L-thyroxine 50 Berlin-Chemie - instructions for use, dose, side effects, contraindications

Excipients: calcium hydrophosphate dihydrate 15.95 mg, microcrystalline cellulose 16.00 mg, sodium carboxymethyl starch (type A) 12.00 mg, dextrin 6.80 mg, long chain partial glycerides 1.20 mg.

Description:Round slightly bulbous tablets white or white with a slightly yellowish tint of color, with a risk on one side and embossed "50" on the other.

Pharmacotherapeutic group:Thyroid agent

ATX: & nbsp

H.03.A.A Thyroid hormones

H.03.A.A.01 Levothyroxine sodium

Pharmacodynamics:

Synthetic levorotatory isomer of thyroxine. After partial conversion into triiodothyronine (in the liver and kidneys) and transition into the cells of the body, it affects the development and growth of tissues, metabolism. In small doses, it has an anabolic effect on protein and fat metabolism. In medium doses stimulates growth and development, raises the need for tissues in oxygen, stimulates the metabolism of proteins, fats and carbohydrates, increases the functional activity of the cardiovascular system and the central nervous system.

In large doses, the production of thyrotropin-releasing hormone of the hypothalamus and thyroid-stimulating hormone (TTG) of the pituitary is inhibited.

Therapeutic effect is observed after 7-12 days, during the same time the action remains after drug discontinuation. The clinical effect with hypothyroidism is manifested in 3-5 days. Diffuse goiter decreases or disappears within 3-6 months.

Pharmacokinetics:

Ingestion levothyroxine sodium absorbed almost exclusively in the upper part of the small intestine. Absorbed up to 80% of the dose of the drug. Eating lowers the absorption of sodium levothyroxine.The maximum concentration in the serum is reached approximately 5-6 hours after ingestion. After absorption, more than 99% of the drug binds to blood serum proteins (thyroxine-binding globulin, thyroxine-binding prealbumin and albumin). In various tissues, approximately 80% of levothyroxine sodium monideiodinated to form triiodothyronine (T₃) and inactive products. Thyroid hormones are metabolized mainly in the liver, kidneys, brain and muscles. A small amount of the drug is subjected to 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 period is shortened to 3-4 days, and with hypothyroidism it lengthens to 9-10 days.

Indications:

- hypothyroidism;

- euthyroid goiter;

- as a replacement therapy and for the prevention of recurrence of goiter after resection of the thyroid gland;

- thyroid cancer (after surgical treatment);

- Diffuse toxic goiter: after reaching the euthyroid state with antithyroid drugs (in the form ofcombined or monotherapy);

- as a diagnostic tool in the test of thyroid suppression.

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 insufficiency of the adrenal cortex.

Carefully:

With caution should prescribe the drug for diseases of the cardiovascular system: IHD (atherosclerosis, angina pectoris, myocardial infarction in the anamnesis), arterial hypertension, arrhythmia, diabetes mellitus, severe long-term hypothyroidism, malabsorption syndrome (dose adjustment may be required).

Pregnancy and lactation:

During pregnancy and breastfeeding, therapy with a drug prescribed for hypothyroidism should continue. During pregnancy, an increase in the dose of the drug is required due to an increase in the content of thyroxine-binding globulin. The amount of thyroid hormone, secreted in breast milk during lactation (even during treatment with high doses of the drug), not enough to cause any disorder 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 penetrate the placenta, the fetus may develop hypothyroidism. During breastfeeding, the drug should be taken with caution, strictly at recommended doses under the supervision of a doctor.

Dosing and Administration:

The daily dose is determined individually depending on the indications.

L-Tyroxine 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 cup of water) and without chewing.

When carrying out substitution therapy for hypothyroidism (in the absence of cardiovascular diseases) L-Tiroksin 50 Berlin-Chemie is prescribed in a daily dose of 1.6-1.8 μg / kg body weight. With significant obesity, the calculation should be done on "ideal weight".

The initial stage of replacement therapy for hypothyroidism

Patients without cardiovascular disease younger than 55 years

- the initial dose: women - 50-100 mcg / day, men -50-150 mcg / day

Patients with cardiovascular disease or over 55 years of age

- The initial dose is 25 mcg per day

- Increase by 25 mcg with an interval of 3-6 weeks before the normalization of the TSH in the blood

- With the appearance or worsening of symptoms from the cardiovascular system, correction of cardiovascular disease

Breast children and children under 3 years of daily dose of the drug L-Tiroksin 50 Berlin-Chemie is given in one session 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, from small doses of 25 μg / day, the dose is increased to maintenance at longer intervals by 25 μg / day every 2 weeks and the concentration of TTT in the blood is more often determined. With hypothyroidism L-Tyroxine 50 Berlin-Chemie is taken, as a rule, throughout life. With thyrotoxicosis L-Tiroxin 50 Berlin-Chemie is used in complex therapy with antithyroid drugs after reaching the euthyroid status.In all cases, the duration of treatment with the drug is determined by the doctor.

