L-Tyroxine 75 Berlin Chemi, tablets 75 mcg 100 pcs

A synthetic preparation of thyroid hormone, the left-handed isomer of thyroxine. After partial conversion to triiodothyronine (in liver and kidneys) and transfer to body cells, it influences development and growth of tissues and metabolism.

In low doses it has an anabolic effect on protein and fat metabolism. In medium doses it stimulates growth and development, increases tissue oxygen demand, stimulates metabolism of proteins, fats and carbohydrates, increases functional activity of the cardiovascular system and the CNS. In high doses it inhibits hypothalamic and pituitary TTH production.

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

Pharmacokinetics

Intake

Levothyroxine is absorbed almost exclusively from the upper small intestine after oral administration. Up to 80% of the dose taken is absorbed. Simultaneous intake of food reduces absorption of levothyroxine. Cmax in blood serum is reached about 5-6 hours after oral administration.

Distribution

Bound to serum proteins (thyroxine-binding globulin, thyroxine-binding prealbumin and albumin) by more than 99%. In various tissues approximately 80% of levothyroxine is monodeiodinated with the formation of triiodothyronine (T3) and inactive products.

Metabolism

The thyroid hormones are metabolized mainly 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).

Elimination

The metabolites are excreted in the urine and bile.

The T1/2 is 6-7 days.

Pharmacokinetics in special clinical cases

In thyrotoxicosis the T1/2 is shortened to 3-4 days and in hypothyroidism it is prolonged to 9-10 days.

Indications

Cancer, Hypothyroidism

Hypothyroid conditions of different etiology (including. caused by surgery or medication), prevention of recurrence of nodular goiter after thyroid resection, diffuse euthyroid goiter; diffuse toxic goiter – after creating an euthyroid state with thyreostatics (as combined or monotherapy); Thyroid cancer after surgical treatment (in order to suppress tumor recurrence and as replacement therapy), as a diagnostic tool in the thyroid suppression test.

In the complex therapy: Graves’ disease, autoimmune thyroiditis.

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Active ingredient

Levothyroxine sodium

Composition

1 tabletlevothyroxine sodium75 mcg

Associated substances:

calcium hydrophosphate dihydrate,

microcrystalline cellulose,

Sodium carboxymethyl starch (type A),

dextrin,

long-chain partial glycerides.

How to take, the dosage

The daily dose is determined individually depending on the indication.

The daily dose of L-Tyroxine Berlin-Chemie is taken orally in the morning on an empty stomach at least 30 min before a meal, with a small amount of liquid (half a glass of water) and without chewing.

In hypothyroidism replacement therapy, patients under 55 years of age in the absence of cardiovascular disease L-Tyroxine Berlin-Chemie is prescribed at a daily dose of 1.6-1.8 mcg/kg body weight; patients over 55 years or with cardiovascular disease – 0.9 mcg/kg body weight. In case of significant obesity the calculation should be made on the “ideal body weight”.

The initial stage of substitution therapy in hypothyroidismPatients without cardiovascular disease younger than 55 yearsThe initial dose:
women – 50-100 mcg/day,
men – 50-150 mcg/dayPatients with cardiovascular disease or older than 55 yearsThe initial dose is 25 mcg/day.
Increase by 25 mcg with the interval of 2 months to the normalization of the TSH level in blood.
In case of occurrence or worsening of symptoms of cardiovascular system we should correct the therapy of cardiovascular diseases.Recommended thyroxine doses for the treatment of congenital hypothyroidismAgeDaily dose of thyroxine (mcg)Dose of thyroxine per body weight (mcg/kg)0-6 months25-5010-156-24 months50-758-10 from 2 to 10 years75-1254-6 from 10 to 16 years100-2003-4> 16 years old100-2002-3Recommended doses of L-Tyroxine Berlin-Chemie (mcg/day)Treatment of euthyroid goiter50- 200Preventive treatment of recurrence after surgical treatment of euthyroid goiter50- 200200In complex therapy for thyrotoxicosis50-100Thyroid cancer suppression therapy150-300Thyroid suppression test4 weeks before test3 weeks before test2 weeks before test1 week before test50-7575-100150-200150-200

The most appropriate dosage of L-Tyroxine Berlin-Chemie (50, 75, 100, 125, or 150 mcg) should be used for accurate dosing.

