YODTYROKS

Active material: Levothyroxine sodium, Potassium iodide
When ATH: H03AA
CCF: The preparation of thyroid hormone
ICD-10 codes (testimony): E01.0, E03, E04, O99.2
When CSF: 15.04.03
Manufacturer: MERCK KGaA (Germany)

Pharmaceutical form, composition and packaging

Pills almost white, round, flat on both sides, with a beveled edge, with a dividing notch on one side and with an engraving “EM 45” – with another.

Excipients: microcrystalline cellulose, gelatin, Croscarmellose sodium, magnesium stearate.

25 PC. – blisters (2) – packs cardboard.
25 PC. – blisters (4) – packs cardboard.

Pharmacological action

Combined preparation, comprising a synthetic thyroid hormone levothyroxine and iodine as potassium iodide, which is a structural element in the synthesis of thyroid hormones (thyroxine and triiodothyronine).

The product fills the shortage of thyroid hormones. Increases tissue oxygen demand, stimulates growth and differentiation, increases the basal metabolic rate (proteins, fats and carbohydrates). In small doses it has anabolic, and large – catabolic effect. Inhibits the production of thyroid stimulating hormone. It increases energy processes, It has a positive effect on the function of the nervous and cardiovascular systems, liver and kidneys. It compensates for the deficiency of iodine in the body.

Pharmacokinetics

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Testimony

- Gipotireoz;

- Euthyroid goiter, related to iodine deficiency in children, adolescents and adults, incl. during pregnancy;

- Prevention of relapse weeks after resection of the thyroid gland.

Dosage regimen

The daily dose is determined individually depending on indications. Yodtyroks^® taking a daily dose of 1 time / day in the morning, fasting, for 30 minutes before breakfast, washed down a pill and a small amount of liquid without chewing. Infants daily dose Yodtiroksa^® to give 1 Reception for 30 minutes before the first feeding. The tablet is dissolved in a little water to thin the slurry just before taking this medication.

The initial dose the drug is 1/2 tab. / day. Through 2-4 weeks of dosage is increased by age, body weight of the patient and tolerability.

Maintenance dose is 1 tab. / day. When pregnancy is increased to the maintenance dose 1-1.5 tab. / day.

Course duration is determined individually and is usually from a few months to life application.

Side effect

Allergic reactions: if you are sensitive to iodine – fever, rash, dermahemia, itching and burning in the eyes, cough, diarrhea, headache.

Contraindications

- Hyperthyroidism of any origin;

- Autonomous thyroid adenoma;

- Acute myocardial infarction, acute myocarditis;

- Untreated adrenal insufficiency;

- Dermatitis herpetiformis Duhring;

- Hypersensitivity to iodine.

FROM caution It should be prescribed for diseases of the cardiovascular system, incl. CHD (atherosclerosis, angina, myocardial infarction), heart failure, arterial hypertension, tachycardia, integuments; for patients with diabetes, nesaxarnom diabetes, severe long-existing hypothyroidism, adrenal insufficiency, malabsorption syndrome, and elderly patients (may require dose adjustment).

Pregnancy and lactation

During pregnancy and lactation therapy Yodtiroksom^®, appointed over hypothyroidism, must go.

During lactation the drug should be taken with caution.

Cautions

Before the appointment Yodtiroksa^® Patients with cardiac disease should be performed correction of cardiovascular disease. Admission Yodtiroksa^® start in small doses. With the development of pain in the chest or other symptoms, indicating the deterioration of the current cardiovascular disease, dose should be reduced Yodtiroksa^®.

Elderly patients should be prescribed the drug at lower doses.

Application Yodtiroksa^® for patients with diabetes, diabetes insipidus or adrenal insufficiency can lead to increased severity of these diseases, which may require correction doses of drugs, used to treat them.

When allergic reactions Yodtiroks^® should be abolished.

In hypothyroidism, due to lesions of the pituitary gland, We need to find out, whether there is a simultaneous failure of the adrenal cortex. In this case, replacement therapy should be started corticosteroids prior to treatment of hypothyroidism thyroid hormones to prevent the development of acute adrenal insufficiency.

Effects on ability to drive vehicles and management mechanisms

Admission Yodtiroksa^® in an adequate therapeutic dose has no effect on the ability to perform work, require increased attention and psychomotor speed reactions.

Overdose

Symptoms: an overdose of the drug (especially if the dose is increased too quickly at the beginning of treatment) may experience symptoms, typical of thyrotoxicosis: tachycardia, irregular heartbeat, tremor fingers, inner restlessness, insomnia, increased sweating, weight loss, diarrhea.

Treatment: removal of the drug. After the disappearance of the symptoms resume treatment at a lower dose.

Drug Interactions

Levothyroxine increases the effect of indirect anticoagulants, which may require the reduction of dose, and also requires monitoring of blood coagulation index, while the use of these drugs with Yodtiroksom^®.

Thyroid hormones may increase the need for insulin and oral hypoglycemic drugs, which requires more frequent monitoring of blood glucose during the beginning of treatment, and when changing its dosing regimen.

The rapid on / in the introduction of phenytoin may increase the levels of free levothyroxine plasma, which can cause heart rhythm disturbances.

While the use of salicylates, dikumarinom, clofibrate, furosemide in high doses of levothyroxine may be displaced from the compounds to plasma proteins.

The use of tricyclic antidepressants with the drug Yodtiroks^® could increase their activities.

With simultaneous use of cholestyramine, colestipol and aluminum-containing antacids decrease plasma concentrations of levothyroxine by its inhibition of absorption in the intestine, so the interval between doses Yodtiroksa^® and these drugs should be 4-5 no.

With simultaneous use of potassium iodide with potassium-sparing diuretics may increase the level of potassium in the blood.

Yodtyroks^® while the application reduces the effect of cardiac glycosides.

While the use of anabolic steroids, asparaginase, tamoxifen possible pharmacokinetic interaction at the level of protein binding.

When concomitant administration with estrogens or estrogenosoderzhaschimi oral contraceptives may require higher doses Yodtiroksa^®.

Growth Hormone while the use of medication Yodtiroks^® can speed up the closure of the epiphyseal growth zones.

Admission phenobarbital, karʙamazepina and rifampin may increase the clearance of levothyroxine and require increasing doses of the drug Yodtiroks^®.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored in a dry, inaccessible to children at temperature from 15 ° to 25 ° C. Shelf life – 2 year.