Instruction for use: Thyreotom

Active substanceLevothyroxine sodium + Liothyronine

ATX codeH03AA03 Levothyroxine in combination with lyotyronine

Pharmacological group of substance Calcitonin

Hormones of the thyroid and parathyroid glands, their analogs and antagonists (including antithyroid agents) / 67 /

Nosological classification (ICD-10)

C73 Malignant neoplasm of thyroid

Thyroid cancer, Thyrotropin-Dependent Thyroid Carcinoma, Anaplastic thyroid cancer, Thyroid carcinoma, Medullary thyroid cancer, Thyroid tumors, Papillary thyroid cancer

E01 Thyroid gland diseases associated with iodine deficiency and similar conditions

Hormonal deficiency of the thyroid gland due to iodine deficiency in the body, Goiter endemic, Iodine deficiency alimentary state, Iodine deficiency disease, Iodine Deficiency, Endemic cretinism

E01.2 Goiter (endemic), associated with iodine deficiency, unspecified

Goiter, Goiter in areas with iodine deficiency

E01.8 Other thyroid disorders associated with iodine deficiency and similar conditions

Iodine deficiency disease

E03.9 Unspecified hypothyroidism

Hypothyroidism, Hypothyroid conditions, Thyroid hypothyroidism, Diagnosis of hypothyroidism, Simple goiter, Hypothyroid edema,Wolf-Chaikoff effect, Congenital hypothyroidism, Secondary hypothyroidism, Hypothyroid obesity, Hypothyroid status, Obstructive hypothyroidism

E05 Thyrotoxicosis [hyperthyroidism]

Von Bazedova's disease, Basedova's disease, Hyperthyroidism, Goiter toxic diffuse, Increased function of the thyroid gland, Thyrotoxic reaction, Toxic diffuse goiter, Toxic goiter, Thyroid enlargement with hyperthyroidism, The phenomenon of iodine-Bashedov

Composition and form of release

Tablets 1 table.

Levothyroxine sodium 40 mcg

Lyotyronine 10 μg

Auxiliary substances: lactose monohydrate; corn starch; gelatin; Silicon dioxide highly dispersed; Magnesium stearate; Glycerol 85%

In glass bottles of 60 pcs .; In a pack of cardboard 1 bottle or in a blister pack of 50; In a pack of cardboard 1 or 2 blisters.

Description of dosage form

Round flat cylindrical tablets of white color, with bevelled edge, with one-sided incision for division.

pharmachologic effect

Pharmacological action - replenishing deficiency of thyroid hormones.

A drug of synthetic hormones of the thyroid gland. Increases the need for tissues in oxygen, stimulates their growth and differentiation, increases the level of basal metabolism (proteins, fats and carbohydrates). In small doses anabolic, and in large - catabolic effect. Inhibits the production of thyroid-stimulating hormone. Strengthens energy processes, has a positive effect on the functions of the nervous and cardiovascular systems, liver and kidneys.

Pharmacokinetics

Levothyroxine. When ingested, levothyroxine is absorbed almost exclusively in the upper part of the small intestine. Absorbed up to 80% of the accepted dose of the drug. Eating lowers the absorption of levothyroxine. Cmax in the blood serum is reached approximately 5-6 hours after ingestion. After absorption, more than 99% of the drug binds to serum proteins (thyroxine-binding globulin, thyroxine-binding prealbumin and albumin). In various tissues, approximately 80% of levothyroxine is monodegraded with the formation of triiodothyronine 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. T1 / 2 levothyroxine - 6-7 days. With thyrotoxicosis, T1 / 2 is shortened to 3-4 days, and when hypothyroidism is prolonged to 9-10 days.

Lyotyronine. Absorption on intake - 95% (within 4 hours). Binding to plasma proteins is high. T1 / 2 - 2.5 days.

Indication

Hypothyroidism of any genesis.

Euthyroid goiter.

Replacement therapy and prevention of goitre recurrence after resection of the thyroid gland.

Thyroid cancer (after surgical treatment).

