L-thyroxine 75 Berlin-Chemie (L-Thyroxin 75 Berlin Chemi)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceLevothyroxine sodiumLevothyroxine sodium
Dosage form: & nbsppills
Composition:

One tablet contains:

Active ingredient: levothyroxine sodium - 0.075 mg

Excipients:

calcium hydrophosphate 2-water 23.925 mg, microcrystalline cellulose 24.00 mg, carboxymethyl starch sodium salt, type A 18.00 mg, dextrin 10.20 mg, long chain partial glycerides 1.80 mg.

Description:Round, slightly biconcave tablets from white to slightly beige, with a risk for dividing on one side and embossing "75" 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, it inhibits the production of thyrotropin-releasing hormone of the hypothalamus and thyroid-stimulating hormone of the pituitary gland.

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:

When administered, levothyroxine is 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 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 serum proteins (thyroxin-binding globulin, thyroxine-binding prealbumin and albumin). In different tissues monodeiodination occurs approximately 80 % levothyroxine with the formation of 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 in urine and bile. 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 status thyreostatics (in the form of combined or monotherapy);

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

Contraindications:

- Increased individual sensitivity to the drug;

- untreated thyrotoxicosis;

- acute myocardial infarction, acute myocarditis;

- untreated adrenal insufficiency.

Carefully:

Carefully should prescribe the drug for cardiovascular disease: IHD (atherosclerosis, angina pectoris, myocardial infarction in history), arterial hypertension, arrhythmia, diabetes mellitus, severe long-term hypothyroidism, malabsorption syndrome (dose adjustment may be required).

Pregnancy and lactation:

During pregnancy and breastfeeding, the drug prescribed about hypothyroidism, should continue. 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 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 thyreostatics in pregnancy is contraindicated, since taking levothyroxine may require an increase in thyrotoxic doses. Since thyreostatics, in contrast to levothyroxine, 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- The thyroxine 75 Berlin-Chemie in a daily dose is taken orally in the morning on an empty stomach, 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 patients younger than 55 years with no cardiovascular disease L- Thyroxine 75 Berlin-Chemie is prescribed in a daily dose of 1.6-1.8 μg / kg body weight; in patients over 55 years of age or with cardiovascular diseases - 0,9 mkg / kg of 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 - 75-100 mcg / day, men -100-150 mcg / day

Patients with cardiovascular diseases or over 55 years of age

- The initial dose is 25 mcg per day

- Increase by 25 mcg with an interval of 2 months to normalize the level of TSH in the blood

- When cardiac symptoms appear or worsen, correct cardiac therapy

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- Thyroxine 75 Berlin-Chemie, μg / day)


Treatment of euthyroid goiter

75-200


Prevention of relapse after surgical treatment of euthyroid goiter

75-200


In the complex therapy of thyrotoxicosis

50-100


Suppressive Thyroid Cancer Therapy

150-300


Thyroid suppression test


For 4

weeks before the test

For 3

weeks before the test

For 2

weeks before the test

1 week before the test


L-Tyroxine 75 Berlin-Chemie

75 mcg / day

75 mcg / day

150-200

mcg / day

150-200

mcg / day













For the exact dosage of the drug, use the most appropriate dosage of the drug L-tiroxine Berlin-Chemie (50, 75, 100, 125 or 150 μg.)

Breast children and children under 3 years of age daily dose L -Tyroxine 75 Berlin-Chemie give 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 - from 25 μg / day, the dose is increased to maintenance at longer intervals - by 25 μg / day every 2 weeks and the level of TSH in the blood is more often determined. With hypothyroidism L -Tyroxine 75 Berlin-Chemie take, as a rule, throughout life. With thyrotoxicosis L -Tyroxine 75 Berlin-Chemie They are used in complex therapy with thyreostatics after reaching the euthyroid state. In all cases, the duration of treatment with the drug is determined by the doctor.

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: palpitation, heart rhythm disturbance, heart pain, anxiety, tremor, sleep disorders, excessive sweating, decreased appetite, weight loss, diarrhea.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.

Interaction:

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

The use of tricyclic antidepressants with levothyroxine 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 levels is recommended during the start of treatment with levothyroxine, as well as when changing the dose of the drug.

Levothyroxine reduces the action of cardiac glycosides. With simultaneous application colestramine, colestipol and aluminum hydroxide reduce the plasma concentration of levothyroxine 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 and T4 increases.

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

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

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

Amiodarone, aminoglutethimide, para-aminosalicylic acid (PASC), ethionamide, antithyroid drugs, beta-blockers, carbamazepine, chloral hydrate, diazepam, levodopa, dopamine, metoclopramide, lovastatin, somatostatin influence the synthesis, secretion, distribution and metabolism of the drug.

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 therapyshould be started before the beginning of treatment of hypothyroidism with thyroid hormones in order to avoid the development of acute adrenal insufficiency.
Effect on the ability to drive transp. cf. and fur:

The drug does not affect the professional activities associated with driving vehicles and controlling mechanisms.

Form release / dosage:

Tablets 75 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 with instructions for use in a cardboard box.

Storage conditions:At a temperature of no higher than 25 ° C. Keep out of the reach of children!
Shelf life:

2 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription
Registration number:LSR-001294/08
Date of registration:28.02.2008 / 29.08.2014
Expiration Date:Unlimited
The owner of the registration certificate:Berlin-Chemie / A. Menarini, LLCBerlin-Chemie / A. Menarini, LLC Russia
Manufacturer: & nbsp
Information update date: & nbsp28.06.2016
Illustrated instructions
    Instructions
    Up