Trade name of the drug: L-Thyroxin 50 Berlin-Chemie
International non-proprietary name:
Levothyroxine sodiumDosage form:
pillsComposition:
Active substance: levothyroxine sodium - 0.05 mg.Excipients: calcium hydrogen phosphate dihydrate - 15.95 mg, microcrystalline cellulose 16.00 mg, sodium carboxymethyl starch (type A) - 12.00 mg, dextrin - 6.80 mg, long-chain incomplete glycerides - 1.20 mg.
Description: round, slightly convex tablets, white or white with a slightly yellowish sheen, with a notch on one side and embossing "50" on the other.
Pharmacological group: Thyroid remedy.
ATX code:Н03AA01
Pharmacological properties
Pharmacodynamics
Synthetic levorotatory isomer of thyroxine. After partial transformation into triiodothyronine (in the liver and kidneys) and transition into the cells of the body, it affects the development and growth of tissues, and metabolism. In small doses, it has an anabolic effect on protein and fat metabolism. In medium doses, it stimulates growth and development, increases tissue oxygen demand, stimulates the metabolism of proteins, fats and carbohydrates, increases the functional activity of the cardiovascular system and the central nervous system.
In large doses, it inhibits the production of thyrotropin-releasing hormone of the hypothalamus and thyroid-stimulating hormone (TSH) of the pituitary gland.
The therapeutic effect is observed after 7-12 days, during the same time the effect persists after the drug is discontinued. The clinical effect in hypothyroidism is manifested after 3-5 days. Diffuse goiter decreases or disappears within 3-6 months.
Pharmacokinetics
When taken orally, levothyroxine sodium is absorbed almost exclusively in the upper part of the small intestine. Up to 80% of the taken dose of the drug is absorbed.
Food intake reduces the absorption of levothyroxine sodium. The maximum serum concentration is reached approximately 5-6 hours after ingestion. After absorption, more than 99% of the drug binds to serum proteins (thyroxine-binding globulin, thyroxine-binding prealbumin and albumin). In various tissues, monodeiodination of approximately 80% of sodium levothyroxine occurs with the formation of triiodothyronine (T 3) and inactive products. Thyroid hormones are metabolized primarily in the liver, kidneys, brain and muscles.
A small amount of the drug undergoes deamination and decarboxylation, as well as conjugation with sulfuric and glucuronic acids (in the liver). Metabolites are excreted by the kidneys and through the intestines. The half-life of the drug is 6-7 days. With thyrotoxicosis, the half-life is shortened to 3-4 days, and with hypothyroidism it is extended to 9-10 days.
Indications for use
- hypothyroidism;
- euthyroid goiter;
- as replacement therapy and for the prevention of recurrence of goiter after resection of the thyroid gland;
- thyroid cancer (after surgery);
- diffuse toxic goiter: after reaching the euthyroid state with antithyroid drugs (in the form of combined or monotherapy);
- as a diagnostic tool when performing a thyroid suppression test.
Contraindications
- hypersensitivity to the active substance or to any of the excipients that make up the drug (see section Composition);
- untreated thyrotoxicosis;
- acute myocardial infarction, acute myocarditis;
- untreated adrenal cortex insufficiency.
Carefully the drug should be prescribed for diseases of the cardiovascular system: coronary artery disease (atherosclerosis, angina pectoris, history of myocardial infarction), arterial hypertension, arrhythmias, diabetes mellitus, severe long-term hypothyroidism, malabsorption syndrome (dose adjustment may be required).
Use during pregnancy and lactation
During pregnancy and breastfeeding, therapy with a drug prescribed for hypothyroidism should be continued. During pregnancy, an increase in the dose of the drug is required due to an increase in the content of thyroxin-binding globulin. The amount of thyroid hormone secreted in breast milk during lactation (even when treated with high doses of the drug) is not enough to cause any disturbance in the child.
The use of the drug in combination with antithyroid drugs during pregnancy is contraindicated, since taking levothyroxine sodium may require an increase in the doses of antithyroid drugs. Since antithyroid drugs, unlike levothyroxine sodium, can cross the placenta, the fetus may develop hypothyroidism. During the period of breastfeeding, the drug should be taken with caution, strictly in the recommended doses under the supervision of a doctor.
Method of administration and dosage
The daily dose is determined individually, depending on the indications.
L-Thyroxin 50 Berlin-Chemie in a daily dose is taken orally in the morning on an empty stomach, or at least 30 minutes before a meal, with a small amount of liquid (half a glass of water) on the tablet without chewing.
When carrying out replacement therapy for hypothyroidism (in the absence of cardiovascular diseases), L-Tyroxin 50 Berlin-Chemie is prescribed in a daily dose of 1.6-1.8 μg / kg of body weight. In case of significant obesity, the calculation should be made on the "ideal weight".
For infants and children under 3 years of age, the daily dose of L-Tyroxin 50 Berlin-Chemie is given in one dose 30 minutes before the first feeding. The tablet is dissolved in water to a fine suspension, which is prepared immediately before taking the drug.
In patients with severe long-term hypothyroidism, treatment should be started with extreme caution, with low doses - 25 μg / day, the dose is increased to a maintenance dose at longer intervals - by 25 μg / day every 2 weeks, and the concentration of TSH in the blood is often determined. In hypothyroidism, L-Thyroxin 50 Berlin-Chemie is taken, as a rule, throughout life. In case of thyrotoxicosis, L-Thyroxin 50 Berlin-Chemie is used in complex therapy with antithyroid drugs after reaching the euthyroid state. In all cases, the duration of drug treatment is determined by the doctor.
For accurate dosage of the drug, use the most suitable form of release of the drug L-Tyroxin Berlin-Chemie (50, 75, 100, 125 or 150 mcg).
Side effect
When used correctly under the supervision of a physician, side effects are not observed.
With hypersensitivity to the drug, allergic reactions may occur.
Overdose
In case of an overdose of the drug, symptoms characteristic of thyrotoxicosis are observed: tachycardia, heart rhythm disturbances, heart pain, anxiety, tremors, insomnia, hyperhidrosis, loss of appetite, weight loss, diarrhea, vomiting, headache, fatigue, muscle spasm. Depending on the severity of symptoms, the doctor may recommend a decrease in the daily dose of the drug, a break in treatment for several days, the appointment of beta-blockers. After the disappearance of side effects, treatment should be started with caution with a lower dose. Antithyroid drugs are not recommended.
Interaction with other medicinal products
Levothyroxine sodium enhances the effect of indirect anticoagulants, which may require a reduction in their dose.
The use of tricyclic antidepressants with levothyroxine sodium can lead to an increase in the effect of antidepressants.
Thyroid hormones can increase the need for insulin and oral hypoglycemic drugs. More frequent monitoring of blood glucose concentration is recommended during the period of initiation of treatment with levothyroxine sodium, as well as when the dose of the drug is changed.
Levothyroxine sodium reduces the action of cardiac glycosides. With the simultaneous use of cholestyramine, colestipol and aluminum hydroxide, the plasma concentration of levothyroxine sodium decreases by inhibiting its absorption in the intestine.
With simultaneous use with anabolic steroids, asparaginase, tamoxifen, pharmacokinetic interaction is possible at the level of protein binding.
With simultaneous use with phenytoin, salicylates, clofibrate, furosemide in high doses, the content of levothyroxine sodium and T 4, not associated with blood plasma proteins, increases.
Growth hormone, when used simultaneously with sodium levothyroxine, can accelerate the closure of the epiphyseal growth zones.
Taking phenobarbital, carbamazepine and rifampicin may increase the clearance of sodium levothyroxine and require an increase in the dose.
Estrogens increase the concentration of the thyroglobulin-related fraction, which can lead to a decrease in the effectiveness of the drug.
Amiodarone, aminoglutethimide, para-aminosalicylic acid (PASK), ethionamide, antithyroid drugs, beta-blockers, chloral hydrate, diazepam, levodopa, dopamine, metoclopramide, lovastatin, somatostatin affect the synthesis, secretion, distribution and metabolism of sodium.
Soy products may reduce absorption of levothyroxine sodium (dose adjustment may be required).
special instructions
In hypothyroidism caused by damage to the pituitary gland, it is necessary to find out whether there is simultaneously an insufficiency of the adrenal cortex. In this case, glucocorticosteroid replacement therapy should be started before starting treatment for hypothyroidism with thyroid hormones in order to avoid the development of acute adrenal insufficiency.
