NMPA: Revision of 巯 and methiciltic preparation instructions Adverse reactions, taboos and many other content

In order to further ensure the safety of public drug use, the State Drug Administration has decided to reviseof preparations for methamphetium.
The relevant matters are heeded as follows: First, the market license holders of this product shall, in accordance with the Measures for the Administration of Drug Registration and other relevant provisions, and in accordance with the revised requirements of the Amisium preparation instructions (see annex), file a supplementary application for the revision of the instructions and report them to the Drug Review Center of the State Drug Administration or the provincial drug regulatory department for the record by May 3, 2021.
of the amendment relates to the drug label, it shall be revised together, and the instructions and other contents of the label shall be consistent with the original approval content.
the original drug instructions for medicines produced on the date of filing.
drug market license holders shall replace all factory-issued drug instructions and labels within 9 months of filing.
II. Drug market license holders shall conduct in-depth research on the mechanism for the occurrence of new adverse reactions, take effective measures to do a good job in the publicity and training of use and safety issues, and immediately notify drug management and use units in an appropriate manner of changes in content related to drug safety, and guide physicians and pharmacists to use drugs rationally.
. Clinicians and pharmacists shall carefully read the revised contents of the preparation instructions for Amythyl, and shall conduct a full benefit/risk analysis in accordance with the newly revised instructions when selecting medications.
, patients should carefully read the instructions before taking the drug, should strictly follow the doctor's instructions to use the drug.
. The provincial drug supervision and administration department shall urge the holders of the drug listing licenses of the products in the administrative area to do a good job in revising the corresponding instructions and replacing the labels and instructions as required, and severely investigate and punish the violations of laws and regulations in accordance with the law.
this announcement.
: AMide preparation instructions revision requirements of the State Drug Administration February 4, 2021 Annex Amythyl preparation instructions revision requirements I, a meth mimi oral preparations (i) (i) The following should be included in the blood and lymphatic system: more white blood cells, fewer granulocytes, less severe granulocyte deficiency (which can manifest as stomatitis, pharyngitis, fever, etc.), plate plate reduction, whole blood cell reduction, clotting enzyme or clotting factor VII. reduction.
2. Liver and bile systems: liver damage, elevated laboratory indicators such as alkaline phosphatase (ALP), alanine amino transferase (ALT), mendonine amino transferase (AST), total bilirubin (T-BIL), direct bilirubin (D-BIL), indirect bilirubin (I-BIL), etc.;
cases of bile silt jaundice or toxic hepatitis have been reported.
3. Skin and its accessories: more rashes, itching, hair loss, rare peeling dermatitis, very rare and severe allergic skin reactions, including general dermatitis, drug-induced lupus erythematosus.
. Gastrointestinal system: nausea, vomiting, anorexia, upper abdominal discomfort;
5. Endocrine system: Adverse reactions were reported with insulin autoimmune syndrome (accompanied by a significant decrease in blood sugar levels).
6. Musculoskeletal system: joint pain, muscle pain.
7. Nervous system: dizziness, headache, taste disorders (taste disorders, loss of taste, loss of taste);
8. Other: anti-neutrinotic cell plasma antibody-associated small angiotisitis (can be manifested as nephritis and kidney-related small angiotisitis, pulmonary immersion or alba hemorrhage, skin ulcers and joint pain, etc.), lupus-like syndrome, interstitial pneumonia, drug fever.
(ii) "Taboo" item should contain the following 1. Banned from allergies to acetyles, other thiopental derivatives or any accessories of this product.
2. Moderate to severe blood cell count disorder (neo-granulocyte reduction) is disabled.
3. Bile siltation caused by hyperthyroidism is disabled.
4. After receivingmetformin or propylene thioxyxine, granulocyte deficiency or severe bone marrow inhibitors were disabled.
5. People who havewith methamphetazole or kabimazole in the past are disabled.
(iii) "Precautions" should include the following 1. Pregnant women, abnormal liver function, granulocyte reduction should be used with caution.
. During treatment, women of childbearing age are required to use effective contraception.
3. Approximately 0.3 to 0.6 per cent of cases have been reported to have granulocytic deficiency, which can occur weeks or months after the start of treatment and during re-treatment.
recommends that patients have regular blood tests once a week for the first 3 months of treatment.
routine blood tests are done once a month during maintenance treatment.
to remind patients of stomatitis, pharyngitis, fever and other symptoms, should be immediately referred to the doctor.
