Thyrozol 5mg Merck medicine for treatment of hyperthyroidism (10 blisters x 10 tablets)

Dosage form Box of 10 blisters x 10 tablets
Specifications Thiamazol

Ingredient

Composition information	Content
Thiamazol	5mg

Uses

Indications

Thyrozol medicine 5mg is indicated in the following cases:

Treatment hyperthyroidism .

Interlacious treatment after radioactive iodine treatment.

Preventive treatment in patients with hidden hyperthyroidism, automatic thyroid tumors or hyperthyroidism when exposed to iodine (such as X -rays with contrast containing iodine).

Pharmacokological

Thiamazole inhibits depending on the dosage of iodine combination into tyrosine and thus inhibiting the new hormone creation of thyroid hormones. This feature allows the treatment of symptoms of hyperthyroidism without caring for the cause. Currently, it has not been certified by ThiamazolbC to affect the natural process of immune hyperthyroidism (Graves disease), which means whether it inhibits the process of basic immunosuppressants.

The release of thyroid hormones that have been synthesized from the thyroid gland is not affected. This explains the reason why the potential time until normalization of thyroxine and triiodyroninine concentrations, and thus leads to clinical improvement, different in each case. Hypothyroidism due to hormone release after destroying thyroid cells, for example, after radioactive iodine treatment or in thyroid inflammation is not affected.

pharmacokinetic

absorption:

Thiamazole is absorbed quickly and completely. After drinking, the maximum serum concentration is reached within 0.4 to 1.2 hours. The cohesion with protein is negligible.

Distribution:

Thiamazole accumulates in the thyroid gland when it is slowly metabolized. Although the serum concentration changes, the accumulation of thiamazole in the thyroid gland leads to concentration stability. This leads to nearly 24 hours of impact time for single dose. According to the current knowledge, Thiamazole's dynamics does not depend on the thyroid function. The sale time is from 3 to 6 hours and lasts for liver failure.

Era:

Thiamazole is eliminated through the kidneys and bile; The excretion through small stool, the hypothesis is to follow the bowel circulation. 70% is excreted through the kidney within 24 hours. Only a small amount of excretion in constant form.

Before taking Thyrozol 5mg Merck medicine for treatment of hyperthyroidism (10 blisters x 10 tablets)

How to use

Swallow the pills with sufficient water.

During the treatment of hyperthyroidism with a high starting dose, daily dose should be broken down and drink regularly during the day.

Maintenance dose can be used in the morning, during or after breakfast.

Dosage

Thiamazole is a carbimazole metabolic form, but 1mg of thiamazole is not equivalent to 1mg of carbimazole. This should be noted when starting with thiamazole or in case of transferring from carbimazole to thiamazole. Should be used according to the recommended dose below:

General recommendations

Dosage for adults

Depending on the severity of the disease and the amount of iodine used, usually begins to treat daily dose from 10mg to 40mg. In many cases, the inhibition of thyroid hormone production can usually be achieved at a starting dose of 20 to 30mg of thiamazole every day. In lighter cases, a full dose may not be necessary, so it may consider a lower starting dose. In case of heavy hyperthyroidism, the starting dose of 40mg thiamazole.

Dosage is adjusted according to patient metabolic conditions, indicating by the progression of thyroid hormones.

For maintenance treatment, should be used according to one of the following recommendations:

a) Daily maintenance dose from 5 to 20mg thiamazole combined with levothyroxine, to avoid hypothyroidism.

b) Single treatment with daily dose from 2.5 to 10mg Thiamazole.

Hyperthyroidism due to iodine may need higher doses.

Dosage for children

Children and young people (3 to 17 years old)

The starting dose for children and young people (3 to 17 years old) should be adjusted according to the patient's weight. Typically, the treatment is started at a dose of 0.5mg/kg daily, divided evenly into 2 or 3 times. For maintenance treatment, daily dose may be reduced and used once a day, depending on the response of the patient with treatment. Levothyroxine may be needed to avoid hypothyroidism. The maximum total recommended dose must not exceed 40mg/day.

Used in young children (2 years old and under 2 years old)

Safety and effectiveness of Thiamazole in 2 -year -old children and under 2 years of age has not been systematically evaluated, so it is not recommended to use Thiamazole to 2 years old and under 2 years old.

Hyperthyroidism conservation treatment

The purpose of the treatment is to achieve the metabolism of the armor and recover for a long time after a certain treatment.

In the treatment of hyperthyroidism conservation, the treatment time usually lasts from 6 months to 2 years (average is 1 year). According to statistics, the recovery capacity increases over time of treatment. In cases where the recovery cannot be achieved and the determined treatments are not applied or denied, Thiamazole can be used as long -term anti -thyroid treatment at a low dose that may not be used or combined with low doses of Levothyroxine.