Contraindications

Increased individual sensitivity to the drug, untreated thyrotoxicosis, acute myocardial infarction, angina pectoris of the III-IV functional class, acute myocarditis, untreated adrenal insufficiency.

pregnancy and lactation

During pregnancy and breastfeeding, thyroid hormone therapy prescribed for hypothyroidism should continue. During pregnancy, an increase in the dose of the drug is required due to an increase in the level of thyroxin-binding globulin. In pregnancy, the use of the drug in combination with thyreostatics is contraindicated, because It may be necessary to increase the doses of thyreostatics. Since thyreostatics, in contrast to levothyroxine, can penetrate the placenta, the fetus may develop hypothyroidism.

The number of thyroid hormones secreted with breast milk during breastfeeding (even when treating with high doses of the drug) is not enough to cause any disturbances in the child. However, during breastfeeding, the drug should be taken with caution, strictly at recommended doses under the supervision of a doctor.

Side effects

Side effects are usually not observed when properly applied under the supervision of a doctor.

Possible - allergic reactions, the progression of heart failure and angina.

Interaction

Thyreotom enhances the effect of indirect anticoagulants (possibly reducing their dose).

The use of tricyclic antidepressants with Thyreotom 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 periods when the drug was started and when the dosage regimen is changed.

Thyreotom reduces the action of cardiac glycosides.

With simultaneous application of colestramine, colestipol and aluminum hydroxide reduce the plasma concentration of the drug 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.

With simultaneous application with phenytoin, salicylates, clofibrate, furosemide in high doses (250 mg), the content of thyroid hormones unrelated to proteins of the blood plasma increases.

Admission of estrogen-containing drugs increases the content of thyroxine-binding globulin, which may increase the need for thyrotoxic in some patients. Somatotropin, when used concomitantly with Thyreotom, can 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 thyrotoxic dose.

Dosing and Administration

Dosing and Administration Inside, at least 30 minutes before breakfast, without chewing and washing down with a sufficient amount of liquid, once.

The daily dose is determined individually depending on the indications.

Hypothyroidism. Adults: the initial dose is 1 table. Per day, then it is possible to increase the dose by 1 table. Every 2-4 weeks before reaching a maintenance daily dose of 2-5 tablets.

Children: when choosing a dose for prolonged treatment, take into account the body weight, height and surface of the child's body. The average recommended maintenance dose is 2-2.5 tablets. per day.

Euthyroid goiter. Adults: the initial dose is 1-2 tablets. Per day, the maintenance dose is 3-6 tablets. per day.

To adolescents: the initial dose is 1-1.5 tablets. Per day, the maintenance dose - 2,5-3,5 tab. per day.

Children: 0.5-1 table. per day.

Preventive maintenance of a recurrence of a struma after operative treatment: to adults - 2-3 tab. per day.

After surgical treatment for thyroid cancer: the initial dose is 3 tablets. Per day, a maintenance dose of 6 tablets. per day.

The drug should be taken regularly.

The duration of treatment is determined by the form of the disease. Typically, with hypothyroidism and after thyroidectomy for thyroid cancer treatment is carried out throughout life. The duration of use for euthyroid goiter, as well as for the prevention of recurrence of goiter after surgical treatment, ranges from several months or years to lifelong administration.

Overdose

Symptoms (typical of thyrotoxicosis): palpitation, heart rhythm disturbance, heart pain, anxiety, tremor, sleep disorders, increased sweating, increased appetite, weight loss, diarrhea.

Treatment: depending on the severity of symptoms, a reduction in the daily dose of the drug is recommended, or a break in treatment for several days or the appointment of beta-blockers. After the disappearance of side effects, treatment should be started with caution from a lower dose.

Precautionary measures

When hypothyroidism, caused by damage to the pituitary, it is necessary to find out whether there is a concomitant failure of the adrenal cortex. In this case, glucocorticosteroid replacement therapy should be started before the beginning of hypothyroidism treatment with thyroid hormones in order to avoid the development of acute adrenal insufficiency. The drug does not affect the professional activities associated with driving vehicles and controlling mechanisms.

Storage conditions

At a temperature of 15-25 ° C.

Keep out of the reach of children.

Shelf life

3 years.

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