. Patients are advised to have a monthly liver function check-up for the first 3 months of treatment.
liver damage occurs mostly within 12 weeks of the start of treatment, patients should be reminded to see a doctor immediately if they experience symptoms such as anorexia, nausea, upper abdominal pain, urine yellowing, skin or sclera yellowing.
5. Rare bone marrow inhibition at the recommended dose of the instruction manual.
bone marrow inhibition is often associated with the use of high doses (approximately 120 mgdaily) of methamphetazole.
high doses of methamphetamide are required in some special adaptations (severe diseases such as thyroid )
bone marrow inhibition occurs, the drug needs to be stopped immediately.
other types of antithyroid drugs can be adjusted if necessary.
. In patients with impaired liver function, theremoval rate of methamphetium decreased.
, the dose should be as low as possible and patients should be closely monitored.
7. In patients with impaired renal function, due to the lack of data on the generational dynamics of the drug Amythyl, it is recommended that the dose be carefully individualized under close monitoring and that the dose be as low as possible.
8. Interference with diagnosis: Amide can prolong the original time of clotting enzymes and increase the serum alkaline phosphatase, mendonine amino transferase (AST) and alanine amino transferase (ALT).
may also cause elevated hemocholine and hematochloric acid dehydrogenase.
reports ofpancreatitis were found in post-market monitoring reports of methamphetazole or kabimazole.
if acute pancreatitis occurs during treatment, thymosin should beimmediately.
who havehistory of acute pancreatitis after giving methamphetazole or kabimazole should avoid receivingmethamphetazole again.
may lead to a recurrence of acute pancreatitis and a shorter onset time.
(4) (Iv) (Pregnant and lactating women's medication) and pregnant women related to the content replaced by the following treatment period, women of childbearing age need to use effective contraception.
should be fully treated for hyperthyroidism in pregnant women to prevent serious pregnancy complications and fetal complications.
methamphetcan pass through the placental barrier.
epidemiological studies and spontaneous reports, it is suspected that treatment with metformine during pregnancy (especially in the early stages of pregnancy, when used in high doses) may lead to congenital malformations.
reported deformities include congenital skin dysplocy, craniofacial malformations (rear nostril latching, facial deformities), umbilical cord palate, esophardoal latching, umbilical-intestinal membrane catheter abnormalities, and room space defects.
can only be taken during pregnancy after a rigorous individual benefit/risk assessment, and only the lowest effective dose is given and treatment with thyroid hormone is avoided.
close maternal, fetal and neonatal monitoring is recommended if methamphetamide is used during pregnancy.
(v) (5) "Drug for the elderly" should be revised to read the following in elderly patients, although drug accumulation is not expected, but it is recommended to carefully individualize the dose under close monitoring.
(vi) "Drug Interactions" should include the following iodine deficiency to enhance the thyroid gland's response to thyroid , and iodine overdose can reduce the reaction.
, however, it should be noted that in the case of hyperthyroidism, the decomposition and excretion of other drugs can be accelerated, and these reactions can return to normal as thyroid function gradually returns to normal.
need it, the doctor should adjust its dose.
(vii) (Drug overdose) should be revised to the following drug overdose can lead to hypothyroidism, metabolic decline of the corresponding symptoms, through feedback effect, can activate the pituitary gland, followed by the growth of goiter.
once the metabolic state of normal thyroid function is reached, this can be avoided and, if necessary, left thyroxine can be added.
consequences of accidentallyhigh doses of methamphetamide are unknown.
(Note:oral preparation of methamphetium includesmimi tablets and methamphetiumintestinal solution tablets.
other contents of the instruction manual that are inconsistent with the above-mentioned amendment requirements shall be revised in une.d.
) II, A Mimi cream (i) "adverse reactions" should include the following content of this clinical study of the whole body adverse reactions significantly less than oral administration (20.3%), mainly liver abnormalities and white blood cell reduction, the incidence rate is 1.4% (1/72);
Animal studies have shown that there is still some systemic exposure to amphetium after use of this product (see Pharmacodynamics) and that clinical use of this product should also be concerned about the following adverse reactions that may occur during oral preparation use: 1. Blood and lymphatic System: more white blood cell reduction, less granulocyte reduction, less serious granulocytic deficiency (can be manifested as stomatitis, pharyngitis, fever, etc.), plate reduction, whole blood cell reduction, clotting enzyme or clotting factor VII.