Recommended doses of thyroxine for the treatment of congenital hypothyroidism
Age	The daily dose of thyroxin (μg)				The dose of thyroxin in terms of body weight (μg / kg)
0-6 months	25-50				10-15
6-24 months	50-75				8-10
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		Recommended doses (L-Tiroksin 50 Berlin-Chemie, μg / day)
Treatment of euthyroid goiter		50-200
Prevention of relapse after surgical treatment of euthyroid goiter		50-200
In the complex therapy of thyrotoxicosis		50-100
Suppressive Thyroid Cancer Therapy		150-300
Thyroid suppression test			For 4 weeks before the test	ZAZ weeks before the test		For 2 weeks before the test	For 1 a week before the test
		L - Thyroxine 50 Berlin-Chemie	75 mcg / day	75 mcg / day		150-200 mcg / day	150-200 mcg / day

To accurately dose the drug, use the most appropriate form of drug release L-Tyroxine Berlin-Chemie (50, 75, 100, 125 or 150 μg).

Side effects:

With proper application under the supervision of a doctor, side effects are not observed.

With hypersensitivity to the drug, allergic reactions can be observed.

Overdose:

In case of an overdose of the drug, symptoms typical of thyrotoxicosis are observed: tachycardia, heart rhythm disturbance, heart pain, anxiety, tremor, insomnia, hyperhidrosis, decreased appetite, weight loss, diarrhea, vomiting, headache, fatigue, muscle spasm. Depending on the severity of symptoms, a doctor may recommend a reduction 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 initiated with caution from a lower dose. Antithyroid drugs are not recommended.

Interaction:

Levotiroksin sodium increases the effect of indirect anticoagulants, which may require a reduction in their dose.

The use of tricyclic antidepressants with levothyroxine sodium may lead to an increase in the action of antidepressants.

Thyroid hormones can increase the need for insulin and oral hypoglycemic drugs. More frequent monitoring of blood glucose is recommended during the start of treatment with levothyroxine sodium, as well as when changing the dose of the drug.

Levotiroksin sodium reduces the action of cardiac glycosides. With simultaneous application colestramine, colestipol and aluminum hydroxide reduce the plasma concentration of levothyroxine sodium due to inhibition of its absorption in the intestine.

When used simultaneously with anabolic steroids, asparaginase, tamoxifen, pharmacokinetic interaction at the level of binding to the protein is possible.

When used simultaneously with phenytoin, salicylates, clofibrate, furosemide in high doses, the content of non-protein-bound plasma of levothyroxine sodium and T₄.

Somatotropin with simultaneous application with levothyroxine sodium can accelerate the closure of epiphyseal growth zones.

The intake of phenobarbital, carbamazepine and rifampicin can increase the clearance of levothyroxine sodium and require an increase in the dose.

Estrogens increase the concentration of thyreoglobulin-associated fraction, which may lead to a decrease in the effectiveness of the drug.

Amiodarone, aminoglutethimide, para-aminosalicylic acid (PASC), ethionamide, antithyroid drugs, beta-blockers, chloral hydrate, diazepam, levodopa, dopamine, metoclopramide, lovastatin, somatostatin influence the synthesis, secretion, distribution and metabolism of levothyroxine sodium.Products containing soy can reduce absorption of the drug levotiroksina sodium (may require dose adjustment).

Special instructions:

When hypothyroidism, due to the pituitary lesion, it is necessary to find out whether there is a simultaneous insufficiency of the adrenal cortex. In this case, glucocorticosteroid replacement therapy should be started before thyroid hormone therapy begins to avoid hypothyroidism in order to avoid the development of acute adrenal insufficiency.

Effect on the ability to drive transp. cf. and fur:

L-Tyroxine 50 Berlin-Chemie does not affect the ability to drive vehicles and work requiring increased concentration of attention.

Form release / dosage:

Tablets 50 mcg.

Packaging:

For 25 tablets in a contour mesh package (blister) [PVC / PVDH / aluminum foil or aluminum foil / aluminum foil].

For 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 medicine out of the reach of children!

Shelf life:

2 years.

Do not use after the expiry date printed on the package!

Terms of leave from pharmacies:On prescription

Registration number:P N008963

Date of registration:28.02.2011 / unlimited

The owner of the registration certificate:Berlin-Chemie / Menarini Pharma, GmbH Berlin-Chemie / Menarini Pharma, GmbH Germany

Manufacturer: & nbsp

BERLIN-CHEMIE, AG Germany

Representation: & nbspBERLIN-CHEMI / MENARINI PHARMA GmbH BERLIN-CHEMI / MENARINI PHARMA GmbH Germany

Information update date: & nbsp27.06.2016

Illustrated instructions

Instructions

L-thyroxine 50 Berlin-Chemie (L-Thyroxin 50 Berlin-Chemie)