Producer: Berlin-Chemie AG/Menarini Group (Berlin-Hemi AG/Menarini Group) Germany
Code of automatic telephone exchange: H03AA01
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
L-thyroxine 50 Berlin-Hemi
Active ingredient: sodium left thyroxine - 0,05 mg.
L-thyroxine 75 Berlin-Hemi
Active ingredient: sodium left thyroxine - 0,075 mg.
L-thyroxine 100 Berlin-Hemi
Active ingredient: sodium left thyroxine - 0,10 mg.
L-thyroxine 125 Berlin-Hemi
Active ingredient: sodium left thyroxine - 0,125 mg.
L-thyroxine 150 Berlin-Hemi
Active ingredient: sodium left thyroxine - 0,15 mg.
Excipients: calcium hydrophosphate 2-water; cellulose microcrystallic; carboxymethylstarch sodium salt, type A; dextrin: glycerides long-chain partial.
Pharmacodynamics. Synthetic left-handed isomer of thyroxine. After partial transformation into triiodothyronine (in a liver and kidneys) and transition to organism cells, exerts impact on development and growth of fabrics, on a metabolism. In small doses also the lipometabolism possesses anabolic action on proteinaceous. Stimulates growth and development in average doses, increases the need of fabrics for oxygen, stimulates metabolism of proteins, fats and carbohydrates, increases functional activity of cardiovascular system and the central nervous system.
In high doses oppresses development Thyrotropinum-rileasing of hormone of a hypothalamus and thyritropic hormone of a hypophysis.
The therapeutic effect is observed in 7-12 days, during the same time action after drug withdrawal remains. The clinical effect at a hypothyroidism is shown in 3-5 days. The diffusion craw decreases or disappears within 3-6 months.
Pharmacokinetics. At intake left thyroxine is soaked up almost only in an upper part of a small bowel. About 80% of the accepted drug dose are soaked up. Meal reduces absorbability of left thyroxine. The maximum concentration in blood serum is reached approximately in 5-6 hours after intake. After absorption more than 99% of drug contact proteins of serum (thyroxine - the connecting globulin, thyroxine - the connecting prealbumin and albumine). In various fabrics there is a monodeiodinating about 80% of left thyroxine to formation of triiodothyronine (T3) and inactive products. Thyroid hormones are metabolized mainly in a liver, kidneys, a brain and in muscles. A small amount of drug is exposed to deamination and decarboxylation, and also a konjyugirovaniye with a chamois and glucuronic acids (in a liver). Metabolites are removed with urine and bile. The elimination half-life of drug makes 6-7 days. At a thyrotoxicosis the elimination half-life is shortened up to 3-4 days, and at a hypothyroidism is extended up to 9-10 days.
Indications to use:
• euthyroid craw;
• as replacement therapy and for prevention of a recurrence of a craw after a resection of a thyroid gland;
• cancer of a thyroid gland (after operational treatment);
• diffusion toxic craw: after achievement of an euthyroid condition of a tireostatikama (in the form of combined or monotherapies);
• as diagnostic means at test of thyroid suppression.
Route of administration and doses:
The daily dose is defined individually depending on indications.
L-thyroxine Berlin-Hemi in a daily dose is accepted inside in the morning on an empty stomach, at least, in 30 min. prior to meal, washing down a tablet with a small amount of liquid (a half-glass of water) and without chewing.
When performing replacement therapy of a hypothyroidism to patients 55 years in the absence of cardiovascular diseases L-thyroxine Berlin-Hemi are younger appoint 1.6-1.8 mkg/kg of body weight in a daily dose; to patients 55 years or with cardiovascular diseases - 0.9 mkg/kg of body weight are more senior. At considerable obesity calculations should be made on "the ideal body weight".
|The initial stage of replacement therapy at a hypothyroidism|
|Patients without cardiovascular diseases are younger than 55 years||Initial dose:
women - 75-100 mkg/days,
men - 100-150 mkg/days
|Patients with cardiovascular diseases or are more senior than 55 years||Initial dose - 25 mkg/days.
To increase 25 mkg with an interval of 2 months before normalization of the TTG level in blood.
At emergence or deterioration in cardial symptoms to carry out correction of cardiovascular therapy.
|The recommended thyroxine doses for treatment of an inborn hypothyroidism|
|Age||Daily dose of thyroxine (mkg)||Thyroxine dose per the body weight (mkg/kg)|
|from 2 to 10 years||75-125||4-6|
|from 10 to 16 years||100-200||3-4|
|> 16 years||100-200||2-3|
|Indications||The recommended doses L-thyroxine Berlin-Hemi (mkg/days)|
|Treatment of an euthyroid craw||75-200|
|Prevention of a recurrence after surgical treatment of an eutireodiny craw||75-200|
|In complex therapy of a thyrotoxicosis||50-100|
|Suppressive therapy of cancer of thyroid gland||150-300|
|Test of thyroid suppression||In 4 weeks prior to the test||In 3 weeks prior to the test||In 2 weeks prior to the test||In 1 week prior to the test|
For an exact drug dosing it is necessary to use the most suitable dosage of the drug L-thyroxine Berlin-Hemi (50, 75, 100, 125 or 150 mkg).