2. Liver and bile systems: liver damage, elevated laboratory indicators such as alkaline phosphatase (ALP), alanine amino transferase (ALT), mendonine amino transferase (AST), total bilirubin (T-BIL), direct bilirubin (D-BIL), indirect bilirubin (I-BIL), etc.;
cases of bile silt jaundice or toxic hepatitis have been reported.
3. Skin and its accessories: more rashes, itching, hair loss, rare peeling dermatitis, very rare and severe allergic skin reactions, including general dermatitis, drug-induced lupus erythematosus.
. Gastrointestinal system: nausea, vomiting, anorexia, upper abdominal discomfort;
5. Endocrine system: Adverse reactions were reported with insulin autoimmune syndrome (accompanied by a significant decrease in blood sugar levels).
6. Musculoskeletal system: joint pain, muscle pain.
7. Nervous system: dizziness, headache, taste disorders (taste disorders, loss of taste, loss of taste);
8. Other: anti-neutral granulocyte plasma antibody-related small angiotisitis (can be manifested as nephritis and kidney-related small angiotisitis, pulmonary immersion or alba hemorrhage, skin ulcers and joint pain, etc.), lupus-like syndrome, interstitial pneumonia, drug fever.
(ii) "Taboo" item should contain the following 1. Banned from allergies to acetyles, other thiopental derivatives or any accessories of this product.
2. Moderate to severe blood cell count disorder (neo-granulocyte reduction) is disabled.
3. Bile siltation caused by hyperthyroidism is disabled.
4. After receivingmetformin or propylene thioxyxine, granulocyte deficiency or severe bone marrow inhibitors were disabled.
5. People who havewith methamphetazole or kabimazole in the past are disabled.
(iii) "Precautions" should include the following 1. Pregnant women, abnormal liver function, granulocyte reduction should be used with caution.
. During treatment, women of childbearing age are required to use effective contraception.
3. It has been reported that approximately 0.3 to 0.6 per cent of cases with oral preparations for methmide have experienced granulocyte deficiency, which can occur weeks or months after the on-start of treatment and during re-treatment.
patients to have regular blood tests once a week for the first 3 months of treatment.
routine blood tests are done once a month during maintenance treatment.
to remind patients of stomatitis, pharyngitis, fever and other symptoms, should be immediately referred to the doctor.
. Patients are advised to have a monthly liver function check-up for the first 3 months of treatment.
liver damage occurs mostly within 12 weeks of the start of treatment, patients should be reminded to see a doctor immediately if they experience symptoms such as anorexia, nausea, upper abdominal pain, urine yellowing, skin or sclera yellowing.
5. orthopedic preparation is inhibited by rare bone marrow at the recommended dose in the instruction manual.
bone marrow inhibition is often associated with oral high doses (approximately 120 mg ) of methamphetazole.
bone marrow inhibition occurs, the drug needs to be stopped immediately.
other types of antithyroid drugs can be adjusted if necessary.
. In patients with impaired liver function, the removal rate of methamphetium decreased.
, the dose should be as low as possible and patients should be closely monitored.
7. In patients with impaired renal function, due to the lack of data on the generational dynamics of the drug Amythyl, it is recommended that the dose be carefully individualized under close monitoring and that the dose be as low as possible.
8. Interference with diagnosis: Amide can prolong the original time of clotting enzymes and increase the serum alkaline phosphatase, mendonine amino transferase (AST) and alanine amino transferase (ALT).
may also cause elevated hemocholine and hematochloric acid dehydrogenase.
reports of pancreatitis were found in post-market monitoring reports of oral preparations such as methamphetumazole or kabimazole.
if acute pancreatitis occurs during treatment, thyroxine should be immediately.
who have history of acute pancreatitis after giving methamphetazole or carbimatrophic should avoid treatment methamphetumazole again.
may lead to a recurrence of acute pancreatitis and a shorter onset time.
(4) (Iv) (Pregnant and lactating women's medication) and pregnant women related to the content replaced by the following treatment period, women of childbearing age need to use effective contraception.
should be fully treated for hyperthyroidism in pregnant women to prevent serious pregnancy complications and fetal complications.
methamphet can pass through the placental barrier.
according to epidemiology