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Tyrosol 10 mg 50 pcs. film-coated tablets

pharmachologic effect

Antithyroid drug.
It disrupts the synthesis of thyroid hormones by blocking the enzyme peroxidase, which is involved in the iodination of thyronine in the thyroid gland with the formation of triiodo- and tetraiodothyronine. This property allows for symptomatic therapy of thyrotoxicosis, with the exception of cases of development of thyrotoxicosis due to the release of hormones after the destruction of thyroid cells (after treatment with radioactive iodine or with thyroiditis). Tyrosol® does not affect the release of synthesized thyronines from the thyroid follicles. This explains the latent period of varying duration, which may precede the normalization of T3 and T4 levels in the blood plasma, i.e. improvement of the clinical picture.

Reduces basal metabolism, accelerates the removal of iodides from the thyroid gland, increases reciprocal activation of the synthesis and secretion of TSH by the pituitary gland, which may be accompanied by some hyperplasia of the thyroid gland.

The duration of action of the drug after a single dose is almost 24 hours.

Composition and release form Tyrosol 10 mg 50 pcs. film-coated tablets

Tablets - 1 tablet:

Active substance: thiamazole 10 mg.
Excipients: colloidal silicon dioxide - 2 mg, sodium carboxymethyl starch - 2 mg, magnesium stearate - 2 mg, hypromellose 2910/15 - 3 mg, talc - 6 mg, cellulose powder - 10 mg, corn starch - 20 mg, lactose monohydrate - 195 mg.
Film shell composition: yellow iron oxide dye - 0.54 mg, red iron oxide dye - 0.004 mg, dimethicone 100 - 0.16 mg, macrogol 400 - 0.79 mg, titanium dioxide - 0.89 mg, hypromellose 2910/15 - 3.21 mg.

10 pieces. - blisters (5) - cardboard packs.

25 pcs. - blisters (2) - cardboard packs.

Description of the dosage form

Gray-orange film-coated tablets, round, biconvex, scored on both sides; On a cross section, the core is white or almost white.

Characteristic

Antithyroid drug.

Directions for use and doses

The tablets should be taken orally after meals, without chewing, with a sufficient amount of liquid.

The daily dose is prescribed in 1 dose or divided into 2-3 single doses. At the beginning of treatment, single doses are taken throughout the day at strictly defined times. The maintenance dose should be taken in one dose after breakfast.

Thyrotoxicosis

Depending on the severity of the disease, the drug is prescribed at a dose of 20-40 mg/day for 3-6 weeks. After normalization of thyroid function (usually after 3-8 weeks), they switch to a maintenance dose of 5-20 mg/day. From this time on, additional intake of levothyroxine sodium is recommended.

In preparation for surgical treatment of thyrotoxicosis, 20-40 mg/day is prescribed until a euthyroid state is achieved. From this time on, additional intake of levothyroxine sodium is recommended. In order to reduce the time required to prepare for surgery, beta-blockers and iodine preparations are additionally prescribed.

In preparation for treatment with radioactive iodine, 20-40 mg/day of the drug Tyrozol® is prescribed until a euthyroid state is achieved.

Therapy during the latent period of radioactive iodine action: depending on the severity of the disease, 5-20 mg/day of the drug Tyrozol® is prescribed until the onset of the effect of radioactive iodine (4-6 months).

Long-term thyreostatic maintenance therapy

Tyrosol® is prescribed in doses of 1.25-2.5-10 mg/day with additional levothyroxine sodium in small doses. When treating thyrotoxicosis, the duration of therapy is from 1.5 to 2 years.

Prevention of thyrotoxicosis when prescribing iodine preparations (including cases of use of iodine-containing radiocontrast agents) in the presence of latent thyrotoxicosis, autonomous adenomas or a history of thyrotoxicosis: prescribe 10-20 mg/day of the drug Tyrozol® and 1 g of potassium perchlorate per day for 8-10 days before taking iodine-containing products.

Dosage in children

Not recommended for use in children aged 0 to 3 years.

For children from 3 to 17 years old, Tyrozol® is prescribed at an initial dose of 0.3-0.5 mg/kg, which is divided into two or three equal doses daily. The maximum recommended dose for children weighing more than 80 kg is 40 mg/day. Maintenance dose - 0.2-0.3 mg/kg/day. If necessary, sodium levothyroxine is additionally prescribed.

Dosage in pregnant women

Pregnant women are prescribed in the lowest possible doses: single - 2.5 mg, daily - 10 mg.