At heavy it is long the existing hypothyroidism treatment should be begun with extra care, with small doses - from 25 mkg/days, the dose is increased to supporting through more long intervals of time - by 25 mkg/days each 2 weeks and more often determine the TTG level in blood. At a hypothyroidism L-thyroxine Berlin-Hemi is accepted, as a rule, during all life.
At a thyrotoxicosis L-thyroxine Berlin-Hemi is applied in complex therapy from tireostatika after achievement of an euthyroid state. In all cases treatment duration by drug is determined by the doctor.
Babies and children up to 3 years a daily dose of the drug L-thyroxine Berlin-Hemi are given in one step in 30 min. prior to the first feeding. The tablet is dissolved in water to a thin suspension which is prepared just before administration of drug.
Features of use:
At the hypothyroidism caused by damage of a hypophysis it is necessary to find out whether there is at the same time an insufficiency of bark of adrenal glands. In this case replacement therapy by glucocorticosteroids should be begun prior to treatment of a hypothyroidism with thyroid hormones in order to avoid development of acute adrenal insufficiency. Drug does not exert impact on the professional activity connected with driving of vehicles and control of mechanisms.
At the correct use under control of the doctor side effects are not observed.
At hypersensitivity to drug allergic reactions can be observed.
Interaction with other medicines:
Left thyroxine strengthens effect of indirect anticoagulants that can demand decrease in their dose.
Use of tricyclic antidepressants with left thyroxine can lead to strengthening of effect of antidepressants.
Thyroid hormones can increase the need for insulin and peroral hypoglycemic drugs. More frequent control of level of glucose of blood is recommended to be carried out to the periods of an initiation of treatment by left thyroxine, and also at change of a dose of drug.
Left thyroxine reduces effect of cardiac glycosides. At simultaneous use Colestyraminum, колестипол and aluminum hydroxide reduce plasma concentration of left thyroxine due to braking of absorption it in intestines.
At simultaneous use with anabolic steroids, asparaginase, Tamoxifenum perhaps pharmacokinetic interaction at the level of protein-binding.
At simultaneous use with Phenytoinum, salicylates, Clofibratum, furosemide in high the dose raises the content of the left thyroxine which is not connected with proteins of a blood plasma and T4.
Somatotropinum at simultaneous use with left thyroxine can accelerate closing of epiphyseal regions of growth.
Reception of phenobarbital, carbamazepine and rifampicin can increase clearance of left thyroxine and demand increase in a dose.
Estrogen increases concentration of the fraction connected with thyreoglobulin that can lead to decrease in efficiency of drug.
Amiodaronum, аминоглутетимид, p-aminosalicylic acid (PASK), Etioniamidum, anti-thyroid medicines, beta adrenoblockers, carbamazepine, Chlorali hydras, diazepam, a levodopa, a dopamine, Metoclopramidum, ловастатин, somatostatin exert impact on synthesis, secretion, distribution and metabolism of drug.
• The increased individual sensitivity to drug;
• Not treated thyrotoxicosis;
• Acute myocardial infarction, acute myocarditis;
• Not treated insufficiency of adrenal glands.
With care it is necessary to appoint drug at diseases of cardiovascular system: An ischemic heart disease (atherosclerosis, stenocardia, a myocardial infarction in the anamnesis), arterial hypertension, arrhythmia, at a diabetes mellitus, heavy it is long the existing hypothyroidism, a sprue (dose adjustment can be required).
Use at pregnancy and a lactation
During pregnancy and breastfeeding therapy by the left thyroxine appointed concerning a hypothyroidism has to continue. During pregnancy increase in a dose of drug because of increase in level of contents globulin thyroxine-svyazyvayushego is required. The amount of the thyroid hormone cosecreted with breast milk at a lactation (even when performing treatment by high doses of drug), is not enough to cause any disturbances in the child. Use of drug in a combination from tireostatika at pregnancy is contraindicated as reception of left thyroxine can demand increase in doses of tireostatik. As tireostatik, unlike left thyroxine, can get through a placenta, at a fruit the hypothyroidism can develop. During breastfeeding drug should be taken with caution, it is strict in the recommended doses under observation of the doctor.
At overdose of drug the symptoms characteristic of a thyrotoxicosis are observed: heartbeat, disturbance of a heart rhythm, a heartache, concern, a tremor, a sleep disorder, the increased perspiration, increase in appetite, decrease in body weight, diarrhea. Depending on expressiveness of symptoms the doctor reduction of a daily dose of drug can be recommended, having rummaged in treatment for several days, purpose of beta adrenoblockers. After disappearance of side effects treatment should be begun with care with lower dose.
List B. At a temperature not above 25 °C.
To store medicine in the place, unavailable to children!
Period of validity 2 years.
According to the recipe