Item nanme:thiamazole tablets Item character:This product is white
Indication: ·The drug treatment of hyperthyroidism is especially suitable for patients without or with mild goiter and young patients.
·It is used for preoperative preparation of various types of hyperthyroidism.
·In order to prevent the occurrence of thyroid toxic crisis after treatment, the patients with hyperthyroidism should be treated with radioiodine.
·Intermittent treatment after radioiodine therapy.
·In individual cases, because the patient's general condition or personal reasons can not use conventional treatment measures, or because the patient refuses to accept conventional treatment measures, because of the good tolerance of methimazole tablets (in the lowest possible dose), the long-term treatment of hyperthyroidism can be used.
·For patients with history of hyperthyroidism and patients with autonomous thyroid tumor who must use iodine irradiation (such as using iodine containing contrast agent) as preventive medication
Item specifications: 10mg*50tab/box
Usage and dosage:This product is usually taken with an appropriate amount of liquid (such as half a cup of water) after meals.
·Drug treatment of hyperthyroidism (conservative treatment)
At the initial stage of treatment, according to the severity of the disease, the dosage of methimazole was 20mg-40mg (based on methimazole) (initial treatment), once a day or twice a day (the total dosage was the same). If the condition is improved from the second week to the sixth week after treatment, the doctor can gradually adjust the dose according to the need. The dosage for the next 1 to 2 years is 2.5mg-10mg per day (based on methimazole); the dosage is recommended to be taken once a day after breakfast, and can be taken together with thyroid hormone if necessary. The dosage of iodine can be increased in patients with serious disease, especially in patients with hyperthyroidism caused by iodine intake.
In the conservative treatment of hyperthyroidism, the course of treatment is usually 6 months to 2 years (average 1 year). From the statistical point of view, prolonged treatment can increase the remission rate.
·It is used for preoperative preparation of various types of hyperthyroidism
As mentioned above, the same treatment principle was used.
In the last 10 days before surgery, the surgeon may add iodine to fix the thyroid tissue.
When patients with hyperthyroidism are prepared for surgery, the use of this drug can start 3-4 weeks before the elective surgery (individual cases may need earlier), and stop the drug one day before the surgery.
·Medication before radioiodine treatment
As mentioned above, it is up to the doctor to decide the dosage and course of treatment.
·Long term antithyroid therapy is used when the disease can not be alleviated and the conventional treatment can not be adopted or rejected by the patient
Give as low a dose of methimazole as possible, usually use 2.5-10mg of this product (calculated by methimazole) every day, with or without thyroid hormone.
·For patients who must use iodine containing preparations for diagnosis (such as contrast media), in order to prevent hyperthyroidism:
Before using the iodine containing preparation, use 10-20 mg of this product per day (calculated by methimazole) and 1 g of perchlorate per day according to the doctor's advice, with a cycle of 8-10 days (such as contrast agent excreted through the kidney).
For patients with functional adenoma or potential hyperthyroidism, if Bishun uses iodine preparation, the course of treatment should be determined according to the time of iodine preparation staying in the body.
In addition, for patients with significant goiter and tracheal stenosis, this product can only be used for short-term treatment, because its long-term treatment will further goiter, resulting in more narrow respiratory tract. The whole course of treatment should be monitored, and it is best to use thyroxine at the same time.
Or follow the doctor's advice.
Adverse reactions Adverse reactions were assessed based on the following incidence definitions:
Very common ≥ 1/10
Common ≥ 1/100, < 1/10
Uncommon ≥ 1/1000, < 1 / 100
Rare ≥ 1/10000, < 1/1000
Very rare < 1/10000
[u] Abnormal blood and lymph system [/u]
Not common
Granulocytopenia was found in about 0.3% to 0.6% of cases. Granulocytopenia can also occur weeks or months after treatment, and the drug must be stopped if there is a granulocytopenia. Most cases can be recovered spontaneously.
Very rare
Thrombocytopenia, whole blood cell reduction, generalized lymphadenopathy.
[u] Endocrine abnormality [/u]
Very rare
Insulin autoimmune syndrome (with a significant decrease in blood glucose levels).
[u] Nervous system abnormality [/u]
rare
There are rare occurrence of taste disorder (taste disorder, loss of taste); it can be recovered after stopping medicine. However, it may take weeks to get back to normal.
Very rare
Neuritis, multiple neuropathy.
[u] Gastrointestinal abnormalities [/u]
Very rare
Acute salivary gland swelling.
[u] Liver and gall abnormality [/u]
Very rare
There have been reports of cholestasis jaundice or toxic hepatitis in some cases. Symptoms can be recovered after stopping the drug. It is important to distinguish the non significant clinical signs caused by cholestasis during treatment and the changes caused by hyperthyroidism, such as the increase of GGT (γ - glutamyl) and alkaline phosphatase or its bone specific isoenzyme.
[u] Abnormal skin and subcutaneous tissue [/u]
Very common
Allergic skin reactions (pruritus, rash, rubella) of different degrees. Most of these skin reactions are mild and often ease during the continuation of treatment.
Very rare
Severe allergic skin reactions, including generalized dermatitis, hair loss, drug-induced lupus erythematosus.
[u] Abnormal skeletal muscles and connective tissue [/u]
common
Joint pain may gradually occur and even after months of treatment.
[u] General diseases and administration site status [/u]
rare
Drug fever.
