly prepared suspension should be given to the child by adding a small amount of water (5-10 ml) to it.
Elderly patients. In some cases, in elderly patients, for example, for patients with heart disease, preference should be given to a gradual decrease in the dose of levothyroxine with a constant determination of the TSH level. Experience shows that the use of the minimum dose is the optimal solution for low body weight and large nodular goiter. The entire daily dose should be swallowed without chewing the tablets, washed down with a small amount of liquid, for example ½ glass of 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: place the tablet on a hard surface with a notch for dividing upwards and press it with your finger from above in a perpendicular direction
Expiration date:
2 years. Do not use after the expiration date stated on the package.
Storage conditions:
Store at a temperature not exceeding 25 ° C. Store the medicinal product out of the reach of children.
Produced in Germany