The effect of the drug on the ability to drive vehicles and control mechanisms
L-Thyroxin 50 Berlin-Chemie does not affect the ability to drive vehicles and work requiring increased concentration.
Release form
Tablets 50 mcg.
On 25 tablets in a blister strip packaging (blister) [PVC / PVDC / aluminum foil or aluminum foil / aluminum foil].
1, 2 or 4 blisters, together with instructions for use, are placed in a cardboard box.
Storage conditions
Store at a temperature not exceeding 25 ° C.
Keep the medicinal product out of the reach of children!
Shelf life
2 years.
Do not use after the expiry date indicated on the package!
Conditions of dispensing from pharmacies
On prescription.
Manufacturer
Berlin-Chemie AG
Gliniker Veg 125
12489, Berlin
Germany
Complaints address
115162, Moscow, st. Shabolovka, house 31, building B.
What L-Thyroxin 150 Berlin-Chemie is and what it is used for
L-Thyroxin 150 Berlin-Chemie is a drug whose active ingredient is the thyroid hormone levothyroxine. It has the same effect as a natural hormone. L-Thyroxin 150 Berlin-Chemie is taken to replace the missing thyroid hormone and / or to reduce the load on the thyroid gland.
L-Thyroxin 150 Berlin-Chemie is used:
- as a replacement for the missing hormone in all forms of thyroid hypofunction
- to prevent the recurrence of goiter (enlargement of the thyroid gland) after surgery to remove the goiter with normal thyroid function
- for the treatment of benign goiter with normal thyroid function
- in case of a malignant tumor of the thyroid gland, mainly after surgery, to suppress tumor recurrence and replace the absent thyroid hormone.
- to study the function of the thyroid gland (thyroid suppression test)
L-Thyroxin 150 Berlin-Chemie is used in all age groups.
L-Thyroxin 150 Berlin-Chemie is contraindicated:
If you are allergic (hypersensitive) to levothyroxine sodium or other components of the drug (listed in the section "Composition of the drug L-Tyroxine 150 Berlin-Chemie")
- in the presence of the following diseases or conditions:
- untreated hyperthyroidism
- untreated adrenocortical insufficiency
- untreated pituitary insufficiency, if it has led to adrenocortical insufficiency requiring treatment
- recent acute myocardial infarction
- acute inflammation of the heart muscle (myocarditis)
- acute inflammation of all layers of the heart wall (pancarditis)
- If you are pregnant and are taking medications for the treatment of hyperfunction of the thyroid gland (thyreostatics), L-Thyroxin 150 Berlin-Chemie should not be taken (see also the section "Pregnancy, breastfeeding and fertility").
Before you start taking the drug L-Tyroxin 150 Berlin-Chemie, you should exclude the presence of the following diseases or conditions, or carry out their treatment:
- coronary artery disease
- pain in the region of the heart and a feeling of tightness in the chest (angina pectoris)
- high blood pressure
- insufficiency of the pituitary gland and / or adrenal cortex
- the presence in the thyroid gland of areas that uncontrollably produce thyroid hormone (thyroid autonomy)
- atherosclerosis
Before carrying out the so-called thyroid suppression test to study its function, it is necessary to exclude the presence of these diseases or conditions, or to carry out their treatment. However, it is not required to exclude the presence of thyroid autonomy, since, among other things, the test serves to detect it.
Warnings and Precautions
If you have had a myocardial infarction or have coronary artery disease, weakness of the heart muscle, rhythm disturbances (tachycardia), heart failure, inflammation of the heart muscle without exacerbation, or long-term hypothyroidism, then too high levels of hormones in the blood should be avoided. Therefore, it is necessary to check the level of thyroid hormones more often. If there are minor signs of thyroid hyperfunction associated with taking the drug L-Tyroxin 150 Berlin-Chemie, you should inform your doctor about it (see the section "Possible side effects")
- If the hypothyroidism is caused by a disease of the pituitary gland. It is possible that this condition is accompanied by insufficiency of the adrenal cortex, which must be eliminated before starting treatment with thyroid hormone (hydrocortisone therapy).
- If there is a suspicion of the presence of areas in the thyroid gland that uncontrollably produce thyroid hormone, a thyroid function test should be performed before starting treatment.
- In postmenopausal women who are at increased risk of developing osteoporosis, thyroid function should be checked more frequently to avoid an increase in thyroid hormone levels in the blood.
- If you have diabetes or are taking certain anticoagulants (eg dicumarol), you should look at the section “Taking other medications”.
- If you notice signs of mental disorders, contact your doctor immediately, as you may need to adjust the dose of levothyroxine.
- If you, as a patient undergoing dialysis, are prescribed, for example, the drug "Sevelamer" for an increased level of phosphate in the blood, then the attending physician may consider it necessary to monitor certain blood parameters in order to determine the effectiveness of taking levothyroxine (see also section "Taking other medications").
- If you are taking orlistat (a drug for the treatment of obesity), stop taking it, or ask your doctor for a dose adjustment. Your doctor will likely consider monitoring certain blood counts and adjusting the dose of levothyroxine.
Talk to your doctor or pharmacist before taking L-Thyroxin 150 Berlin-Chemie.
Improper use
You should not take the drug L-Tyroxin 150 Berlin-Chemie in order to reduce body weight. If you have normal thyroid hormone levels in your blood, supplementing with thyroid hormones will not lead to weight loss. Additional use can lead to serious or even life-threatening side effects, especially when combined with certain weight loss medications.
Change in therapy
If you are already taking L-Thyroxin 150 Berlin-Chemie, the change of this medication to another medication containing thyroid hormones should only be carried out under medical supervision and monitoring of blood parameters.
Elderly patients
For elderly patients, careful dosing of the drug (especially in the presence of heart disease) and more frequent medical supervision are necessary.
Taking L-Tyroxin 150 Berlin-Chemie and other medications
Contact your doctor or pharmacist if you are taking / using or have recently taken / used or could take / use other drugs.
L-Thyroxin 150 Berlin-Chemie affects the action of the following drugs or drug groups:
Antidiabetic drugs (medicines that lower blood sugar):
If you have diabetes; blood sugar should be checked regularly, mainly at the beginning of thyroid hormone treatment. It may be necessary for the attending physician to adjust the dose of drugs that lower blood sugar levels, since levothyroxine can reduce the effect of these drugs.
Coumarin derivatives (anticoagulants):
When taking the drug L-Tyroxin 150 Berlin-Chemie and coumarin derivatives (for example, dicumarol) together, blood coagulation should be monitored regularly. It may be necessary to reduce the dose of anticoagulants by the attending physician, since levothyroxine can enhance the effect of these drugs.
The following drugs affect the action of L-Tyroxin 150 Berlin-Chemie:
drugs that lower blood lipids, drugs to lower the concentration of potassium in the blood (ion exchange resins):
Drugs to lower blood lipids (e.g. cholestyramine, colestipol and colesevelam) or drugs to lower blood potassium (calcium and sodium salts of polystyrene sulfonic acid) should be taken 4 to 5 hours after taking L-Tyroxin 150 Berlin -Hemi. These drugs suppress the flow of levothyroxine from the intestine, thus reducing its effectiveness.
Sevelamer and lanthanum carbonate:
Sevelamer and lanthanum carbonate (drugs for lowering blood phosphate levels in dialysis patients) can reduce the absorption and effectiveness of levothyroxine. Your doctor should check your thyroid function more often than usual (see also the Warnings and Precautions section),
aluminum-containing antacids, as well as iron-containing and calcium-containing drugs:
L-Tyroxin 150 Berlin-Chemie should be taken at least 2 hours before taking aluminum-containing antacids (antacids, sucralfate), as well as iron-containing and calcium-containing drugs. These drugs suppress the flow of levothyroxine from the intestine, thus reducing its effectiveness.
Propylthiouracil, glucocorticoids, beta-blockers: Propylthiouracil (a drug to treat hyperthyroidism), glucocorticoids (adrenal hormones, "cortisone"), and β-blockers (drugs that decrease heart rate and lower blood pressure) can inhibit the conversion of levothyroxine its more effective form is liothyronine, thus reducing the effectiveness of the drug L-Tyroxin 150 Berlin-Chemie.