In severe long-term hypothyroidism, treatment should be started with extreme caution, with low doses of 25 mcg/day, the dose should be increased to maintenance at longer intervals – by 25 mcg/day every 2 weeks and blood TSH levels should be determined more frequently. For hypothyroidism, L-Tyroxine Berlin-Chemie is usually taken for life.

In thyrotoxicosis L-Tyroxine Berlin-Chemie is used in combination therapy with thyreostatics after achieving euthyroidism. In all cases, the duration of treatment with the drug is determined by the doctor.

Interaction

Levothyroxine increases the effect of indirect anticoagulants, which may require reducing their dose.

The use of tricyclic antidepressants with levothyroxine may increase the effect of antidepressants.

The thyroid hormones may increase the need for insulin and oral hypoglycemic medications. More frequent monitoring of blood glucose levels is recommended during periods when levothyroxine treatment is initiated and also when the dose of the drug is changed.

Levothyroxine reduces the effect of cardiac glycosides. When used concomitantly, colestyramine, colestipol and aluminum hydroxide decrease the plasma concentration of levothyroxine by inhibiting its absorption in the intestine.

In concomitant use with anabolic steroids, asparaginase, tamoxifen there may be pharmacokinetic interaction at the level of protein binding.

Concomitant use with phenytoin, salicylates, clofibrate, furosemide in high doses increases unbound plasma protein levels of levothyroxine and T4.

Somatotropin when used concomitantly with levothyroxine may accelerate the closure of epiphyseal growth zones.

The administration of phenobarbital, carbamazepine and rifampicin may increase the clearance of levothyroxine and may require increasing the dose.

Estrogens increase the concentration of the thyroglobulin-bound fraction, which may decrease the effectiveness of the drug.

Amiodarone, aminoglutethimide, PASC, etionamide, antithyroid drugs, beta-adrenoblockers, carbamazepine, chloral hydrate, diazepam, levodopa, dopamine, metoclopramide, lovastatin, somatostatin have an effect on synthesis, secretion, distribution and metabolism of the drug.

Special Instructions

In hypothyroidism caused by pituitary lesions, it is necessary to find out whether there is simultaneously insufficiency of the adrenal cortex. In this case, GCS replacement therapy should be started before treatment of hypothyroidism with thyroid hormones to avoid development of acute adrenal insufficiency.

Impact on ability to drive and operate machinery

The drug does not affect the ability to drive vehicles and work requiring increased concentration.

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Contraindications

• Hypersensitivity;
• untreated thyrotoxicosis;
• acute myocarditis;
• acute myocardial infarction;
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• high blood pressure;
• untreated insufficiency of the adrenal cortex (must be compensated before therapy).

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Side effects

• Tachycardia;
• Disorder of heart rhythm;
• Pain in the sternum;
• Tremor;
• Insomnia;

Hyperhidrosis.

• restlessness;
• insomnia;
• hyperhidrosis;
• weight loss;
• diarrhea;
• alopecia;
• adrenal dysfunction (in hypophysial or hypothalamic hypothyroidism);
• renal dysfunction in children;
• allergic reactions (skin rash, skin itching).

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Overdose

Symptoms characteristic of thyrotoxicosis: palpitations, abnormal heart rhythm, heart pain, anxiety, tremors, sleep disturbances, increased sweating, decreased appetite, weight loss, diarrhea.

Treatment:A reduction in the daily dose of the drug, a break in treatment for several days, and the prescription of beta-adrenoblockers may be recommended. After side effects have disappeared, treatment should be started with caution at a lower dose. Antithyroid drugs are not recommended.

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Pregnancy use

Treatment with levothyroxine sodium prescribed for hypothyroidism should be continued during pregnancy and breastfeeding. During pregnancy, it is required to increase the dose of the drug due to increased levels of thyroxine-binding globulin.

The amount of thyroid hormone secreted with breast milk (even when treated with high doses of the drug) is not enough to cause any disturbances in the baby during breastfeeding.

The use in pregnancy in combination with thyreostatics is contraindicated because the administration of levothyroxine sodium may require increasing doses of thyreostatics. Since thyreostatics, unlike sodium levothyroxine, can pass through the placenta, the fetus may develop hypothyroidism.

The FDA fetal category of action is A.

The drug should be taken with caution during breastfeeding, strictly in the recommended doses, under medical supervision.

Infants and children under 3 years of age take a single daily dose of the preparation L-Tyroxine Berlin-Chemie 30 min before the first feeding. The tablet is dissolved in water to a fine suspension, which is prepared immediately before taking the drug.

Similarities

Euthyrox 100, Euthyrox