Patients with large goiter and trachea -blocking should only be treated for short -term with Thiamazole because long -term use can lead to tumor growth. It may be necessary to specially monitor the entire treatment process (TSH concentration, trachea). It is best to treat in combination with using more levothyroxine.

Treatment before surgery

Temporary treatment (for 3 to 4 weeks or longer, in individual cases) can achieve conditions for metabolism of the armor, thus reducing the risk of surgery.

Surgery should be conducted as soon as the patient reaches the level of armor. If not, levothyroxine should be used. The treatment may end the day before surgery.

The risk of increased crunching and hemorrhage of thymazole can be compensated by high doses of iodine 10 days before surgery (iodine therapy).

Treatment before treatment with radioactive iodine

Achieving the metabolism of the armor before treatment with radioactive iodine is especially important in cases of severe hyperthyroidism, because the post -treatment poisoning has occurred in cases of individuals after radioactive iodine treatment without previous treatment.

Note: Thionamide derivatives may reduce the sensitivity to the radioactive of the thyroid tissue. In the treatment of automatic thyroid tumors with radioactive iodine according to the program, the activation of the thyroid tissue by the core by the previous treatment must be prevented.

Explain treatment after radioactive iodine treatment

The time and treatment do the dose must be adjusted for each individual depending on the clinical condition and the prediction time until the radioactive iodine therapy starts to work (about 4 to 6 months).

Preventive treatment in patients is at risk of developing hyperthyroidism due to the use of iodine containing substances for diagnostic purposes.

In general, daily dose from 10 to 20mg of thiamazole and/ or 1 g perchlorate for about 10 days (for example: for contrasting excreted kidneys). Treatment time depends on the time of containing iodine stored in the body.

Special case

In patients with hepatic failure, the plasma clearance of Thiamazole is reduced. Therefore, the dose should be kept at the lowest possible and patients should be carefully monitored.

Because there is no full range of figures related to Thiamazole's pharmacokinetics in patients with renal impairment, it is recommended to adjust the dose carefully for each individual and should be monitored carefully. Dosage should be kept low as possible.

Although there is no accumulation in the elderly, it is necessary to adjust the dose carefully for each individual and should monitor carefully.

Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.

What to do when overdose? This can be avoided by reducing the dose as soon as the metabolism of the armor, and if necessary, Levothyroxine can be used. The consequences of accidentally taking high dose Thiamazole is not known.

What to do when forgetting 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.

Side Effects

When using thyrozol 5mg medicine , you may experience unwanted effects (ADR).

Common, ADR> 1/100

Skin and subcutaneous tissue disorders: allergic reactions on the skin at different levels (itching, skin redness, urticaria ).

musculoskeletal and connective tissue disorders: joint pain gradually progresses and occurs even after months of treatment.

Uncommon, 1/1000

Blood disorders and lymphatic systems: granulocytes occur at 0.3 to 0.6% of cases. It can become clear after a few weeks or months of treatment and need to stop using the drug. Most cases of self -recovery.

Rare, 1/10000

Nervous system disorders: Intence buds (taste disorders, loss of taste) rarely occur, can recover after stopping treatment. However, it takes weeks to return to normal state.

General disorders and diseases at the position of oral medication: Drug fever.

Very rare, ADR

Blood disorders and lymphatic systems: decreased urinary tract, reduced all bloody hematopleus, lymph nodes

Endocrine disorders: Insulin syndrome (obvious blood glucose).

Nervous system disorders: neuritis, multiple nerve disease.

Gastrointestinal disorders: Salivation glands.

Hepatic disorders: There is a description of cases of jaundice cholestas or toxic hepatitis. Symptoms are almost regression after stopping the drug. The clinical signs of biliary stasis during the treatment process are different from the disorders caused by hyperthyroidism, such as gamma (gamma glutamyl transferase) and alkaline phosphatase or its main specificities.

Skin and subcutaneous tissue disorders: The severity of allergic reactions on the skin include all -dermatitis, hair loss, lupus erythematosus due to drugs.

Instructions on how to handle ADR

When experiencing side effects of the drug, it is necessary to stop using and notify the doctor or go to the nearest medical facility for timely treatment.

Warnings

Before using the drug you need to read the instructions carefully and refer to the information below.

Contraindicated

Thyrozol 5mg medicine contraindicated in the following cases:

Hypersensitivity to Thiamazole, with other thionamide derivatives or any ingredients of the drug.

Average blood to severe blood formula disorders (granulocytes).

The previous cholestatic condition is not due to hyperthyroidism.

Has had bone marrow damage after treatment with thiamazole or carbimazole.

Thiamazole combination treatment and thyroid hormone are contraindicated during pregnancy.

Caution when using

should not use thyrozol for prehistoric patients with mild hypersensitivity reactions (such as allergies, itching).

Should only use Thiamazole in a short time under the careful monitoring of large goiter patients with tracheal congestion due to the risk of tumor growth.

