Ë«ñ«¬«¼í® 50/150/Йодокомб® 75/150

General characteristics. Structure:

Active ingredients:

Ë«ñ«¬«¼í® 50/150 left thyroxine of sodium monohydrate (in terms of sodium left thyroxine) – 0,050 mg, potassium iodide – 0,196 mg (that corresponds to 0,150 mg of iodine);

Ë«ñ«¬«¼í® 75/150 left thyroxine of sodium monohydrate (in terms of sodium left thyroxine) – 0,075 mg, potassium iodide – 0,196 mg (that corresponds to 0,150 mg of iodine);

Excipients:

gipromelloza, magnesium hydroxycarbonate (magnesium carbonate the main easy), cellulose microcrystallic, starch corn, silicon dioxide colloid, calcium бегенат*.

* mix of salts of calcium of higher fatty acids: behenic, arachidic, lignoceric, palmitic, stearin, olein. Substance contains from 5,7 to 6,3% of calcium.

Pharmacological properties:

Pharmacokinetics. At intake left thyroxine of sodium is soaked up preferential from a small bowel (to 80% of the dose accepted on an empty stomach) and reaches the maximum concentration in plasma (Cmax) approximately in 6 h after reception. The therapeutic effect occurs in 3-5 days after the beginning of peroral therapy. Sodium left thyroxine more than for 99% contacts proteins of plasma. It is metabolized preferential in a liver, kidneys, muscles and tissues of a brain.

Inorganic iodine is soaked up from a small bowel almost for 100%. Distribution volume at healthy people averages about 23 l (38% of body weight). Concentration of inorganic iodine in serum usually makes 0,1-0,5 mkg/dl. In an organism iodine collects in a thyroid gland and other fabrics, such as sialadens, chest glands and a stomach. In saliva, a gastric juice and breast milk concentration of iodine is 30 times higher than its concentration in plasma. First of all iodine is emitted with kidneys, an insignificant part of iodine is allocated through intestines.

Indications to use:

• treatment of the diffusion euthyroid craw caused by an iodine deficiency;
• prevention of a recurrence of a craw after a resection of a thyroid gland or therapy by a radioiodine.

Route of administration and doses:

Tablets for intake.

Accept on 1 tablet of the drug Йодокомб® 50/150 a day.

The pill is taken in the morning on an empty stomach, in 30 min. prior to a breakfast, without chewing, washing down with a small amount of liquid.

Duration of a course of treatment is established by the attending physician and usually makes of several months or years to lifelong.

In need of increase in a dose (on the basis of results of laboratory diagnostic testings) it is recommended to accept Йодокомб® 75/150.

Features of use:

Before therapy by hormones of a thyroid gland it is necessary to exclude existence or to carry out treatment of the following diseases: An ischemic heart disease, pituitary insufficiency or insufficiency of bark of adrenal glands, autonomy of function of a thyroid gland (at suspicion on autonomy of function of a thyroid gland it is necessary to carry out the test with the thyrotropin-rileasing-hormone (TR) or to execute a supressionny stsintigrafiya).

Influence of drug on ability to driving of motor transport and to control of mechanisms is not known.

Side effects:

Side effect at therapy by the drug Yodokomb® usually is not observed. Emergence of symptoms of a hyperthyroidism is in some cases possible: tachycardia, arrhythmia, stenocardia, tremor, feeling of internal concern, sleeplessness, hyperhidrosis, loss of body weight, diarrhea. In such cases the daily dose should be reduced or for several days to stop administration of drug. After disappearance of the specified symptomatology treatment can be continued under control of the TTG and T4 level.

At hypersensitivity allergic reactions are possible: skin rash, eosinophilia; in some cases – an acute anaphylaxis.

Interaction with other medicines:

At a hyperthyroidism the iodine deficiency raises, and surplus reduces it efficiency of therapy by anti-thyroid drugs therefore to and during treatment of a hyperthyroidism it is necessary to avoid any possible intake of iodine in an organism.

Amiodaronum in connection with the high content of iodine can cause both a hyperthyroidism, and a hypothyroidism. Extra care is required at a nodal craw with perhaps not recognizable autonomy of function of a thyroid gland.

Colestyraminum and колестипол reduce sodium left thyroxine absorption in this connection it is necessary to accept them only in 4-5 h after administration of drug of Yodokomb®.

Aluminum-bearing antacids and salts of iron can reduce sodium left thyroxine absorption at their concomitant use. Therefore Yodokomb® should take not less than for 2 h before reception of these drugs.

Bystry intravenous administration of Phenytoinum can lead to increase in level of free left thyroxine in plasma and in some cases promote development of disturbance of a cordial rhythm.

Salicylates, дикумарол, furosemide in high doses (250 mg), Clofibratum can force out sodium left thyroxine from its connections with proteins of plasma.

As left thyroxine of sodium forces out anticoagulants (coumarin derivatives) from their connections with proteins of plasma, the effect of therapy by these drugs can amplify. For this reason at simultaneous use of the specified medicines regular control of coagulability of blood and, in case of need, correction (decrease) of a dose of anticoagulants is required.

Left thyroxine of sodium can weaken effect of hypoglycemic drugs therefore at patients with a diabetes mellitus, first of all at the beginning of therapy by hormones of a thyroid gland, carrying out regular control of level of glucose in blood and, in case of need, dose adjustment of hypoglycemic medicines is necessary.

Contraindications:

• the increased function of a thyroid gland of any genesis;
• hypersensitivity to drug components;
• recently postponed myocardial infarction;
• stenocardia;
• acute myocarditis;
• uncured insufficiency of bark of adrenal glands;
• focal or diffusion autonomy of function of a thyroid gland;
• herpetiform dermatitis of Dyuringa;
• pituitary insufficiency;
• children up to 18 years.

With care:
• coronary heart disease (CHD);
• heart failure;
• tachyarrhythmia;
• arterial hypertension;
• epilepsy, including in the anamnesis;
• diabetes mellitus;
• not diabetes mellitus;
• it is long the existing hypothyroidism;
• adrenal insufficiency;
• sprue;
• advanced age (65 years are more senior).

Use at pregnancy and a lactation

Use of drug at pregnancy and in the period of a lactation perhaps only in the recommended doses. During pregnancy correction of a dose is possible.

Overdose:

At overdose development of a hyperthyroidism is possible.

Symptoms: cm. Side effect.

Treatment: at rather moderate signs of overdose – reduction of a dose of drug. At expressed – symptomatic therapy: termination of administration of drug, gastric lavage, purpose of Colestyraminum, oxygenotherapy, use of beta adrenoblockers, glucocorticosteroids, cardiac glycosides. It is not recommended to appoint anti-thyroid drugs. At administration of drug in extreme doses (suicide attempt) carrying out a plasma exchange is possible.

At the hyperthyroidisms caused by presence of iodine at the drug Yodokomb® (in the presence of autonomy of function of a thyroid gland), thyreostatic therapy is shown. In hard cases (thyrocardiac crisis) the intensive care, a plasma exchange and, if necessary, a thyroidectomy is shown.

Storage conditions:

At a temperature not above 25 °C. To store in the place, unavailable to children! Period of validity 2 years. Not to use after the period of validity specified on packaging.

 

Issue conditions:

According to the recipe

Packaging:

Tablets of 50 mkg / 150 mkg

Tablets of 75 mkg / 150 mkg

On 10 tablets in a blister strip packaging (blister) [aluminum PVC / PVDH / foil]. On 10 blisters together with the application instruction in a cardboard pack.