Amiodarone, iodinated X-ray contrast agents:
Amiodarone (a drug for treating heart rhythm disorders) and iodinated X-ray contrast agents (certain drugs for X-ray diagnostics), due to their high iodine content, can cause both an increase and a decrease in the activity of the thyroid gland. Particular attention should be paid to nodular goiter with possibly unrecognized areas in the thyroid gland, uncontrollably producing thyroid hormones (autonomy). If necessary, the attending physician will adjust the dose of L-Tyroxin 150 Berlin-Chemie.
Contraceptives or hormone replacement therapy: The need for levothyroxine may increase with the use of hormonal contraceptives (“pills”) or during hormone replacement therapy in the postmenopausal period.
Sertraline, chloroquine / proguanil:
Sertraline (a drug used to treat depression) and chloroquine / proguanil (drugs used to treat malaria and rheumatoid diseases) decrease the effectiveness of levothyroxine.
Barbiturates, rifampicin, carbamazepine:
Barbiturates (drugs used to treat seizures, anesthesia, certain types of sleeping pills), rifampicin (an antibiotic), and carbamazepine (a drug used to treat seizures) can weaken the effects of levothyroxine.
Protease inhibitors (drugs used to treat HIV infection), phenytoin (drugs used to treat seizures):
When taking levothyroxine and protease inhibitors (lopinavir, ritonavir) or phenytoin together, the attending physician should closely monitor the symptoms of the disease and monitor the function of the thyroid gland. When lopinavir / ritonavir or phenytoin are taken together, the effect of levothyroxine may decrease.
Tyrosine kinase inhibitors (imatinib and sunitinib):
Treatment with imatinib and sunitinib (drugs for the treatment of chronic myeloid leukemia) increases the need for levothyroxine in patients with hypothyroidism.
Orlistat (drug for the treatment of obesity)
Orlistat may decrease the effectiveness of levothyroxine.
The following drugs can enhance the effect of L-Tyroxin 150 Berlin-Chemie:
- salicylates (antipyretic and pain relievers)
- dicumarol (a drug that suppresses the formation of blood clots)
- high doses of furosemide (diuretic) (250 mg)
- clofibrate (a drug to lower blood lipids)
- phenytoin (a drug for the treatment of seizures and heart rhythm disturbances)
Taking L-Tyroxin 150 Berlin-Chemie with food and drinks
L-Thyroxin 150 Berlin-Chemie should not be taken with food, especially calcium-rich foods (eg milk and dairy products), as this can significantly reduce the absorption of levothyroxine.
If you are consuming foods containing soy, your doctor will need to monitor your thyroid hormone levels more often. During and at the end of the soy diet, a dose adjustment may be required (unusually high doses may be required), as foods containing soy can interfere with intestinal absorption of levothyroxine, thus reducing its effectiveness.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you might have a pregnancy, or are planning to become pregnant, you should consult your doctor or pharmacist before using this drug.
During pregnancy and breastfeeding, proper thyroid hormone therapy is especially important. Therefore, it must be continued continuously under the supervision of the attending physician. Despite the widespread use of the drug during pregnancy, undesirable effects of levothyroxine on the course of pregnancy and on the health of the fetus or newborn have been identified so far.
Thyroid function should be monitored both during and after pregnancy. Due to the increased level of estrogen in the blood (female sex hormone), the need for thyroid hormone during pregnancy may increase, which may require a dose adjustment by the attending physician.
During pregnancy, L-Thyroxin 150 Berlin-Chemie should not be taken simultaneously with drugs for the treatment of hyperthyroidism (thyreostatics), as this leads to the need for higher doses of thyreostatics. Thyrostatics can (unlike levothyroxine) cross the placenta into the fetal bloodstream and lead to hypothyroidism in the fetus. Therefore, hyperthyroidism during pregnancy should be treated with extremely low doses of thyreostatics.
The amount of thyroid hormone that passes into breast milk is very small even with therapy with high doses of levothyroxine and, therefore, the drug is not dangerous.
During pregnancy and breastfeeding, your doctor should not perform a thyroid suppression test.
There is no scientific evidence of impaired fertility in men or women. There are no suspicions or indications of this.
Influence on the ability to drive vehicles and service mechanisms
Since levothyroxine is identical to the natural thyroid hormone, L-Thyroxine 150 Berlin-Chemie is not expected to affect the ability to drive or operate machinery.
Studies on the effect of the drug L-Tyroxin 150 Berlin-Chemie on the ability to drive vehicles and maintain mechanisms have not been conducted.
How to take L-Thyroxin 150 Berlin-Chemie
L-Thyroxin 150 Berlin-Chemie should be taken strictly as directed by your doctor. If in doubt, consult your doctor or pharmacist.
The individual daily dose should be determined by the attending physician based on the results of examinations.
Dosage
Divisible tablets are available with different active ingredient contents for individual treatment, for example, for starting treatment, increasing the dose in adults, and for treating children.
Depending on the existing symptoms, the attending physician is guided by the following recommendations:
For the treatment of hypothyroidism, adults should take at the beginning 25-50 mcg of sodium levothyroxine per day. At the direction of the doctor, this dose can be increased at intervals of 2-4 weeks by 25-50 mcg of levothyroxine sodium to a daily dose of 100-200 mcg of levothyroxine sodium.
To prevent recurrence of goiter after surgical removal of goiter and treatment of benign goiter, 75-200 mcg of levothyroxine sodium should be taken per day.
After surgical intervention on the thyroid gland for a malignant tumor of the thyroid gland, 150 - 300 mcg of levothyroxine sodium should be taken per day (corresponds to 2 tablets of the drug L-Tyroxin 150 Berlin-Chemie).
When examining thyroid function using a thyroid suppression test, 75 μg of levothyroxine sodium (equivalent to 1/2 tablet of L-Thyroxin 150 Berlin-Chemie) should be taken once a day 4 weeks before the test. 3 weeks before the test, the aforementioned regimen is maintained. Then you need to take 150 μg of levothyroxine sodium (1 tablet of the drug L-Tyroxin 150 Berlin-Chemie) per day for 14 days before the radiological examination (scintigraphy).
Lower doses of thyroid hormone may also be sufficient.
Children with decreased thyroid function (congenital and acquired hypothyroidism)
- For long-term treatment of decreased thyroid function (congenital and acquired hypothyroidism), the maintenance dose is usually 100-150mcg of levothyroxine per square meter of body surface area per day.
- For newborns and infants with a congenital decrease in thyroid function, for whom rapid replenishment of levothyroxine in the body is especially important for their normal mental and physical development, the recommended initial dose is 10-15 μg of levothyroxine per kilogram of body weight per day during the first 3 months. Then the doctor must select the dose on an individual basis - depending on the clinical data (especially on the level of thyroid hormone in the blood).
- For children with acquired decreased thyroid function, the recommended starting dose is 12.5-50 mcg of levothyroxine per day. Every 2-4 weeks, the doctor should gradually increase this dose until the full dose is reached, when the hormone replacement is complete. At the same time, for the doctor, the level of the thyroid hormone in the blood is of particular importance.
Elderly patients, patients with coronary artery disease, and patients with hypothyroidism
Treatment with thyroid hormones should be initiated with extreme caution in elderly patients, patients with coronary artery disease, and in patients with severe or prolonged hypothyroidism. This means that taking the drug should start with the lowest dose and increase it slowly, at long intervals, exercising frequent control of thyroid hormones.
Patients with low body weight and patients with large nodular goiter
The accumulated experience shows that with low body weight and in the presence of a large nodular goiter, a lower dose of the drug is also quite sufficient.
Tablet splitting note:
The tablets can be divided into two equal portions.
Place the tablet on a hard, level surface with the scoring notch facing up. After pressing on the tablet with your finger, it will divide into two halves.
Mode of application
The full daily dose should be swallowed with plenty of liquid, if possible with a glass of water. The drug should be taken in the morning on an empty stomach, at least half an hour before breakfast.
It is better to take the drug on an empty stomach than before or after meals.
