Эутирокс®

General characteristics. Structure:

Active component: sodium left thyroxine - 25 mkg, 50 mkg, 75 mkg, 88 mkg, 100 mkg, 112 mkg, 125 mkg, 137 mkg or 150 mkg.
Excipients: starch corn - 25,00 mg, gelatin - 5,00 mg, croscarmellose sodium - 3,50 mg, magnesium stearate - 0,50 mg, lactoses monohydrate -65,975/65,95/65,925/65,912/65,90/65,888/65,875/65,863/65,85 mg.

Description
 White, round tablets, flat from two parties, with slanted edges. On both parties of a tablet is dividing risk, on one party of a tablet - an engraving "I eat + a dosage".

Pharmacological properties:

Pharmacodynamics. Synthetic left-handed isomer of thyroxine. After partial transformation into triiodothyronine (in a liver and kidneys) and transition to organism cells, exerts impact on development and growth of fabrics, on a metabolism. In small doses also the lipometabolism has anabolic effect on proteinaceous. Stimulates growth and development in average doses, increases the need of fabrics for oxygen, stimulates metabolism of proteins, fats and carbohydrates, increases functional activity warmly - vascular system and the central nervous system. In high doses oppresses development thyrotropin - a releasing of hormone of a hypothalamus and thyritropic hormone (TTG) of a hypophysis.
The therapeutic effect is observed in 7-12 days, during the same time action after drug withdrawal remains. The clinical effect at a hypothyroidism is shown in 3-5 days. The diffusion craw decreases or disappears within 3-6 months.

Pharmacokinetics. At intake left thyroxine of sodium is soaked up almost only in an upper part of a small intestine. About 80% of the accepted sodium left thyroxine dose are soaked up. Meal reduces absorbability of left thyroxine of sodium. The maximum concentration in blood serum is reached approximately in 5-6 hours after intake. After absorption more than 99% of drug contact proteins of serum (thyroxine - the connecting globulin, thyroxine - the connecting prealbumin and albumine). In various fabrics there is a monodeiodinating about 80% of left thyroxine of sodium to formation of triiodothyronine (Тз) and inactive products. Thyroid hormones are metabolized mainly in a liver, kidneys, a brain and in muscles. A small amount of drug is exposed to deamination and decarboxylation, and also a konjyugirovaniye with sulfuric and glucuronic acids (in a liver). Metabolites are removed by kidneys and through intestines.
The elimination half-life of drug makes 6-7 days. At a thyrotoxicosis the elimination half-life is shortened up to 3-4 days, and at a hypothyroidism is extended up to 9-10 days.

Indications to use:

• hypothyroidism;
• euthyroid craw;
• as replacement therapy and for prevention of a recurrence of a craw after a resection of a thyroid gland;
• cancer of a thyroid gland (after operational treatment);
• diffusion toxic craw: after achievement of an euthyroid state anti-thyroid means (in the form of combined or monotherapies);
• as diagnostic means at test of thyroid suppression.

Route of administration and doses:

The daily dose is defined individually depending on indications.
Эутирокс® in a daily dose accept inside in the morning on an empty stomach, at least, in 30 minutes prior to meal, washing down a tablet with a small amount of liquid (a half-glass of water) and without chewing.
When performing replacement therapy of a hypothyroidism at patients 55 years in the absence of cardiovascular diseases of Eutiroks® are younger appoint in a daily dose 1,6 - 1,8 mkg to 1 kg of body weight; at patients 55 years or with cardiovascular diseases - 0,9 mkg on 1 kg of body weight are more senior. At considerable obesity calculations should be made on "the ideal weight".

The initial stage of replacement therapy at a hypothyroidism.

Patients without cardiovascular    • an initial dose: women - 75-100 mkg/days,
55 years                of the man - 100-150 mkg/days are younger than diseases
Patients with cardiovascular      • An initial dose - 25 mkg a day
diseases or 55 years     • Are more senior to increase 25 mkg with an interval of 2 months 
                                                         before normalization of an indicator of TTG in blood
                                                         • At emergence or deterioration in symptoms with 
                                                          to carry out the parties of cardiovascular system 
                                                           correction of therapy of cardiovascular diseases

The recommended thyroxine doses for treatment of an inborn hypothyroidism
Age              the Daily dose of left thyroxine     a sodium left thyroxine Dose in 
                            sodium (mkg)                            calculation on the body weight (mkg/kg)
0-6 months                                                                     25-50 10-15
6-12 months                                                                    50-75 6-8
1 - 5 years                                                                          75-100 5-6
6-12 years                                                                        100-150 4-5
> 12 years                                                                          100-200 2-3

Indications                                               the Recommended doses (Eutiroks® of mkg/days)
Treatment of an euthyroid craw                   75-200
Prevention of a recurrence later
surgical treatment euthyroid
craw                                                        75-200
In complex therapy of a thyrotoxicosis   50-100
Suppressive therapy of cancer of thyroid
                                                    glands 150-300 
                                                                              In 4 weeks  In 3 weeks   In 2 weeks  In 1 week
The test of thyroid suppression                                    to the test        to the test          to the test        to the test
                                                              Эутирокс® 75      mkg/days 75 mkg/days            150-200 150-200 
                                                                                                                                     mkg/days mkg/days

