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Sodium left thyroxine

Препарат Левотироксин натрия. РУП "Белмедпрепараты" Республика Беларусь


Producer: RUP of Belmedpreparata Republic of Belarus

Code of automatic telephone exchange: H03AA01

Release form: Firm dosage forms. Tablets.

Indications to use: Simple (nontoxic) craw. Cancer of a thyroid gland.


General characteristics. Structure:

Active ingredient: 0,1 mg or 0,05 mg of sodium left thyroxine.

Drug promotes completion of deficit of hormones of a thyroid gland.




Pharmacological properties:

Pharmacodynamics. In small doses has anabolic effect, – stimulates growth and development in averages, increases the need of fabrics for oxygen, regulates metabolism of proteins, fats and carbohydrates, increases functional activity of cardiovascular system and TsNS, in big – oppresses development thyrotropin-rileasing and thyritropic hormones.

Mechanisms of metabolic effects include receptor linkng with a genome, changes of oxidizing exchange in mitochondrions and a regulirvaniye of a flow of substrates and cations out of and in a cell.

The clinical effect at a hypothyroidism is shown in 3-5 days. The early diffusion hyperplastic craw decreases or disappears within 3-6 months, at late nodal stages the considerable reduction of the sizes of a thyroid gland in 30% of cases is reached, practically at all patients its further growth is prevented.

Pharmacokinetics. After intake drug is well soaked up in digestive tract. Absorption makes 48-79%. Reception on an empty stomach increases absorption of active agent. The maximum concentration in plasma is reached in 6 hours. Linkng with proteins of plasma – more than 99%. Metabolic clearance - 1,2 l of plasma a day. The semi-removal period - about 8 days. Biotransformation consists in consecutive deiodinating (including leading to formation of T3) is preferential in a liver, muscles, a brain, and also a konyyugirovaniye with glyukuronaty and sulfate in a liver.


Indications to use:

Hypothyroid conditions of various etiology (including caused by surgical or medicamentous influence), suppressive thyroid therapy of a simple (nontoxic) craw, an autoimmune thyroiditis of Hashimoto, a multinodal craw, thyreostatic treatment of a hyperthyroidism (complex therapy after achievement of an euthyroid state), the tireotropinzavisimy high-differentiated papillary or follicular carcinomas of a thyroid gland (complex treatment), prevention of a recurrence of a craw after a resection, carrying out the supressionny scintigraphic test of a thyroid gland.


Route of administration and doses:

Inside, on an empty stomach, washing down with a small amount of liquid. At a hypothyroidism – an initial dose of 25-100 mkg a day, with gradual increase (on 25-50 mkg each 2-3 weeks) to supporting – 125-250 mkg a day, after operation for a malignant tumor of a thyroid gland – to 300 mkg a day. To children – the initial dose of 12,5-50 mkg supporting 100-150 mkg a day. At complex treatment of a hyperthyroidism – 5-100 mkg a day. For carrying out the supressionny test – within 14 days of 200 mkg a day or 3 mg of 1 times in 7 days prior to a repeated stsintigramma. An euthyroid craw and prevention of its recurrence after a resection: adult – 75-200 mkg a day, to children – 12,5-150 mkg a day.


Features of use:

It is recommended to determine periodically in blood the content of thyritropic hormone which increased level indicates insufficiency of a dose of drug. Adequacy of suppressive thyroid therapy is estimated also on suppression of capture of a radioiodine. At it is long the existing multinodal craw before an initiation of treatment it is necessary to carry out the stimulation test with thyrotropin-rileasing-hormone.

In most cases at a hypothyroidism the metabolic status should be recovered gradually, especially at patients of advanced age and patients with cardiovascular pathology. For elderly patients the initial dose should not exceed 50 mkg.

With care apply at stenocardia, arterial hypertension, a tachyarrhythmia, epilepsy, at insufficiency of functions of bark of adrenal glands and a hypophysis, a diabetes mellitus. When conducting differential diagnostic test of thyroid suppression by the patient with a diabetes mellitus it is recommended to increase doses of antidiabetic means.

At children use of too high initial doses can lead to renal failures. At children with convulsive attacks their increase is possible.

At use in II and III trimesters of pregnancy the dose is usually raised for 25%. With care appoint at heavy it is long the existing hypofunction of a thyroid gland. Prior to treatment it is necessary to exclude a possibility of a pituitary or hypothalamic hypothyroidism.

At pregnancy and in the period of a lactation drug should be used under observation of the doctor. Use in a combination with thyreostatic means at pregnancy is contraindicated.


Side effects:

Tachycardia, disturbances of a rhythm, pain behind a breast, a tremor, concern, sleeplessness, a hyperhidrosis, decrease in body weight, diarrhea, an alopecia, dysfunction of adrenal glands (at a pituitary or hypothalamic hypothyroidism), disorders of function of kidneys at children. In some cases increase in body weight owing to increase in appetite can be noted.


Interaction with other medicines:

Drug strengthens effect of antidepressants, anticoagulants, reduces effect of insulin and peroral gipoglikemiziruyushchy means, cardiac glycosides. Colestyraminum, колестипол, a hydroxide of aluminum reduce drug absorption.

At simultaneous use with estrogen or estrogensoderzhashchy contraceptives for intake increase in a dose of drug can be required.

Phenobarbital and Phenytoinum accelerate metabolic clearance, without increasing a share of free T3 and T4 in blood.

Proteinaceous binding is changed by anabolic steroids, asparaginase, Clofibratum, furosemide, salicylates, Tamoxifenum.

Exert impact on synthesis, distribution and metabolism Amiodaronum, аминоглутетимид, paraaminosalatsilovy acid, Etioniamidum, anti-thyroid drugs, beta adrenoblockers, carbamazepine, Chlorali hydras, diazepam, a levodopa, dopamine, Metoclopramidum, ловастатин, somatostatin, etc.


Contraindications:

Hypersensitivity, uncured thyrotoxicosis, acute myocardial infarction, stenocardia, myocarditis, takhisistolichesky disturbances of a rhythm, heart failure, heavy idiopathic hypertensia, neskorrigirovanny dysfunction of bark of adrenal glands, advanced age (65 years are more senior).


Overdose:

Symptoms: the thyrocardiac crisis sometimes delayed for several days after administration of drug in a high dose.

Treatment: purpose of beta adrenoblockers, intravenous administration of corticosteroids, plasma exchange.



Issue conditions:

According to the recipe


Packaging:

Tablets of 0,05 mg and 0,1 mg in packaging No. 50 (No. 10х5 in blister strip packagings).



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