L thyroxine 50 mcg. 50 tablets
Prevention of recurrence after resection of goiter with euthyroid goitre.
L - thyroxine 50 mcg. 50 tablets
One tablet of L-Thyroxin Berlin-Chemie 50 contains as pharmaceutically active ingredient 50 mg levothyroxine sodium.
3 . formulation
4 . clinical data
- Substitution therapy with thyroid hormone in hypothyroidism of any origin (primary and secondary hypothyroidism after surgery of the neck following treatment with radioactive iodine )
- Prevention of recurrence after resection of goiter with euthyroid goitre ,
- Benign goiter in euthyroid
- Concomitant therapy for treatment of hyperthyroidism thyreostatics after achieving euthyroid ,
- Suppression and replacement therapy in malignant diseases of the thyroid gland , especially after thyroidectomy ,
- Thyroid suppression test .
4.2 Posology and method of administration
Presented doses are recommended.
Individual daily dose should be determined by laboratory and clinical studies. Correction of individual daily needs should be made at intervals of 2 to 4 weeks.
Treatment with thyroid hormones should be started with caution in elderly patients , in patients with coronary heart disease, hypertension , seizures, lack of adrenocortical function in patients with severe or prolonged hypothyroidism , ie should be given a low dose and slowly increase with frequent monitoring of thyroid hormone ( intervlat of increase may be extended to 4-6 weeks).
Experience has shown that in the case of low body weight and a large Struma nodosa lower dose is also sufficient.
Small with euthyroid goitre and prevention of recurrence after resection of goiter : 75 to 200 mg levothyroxine sodium per day.
Hypothyroidism in adults : the beginning 25 to 100 mg levothyroxine sodium daily maintenance dose of 125 to 250 mg levothyroxine sodium per day.
Adjunctive therapy in the treatment of hyperthyroidism thyreostatics : 50 to 100 mg levothyroxine sodium per day.
Hypothyroidism in children: early 12.5 to 50 mg levothyroxine sodium, a maintenance dose of 100 mg to 150 levothyroxine natriy/m2 body surface area.
Suppression tireoideyata scintigraphy before : 14 days 200 mg levothyroxine sodium per day or 3 mg levothyroxine sodium once 7 days before re- imaging .
Postoperative treatment of a malignant disease of the thyroid gland : 150 to 300 mg levothyroxine sodium per day.
Individual requirements can be larger or smaller . Children receive a lower dose according to their body weight.
The recommended maintenance dose of levothyroxine sodium in mg / day
4 mg / kg
Infants quarter ??????
25 to 37.5
Infants half ??????
25 to 37.5
Children 1 year
25 to 37.5
Children 5 years
25 to 62.5
Students children 7 1/2 , the
Students on detsa12
The overall daily dose is administered in the morning on an empty stomach with a little water . This ensures good absorption of the drug.
Patients with sensitive stomachs can also take a daily dose after a meal with some water.
Duration of use : in hypothyroidism after thyroidectomy due to malignancy - usually life in euthyroid goitre and prevention of recurrence of the neck - a few months or years to life in concomitant treatment of hyperthyroidism - the length of treatment thyreostatics .
The tablets must be taken continuously if I miss a dose , the next dose should not be increased compensatory .
Hyperthyroidism of any origin (exception: adjunctive therapy in the treatment of hyperthyroidism with thyreostatics after achieving euthyroid , however, concomitant administration of levothyroxine and antithyroid drug is contraindicated during pregnancy ), recent myocardial infarction, angina pectoris or myocardial infarction in the elderly with goiter , myocarditis , untreated adrenocortical dysfunction, known hypersensitivity to any component of the drug.
4.4 Special warnings and precautions for use
These diseases should be excluded or treated before treatment with thyroid hormone :
coronary insufficiency , pituitary or adrenocortical insufficiency , thyroid autonomy.
Under no circumstances should you allow even mild drug - induced hyperthyroidism in coronary insufficiency or tachyarrhythmia . It is therefore necessary carefully determined appropriate dosage.
In these cases require more frequent monitoring of the parameters of thyroid hormone ( see recommended dosage ) .
In secondary hypothyroidism must determine whether there is simultaneously adrenocortical insufficiency . If this is the case , treatment should begin first with glucocorticoids ( hydrocortisone ) .
Blood glucose should be monitored more frequently at the beginning of treatment with thyroid hormone .
If the suspected thyroid autonomy should be performed or TRH test be made supresionna scintigraphy .
4.5 Interaction with other medicinal products and other forms of interaction
Hypoglycaemic effect of insulin and oral antidiabetic agents may be reduced by levothyroxine as insulin action is neutralized by thyroxine . Therefore, blood sugar levels should be monitored regularly, especially at the beginning of treatment with thyroid hormone , and if necessary the dose of hypoglycemic drugs to correct .
The effect of treatment with coumarin derivatives can be increased as levotiroksinat displace anticoagulants from their protein binding . Therefore, in case of simultaneously treatment necessary control coagulation and if needed, the dose of anticoagulant is to be adjusted ( reduced ) .
Cholestyramine inhibits the absorption of levothyroxine and therefore should not be administered within 4-5 hours after taking levothyroxine .
Levotiroksinat can be displaced from plasma protein binding of salicylates, dicumarol , furosemide high dose (250mg), clofibrate , phenytoin . The rapid intravenous administration of phenytoin can increase plasma levels of free levothyroxine , liothyronine and in isolated cases and to contribute to the development of the arrhythmia .
4.6 Pregnancy and lactation
Thyroid hormones cross the placenta was very small . After injection of the low dose (24 mg) in a chick embryo levothyroxine frequency strofosomiya increased. Has gained extensive experience of treatment with levothyroxine in all phases of pregnancy in humans.
