Instruction for use: Jodthyrox

Active substanceLevothyroxine sodium + Potassium iodide

ATX codeH03AA Thyroid hormones

Pharmacological group of substance Calcitonin

Thyroid agent [Thyroid and parathyroid hormones, their analogs and antagonists in combinations / 575]

Nosological classification (ICD-10)

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

E07.8.0 * Euthyroid syndrome

Goiter after thyroid resection, Recurrence of goiter after resection of the thyroid gland, Euthyroid goiter, Euthyroid hyperplasia of the thyroid gland

Composition

Tablets 1 table.

Active substances:

Levothyroxine sodium 0.1 mg

Potassium iodide 0.131 mg

Auxiliary substances: MCC - 81.514 mg; Gelatin 4.5 mg; Croscarmellose sodium - 3.5 mg; Magnesium stearate 0.25 mg

Description of dosage form

Almost white, round, flat on both sides tablets with bevelled edge, dividing notch on one side and engraving "EM 45" on the other.

pharmachologic effect

Pharmacological action - replenishing the deficiency of iodine, replenishing the deficiency of thyroid hormones.

Pharmacodynamics

Jodthyrox® is a combined preparation containing the synthetic thyroid hormone levothyroxine (T4) and iodine in the form of potassium iodide, which is a structural element in the synthesis of thyroid hormones (thyroxine and triiodothyronine). Replenishes the deficiency of thyroid hormones. 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. Replenishes the lack of iodine in the body.

Indications

Hypothyroidism;

Euthyroid goiter associated with a deficiency of iodine in the body in children, adolescents and adults, incl. During pregnancy;

Prevention of recurrence of goiter after resection of the thyroid gland.

Contraindications

Increased individual sensitivity to the drug;

Thyrotoxicosis of any origin;

Autonomic adenomas of the thyroid gland;

Acute myocardial infarction, acute myocarditis;

Untreated insufficiency of the adrenal cortex;

Herpetiform dermatitis (Dühring's disease).

Carefully:

IHD (atherosclerosis, angina pectoris, myocardial infarction in the anamnesis);

heart failure;

arterial hypertension;

Tachycardia, tachyarrhythmia;

Diabetes mellitus, diabetes insipidus;

Severe, long-term hypothyroidism;

Adrenal insufficiency;

Malabsorption syndrome;

Elderly patients (dose adjustment may be required).

pregnancy and lactation

During pregnancy and breastfeeding, therapy with Jodthyrox®, prescribed for hypothyroidism, should continue. In nursing mothers, the drug should be used in strictly recommended doses.

Side effects

With increased sensitivity to iodine, there may be: fever, rash, redness of the skin, itching, burning in the eyes, coughing, diarrhea, headache.

In this case, the drug should be discontinued.

Interaction

Jodthyrox® enhances the effect of indirect anticoagulants, which may require a reduction in their dose. With simultaneous administration of Jodthyrox® and drugs that affect blood clotting, blood coagulability should be monitored.

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 its dosage regimen is changed. With rapid intravenous injection of phenytoin, an increase in the level of free levothyroxine in the blood plasma is possible, with violations of the rhythm of the heart. Levothyroxine can be displaced from compounds with blood plasma proteins by salicylates, dicumarol, high doses of furosemide (250 mg), clofibrate and other substances.

The use of tricyclic antidepressants with the drug Jodthyrox ® may lead to an increase in the effect of antidepressants.

With simultaneous application of colestyramine, colestipol and aluminum hydroxide reduce the plasma concentration of the drug due to inhibition of its absorption in the intestine, therefore it is recommended to take Jodthyrox 4-5 hours before taking these medications.

When used simultaneously with potassium-sparing diuretics potassium iodide can lead to an increase in the level of potassium in the blood.

Jodthyrox® reduces the action of cardiac glycosides.

When used simultaneously with anabolic steroids, asparaginase, tamoxifen, pharmacokinetic interaction at the level of binding to the protein is possible.

When administered concomitantly with estrogens or estrogen-containing oral contraceptives, an increase in the dose of Jodthyrox® may be required.

Somatotropin with simultaneous application with the drug Jodthyrox® can accelerate the closure of epiphyseal growth zones.

The intake of phenobarbital, carbamazepine and rifampicin can increase the clearance of levothyroxine and require an increase in the dose of Jodthyrox®.

Dosing and Administration

Inside.

The daily dose is determined by the doctor individually, depending on the indications. The daily dose of Jodthyrox® is taken once a day in the morning on an empty stomach 30 minutes before breakfast, taking a small amount of liquid (half a glass of water) and not chewing the tablet. Breast children a daily dose of the drug given at one time for 30 minutes before the first feeding. The tablet is dissolved in water to a fine suspension, which is prepared immediately before taking the drug.

The following dosing regimen is recommended.

The initial dose is 1/2 table. Drug Jodthyrox® per day. After 2-4 weeks, the dose is increased to a maintenance dose, depending on the age, body weight of the patient and the tolerability of the drug.

The maintenance dose is 1 tab. in a day. During pregnancy 1-1 / 2 table. in a day.

The duration of treatment is set by the doctor and usually ranges from a few months to a lifetime.

Overdose

Symptoms of thyrotoxicosis (especially if the dose is increased too quickly at the beginning of treatment): tachycardia, cardiac rhythm disturbance, finger tremor, internal anxiety, insomnia, excessive sweating, weight loss, diarrhea.

Treatment: reduce the dose or stop for several days, taking the drug, to conduct a follow-up examination.

After the disappearance of side effects, treatment should be started with caution from a lower dose.

special instructions

In acute overdose and intoxication, it is recommended to stop taking the drug and to conduct a follow-up examination. The drug is administered with caution to patients with cardiovascular diseases, including arterial hypertension, angina, heart failure. In these cases, the treatment of the underlying disease should be performed prior to administration of the Yodthyrox® drug. Yoddiroks® is started with small doses. With the development of pain in the chest or other symptoms, indicating a worsening of the course of cardiovascular diseases, you should reduce the dose of the drug.

Particular care should be taken when prescribing the medication to the elderly. Treatment at them should be spent in lower doses.

The use of the drug in patients with diabetes mellitus, diabetes insipidus or adrenocortical insufficiency may lead to an increase in the severity of the symptoms of these diseases. In this period, careful selection of doses of drugs for the treatment of these diseases is required.

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, the replacement therapy of GCS should be started before the beginning of treatment of hypothyroidism with thyroid hormones in order to avoid the development of acute adrenal insufficiency.

With a properly selected therapeutic dose, the drug does not affect the ability to drive vehicles and control mechanisms.

Form of issue

Tablets 0.1 mg / 0.131 mg: in PVC blisters / aluminum foil or polypropylene / aluminum foil, 25 pieces each; In a pack of cardboard 2 or 4 blisters.

Terms of leave from pharmacies

On prescription.

storage Conditions

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life

3 years.

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