For infants, the full daily dose should be given at least half an hour before the first meal. The tablet should be dissolved in a small amount of water (10-15 ml) and the resulting suspension should be given to the baby (each time it must be freshly prepared!) With some additional amount of liquid (5-10 ml).
Duration of use
In case of hypothyroidism and after surgery on the thyroid gland for a malignant tumor of the thyroid gland, L-Tyroxin 150 Berlin-Chemie is usually taken throughout life. In case of benign goiter and for the prevention of goiter recurrence: from several months or years to taking it throughout life. For the treatment of benign goiter with normal thyroid function, a treatment period of 6 months to two years is required. If treatment with L-Tyroxin 150 Berlin-Chemie does not bring the desired result during this time, the attending physician should consider using another treatment.
What to do in case of an overdose of the drug L-Tyroxin 150 Berlin-Chemie
An overdose of levothyroxine can cause symptoms of hyperthyroidism and acute psychosis, especially in patients at high risk of psychotic disorders.
Other signs of overdose are described in the section "Possible side effects". If you experience these symptoms, you should consult your doctor.
If you forget to take the drug L-Thyroxin 150 Berlin-Chemie
If you have taken too little dose or missed a dose, do not take a double dose to compensate for the missed dose. The next pill should be taken at the usual time, observing the established frequency of administration.
If you stop taking the drug L-Thyroxin 150 Berlin-Chemie
For treatment to be successful, L-Tyroxin 150 Berlin-Chemie must be taken regularly at the prescribed dosage. Treatment should not be changed, interrupted or completed early at its discretion under any circumstances, as the symptoms of the disease may recur.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Possible side effects
Like all medicines, L-Thyroxin 150 Berlin-Chemie can cause side effects, although not everybody gets them.
Dose level intolerance, overdose
If in some cases the dose level is not tolerated by the patient or an overdose has occurred, then, especially in the case of a too rapid increase in the dose at the beginning of treatment, typical signs of an overactive thyroid gland may occur:
- cardiopalmus
- abnormal heart rhythms, especially increased heart rate (tachycardia)
- pain accompanied by a feeling of squeezing in the chest (angina pectoris)
- muscle weakness and muscle cramps
- feeling hot, excessive sweating
- shaking (tremor)
- anxiety, insomnia
- diarrhea, weight loss
- headache
- menstrual irregularities
There may also be atypical signs such as fever, vomiting, and increased brain pressure (especially in children).
There have been reports of cases of angioedema (Quincke's edema).
Hypersensitivity to the active substance or other components of the drug L-Tyroxin 150 Berlin-Chemie
In the presence of hypersensitivity to levothyroxine or any other component of L-Tyroxin 150 Berlin-Chemie, allergic skin reactions and allergic reactions from the respiratory tract may occur. If hypersensitivity reactions occur, stop taking the drug and consult a doctor immediately.
If any side effects occur, inform your doctor. He will determine if the daily dose should be reduced or if the pill should be interrupted for a few days. Immediately after the disappearance of the side effect, it is recommended to resume treatment, carefully choosing the dose of the drug.
Message about the occurrence of side effects
If you experience any side effects, inform your doctor or pharmacist about it. This applies to any side effects, including those not listed in this leaflet.
How to store L-Thyroxin 150 Berlin-Chemie
Keep this drug out of the reach of children.
Do not use this drug after the expiration date printed on the blister and cardboard box. The expiry date refers to the last day of the specified month.
Store at a temperature not exceeding 25 ° C.
Do not throw away any medicinal products down the drain. Talk to your pharmacist about how to dispose of unnecessary medication. These measures help to protect the environment.
The tablets can be divided into two equal halves.
Package
Primary packaging: Aluminum-aluminum blister
Blister made of coated aluminum foil and hermetically sealed with aluminum foil
One original package contains: 100 tablets (4 blisters of 25 tablets) and a package insert.
Vacation conditions
L-Thyroxin 150 Berlin-Chemie is a prescription only.
Applicant / manufacturer information
BERLIN-CHEMY AG
Gliniker Veg 125
12489 Berlin
Germany
Taking tirocsin is recommended for various abnormalities in the thyroid gland. Under the action of the drug, metabolic processes are accelerated, the work of the cardiovascular system is activated. Like all medicines, L-thyroxine has contraindications and is capable of causing side effects, therefore, it should be used only in the dosage indicated by the attending physician.
The main active ingredient of the drug is sodium levothyroxine. It can be contained in a medicine at a dosage of 25, 50, 75 and 100 mcg. Also in the composition there are auxiliary components, including lactose.
L-thyroxine is classified as hormonal by the instructions for use. The remedy is used if the body lacks l-thyroxine. This condition is caused by injury, surgical removal of the thyroid gland, radiation injury, functional failures in the production of thyroid-stimulating hormone, insufficient intake of iodine, amino acids and other necessary components into the body.
The active substance of the drug has the same properties as the endogenous human thyroid hormone. The body metabolizes levothyroxine into liothyronine. It enters the composition of cells and tissues, regulating their growth and development, influencing metabolic processes.
The medication has the following properties:
- Influences the oxidation processes in mitochondria and regulates the internal and external cellular flow of cations.
- In small doses, the agent has an anabolic effect.
- Medium dosage can affect cells and tissues.
- Promotes an increase in tissue oxygen demand.
- Promotes the stimulation of oxidative processes.
- Under the action of the active component, an accelerated breakdown of proteins, fats and carbohydrates occurs.
- The work of the cardiovascular system is activated.
- Stimulates the functions of the central nervous system.
- Higher doses contribute to the suppression of the production of thyrotropin-releasing factor by the hypothalamus, due to which thyroid-stimulating hormone (TSH) is produced by the pituitary gland in smaller quantities.
You can notice an improvement in well-being within three days after starting to use the drug. If you use the drug for six months, then you can achieve a decrease or complete disappearance of diffuse goiter of the thyroid gland.
L-thyroxine is a useful remedy in the treatment of thyroid diseases, but for a positive result, the instructions for use must be carefully followed.
After taking the drug, it is absorbed by 80% from the gastrointestinal tract. The highest concentration of the active ingredient in the blood is observed within six hours. The free hormone quickly exchanges with levothyroxine.
The half-life of the active component occurs at different times, depending on how much thyroxine (T4) and triiodothyronine (T3), calcitonin, as well as thyroglobulin necessary for the synthesis of these hormones are contained in the body.
If hormones in the blood are concentrated in excessive doses, then the drug is excreted within four days. With low hormone levels, half-life lasts for ten days.
With normal functioning of the thyroid gland and the absence of abnormalities in the production of hormones, the active substance is excreted in seven days.
After taking the pill, the drug is metabolized in the liver and kidneys into active liothyronine. Excretion of levothyroxine is carried out with bile.
L-thyroxine tablets are prescribed as part of replacement therapy if the thyroid gland does not produce enough hormones. The drug is used to eliminate primary and secondary hypothyroidism after surgical treatment of the thyroid gland, as well as after a therapeutic course with radioactive iodine.
Also, the tool can be prescribed:
- To eliminate congenital or acquired hypothyroidism.
- With edema of the mucous membrane caused by insufficient supply of thyroid hormones.
- With delayed physical and mental development.
- For obesity caused by hormone imbalance. For weight loss, the drug is used quite often.
- For the treatment of diseases of cerebral-pituitary origin.
- As a prophylactic agent in the presence of recurrent goiter after surgery, if the thyroid gland is functioning normally.
- As part of the combined treatment of diffuse goiter, after compensatory therapy with thyrostatic drugs.
- With Graves' pathology.
- With Hashimoto's autoimmune thyroiditis.
- As part of the treatment of a highly differentiated hormone-dependent thyroid tumor. With follicular and papillary carcinomas.
Also, the use of thyroxine is recommended as a substitution or suppressive treatment for malignant processes in the thyroid gland, as well as after surgery for thyroid cancer.
The drug is used as a diagnostic tool in the thyroid suppression test.
L-thyroxine, dosages and methods of administration
To achieve a positive effect of the drug, it must be taken in accordance with the recommendations of the doctor. The instruction says that they use the hormone in the morning on an empty stomach. After taking the medicine, half an hour should pass before breakfast. The entire daily dosage is taken at one time and washed down with clean water.