Taboo: Saizhi is strictly prohibited in the following patients: allergic to methimazole, other thioamide derivatives or any excipients; moderate to severe disorder of blood cell count (neutropenia); existing cholestasis not caused by hyperthyroidism; bone marrow damage after treatment with methimazole or carbimazole. During pregnancy, the combination of methimazole and thyroid hormone is contraindicated.
Matters needing attention: Saizhi should not be used in patients with a history of mild hypersensitivity (e.g., allergic rash, pruritus).
In the following patients, methimazole can only be used as short-term treatment under close monitoring
Patients with large goiter due to tracheal compression are at risk of goiter growth.
About 0.396-0.696 cases of agranulocytosis have been reported. Therefore, patients should be reminded of the symptoms of agranulocytosis (stomatitis, pharyngitis, fever) before starting treatment. This usually occurs in the first few weeks of treatment, but may also occur a few months after the start of treatment and at the time of retreatment. Close monitoring of blood cell count is recommended before and after treatment, especially in patients with previous mild neutropenia. If any of these symptoms are observed, especially in the toughest weeks of treatment, patients should be advised to contact their doctor for immediate blood cell count. If diagnosed as agranulocytosis, the drug must be stopped.
At the recommended dose, other myelotoxic adverse reactions are rare. It is usually reported in treatment with very high doses of methimazole (about 120 mg daily). These doses should be retained for specific indications (severe disease, thyroid crisis). During the treatment of methimazole, if there is bone marrow toxicity, the administration should be stopped. If necessary, other types of antithyroid drugs should be used.
Overdose can lead to subclinical or clinical hypothyroidism and goiter growth, which is due to the increase of TSH. Therefore, once the metabolic state of thyroid function is normal, the dose of methimazole should be reduced, and levothyroxine should be added if necessary. Complete cessation of methimazole and continued levothyroxine treatment alone are not effective.
When treated with methimazole, although TSH was inhibited, goiter still grew, which was caused by underlying diseases and could not be prevented by adding levothyroxine. In order to minimize the risk of deterioration of endocrine ophthalmopathy, it is critical to obtain normal TSH level. However, this condition is often independent of the course of thyroid disease. Such complications are not the reason for changing the appropriate treatment plan, nor are they considered as adverse reactions caused by the correct implementation of treatment.
After antithyroid therapy, a low proportion of patients may have long-term hypothyroidism, even if there is no other surgical treatment. This is probably not an adverse drug reaction, but a process of inflammation and destruction of thyroid parenchyma caused by underlying diseases.
In hyperthyroidism patients treated with methimazole, the decrease of pathologically increased energy expenditure may lead to (generally expected) weight gain. Patients should be told that improvement in clinical symptoms indicates normalization of their energy expenditure.
Saizhi contains lactose; therefore, it is not recommended in patients with rare genetic diseases such as galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption.
Medication for special population:
In patients with impaired liver function, the plasma clearance rate of methimazole decreased. Therefore, the dosage should be as low as possible, and the patients should be closely monitored.
In patients with impaired renal function, due to the lack of data on pharmacokinetic behavior of methimazole, it is recommended that the dosage should be adjusted carefully under close monitoring, and the dosage should be as low as possible.
Driving and operating machines:
Methimazole had no effect on the ability to drive and operate machinery.
Medication for pregnant and lactating women: Generally speaking, pregnancy has a positive effect on hyperthyroidism. However, hyperthyroidism is usually treated during pregnancy, especially in the first month of pregnancy, and untreated hyperthyroidism during pregnancy can lead to serious complications (such as preterm birth and malformation). However, hypothyroidism caused by inappropriate doses of methimazole is also associated with the tendency to miscarriage.
Methimazole can pass through the placental barrier, and the concentration in fetal blood is equal to that in maternal serum. If the dosage is not appropriate, it can lead to fetal goiter formation and hypothyroidism, and can also reduce the birth weight of the fetus. It has been repeatedly reported that women treated with methimazole gave birth to newborns with partial craniocutaneous hypoplasia. This defect can be recovered spontaneously within a few weeks.
In addition, a variety of specific patterns of malformations are associated with high-dose methimazole treatment in the first few weeks of pregnancy, including posterior nostril atresia, esophageal atresia, nipple hypoplasia, mental and motor retardation. In contrast, studies on multiple cases of pre natal exposure to methimazole have found no morphological abnormalities, nor have children's thyroid or physical and intellectual development been affected.
Because the embryo toxicity effect can not be completely ruled out, so during pregnancy, only after a strict assessment of the benefit risk, can Saizhi be used, and only in the case of no additional thyroid hormone, the application of the effective minimum dose. Methimazole can be secreted into the milk, and the concentration in the milk is the same as that in the mother's serum. Therefore, infants are at risk of hypothyroidism.
Lactation is possible during methimazole treatment; however, the maximum daily dose of methimazole is 10 mg and no additional thyroid hormone can be given.
Thyroid function must be monitored regularly.
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Our Manufacture Factory Fuzhou FUL Fluid Equipment & Pharmaceutical Co., Ltd is a comprehensive enterprise which integrates R & D, production and construction of pharmaceutical production equipments, development and transfer of biotechnology, and cooperative production and sales of drugs and vaccines. The self-developed pharmaceutical production equipment branded FUL has been put into operation in many well-known pharmaceutical enterprises such as SINOPHARM, CSPC and also cooperates with many well-known pharmaceutical enterprises in production and sales, including pharmaceutical intermediates, APIs and finished drug preparations.
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