The grain leukemia is reported in 0.3 to 0.6% of cases and should be noted for patients on its symptoms (stomatitis, sore throat, fever) before starting treatment. Loss of granulocytes often occurs during the first weeks of treatment, but may become clear a few months after the beginning of treatment or during use. It is recommended to carefully monitor the blood formula before and after the beginning of treatment, especially for cases of mild granulocytes. In case of observation, the above symptoms, especially in the first weeks of treatment, people must be consulted, so contact the doctor immediately for blood formula tests. If you identify the loss of granulocytes, stop using the drug is necessary.

Other harmful reactions caused by bone marrow disease are very rare for recommended doses. These reactions are often reported regarding very high doses Thiamazole (about 120mg per day). These doses should only be used for special indications (serious illness, armor poisoning). Thiamazole must be discontinued when bone marrow poisoning occurs during treatment, and if necessary, switch to other anti -thyroid drugs.

Overdose can cause clinical or hidden hyperthyroidism and tumor growth due to increased TSH. Therefore, thiamazole should be reduced as soon as the level of armor and, if necessary, can be used more levothyroxine. It is not helpful to stop using thiamazole but only continue treatment with levothyroxine.

Tumor growth during treatment with Thiamazole despite the inhibition of TSH is the result of the main disease and cannot be prevented by further treatment with levothyroxine.

Achieving normal TSH is the main thing to reduce the risk of occurring/ or decline in hormonal eye disease. However, this situation is usually not dependent on the progression of thyroid disease. This complication is not the reason for changing the treatment and is not considered a harmful reaction to the correct treatment.

With a low dollar, late hypothyroidism can occur after treatment of thyroid resistance without using other surgical methods. This is almost certainly not a harmful reaction of the drug, but it is considered as the process of inflammation and destruction of the main thyroid parenchyma.

Reducing energy consumption increases due to pathology in hyperthyroidism can lead to (common desired) weight gain during treatment with Thiamazole. It should be notified to the patient that the improvement of clinical status shows the normalization of the energy they consume. Thyrozol contains lactose, so it is not recommended for use for genetic galactose tolerance, Lapp Lactase deficiency or absorption of glucose - poor galactose.

The ability to drive and operate machinery

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

Pregnancy

In general, pregnancy has a positive effect on hyperthyroidism. However, treatment of hyperthyroidism is necessary, especially in the first months of pregnancy. Untreated hyperthyroidism during pregnancy can cause complex complications such as premature birth and malformations. However, hyperthyroidism due to the inappropriate thiamazole dose is also related to miscarriage.

Thiamazole passes through the placenta and in the fetal blood, achieving the concentration equivalent to the concentration found in the mother serum. The inappropriate dose can cause goiter and hyperthyroidism for the fetus as well as reduce the weight of newborns. There have been repetitive reports on partially discontinuing the scalp of babies' scalp of mothers treated with Thiamazole. This defect recovers for a few weeks.

In addition, a solid model of various defects related to thiamazole treatment in the first weeks of pregnancy, such as no posterior nostrils, esophagus, nipples, intellectual growth and movement. In contrast, many studies use Thiamazole before pregnancy does not show any disorders of morphological development as well as affecting the thyroid gland and mental and physical development of children.

Because it is not possible to completely eliminate the effects of poisoning on the embryo, thyrozol should only be used during pregnancy after careful consideration between benefits and risks and only use with the lowest doses without using more thyroid hormones.

Breastfeeding period

Thiamazole enters milk and can achieve concentration equivalent to the concentration of mother serum, so there is a risk of hypothyroidism in newborns.

Can breastfeed while being treated with thiamazole; However, low doses of up to 10mg daily without using thyroid hormones. The thyroid function of the newborn must be carefully monitored.

Drug interaction

with aminophylin, oxtriphylin or theophylin: When hyperthyroidism, the metabolism of these drugs increases. Use Thiamazol, if the thyroid gland returns to normal, it is necessary to reduce the dose of these drugs.

With Amiodaron, Iodoglycerol, Iodine or Potassium iodid: drugs with iodine reduces the body's response to thiamazol, so there must be a dose of thiamazol (amiodaron with 37% iodine).

With anticoagulant drugs Coumarin or indandion: Thiamazol can reduce blood prothrombin, so the effects of anticoagulants oral medications increase. Therefore, it is necessary to adjust the anticoagulant dose based on prothrombin.

With Beta blockers, cardiac glycosides: Hyperthyroidism increases metabolism and eliminates Beta or cardiac blockers, cardiac glycosides, the dose of these drugs should be reduced when the thyroid patient returns to normal due to thiamazol.

With radioactive iodine 131i: Thiamazol reduces 131i to the thyroid. If the thiamazol stops suddenly, after about 5 days, the 131i collection will increase again.

Storage

Store at temperatures below 30 ° C.

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