If treatment is prescribed for an infant, the tablet should be crushed and dissolved in a small amount of water. The resulting solution is given half an hour before the first feeding in the morning. Cooking should be done just before the meal, not before.
The dosage is selected individually, taking into account the weight, age, severity and nature of the developing pathology, as well as after studying the results of laboratory tests characterizing the functioning of the thyroid gland.
The following dosages are usually used:
- At the very beginning of treatment, to eliminate hypothyroidism and with euthyroid goiter, 25 to 100 mcg per day are prescribed.
- The dosage must be gradually increased. This is done every two to three weeks, not more than 50 mcg, until the maximum maintenance dose is reached.
- For the treatment of children, the dosage of l-thyroxine is 25-100 mcg per day, the required dose is reached in the same way as in the case of adults.
If hypothyroidism is severe or with a long-standing disease, treatment is started with lower doses and the increase is carried out more slowly.
If the need for replacement therapy has arisen after surgery on a malignant tumor, then the dosage of the drug "L-thyroxine" will be from 150 to 300 mcg throughout the day.
If the development of hypothyroidism occurred as a result of resection of a part of the gland or the entire organ, then it is necessary to take levothyroxine throughout life.
To carry out a suppression scintigram, 200 mcg of levothyroxine per day should be consumed for two weeks.
L-thyroxine - the instructions for use describe in detail that if the dosage is not observed, there is a high risk of adverse reactions.
Adverse effects are rare, but in some patients, the pills lead to:
- An increase in body weight as a result of an increase in appetite, after therapy, weight loss will be required.
- Hair loss.
- Failure of the kidneys.
If the drug is taken by a child with epilepsy or seizures, these diseases are aggravated.
Long-term use of excessive doses of drugs leads to the appearance of symptoms of hyperthyroidism.
In humans:
- the heart rate increases;
- limbs tremble;
- disturbed sleep and wakefulness;
- there is an unreasonable anxiety and anxiety.
Also, patients may feel angina pectoris, suffer from increased sweating, diarrhea, vomiting. There are cases of patients losing weight under the influence of the drug.
In rare cases, allergic dermatitis develops.
If there are side reactions, then it is necessary to reduce the dosage or stop using the drug until you feel better. After that, the course of treatment is resumed with a lower dosage.
You need to take the medicine under the supervision of doctors, since it has contraindications in the form of:
- individual intolerance;
- thyrotoxicosis of various origins, which was not healed to the end;
- heart rhythm disturbances;
- ischemic heart disease, angina pectoris;
- circulatory failure in the coronary arteries;
- organic lesions of the heart muscle;
- hypertension;
- insufficiency of adrenal function, in which aldosterone is not produced in the required quantities.
Also, the medicine should not be used after the age of 65. But these contraindications do not apply to substitution therapy.
Substitution treatment cannot be carried out only with individual intolerance to individual components of the drug. In other cases, it is allowed to use the medicine.
During pregnancy, the drug is recommended if indicated. It does not possess embryotoxic and teratogenic effects; it penetrates the placental barrier poorly. During the treatment of the drug, penetration of its active component into breast milk is observed.
In the second and third trimester of pregnancy, more thyroid hormones are needed, so the dosage can be adjusted.
It is undesirable to combine thyroxine with thyrostatic drugs during childbearing and breastfeeding, as this will affect prolactin, worsen the quality of breast milk and lead to the development of hypothyroidism in the baby.
It is necessary to monitor the amount of thyroid hormones and estradiol in the body during pregnancy planning.
L-thyroxine - the price of the drug starts from 106 rubles, depending on the dosage.
There are also analogues of the remedy.
These include: 
- Eutirox. The drug is prescribed after removal of the thyroid gland, after surgery for thyroid cancer, as well as for the treatment and prevention of goiter.
- Bagotyrox. Suitable for the treatment of hypothyroidism of various etiologies.
- Tivoral. After surgery for thyroid cancer, with euthyroid goiter.
The doctor can prescribe l-thyroxine, the price of which is quite affordable, or its analogue, if indicated.
L-thyroxine, reviews
L-thyroxine tablets have mostly positive reviews. Since the price of the drug is quite affordable, everyone can buy it if necessary.
Many patients report that after taking the drug for three to five days, there was relief. Adverse reactions are rare and usually in case of excess dosage or non-compliance with the regimen.
Interaction with other drugs
During treatment with levothyroxine, it is necessary to become familiar with its ability to influence other drugs:
- It helps to reduce the effectiveness of antidiabetic drugs, therefore, if a person with diabetes is undergoing treatment, he must monitor the blood sugar level, if necessary, adjust the dose of insulin or other antidiabetic drugs.
- If you simultaneously take thyroxine with cardiac glycosides, then the effect of their use is reduced.
- The pharmacological action of antidepressants under the influence of levothyroxine decreases.
- Under the influence of estrogens, the effectiveness of thyroxine decreases.
During the preparation of the course of treatment, it is necessary to inform the doctor about all the drugs taken.
If an overdose occurs, thyrotoxicosis occurs up to a thyrotoxic crisis. This condition requires medical attention. To eliminate the problem, it is necessary to cancel the drug, intramuscularly inject glucocorticosteroids and prescribe beta-blockers. In severe cases, they resort to plasmapheresis.
Composition
One tablet of L-Tyroxin 50 Berlin-Chemie contains 53.2 - 56.8 μg of levothyroxine sodium x H 2 O (which corresponds to 50 μg of levothyroxine sodium).
For a complete list of excipients, see the List of Excipients.
Description
Round, slightly convex tablets from almost white to slightly beige in color, with a notch for division on one side and embossed "50" on the other.
The tablets can be divided into two equal portions with the same dosage.
Pharmacotherapeutic group
Means for the treatment of thyroid diseases. Thyroid hormones.
ATX code: H03AA01
Indications for use
Substitution of thyroid hormones in hypothyroidism of any etiology
- Prevention of recurrence of goiter after removal of euthyroid goiter
- Euthyroid benign goiter
- Adjuvant therapy against the background of therapy of hyperthyroidism with thyreostatics after reaching the state of euthyroidism
- Suppressive and replacement therapy for malignant neoplasms of the thyroid gland, mainly after thyroidectomy
L-Thyroxin 50 Berlin-Chemie is indicated for use in all age groups.
Dosage and method of administration
Dosage
Dosage instructions are considered as a guide. The individual daily dose should be determined based on the results of laboratory and clinical studies.
Thyroid hormone therapy should be started at low doses and gradually increased every 2–4 weeks until the full replacement dose is reached.
If residual thyroid function is preserved, a lower dose may be sufficient for replacement therapy.
In elderly patients, in patients with coronary artery disease, and in patients with severe or chronic hypothyroidism, treatment with thyroid hormones should be initiated with extreme caution - for example, it is recommended to start treatment with a lower dose (for example, 12.5 micrograms of levothyroxine per day), and increase it slowly, at significant intervals (for example, gradually increase the dose of 12.5 micrograms of levothyroxine per day
every 14 days), often checking thyroid hormone levels. The dose of levothyroxine should be lower than the dose required for complete replacement; therefore, not sufficient to completely normalize TSH levels.
Experience has shown that both in patients with low body weight and in patients with large nodular goiter, lower doses of the drug are sufficient.
Since the T 4 or fT 4 level may be elevated in some patients, the determination of the serum TSH concentration is better for monitoring the treatment regimen.
|
Indication |
Dose (micrograms of levothyroxine sodium per day) |
| Hypothyroidism: Adults (25-50 mcg increase at 2-4 week intervals) At the beginning Then |
25-50 |
| Prevention of goiter recurrence: |
75 - 200 |
| Euthyroid benign goiter: |
75 - 200 |
| Adjuvant therapy against the background of thyreostatic therapy for hyperthyroidism: |
50-100 |
| After thyroidectomy due to a malignant neoplasm of the thyroid gland: |
150-300 |
The maintenance dose is usually 100-150 μg of levothyroxine per m2 of body surface area per day.
For newborns and infants with congenital hypothyroidism who require rapid replacement of missing hormones with levothyroxine, the recommended initial dose of levothyroxine for use in the first 3 months is 10-15 μg per kg of body weight per day. In the future, the dose should be adjusted individually, based on clinical data, as well as the level of thyroid hormones and TSH.