In case of liver failure, the drug is prescribed in the minimum effective dose under close medical supervision.

When preparing patients with thyrotoxicosis for surgery, treatment with the drug is carried out until a euthyroid state is achieved within 3-4 weeks before the planned day of surgery (in some cases - longer) and ends the day before it.

Pharmacodynamics

It disrupts the synthesis of thyroid hormones by blocking the enzyme peroxidase, which is involved in the iodination of thyronine in the thyroid gland with the formation of triiodo- and tetraiodothyronine. This property allows for symptomatic therapy of thyrotoxicosis, with the exception of cases of development of thyrotoxicosis due to the release of hormones after the destruction of thyroid cells (after treatment with radioactive iodine or with thyroiditis). Tyrosol® does not affect the release of synthesized thyronines from the thyroid follicles. This explains the latent period of varying duration, which may precede the normalization of T3 and T4 levels in the blood plasma, i.e. improvement of the clinical picture. Reduces basal metabolism, accelerates the removal of iodides from the thyroid gland, increases reciprocal activation of the synthesis and release of thyroid-stimulating hormone by the pituitary gland, which may be accompanied by some hyperplasia of the thyroid gland. The duration of action of a single dose is almost 24 hours.

Pharmacokinetics

Tyrosol® when taken orally is quickly and almost completely absorbed. Cmax in plasma is achieved within 0.4-1.2 hours. It practically does not bind to blood plasma proteins. Tyrosol® accumulates in the thyroid gland, where it is slowly metabolized. Small amounts of thiamazole are found in breast milk. T1/2 is about 3-6 hours, with liver failure it increases. No dependence of kinetics on the functional state of the thyroid gland was revealed.

Metabolism of the drug Tyrosol® occurs in the kidneys and liver, and the drug is excreted through the kidneys and bile. 70% of the drug Tyrozol® is excreted by the kidneys within 24 hours, with 7-12% unchanged.

Indications for use Tyrosol 10 mg 50 pcs. film-coated tablets

Thyrotoxicosis;
preparation for surgical treatment of thyrotoxicosis;
preparation for treatment of thyrotoxicosis with radioactive iodine;
therapy during the latent period of radioactive iodine action - carried out before the onset of radioactive iodine action (within 4-6 months);
in exceptional cases - long-term maintenance therapy for thyrotoxicosis, when due to the general condition or for individual reasons it is impossible to perform radical treatment;
prevention of thyrotoxicosis when prescribing iodine preparations (including cases of use of iodine-containing radiocontrast agents) in the presence of latent thyrotoxicosis, autonomous adenomas or a history of thyrotoxicosis.

Contraindications

Not recommended for use in children aged 0 to 3 years.

hypersensitivity to thiamazole, thiourea derivatives or any other component of the drug;
agranulocytosis during previous therapy with carbimazole or thiamazole;
granulocytopenia (including history);
cholestasis before starting treatment;
therapy with thiamazole in combination with levothyroxine during pregnancy.

Tyrosol® contains lactose, therefore its use is not recommended for patients with rare hereditary diseases associated with galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome.

The drug should be used with caution in patients with very large goiters with narrowing of the trachea (only short-term treatment during preparation for surgery), and with liver failure.

Application Tyrosol 10 mg 50 pcs. film-coated tablets during pregnancy and breastfeeding

Untreated hyperthyroidism during pregnancy can lead to serious complications such as premature birth and fetal malformations. Hypothyroidism caused by treatment with inadequate doses of thiamazole can lead to miscarriage.

Thiamazole penetrates the placental barrier and can reach the same concentration in the fetal blood as in the mother. In this regard, during pregnancy the drug should be prescribed only after a full assessment of the benefits and risks of its use, in the minimum effective dose (up to 10 mg/day) and without additional use of levothyroxine sodium.

Doses of thiamazole significantly higher than recommended can cause goiter and hypothyroidism in the fetus, as well as cause low birth weight.

During lactation, treatment of thyrotoxicosis with Tyrozol® can be continued if necessary. Because Thiamazole penetrates into breast milk and can reach a concentration in it corresponding to its level in the mother’s blood; hypothyroidism may develop in a newborn. It is necessary to regularly monitor thyroid function in newborns.

Use in children

Not recommended for use in children aged 0 to 3 years.

special instructions

For patients with a significant enlargement of the thyroid gland, narrowing the lumen of the trachea, Tyrozol® is prescribed for a short time in combination with sodium levothyroxine, because with prolonged use, an increase in goiter and even greater compression of the trachea is possible. It is necessary to carefully monitor the patient (monitoring TSH levels and tracheal lumen).

