Yodthyrox® (Jodthyrox®)

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Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceLevotiroksin sodium + Potassium iodideLevotiroksin sodium + Potassium iodide
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  • Yodthyrox®
    pills inwards 
    Merck KGaA     Germany
    • Dosage form: & nbsppills
    Composition:

    Each tablet contains:

    Active components: levothyroxine sodium - 0.100 mg; potassium iodide - 0.131 mg.

    Excipients: cellulose microcrystalline - 81.514 mg, gelatin - 4,500 mg, croscarmellose sodium - 3,500 mg, magnesium stearate - 0,250 mg.

    Description:

    Almost white, round tablets, flat on both sides, with bevelled edges. On both sides of the tablet there is a dividing risk, on one side of the tablet - engraving "EM 45".

    Pharmacotherapeutic group:Thyroid agent
    ATX: & nbsp

    H.03.A.A   Thyroid hormones

    Pharmacodynamics:

    Synthetic levorotatory isomer of thyroxine (T4). After partial conversion into triiodothyronine (T3) (in the liver and kidneys) and transition into the cells of the body, it affects the development and growth of tissues, metabolism. In small doses renders anabolic effect on protein and fat metabolism. In medium doses, it stimulates growth and development, increases the oxygen demand of tissues, stimulates the metabolism of proteins, fats and carbohydrates, increases the functional activity of the cardiovascular system and the central nervous system.

    In large doses oppresses the production of thyrotropin-releasing hormone hypothalamus and thyroid-stimulating hormone (TTG) of the pituitary gland.

    Therapeutic effect is observed after 7-12 days, during the same time the action remains after drug discontinuation. The clinical effect with hypothyroidism is manifested in 3-5 days. Diffuse goiter decreases or disappears within 3-6 months. Iodine refers to vital microelements. Without iodine, normal functioning of the thyroid gland is impossible, since it is an integral part of the thyroid hormones. Especially dangerous is iodine deficiency for children, adolescents, pregnant and lactating women.

    The drug replenishes iodine deficiency in the body, prevents the development of iodine-deficient diseases, prevents the development of goiter associated with a lack of iodine in food; normalizes the size of the thyroid gland in newborns, children, adolescents and adults.

    Pharmacokinetics:

    Levothyroxine sodium

    Ingestion levothyroxine sodium absorbed almost exclusively in the upper part of the small intestine. Absorbed up to 80% of the dose of levothyroxine sodium. Eating lowers the absorption of sodium levothyroxine.The maximum concentration in the 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 different tissues, about 80% of levothyroxine sodium mono deiodinates with the formation of triiodothyronine and inactive products. Thyroid hormones are metabolized mainly in the liver, kidneys, brain and muscles. A small amount of levothyroxine sodium is subjected to deamination and decarboxylation, as well as conjugation with sulfuric and glucuronic acids (in the liver). Metabolites are excreted by the kidneys and through the intestines.

    The half-life of levothyroxine sodium is 6-7 days. With thyrotoxicosis, the half-life period is shortened to 3-4 days, and with hypothyroidism it lengthens to 9 10 days.

    Potassium iodide

    Ingestion potassium iodide almost completely absorbed in the - small intestine. The average volume of distribution for healthy people is approximately 23 liters (38% of body weight). The plasma concentration of potassium iodide is normally between 0.001 and 0.005 μg / ml. Potassium iodide accumulates in the thyroid gland, salivary glands, mammary glands and stomach tissues.The concentration of potassium iodide in saliva, gastric juice and breast milk is approximately 30 times higher than in blood plasma. Potassium iodide is excreted by the kidneys, its concentration in the urine relative to creatinine (μg / g) is an indicator of the intake of iodine in the body.

    Indications:

    - Euthyroid goiter associated with lack of iodine in the body and increased need for iodine in children, adolescents and adults, including during pregnancy;

    - prevention of recurrence of goiter after resection of the thyroid gland;

    - hypothyroidism.