For children with acquired hypothyroidism, the recommended starting dose of levothyroxine is 12.5 - 50 mcg per day. Based on clinical data, as well as the level of thyroid hormones and TSH, the dose should be increased gradually at intervals of 2 to 4 weeks until the full dose required for replacement therapy is reached.
Dosage in Elderly Patients
In some cases, in elderly patients, for example, in patients with heart disease, preference should be given to a gradual decrease in the dose of levothyroxine sodium with regular determination of the TSH level.
Mode of application
The full daily dose is taken orally on an empty stomach with liquid; the drug is taken in the morning, at least half an hour before breakfast.
Infants are given their full daily dose at least half an hour before their first meal of the day. The tablets should be pre-dissolved in a small amount of water (10-15 ml), and the resulting suspension, which should only be freshly prepared, should be given to the baby by adding some more liquid (5-10 ml) to it.
Duration of use
With hypothyroidism and after thyroidectomy due to a malignant neoplasm of the thyroid gland - as a rule, throughout life; with euthyroid goiter and for the prevention of recurrence of goiter - from several months or years to use throughout life; with adjuvant therapy for hyperthyroidism - depending on the duration of thyreostatic therapy.
The duration of treatment for euthyroid goiter should be from 6 months to two years. If during this time, therapy with L-Tyroxin 50 Berlin-Chemie does not bring the desired result, other treatment options should be considered.
When you skip the next dose of the drug
In case of taking too small a dose or skipping the drug, you cannot take a double dose to compensate for the missed one. The next pill should be taken at the usual time, observing the established frequency of administration.
Contraindications
Hypersensitivity to the active substance or any of the excipients listed in the "List of excipients" section.
- Untreated hyperthyroidism
- Untreated adrenal insufficiency
- Untreated pituitary insufficiency (this leads to adrenal insufficiency, which requires treatment)
- Acute myocardial infarction
- Acute myocarditis
- Acute pancarditis
During pregnancy, it is contraindicated to take levothyroxine simultaneously with thyreostatic agents.
Special instructions and precautions for use
Before starting thyroid hormone therapy, the presence or treatment of the following diseases or conditions should be excluded:
- Cardiac ischemia
- Angina pectoris
- Atherosclerosis
- Hypertension
- Pituitary insufficiency and / or insufficiency of the adrenal cortex
- Thyroid autonomy
In ischemic heart disease, heart failure, tachyarrhythmias, myocarditis outside the exacerbation phase, chronic hypothyroidism, or in patients who have had myocardial infarction, it is imperative to avoid pharmacologically induced hyperthyroidism, even in its mild degree. During therapy with thyroid hormones, these patients should undergo more frequent monitoring of thyroid hormone levels (see section "Dosage and method of administration").
In secondary hypothyroidism, it is necessary to check for the presence of concomitant adrenocortical insufficiency. In the presence of this disease, replacement therapy (hydrocortisone) should be carried out first.
If thyroid autonomy is suspected, a TRH test or thyroid suppression scintigraphy is recommended.
In postmenopausal women who are at increased risk of developing osteoporosis, while using levothyroxine, thyroid function should be checked more often in order to avoid an increase in the concentration of levothyroxine in the blood to levels higher than physiological.
Thyroid hormones should not be used for weight loss. In patients with euthyroid metabolism, normal doses do not lead to weight loss. Higher doses can lead to serious or even life-threatening adverse events, especially when combined with certain weight loss medications.
If a regimen of levothyroxine therapy is established, switching to another drug containing thyroid hormones should be carried out only under the supervision of laboratory tests and clinical data.
For patients with diabetes and patients receiving anticoagulants, see the section "Interaction with other medicinal products and other forms of interaction"
In very rare cases, there have been reports of hypothyroidism resulting from the simultaneous use of sevelamer and levothyroxine. Therefore, in patients receiving both drugs, it is recommended to carefully monitor the level of TSH (see also the section "Interaction with other drugs and other forms of interaction").
Interaction with other medicinal products and other forms of interaction
Antidiabetic drugs:
Levothyroxine can weaken the effect of antidiabetic drugs, which is to lower blood glucose levels. Therefore, people with diabetes should regularly check their blood glucose levels - mainly at the beginning of thyroid hormone therapy. If necessary, it is necessary to adjust the dose of the antihyperglycemic drug.
Coumarin derivatives:
Levothyroxine can enhance the effect of coumarin derivatives, displacing them from the sites of binding to plasma proteins. For this reason, in persons simultaneously taking levothyroxine and coumarin derivatives, blood clotting should be checked regularly and, if necessary, the dose of the anticoagulant should be adjusted (dose reduction).
Ion exchange resins:
Ion exchange resins such as cholestyramine, colestipol, colesevelam, or the calcium and sodium salts of polystyrene sulfonic acid inhibit the absorption of levothyroxine; therefore, they should not be used earlier than 4-5 hours after taking L-Tyroxin 50 Berlin-Chemie.
Aluminum-containing antacids, as well as iron-containing and calcium-containing drugs:
The absorption of levothyroxine may decrease in the case of the simultaneous use of aluminum-containing antacids (antacids, sucralfate), iron-containing drugs and calcium-containing drugs. Therefore, L-Thyroxin 50 Berlin-Chemie should be taken at least two hours before taking these funds.
Sevelamer and lanthanum carbonate:
Sevelamer and lanthanum carbonate, presumably, can reduce the bioavailability of levothyroxine (see also the section "Interaction with other medicinal products and other forms of interaction"). Therefore, in patients simultaneously taking sevelamer and levothyroxine, it is recommended to carefully monitor the level of TSH. The dose of levothyroxine can be adjusted if necessary.
Tyrosine kinase inhibitors:
Tyrosine kinase inhibitors (imatinib and sunitinib) can reduce the effectiveness of levothyroxine. Therefore, it is recommended that patients be monitored for changes in thyroid function at the beginning and at the end of combination therapy. If necessary, the dose of levothyroxine should be adjusted.
Propylthiouracil, glucocorticoids and beta blockers:
These substances inhibit the conversion of T 4 to T 3
Amiodarone and iodinated X-ray contrast agents due to the high iodine content, they can cause both hyperthyroidism and hypothyroidism. Particular care is required for nodular goiter with possibly existing but undiagnosed autonomy. Due to the effect of amiodarone on the function of the thyroid gland, it may be necessary to adjust the dose of L-Tyroxin 50 Berlin-Chemie.
Phenytoin
Phenytoin can displace levothyroxine from plasma protein binding sites. This leads to an increase in plasma levels of free thyroxine (fT 4) and free triiodothyronine (fT 3). On the other hand, the metabolism of phenytoin in the liver is increased. Careful monitoring of thyroid hormone levels is recommended.
Salicylates, dicumarol, furosemide, clofibrate:
Salicylates, dicumarol, high doses of furosemide (250 mg), clofibrate and other substances can displace levothyroxine from plasma protein binding sites. This leads to an increase in the level of free thyroxine (fT 4) in the blood plasma.
Estrogen-containing contraceptives, drugs for hormone replacement therapy in the postmenopausal period:
The need for levothyroxine may increase with the use of estrogen-containing contraceptives or hormone replacement therapy in postmenopausal women.
Sertraline, chloroquine / proguanil:
These substances reduce the effectiveness of levothyroxine and increase the level of TSH in the blood plasma.
Enzyme-inducing drugs:
Barbiturates, rifampicin, carbamazepine and other drugs that can activate liver enzymes can increase the clearance of levothyroxine through the liver.
Protease inhibitors:
There is a decrease in the therapeutic effect of levothyroxine when used together with lopinavir, ritonavir and indinavir. Therefore, patients concurrently taking levothyroxine and protease inhibitors need to closely monitor clinical symptoms and thyroid function. If necessary, the dose of levothyroxine should be adjusted.
Soy products can reduce intestinal absorption of levothyroxine. Increased plasma TSH levels have been reported in children on a soy diet and taking levothyroxine for congenital hypothyroidism. To achieve normal plasma T 4 and TSH levels, unusually high doses of levothyroxine may be required. During and after discontinuation of the soy diet, plasma T 4 and TSH levels should be closely monitored; it may be necessary to adjust the dose of levothyroxine.