No evidence of toxic effects on the fetus or induce malformations.
Treatment with thyroid hormones must be performed consistently , especially during pregnancy and lactation . Despite the widespread use during pregnancy has risks to the fetus are not known. The amount of thyroid hormone , secreted in milk during lactation , even when high doses of levothyroxine is not enough for developing hyperthyroidism or suppressing the secretion of TSH in the newborn. The use of levothyroxine as adjunctive therapy to the treatment of hyperthyroidism with thyreostatics is contraindicated during pregnancy. Since thyreostatics unlike levothyroxine can pass through the placental barrier in effective doses , the accompanying levothyroxine treatment necessarily resulting in a higher dosage of the drug Thyrostatic . This can cause hypothyroidism in the fetus . Therefore , if there is hyperthyroidism in pregnancy is to be administered in a monotherapy thyreostatic active substance only with a low dose .
4.7 Effects on ability to drive and use machines
No known .
4.8 Adverse Reactions
If used correctly and clinical outcomes are monitored and are carried out laboratory tests , adverse reactions during treatment with levothyroxine is unlikely. If in isolated cases, the dose is not tolerated or accepted a very high dose , then especially in the case of extremely rapid dose increases at the beginning of treatment may experience symptoms of hyperthyroidism, such as tachycardia , arrhythmia, angina -like conditions , tremor , agitation , insomnia , sweating , loss of weight , diarrhea . If the cited symptoms occur daily dose should be reduced or treatment interrupted for several days. After the adverse reactions abate treatment can be continued with very careful dosing.
In isolated cases are possible hypersensitivity reactions such as rash ( allergic exanthema ) to the ingredients of L-Thyroxin 100 Berlin-Chemie. It should be borne in mind the increased likelihood of seizures in children with such a history.
Overdose and poisoning , symptoms of moderate or strong increase metabolism . Interruption of medications and controls. In the case of beta- sympathomimetic effects, complaints can be alleviated by the administration of beta-blockers. Thyreostatics inappropriate because the thyroid gland has been fully suppressed . At very high doses ( attempted suicide ) plasma can be useful .
5 . pharmacological
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Thyroid hormones. ATC code : H03AA01 (levothyroxine).
Synthetic levothyroxine contained in L-Thyroxin Berlin-Chemie 100 is identical in its effect to the natural thyroid hormone produced primarily by the thyroid . Partial conversion to liothyronine , particularly in the liver and kidneys, and crossing in the body cells are observed characteristic action of thyroid hormones on the development , growth and metabolism .
5.2 Pharmacokinetic properties
When administered orally to fasted attached levothyroxine greatly depending on the galenical form is absorbed to a maximum of 80% , predominantly in the small intestine. Peak plasma levels are achieved approximately 6 hours after dosing. At the beginning of oral treatment the onset of action is usually after 3 to 5 days . The volume of distribution of 0.5 l / kg. Levotiroksinat has more than 99 % bound to plasma proteins.
Metabolic clearance is about 1,2 l of plasma daily degradation is primarily in the liver , kidney, brain and muscles.
Due to the high degree of protein binding levotiroksinat occurs in small amounts in hemodialysis.
In 1995 was conducted a randomized, multi-center study with cross- oversteering on 23 patients with eutiroidna the neck in order to determine the bioavailability of L-Thyroxin 100 Berlin-Chemie in comparison with the reference preparation in steady state, on the basis of pharmacokinetic parameters studied.
L-Thyroxin 100 Berlin-Chemie
Maximum plasma concentrations (cmax [pg / ml])
20,17 ± 2,3
20,41 ± 2,99
Time to maximum plasma concentration (tmax [h])
Area under the concentration time curve AUC0- 24 [pg h / ml])
432,41 ± 52,05
437,61 ± 61,09
( Values are presented as mean and range )
Mean serum free levothyroxine (fT4) in steady state
5.3 Preclinical safety data
ToksichnostOstrata acute toxicity of levothyroxine is very low. Intoxication ( suicide ) for people up to 10 mg levothyroxine were tolerated without complications. Serious complications such as threatened vital functions ( respiration and circulation ) are unlikely unless a coronary zabolyavane.Hronichna toksichnostProuchvaniya on chronic toxicity studies were performed in different animal species ( rat, dog) . At high doses evidence of hepatopathy , increased spontaneous nephrosis and changes in organ weights in rats .. There were no significant side effects kucheta.Opisani few cases of sudden cardiac death in patients with prolonged abuse of levothyroxine .
Tumorigenic and mutagenic potential
Have not been conducted long-term studies in animals. In this area there is no available research material.
Currently there is no suspicion or evidence of harm to offspring via changes in the genome caused by thyroid hormones.
There are no scientific material impairment of fertility in male and female gender. No suspected or data.
6 . pharmaceutical particulars
6.1 List of excipients
Lactose monohydrate 154.850 mg
Maize starch 84.000 mg
Gelatin 5.000 mg
Magnesium stearate 1.000 mg
Sodium hydroxide 0.010 mg
Quinolone yellow (E 104 ) 0.040 mg
6.3 Shelf life
Three years .
It should not be used after the expiry date .
6.4 Special precautions for storage
6.5 Nature and contents of container
Carton - 50 and 100 tablets ( blister of 25 tablets)
Blister of PVDC, PVC covered and sealed with aluminum.
6.6 Method of allocation
L-Thyroxin 100 Berlin-Chemie and L-Thyroxin 50 Berlin-Chemie available only on prescription.
7 . Pharmaceutical manufacturers