    Contraindications:

    - Increased individual sensitivity to the drug;

    - thyrotoxicosis of any genesis;

    - autonomic adenomas of the thyroid gland, as well as focal and diffuse autonomy of the thyroid gland.

    Do not start treatment with a drug in the presence of acute myocardial infarction, acute myocarditis and acute pancarditis.
    Carefully:

    With caution should prescribe the drug for diseases of the cardiovascular system: IHD (atherosclerosis, angina pectoris, myocardial infarction in history), arterial hypertension, arrhythmia; with diabetes, severe long-term hypothyroidism,malabsorption syndrome (dose adjustment may be required).

    Pregnancy and lactation:

    During pregnancy and breastfeeding, continue. During pregnancy, an increase in the dose of the drug may be required due to an increase in the thyroxine-binding globulin content.

    The amount of levothyroxine sodium secreted with breast milk during lactation is not enough to cause any disturbances in the child (hyperthyroidism or suppression of secretion of TSH) during treatment at the recommended doses.

    Potassium iodide penetrates the placenta and is excreted in breast milk. When administering therapy, it is necessary to take into account the amount of potassium iodide supplied with food.

    If a lactating woman takes Yodthyrox®, supplemental prescription of potassium iodide to infants who are breastfeeding is not required.

    During breastfeeding, the drug should be taken with caution, strictly at recommended doses under the supervision of a doctor.

    Dosing and Administration:

    The daily dose is determined by the doctor individually, depending on the indications.The daily dose of the drug Yodtiroks ® is taken orally 1 time a day in the morning on an empty stomach 30 minutes before breakfast, washing down the pill with a small amount of liquid (half a cup of water) and not chewing. Breast children a daily dose of the drug given in one session 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:

    Initial dose:

    1/2 Iodotyrox® tablet daily. 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.

    Maintenance dose:

    1 tablet per day. During pregnancy 1-1 1/2 tablets per day.

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

    Side effects:

    With hypersensitivity to the drug, allergic reactions can be observed.

    The development of side effects can be associated with an overdose of the drug (see the section "Overdose") or with a too rapid increase in dose at the beginning of treatment.

    Overdose:

    When an overdose of the drug symptoms are observed,characteristic of thyrotoxicosis: tachycardia, palpitation, heart rhythm disturbance, heart pain, anxiety, tremor, sleep disturbance, increased sweating, increased appetite, weight loss, diarrhea. But even in the case of extremely high doses of sodium levothyroxine for suicide (more 10 mg levothyroxine sodium / day, which corresponds to about 100 tablets of the drug) there were no serious consequences.

    Depending on the severity of the symptoms, a doctor may recommend a reduction in the daily dose of the drug, a break in the treatment for several days, the appointment of beta-blockers or the conduct of plasmapheresis (with an overdose of excessively high doses). After the disappearance of side effects, treatment should be initiated with caution from a lower dose.

    In patients with epilepsy, several cases of epileptic seizures were observed against the background of exogenous thyrotoxicosis caused by taking levothyroxine sodium in a dose significantly exceeding the recommended dose.

    There have been several deaths from cardiovascular complications of patients taking inadequately high doses of levothyroxine sodium for many years.The parameters of an overdose of levothyroxine sodium are: a decrease in the concentration of TSH in combination with an increase in the concentration of T3 and T4 (free thyroxine).

    When developing iodine-induced hypothyroidism, it is recommended to stop the use of the drug and prescribe therapy with thyroid hormones.

    With the development of iodine-induced hyperthyroidism, it is recommended to stop the use of the drug and prescribe therapy with antithyroid drugs. In especially severe cases, intensive therapy, plasmapheresis or thyroidectomy should be performed.

    Interaction:

    Levothyroxine sodium

    Levotiroksin sodium enhances the effect of indirect anticoagulants due to their displacement from the connection with plasma proteins, which requires regular verification of coagulation parameters during the periods when treatment with levothyroxine sodium begins and, if necessary, reducing their dose.

    The use of tricyclic antidepressants with levothyroxine sodium 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 concentration is recommended during the periods when treatment with levothyroxine sodium begins, as well as when its dosage regimen is changed.