Fertility, pregnancy and lactation
Pregnancy
Thyroid hormone therapy should not be interrupted during pregnancy. Despite its widespread use during pregnancy, there is still no information on the presence of undesirable effects of levothyroxine on the course of pregnancy or on the health of the fetus / newborn.
Due to estrogen, the need for levothyroxine may increase during pregnancy. For this reason, during pregnancy, the function of the thyroid gland should be monitored, and, if necessary, the dose of thyroid hormone should be adjusted.
The use of levothyroxine as an adjuvant therapy in the treatment of hyperthyroidism with thyreostatics during pregnancy is contraindicated. With the additional administration of levothyroxine, an increase in the dose of thyreostatics may be required. Unlike levothyroxine, thyrostatics can cross the placental barrier in doses that have an effect. This can lead to hypothyroidism in the fetus. For this reason, in pregnant women with hyperthyroidism, thyrostatic drugs should always be used as monotherapy and in low doses.
A thyroid suppression test should not be performed during pregnancy.
Lactation
Thyroid hormone therapy should not be interrupted during lactation. At present, there is no information on the presence of undesirable effects of levothyroxine on the health of the newborn. Even in the case of high-dose levothyroxine, thyroid hormones pass into breast milk in quantities that are not sufficient to develop hyperthyroidism in infants or to suppress TSH secretion.
Due to estrogen, the need for levothyroxine may increase during pregnancy. For this reason, after pregnancy, thyroid function should also be monitored, and, if necessary, the dose of thyroid hormone should be adjusted.
During lactation, a thyroid suppression test should not be performed.
Fertility
There is no scientific evidence of impaired fertility in men or women. There are no suspicions or indications of this.
Influence on the ability to drive vehicles and service mechanisms
There have been no studies examining the effect on the ability to drive vehicles and maintain mechanisms.
Side effects
If used correctly and provided that the clinical and laboratory parameters are monitored, the occurrence of side effects during treatment with L-Tyroxin 50 Berlin-Chemie is unlikely. In some cases, with intolerance to the drug at a certain dose or in cases of overdose, especially as a result of a too rapid increase in the dose at the beginning of treatment, symptoms of hyperthyroidism such as palpitations, arrhythmias, especially tachycardia, angina pectoris, muscle weakness and muscle cramps, sensation fever, sweating, tremors, anxiety, insomnia, weight loss, diarrhea, headache, menstrual irregularities. Fever, vomiting, and idiopathic intracranial hypertension (especially in children) can be observed as atypical symptoms. In such cases, you should either reduce the daily dose of the drug, or cancel it for several days. Immediately after the disappearance of the undesirable phenomenon, treatment can be resumed with a careful selection of the dose.
In case of hypersensitivity to levothyroxine or to any of the excipients of the drug L-Tyroxin 50 Berlin-Chemie, allergic reactions from the skin and respiratory tract are possible. There are isolated reports of the development of anaphylactic shock. There are separate reports on the development of angioedema (Quincke's edema). In this case, taking the pills should be discontinued.
Reported Adverse Reactions
If the listed adverse reactions occur, as well as a reaction not specified in the instructions for use, you should consult a doctor.
The reporting of side effects after registration of a medicinal product plays an important role. This allows you to continue monitoring the benefit / risk ratio for this drug.
Health workers are required to report any side effects through the national alert system.
Overdose
As an indicator of overdose, an increase in the T 3 level is more reliable than an increase in the T 4 or fT 4 level.
In case of overdose and intoxication, symptoms occur that are characteristic of a moderate or significant acceleration of metabolism (see section "Side effects"). Depending on the degree of overdose, it is recommended to stop taking the drug and undergo a follow-up examination.
In cases of human intoxication (attempted suicide), levothyroxine in doses up to 10 mg is tolerated without complications. The development of such serious complications as impaired vital functions (breathing and circulation) is unlikely, provided there is no history of coronary heart disease. Despite this, there are reports of the development of a thyrotoxic crisis, seizures, heart failure and coma. There are isolated reports of sudden cardiac death in patients with a history of long-term levothyroxine abuse.
In cases of acute overdose, absorption of the drug from the gastrointestinal tract can be reduced by taking activated charcoal. Treatment is usually symptomatic and supportive. Severe beta-sympathomimetic symptoms such as tachycardia, anxiety, agitation, or hyperkinesia can be alleviated with beta-blockers. The use of thyrostatics is not indicated, since the function of the thyroid gland is already completely suppressed.
In the case of taking the drug in a very high dose (suicide attempt), it is advisable to carry out plasmapheresis.
In case of an overdose of levothyroxine, long-term observation is necessary. Due to the gradual conversion of levothyroxine to liothyronine, the development of symptoms may be delayed up to 6 days.
Pharmacological properties
Pharmacodynamic properties
Mechanism of action
Synthetic levothyroxine, which is part of L-Thyroxin 50 Berlin-Chemie, is identical in action to the natural thyroid hormone, which is produced mainly by the thyroid gland. There are no differences between endogenous and exogenous levothyroxine for the body.
Pharmacodynamic action
After partial conversion to liothyronine (T 3), mainly in the liver and kidneys, and after entering the cells of the body, thyroid hormones cause specific effects, affecting the development, growth and metabolism through the activation of T 3 receptors.
Clinical efficacy and safety
Substitution of thyroid hormones leads to the normalization of metabolic processes. For example, taking levothyroxine leads to a significant reduction in high cholesterol levels associated with hypothyroidism.
Pharmacokinetic properties
Suction
In the case of taking levothyroxine orally on an empty stomach, the drug is absorbed mainly in the upper part of the small intestine, and the degree of absorption depends mainly on the dosage form and can be up to 80%. T max is approximately 5-6 hours. In the case of taking levothyroxine with food intake, absorption is significantly reduced.
After the first oral administration, the effect usually occurs after 3-5 days.
Distribution
The volume of distribution is approximately 10-12 liters. Approximately 99.97% of levothyroxine is bound to specific transport proteins. The binding of proteins to the hormone is not covalent, and therefore there is a constant and very rapid exchange between free and bound hormone.
Withdrawal
The metabolic clearance of levothyroxine is approximately 1.2 L of plasma / day. Cleavage occurs mainly in the liver, kidneys, brain and muscles. Metabolites are excreted in urine and feces.
The half-life of levothyroxine is approximately 7 days; with hypothyroidism, it can increase (up to approximately 9-10 days), and with hyperthyroidism, it can decrease (up to 3-4 days).
Pregnancy and lactation
Levothyroxine crosses the placenta only in small amounts. When taking the drug in usual doses, levothyroxine passes into breast milk only in small amounts.
Renal dysfunction
Due to the high degree of protein binding, neither hemodialysis nor hemoperfusion affects the level of levothyroxine.
Preclinical safety data
Acute toxicity
Levothyroxine has a very low acute toxicity.
Chronic toxicity
Chronic toxicity studies have been carried out in various animal species (rats, dogs). Against the background of the use of the drug in high doses, rats showed signs of toxic effects on the liver, an increased frequency of spontaneous nephrosis, as well as changes in the weight of organs. No significant side effects were observed in dogs.
Mutagenicity
There are no data on studies of the mutagenic potential of levothyroxine. So far, no data has been obtained that would indicate the occurrence in the offspring of disorders caused by changes in the genome.
Carcinogenicity
Long-term studies of the carcinogenic effect of levothyroxine in animals have not been conducted.
Reproductive toxicity
Thyroid hormones cross the placenta only in very small amounts. There is no scientific evidence of impaired fertility in men or women. There are no suspicions or indications of this.
List of excipients
Calcium hydrogen phosphate dihydrate, microcrystalline cellulose, sodium starch glycolate (type A) (Ph. Eur.), Dextrin (from corn starch), long-chain partial glycerides
Vacation conditions
L-Thyroxin 50 Berlin-Chemie is a prescription only
Manufacturer (applicant) information
BERLIN-CHEMI AG (MENARINI GROUP)
Gliniker Veg 125
12489 Berlin
Germany
In this article, you can read the instructions for using the medicinal product. L-Thyroxine... Reviews of website visitors - consumers of this medicine, as well as opinions of doctors of specialists on the use of L-Thyroxine in their practice are presented. A big request is to actively add your reviews about the drug: whether the medicine helped or did not help get rid of the disease, what complications and side effects were observed, which may not have been declared by the manufacturer in the annotation. Analogs of L-Thyroxine in the presence of available structural analogs. Use for the treatment of hypothyroidism and goiter in adults, children, as well as during pregnancy and lactation. Composition of the preparation.