During treatment with the drug, regular monitoring of peripheral blood patterns is necessary.

Thiamazole and thiourea derivatives may reduce the sensitivity of thyroid tissue to radiation therapy.

If during treatment with the drug a sore throat, difficulty swallowing, increased body temperature, signs of stomatitis or furunculosis (possible symptoms of agranulocytosis) suddenly appear, you should stop taking the drug and consult a doctor immediately.

If subcutaneous hemorrhages or bleeding of unknown origin, generalized skin rash and itching, persistent nausea or vomiting, jaundice, severe pain in the epigastric region and severe weakness appear during treatment, discontinuation of the drug is required.

If treatment is stopped early, a relapse of the disease is possible.

The appearance or worsening of endocrine ophthalmopathy is not a side effect of treatment with Tyrozol®, carried out properly.

In rare cases, after completion of treatment, late hypothyroidism may occur, which is not a side effect of the drug, but is associated with inflammatory and destructive processes in the thyroid tissue that occur as part of the underlying disease.

Impact on the ability to drive vehicles and machinery

Thiamazole does not affect the ability to drive vehicles and machinery.

Overdose

With long-term use of high doses of the drug, the development of subclinical and clinical hypothyroidism, as well as an increase in the size of the thyroid gland due to an increase in TSH levels, is possible. This can be avoided by reducing the dose of the drug until a state of euthyroidism is achieved or, if necessary, by additionally prescribing levothyroxine sodium. As a rule, after discontinuation of the drug Tyrozol®, spontaneous restoration of thyroid function is observed. Taking very high doses of thiamazole (about 120 mg/day) can lead to the development of myelotoxic effects. Such doses of the drug should be used only for special indications (severe forms of the disease, thyrotoxic crisis).

Treatment: discontinuation of the drug, gastric lavage, symptomatic therapy, if necessary, switching to an antithyroid drug of another group.

Side effects Tyrosol 10 mg 50 pcs. film-coated tablets

Side effect

Determination of the frequency of side effects: very often (≥1/10), often (≥1/100,

Blood and lymphatic system: uncommon - agranulocytosis (symptoms may appear even weeks and months after the start of treatment and lead to the need to discontinue the drug); very rarely - generalized lymphadenopathy, thrombocytopenia, pancytopenia.

Endocrine system: very rarely - insulin autoimmune syndrome with hypoglycemia.

Nervous system: rarely - reversible changes in taste sensations, dizziness; very rarely - neuritis, polyneuropathy.

Gastrointestinal disorders: very rarely - enlargement of the salivary glands, vomiting.

From the liver and biliary tract: very rarely - cholestatic jaundice and toxic hepatitis.

Disorders of the skin and subcutaneous tissues: very often - allergic skin reactions (itching, redness, rash); very rarely - generalized skin rashes, alopecia, lupus-like syndrome.

From the musculoskeletal system and connective tissue: often - slowly progressive arthralgia without clinical signs of arthritis.

General complications and reactions at the injection site: rarely - fever, weakness, weight gain.

Drug interactions

When prescribing the drug after using iodine-containing radiocontrast agents in a high dose, the effect of thiamazole may be weakened.

Lack of iodine enhances the effect of thiamazole.

In patients taking thiamazole for the treatment of thyrotoxicosis, after achieving a euthyroid state, i.e. normalization of the content of thyroid hormones in the blood serum, it may be necessary to reduce the taken doses of cardiac glycosides (digoxin and digitoxin), aminophylline, as well as increase the taken doses of warfarin and other anticoagulants - derivatives of coumarin and indanedione (pharmacodynamic interaction).

Lithium preparations, beta-blockers, reserpine, amiodarone increase the effect of thiamazole (dose adjustment required).

When used simultaneously with sulfonamides, metamizole sodium and myelotoxic drugs, the risk of developing leukopenia increases.

Leukogen and folic acid, when used simultaneously with thiamazole, reduce the risk of developing leukopenia.

Gentamicin enhances the antithyroid effect of thiamazole.

There are no data on the effect of other drugs on the pharmacokinetics and pharmacodynamics of the drug. However, it should be borne in mind that with thyrotoxicosis, the metabolism and elimination of substances is accelerated. Therefore, in some cases it is necessary to adjust the dose of other drugs.