    Levotiroksin sodium reduces the action of cardiac glycosides.

    With the simultaneous use of ion-exchange resins (for example, colestramine or colestipol) reduce the plasma concentration of levothyroxine sodium by inhibiting its absorption in the intestine. Concerning levothyroxine sodium should be used 4-5 hours before taking these medications. Medicines containing aluminum (antacids, sucralfate), iron and calcium carbonate reduce the effect of levothyroxine sodium. Concerning levothyroxine sodium must be used for at least 2 hours before the administration of said drugs.

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

    When used simultaneously with salicylates, dicumarol, furosemide in high doses (250 mg), clofibrate, phenytoin, the content of levothyroxine sodium unbound with plasma proteins increases.

    The use of estrogen-containing drugs increases the content of thyroxine-binding globulin, which may increase the need for levothyroxine sodium in some patients.

    Somatropin, when used concomitantly with levothyroxine sodium, can accelerate the closure of epiphyseal growth zones.

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

    Propylthiouracil, glucocorticosteroids, beta-adrenoblockers and iodine-containing contrast agents inhibit peripheral T4 in T3.

    Amiodarone inhibits peripheral T4 in T3. Due to the high content of iodine amiodarone can cause both hyperthyroidism and hypothyroidism. It is necessary to pay special attention in the case of patients with nodular goiter with unrecognized functional autonomy.

    Sertraline, chloroquine, proguanil reduce the effectiveness of levothyroxine sodium and increase the concentration 111 in blood.

    HIV protease inhibitors can affect the efficacy of levothyroxine sodium. When simultaneous application it is necessary to carry out frequent monitoring of thyroid hormone parameters and, if necessary, adjust the dose of the drug.

    Products containing soy can reduce the absorption of sodium levothyroxine in the intestines, which may require an increase in the dose of the drug.

    Potassium iodide

    The effectiveness of treatment with antithyroid drugs with simultaneous intake of iodine is reduced.

    Potassium perchlorate suppresses the absorption of iodine by the thyroid gland.

    The admission of high doses of iodine and the simultaneous use of potassium-sparing diuretics can lead to the development of hyperkalemia.

    Absorption of iodine by the thyroid gland and its metabolism are stimulated by TSH.

    Special instructions:

    Before the start of therapy with levothyroxine sodium, patients should be excluded from hyperthyroidism, coronary insufficiency, angina pectoris, atherosclerosis, arterial hypertension.

    In patients with coronary insufficiency, heart failure or tachyarrhythmia, the presence of even a weak form of hyperthyroidism induced by drugs should be excluded in patients. In such cases it is necessary to carry out more frequent monitoring of the content of levothyroxine in the blood.

    When hypothyroidism, due to the pituitary lesion, it is necessary to find out whether there is a simultaneous insufficiency 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 adrenal insufficiency.Saturation of the thyroid gland with iodine can prevent the accumulation of radioactive iodine used for therapeutic or diagnostic purposes. In this regard, the use of potassium iodide is not recommended before using radioactive iodine.

    If there is a predisposition to autoimmune diseases of the thyroid gland, antibodies to thyroperoxidase may be formed due to the intake of potassium iodide.
    Effect on the ability to drive transp. cf. and fur:

    The drug does not affect the activities associated with the driving of vehicles and the management of mechanisms.

    Form release / dosage:

    Tablets 0.100 mg / 0.131 mg.

    Packaging:

    For 25 tablets in a blister of PVC / AL or Polypropylene / AL; 2 or 4 blisters together with instructions for use are placed in a cardboard box.

    Storage conditions:

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

    Shelf life:

    3 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-001600
    Date of registration:31.03.2011
    Expiration Date:Unlimited
    Date of cancellation:2016-05-31
    The owner of the registration certificate:Merck KGaAMerck KGaA Germany
    Manufacturer: & nbsp
    Representation: & nbspNycomed Distribution Ltd.Nycomed Distribution Ltd.
    Information update date: & nbsp29.11.2017
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