L-Thyroxine- synthetic preparation of thyroid hormone, levorotatory isomer of thyroxine. After partial transformation into triiodothyronine (in the liver and kidneys) and transition into the cells of the body, it affects the development and growth of tissues, and metabolism.
In small doses, it has an anabolic effect on protein and fat metabolism. In medium doses, it stimulates growth and development, increases tissue oxygen demand, stimulates the metabolism of proteins, fats and carbohydrates, increases the functional activity of the cardiovascular system and the central nervous system. In high doses, it inhibits the production of TSH of the hypothalamus and TSH of the pituitary gland.
The therapeutic effect is observed after 7-12 days, during the same time the effect persists after the drug is discontinued. The clinical effect in hypothyroidism appears after 3-5 days. Diffuse goiter decreases or disappears within 3-6 months.
Composition
Levothyroxine sodium + excipients.
Pharmacokinetics
After oral administration, L-Thyroxine is absorbed almost exclusively from the upper part of the small intestine. Up to 80% of the dose taken is absorbed. Simultaneous food intake reduces the absorption of levothyroxine. Binds to serum proteins (thyroxine-binding globulin, thyroxine-binding prealbumin and albumin) by more than 99%. In various tissues, about 80% of levothyroxine is monodeiodinated with the formation of triiodothyronine (T3) and inactive products. Thyroid hormones are metabolized primarily in the liver, kidneys, brain and muscles. A small amount of the drug undergoes deamination and decarboxylation, as well as conjugation with sulfuric and glucuronic acids (in the liver). Metabolites are excreted in the urine and bile.
Indications
- hypothyroidism;
- euthyroid goiter;
- as replacement therapy and for the prevention of recurrence of goiter after resection of the thyroid gland;
- thyroid cancer (after surgery);
- diffuse toxic goiter: after reaching the euthyroid state with thyreostatics (in the form of combined or monotherapy);
- as a diagnostic tool when performing a thyroid suppression test.
Forms of issue
Tablets 50 mcg, 75 mcg, 100 mcg and 150 mcg.
Instructions for use and dosage
The daily dose is determined individually, depending on the indications.
L-Thyroxine in a daily dose is taken orally in the morning on an empty stomach, at least 30 minutes before a meal, with a pill with a small amount of liquid (half a glass of water) and without chewing.
When carrying out replacement therapy for hypothyroidism in patients under 55 years of age in the absence of cardiovascular diseases, L-Thyroxine is prescribed in a daily dose of 1.6-1.8 μg / kg of body weight; patients over 55 years old or with cardiovascular diseases - 0.9 μg / kg body weight. With significant obesity, the calculation should be made on the "ideal body weight".
- 0-6 months - daily dose 25-50 mcg;
- 6-24 months - daily dose 50-75 mcg;
- from 2 to 10 years - a daily dose of 75-125 mcg;
- from 10 to 16 years old - daily dose of 100-200 mcg;
- over 16 years old - a daily dose of 100-200 mcg.
- Treatment of euthyroid goiter - 75-200 mcg per day;
- Prevention of relapse after surgical treatment of euthyroid goiter - 75-200 mcg per day;
- In the complex therapy of thyrotoxicosis - 50-100 mcg per day;
- Suppressive therapy for thyroid cancer - 150-300 mcg per day.
For accurate dosage of the drug, the most appropriate dosage of the L-Thyroxin drug should be used (50, 75, 100, 125 or 150 μg).
In severe long-term hypothyroidism, treatment should be started with extreme caution, with small doses - from 25 μg per day, the dose is increased to a maintenance dose at longer intervals - by 25 μg per day every 2 weeks and more often the level of TSH in the blood is determined. In hypothyroidism, L-Thyroxine is usually taken throughout life.
In case of thyrotoxicosis, L-Thyroxin is used in complex therapy with thyreostatics after reaching the euthyroid state. In all cases, the duration of drug treatment is determined by the doctor.
For infants and children under 3 years of age, the daily dose of L-Thyroxin is given in one dose 30 minutes before the first feeding. The tablet is dissolved in water to a fine suspension, which is prepared immediately before taking the drug.
Side effect
- allergic reactions.
Contraindications
- untreated thyrotoxicosis;
- acute myocardial infarction, acute myocarditis;
- untreated adrenal insufficiency;
- increased individual sensitivity to the components of the drug.
Application during pregnancy and lactation
During pregnancy and lactation (breastfeeding), therapy with a drug prescribed for hypothyroidism should be continued. During pregnancy, an increase in the dose of the drug is required due to an increase in the level of thyroxine-binding globulin. The amount of thyroid hormone secreted in breast milk during lactation (even when treated with high doses of the drug) is not enough to cause any disturbance in the child.
The use of the drug in combination with thyrostatic drugs during pregnancy is contraindicated, because taking levothyroxine may require an increase in thyreostatics doses. Since thyrostatics, unlike levothyroxine, can penetrate the placental barrier, hypothyroidism may develop in the fetus.
During the period of breastfeeding, the drug should be taken with caution, strictly in the recommended doses under the supervision of a doctor.
Application in children
In children, the initial daily dose is 12.5-50 mcg. With a long course of treatment, the dose of the drug is determined from an approximate calculation of 100-150 μg / m2 of body surface area.
special instructions
In hypothyroidism caused by damage to the pituitary gland, it is necessary to find out whether there is simultaneously an insufficiency of the adrenal cortex. In this case, glucocorticosteroid replacement therapy (GCS) should be started prior to starting treatment of hypothyroidism with thyroid hormones in order to avoid the development of acute adrenal insufficiency.
Influence on the ability to drive vehicles and use mechanisms
The drug does not affect the ability for professional activities associated with driving vehicles and operating mechanisms.
Drug interactions
L-Thyroxine enhances the effect of indirect anticoagulants, which may require a reduction in their dose.
The use of tricyclic antidepressants with levothyroxine may increase the effect of antidepressants.
Thyroid hormones can increase the need for insulin and oral hypoglycemic drugs. More frequent monitoring of blood glucose levels is recommended during the periods of initiation of treatment with levothyroxine, as well as when changing the dose of the drug.
Levothyroxine reduces the action of cardiac glycosides. With the simultaneous use of colestyramine, colestipol and aluminum hydroxide, the plasma concentration of levothyroxine is reduced by inhibiting its absorption in the intestine.
With simultaneous use with anabolic steroids, asparaginase, tamoxifen, pharmacokinetic interaction is possible at the level of protein binding.
With simultaneous use with phenytoin, salicylates, clofibrate, furosemide in high doses, the content of levothyroxine and T4, unbound to plasma proteins, increases.
Growth hormone, when used simultaneously with L-Thyroxin, can accelerate the closure of the epiphyseal growth zones.
Taking phenobarbital, carbamazepine and rifampicin may increase the clearance of levothyroxine and require an increase in the dose.
Estrogens increase the concentration of the thyroglobulin-related fraction, which can lead to a decrease in the effectiveness of the drug.
Amiodarone, aminoglutethimide, PASK, ethionamide, antithyroid drugs, beta-blockers, carbamazepine, chloral hydrate, diazepam, levodopa, dopamine, metoclopramide, lovastatin, somatostatin affect the synthesis, secretion, distribution and metabolism of the drug.
Analogues of the drug L-Thyroxin
Structural analogues for the active substance:
- L-Thyroxin 100 Berlin-Chemie;
- L-Thyroxin 125 Berlin-Chemie;
- L-Thyroxin 150 Berlin-Chemie;
- L-Thyroxin 50 Berlin-Chemie;
- L-Thyroxin 75 Berlin-Chemie;
- L-Thyroxine Hexal;
- L-Thyroxine Acri;
- L-Thyroxin Farmak;
- Bagotyrox;
- L-Tirok;
- Levothyroxine sodium;
- Tyro-4;
- Eutirox.
In the absence of analogues of the drug for the active substance, you can follow the links below to the diseases for which the corresponding drug helps, and see the available analogues for the therapeutic effect.