L-Tyroxine 125 Berlin Chemi, tablets 125 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 in 3-5 days. Diffuse goiter decreases or disappears within 3-6 months.

Indications

Hypothyroidism, Cancer

• Hypothyroidism of any genesis: primary and secondary hypothyroidism, including.
• Hypothyroidism of any genesis: primary and secondary hypothyroidism, including after goiter surgery, as a result of radioiodine or thyreostatic therapy, and as a consequence of various thyroiditis.
• Diffuse euthyroid goiter.
• Diffuse toxic goiter: after thyrotoxicosis compensation with thyreostatics (as part of combined therapy).
• Thyroid cancer after surgical treatment (to suppress tumor recurrence and as substitution therapy).
• As a diagnostic aid in thyroid suppression test.

Active ingredient

Levothyroxine sodium

Composition

1 tabletlevothyroxine sodium125 mcg

Supplementary 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 phase 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.

Add 25 mcg at 2-month intervals until normalization of blood TSH levels.

If cardiovascular symptoms appear or worsen, correct cardiovascular therapy.

Recommended thyroxine doses for the treatment of congenital hypothyroidism

Age Daily dose of thyroxine (mcg)

/p>

Thyroxine dose per body weight (µg/kg)0-6 months 25-5010-156-24 months 50-758-10 2 to 10 years75-1254-6 10 to 16 years100-2003-4> 16 years100-2002-3

The indications

Recommended doses of L-Tyroxine Berlin-Chemie (mcg/day)

Treatment of euthyroid goiter50-200

Prevention of relapse after surgical treatment of euthyroid goiter50-200

In the complex therapy of thyrotoxicosis50-100

Thyroid cancer suppressive therapy150-300

Thyroid 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 case of 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.

Infants and children under 3 years of age take a daily dose of L-Tyroxine Berlin-Chemie 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.

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

• hyperfunction of thyroid gland of any origin;
• untreated insufficiency of adrenal cortex;
• acute myocardial infarction;
• high blood pressure, hepatic and renal dysfunction;
• high individual sensitivity to the drug.

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Side effects

Allergic reactions (in case of hypersensitivity to the drug).

There are no side effects when used correctly under the supervision of a physician.

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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