Description: The instructions for carbimazole tablets (hyperthyroidism) were issued by National Medical Products Administration in the Notice on Printing and Distributing the First Batch of Instructions for Chemical Drugs [21] No.586 on December 31st, 21. The instruction manual published by National Medical Products Administration is a reference sample of the revised specifications. If there are any doubts, enterprises can propose amendments. Indications should be consistent with the original approved content; Adverse reactions, drug interactions and other contents, the instructions provided by the enterprise can not be less than those listed in the sample draft. For empty items or incomplete items in the sample manual, enterprises should be required to fill in according to the actual situation, such as trade names and specifications.
drug name
generic name: Carbimazole Tablets
trade name:
English name: carbimazole tablets
Chinese pinyin: Kabimazuo Pian
main components of this product and its chemical name:
the main component of this product is carbimazole, and its chemical name is: 3 methyl 2 thio-2. 3-dihydro-－1H－-imidazole-1-ethyl formate
has the structural formula:
molecular formula: C7H1N2O2S
molecular weight: 186.23
properties
This product is a white tablet.
Pharmacology and Toxicology
This product is an antithyroid drug. Its mechanism of action is to inhibit peroxidase in thyroid gland, thus preventing the oxidation of iodide absorbed into thyroid gland and the coupling of tyrosine, and preventing the synthesis of thyroxine (T4) and triiodothyronine (T3). Animal experiments show that it can inhibit the synthesis of antibodies by B lymphocytes, reduce the level of thyroid antibodies in blood circulation, and restore the function of inhibitory T cells to normal.
Pharmacokinetics
After being taken orally, this product gradually hydrolyzes into methimazole in the body and acts, so the action is slow, the curative effect lasts for a long time, and the half-life is about 9 hours.
Indications
It is suitable for all types of hyperthyroidism, especially for: ① patients with mild to moderate goiter; ② adolescents and children, elderly patients with thyroid recurrence after operation, and those who are not suitable for radioactive 131I therapy; ④ preparing before operation; ⑤ as an auxiliary treatment of 131I radiotherapy.
Administration and dosage
1. Adults: The initial dosage is generally 3mg(6 tablets) a day, which can be adjusted to 15-4mg (3-8 tablets) according to the severity of the disease, and the maximum dosage is 6mg(12 tablets) a day, which can be taken orally in batches; After the disease is controlled, it is gradually reduced, and the daily maintenance amount is between 5 ~ 15 mg (1 ~ 3 tablets) according to the needs of the disease, and the course of treatment is generally 1824 months.
2. Children: At the beginning, the dosage is .4mg/kg per day according to body weight, taken orally in several times. The maintenance amount depends on the condition. < P > Adverse reactions < P > Rash, itchy skin and leukopenia are more common; Severe agranulocytosis is rare; Aplastic anemia may occur; It may also cause taste loss, nausea, vomiting, epigastric discomfort, joint pain, dizziness and headache, vasculitis and lupus erythematosus-like syndrome. Hepatitis, interstitial pneumonia, nephritis and vasculitis involving the kidney are rare, and thrombocytopenia, prothrombin or factor VII are rare.
contraindications
it is forbidden for lactating women.
Precautions
1. Blood picture should be checked regularly during taking medicine.
2. Pregnant women, patients with abnormal liver function and low white blood cell count in peripheral blood should use it with caution.
3. Interference to diagnosis: Methimazole can prolong prothrombin time and increase serum alkaline phosphatase, aspartate aminotransferase (AST) and alanine aminotransferase (ALT). It may also cause an increase in blood bilirubin and lactate dehydrogenase.
medication for pregnant women and lactating women
it is forbidden for lactating women, and pregnant women should use it with caution.
children should use thyroid tablets as appropriate to avoid hypothyroidism.
medication for elderly patients
elderly people, especially those with renal dysfunction, should reduce their dosage. If hypothyroidism is found, thyroid tablets should be reduced or added in time.
drug interaction
1. Combined with anticoagulants, anticoagulation can be enhanced.
2. The intake of high iodine food or drugs can aggravate the condition of hyperthyroidism, increase the demand for antithyroid drugs or prolong the medication time. Therefore, avoid taking iodine before taking this product.
3. Sulfonamides, p-aminosalicylic acid, phenylbutazone, barbiturates, phentolamine, tolazolin, vitamin B12, sulfonylurea, etc. all have the effects of inhibiting thyroid function and goiter, so attention should be paid to the combination of this product.
drug overdose
if hypothyroidism is found, it should be reduced or added with thyroid tablets in time.
gauge
5mg
effective period
storage
shading, sealed and preserved.
approval number
manufacturer
name of enterprise:
address:
postal code:
telephone number:
instructions for drafting carbimazole tablets
drug name
common name, trade name, English name, Chinese pinyin, main components and chemical name, etc.
characteristics
see page 129 of China Pharmacopoeia 2
Pharmacology and Toxicology
See page 529 of China Pharmacopoeia
Pharmacokinetics
See page 39 of Clinical Drug Instructions 1995; Practical therapeutic pharmacology page 971
Indications
Usage and dosage
Please refer to the 2 edition of Clinical Drug Instructions page 529
Adverse reactions
Contraindications
Precautions
Pregnant women and lactating women
Children
Elderly patients
Drug interactions
Please refer to 2. See the 1995 edition of Instructions for Clinical Use on page 389
Precautions
Specifications
Storage
See the 2 edition of China Pharmacopoeia on page 129.