Babies and children up to 3 years a daily dose of the drug Eutiroks® are given in one step in 30 minutes prior to the first feeding. The tablet is dissolved in water to a thin suspension which is prepared just before administration of drug.
At patients with heavy it is long the existing hypothyroidism treatment should be begun with extra care, with small doses - from 12,5 mkg/days, the dose is increased to supporting through more long intervals of time - by 12,5 mkg/days each 2 weeks and more often define concentration of TTG in blood.
At a hypothyroidism of Eutiroks® accept, as a rule, during all life. At a thyrotoxicosis of Eutiroks® use in complex therapy with anti-thyroid drugs after achievement of an euthyroid state. In all cases treatment duration by drug is determined by the doctor.
For exact dosing it is necessary to use the most suitable dosage of the drug Eutiroks®.

Features of use:

At the hypothyroidism caused by damage of a hypophysis it is necessary to find out whether there is at the same time an insufficiency of bark of adrenal glands. In this case replacement therapy by glucocorticosteroids should be begun prior to treatment of a hypothyroidism with thyroid hormones in order to avoid development of adrenal insufficiency.
Drug does not exert impact on the activity connected with driving of vehicles and control of mechanisms.

Side effects:

At the correct use of the drug Eutiroks® under control of the doctor side effects are not observed. At hypersensitivity to drug allergic reactions can be observed. Development of side effects can be connected with drug overdose (see the section "Overdose").

Interaction with other medicines:

Left thyroxine of sodium strengthens effect of indirect anticoagulants that can demand decrease in their dose.
Use of tricyclic antidepressants with left thyroxine of sodium can lead to strengthening of effect of antidepressants.
Thyroid hormones can increase the need for insulin and peroral hypoglycemic drugs. More frequent control of concentration of glucose of blood is recommended to be carried out to the periods of an initiation of treatment by sodium left thyroxine, and also at change of its mode of dosing.
Left thyroxine of sodium reduces effect of cardiac glycosides.
At simultaneous use Colestyraminum, колестипол and aluminum hydroxide reduce plasma concentration of left thyroxine of sodium due to braking of absorption it in intestines. In this regard left thyroxine of sodium needs to be applied in 4-5 hours prior to reception of the specified drugs.
At simultaneous use with anabolic steroids, asparaginase, Tamoxifenum perhaps pharmacokinetic interaction at the level of linkng with proteins of plasma.
At simultaneous use with Phenytoinum, dikumaroly, salicylates, Clofibratum, furosemide in high doses the content of sodium left thyroxine, untied with proteins of a blood plasma, increases.
Reception of estrogensoderzhashchy drugs increases contents thyroxine - the connecting globulin that can increase the need for sodium left thyroxine at some patients.
Somatropin at simultaneous use with left thyroxine of sodium can accelerate closing of epiphyseal regions of growth.
Reception of phenobarbital, carbamazepine and rifampicin can increase clearance of left thyroxine of sodium and demand increase in a dose.

Contraindications:

• the increased individual sensitivity to drug;
• uncured thyrotoxicosis;
• uncured pituitary insufficiency;
• uncured insufficiency of adrenal glands.
It is not necessary to begin treatment with drug in the presence of an acute myocardial infarction, acute myocarditis and an acute pancarditis.

With care it is necessary to appoint drug at diseases of cardiovascular system: An ischemic heart disease (atherosclerosis, stenocardia, a myocardial infarction in the anamnesis), arterial hypertension, arrhythmia; at a diabetes mellitus, heavy it is long the existing hypothyroidism, a sprue (dose adjustment can be required).

Use during pregnancy and during breastfeeding
 During pregnancy and breastfeeding therapy by the drug appointed concerning a hypothyroidism has to continue. During pregnancy increase in a dose of drug because of increase in contents thyroxine - the connecting globulin is required. The amount of the thyroid hormone cosecreted with breast milk at a lactation (even when performing treatment by high doses of drug), is not enough to cause any disturbances in the child.
Use at pregnancy of drug in a combination with anti-thyroid means is contraindicated as reception of left thyroxine of sodium can demand increase in doses of anti-thyroid means. As anti-thyroid means, unlike sodium left thyroxine, can get through a placenta, at a fruit the hypothyroidism can develop.
During breastfeeding drug should be taken with caution, it is strict in the recommended doses under observation of the doctor.

Overdose:

At overdose of drug the symptoms characteristic of a thyrotoxicosis are observed: a heart consciousness, disturbance of a heart rhythm, a heartache, concern, a tremor, a sleep disorder, the increased perspiration, increase in appetite, decrease in body weight, diarrhea. Depending on expressiveness of symptoms the doctor reduction of a daily dose of drug can be recommended, having rummaged in treatment for several days, purpose of beta adrenoblockers. After disappearance of side effects treatment should be begun with care with lower dose.

Storage conditions:

In the place protected from light at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity 3 years. Not to use after a period of validity.

Issue conditions:

According to the recipe

Packaging:

Mkg tablets 25, 50, 75, 88, 100, 112, 125, 137 or 150. On 25 tablets in the blister from PVH/AL or Polypropylene / is SCARLET; on 2 or 4 blisters together with the application instruction place in a cardboard pack.