Heavy! Paracetamol preparation sits on the specification involving thousands of approvals!

On March 3, the State Drug Administration issued the Notice of the State Drug Administration on the Revision of the Specification of Compound Licorice Tablets (No14 2020) and the Notice of the State Drug Administration on the Revision of the Specifications for the Regular Release of Acetaminophen and The Reprieve (No15 of 2020)the State Drug Administration requires: All production enterprises of paracetamol regular release and reprieve preparations shall, in accordance with the relevant provisions of the Measures for the Administration of Drug Registration, submit supplementary applications for revision of the specifications in accordance with the requirements of the regular release of acetaminophen and the specification of the reprieve preparation (see annex), and submit them to the provincial drug regulatory authorities for the record by May 20, 2020the contentof of the revision of the drug label, it shall be revised together; the specification and other contents of the label shall be consistent with the original approval contentAll factory drug instructions and labels shall be replaced within 9 months of the filing of the supplementary applicationthe above-mentioned production enterprises of paracetamol and reprieve preparations shall conduct in-depth research on the mechanism of the occurrence of new adverse reactions, take effective measures to do a good job in publicity and training on the use and safety of the problem, and immediately notify the drug business and use units in an appropriate manner, and guide physicians and pharmacists to use the drug rationallythe time limit for the application for supplementary application for compound licorice tablets and the requirement to replace the factory instructions, and the above-mentioned consistency, will no longer be notified of it listedinvolved in thousands of batches ofacetaminophen preparations, is a commonly used drug, with "acetaminophen" as the key word, the search results have 3003 records (which will have some compound preparations containing acetaminophen will also be searched out, minus compound acetaminophen 171, 2832)in the spirit of the notice, it should not include compound preparations containing acetaminophenSmall editor believes that for compound preparations, should also refer to the specification to revisein order to reduce the interference of the search, small compilation with "acetaminophen tablets" as the keyword, the search results have 1089 recordsVisible this preparation and the production of many pharmaceutical enterprises!to compound licorice tablets as the key word, the search results have 36 records
Annex 1: acetaminophen regular release prescription drug specification revision requirementsI, "adverse reactions" item"adverse reactions" item added the following:1The use of acetaminophen can cause fatal and serious adverse skin reactions, such as debaritis, toxic epidermal necrosis (TEN), Stevens Johnson syndrome (SJS), acute pantoma pustules (AGEP)These serious events can occur without warningWhen other signs of a rash or allergic reaction appear, discontinue the product immediately and consult a specialist2Excessive use of acetaminophen can cause severe liver damage2, "Taboo" item"Taboo" item addthe the following:to the product of the allergy to the disabledthree, "precautions" item"Precautions" add the following:1Serious liver injury: overdosing use of acetaminophen can cause serious liver damage, so the amount of this product should be strictly applied in accordance with the instructions; During the drug use, if abnormal liver biochemical indicators or the appearance of systemic fatigue, loss of appetite, anorexia, nausea, upper abdominal bloating pain, urine yellow, ophthalmic yellowing, skin yellowing and other clinical manifestations may be related to liver damage, should immediately stop the drug and seek medical treatment, it is recommended that the maximum amount of acetaminophen oral one day not more than 2g2Allergy is used with caution, and it is prohibited for those who are allergic to this product 3 The combined use of drugs containing acetaminophen or other anti-heat analgesics should be avoided in order to avoid drug overdoses or toxic synergies 4.N-acetysteine is an antagonistic drug for acetaminophen poisoning, should be applied as early as possible, within 12 hours of the drug treatment is satisfactory, more than 24 hours of poor efficacy (Note: If the other contents of the specification are inconsistent with the above amendment requirements, they shall be revised together.) Annex 2: The revised specification of the over-the-counter medicine slot of acetaminophen regularly released agents the revision requirements of I, "Adverse Reactions" item the "adverse reaction" item mentioned in the "adverse reaction" item can be recovered on its own, "self-recovery" must be deleted "Adverse Reaction" item adds the following: 1 Occasional rash It has been reported that very few patients who use acetaminophen may experience fatal and severe adverse skin reactions 2 Excessive use of acetaminophen can cause severe liver damage 2, "Taboo" item "Taboo" item addthe the following: to the product of the allergy to the disabled three, "precautionary note" item "Precautions" add the following: 1 When the appearance of rash or allergic reactions of other signs, such as itching, rash, especially after the use of oral, eye, genital erythema, erosion, etc., should immediately stop the drug and consult a doctor 2 Allergy is used with caution, and it is prohibited for those who are allergic to this product 3 Reports of severe liver damage caused by excessive use of acetaminophen should be used strictly in accordance with the instructions During the drug use, if abnormal liver biochemical indicators or the appearance of systemic fatigue, loss of appetite, anorexia oil, nausea, upper abdominal swelling pain, urine yellow, ojainization, skin yellowing and other clinical manifestations may be related to liver damage, should immediately stop the drug and seek medical treatment It is recommended that acetaminophen be taken orally to a maximum of 2 grams a day 4 The combined use of drugs containing acetaminophen or other anti-heat analgesics should be avoided in order to avoid drug overdoses or toxic synergies (Note: If the other contents of the specification are inconsistent with the above amendment requirements, they shall be revised together.) Annex 3: Paracetamol reprieve preparation specification requirements , unified increase warning "excessive use of acetaminophen deinterpreting agent can cause serious liver damage, long-term drinking, liver dysfunction of people using acetaminophen liver damage risk is higher." 2, acetaminophen reprieve tablets the use of the dosage will be modified to: "adults and children over 12 years of age 1 tablets at a time, if the continuous fever or pain, every 8 hours, 24 hours no more than 3 times." "
addition of acetaminophen under "Adverse Reactions" can cause serious liver damage "
add "Add" strictly according to the instructions Adults or children who overdose should seek medical attention immediately, regardless of whether they experience symptoms of discomfort or not "And" N-acetylcysteine is an antagonistic drug for acetaminophen poisoning, should be applied as early as possible, within 12 hours of the drug treatment is satisfactory, more than 24 hours of poor efficacy III, acetaminophen slow release dry suspension agent the use of the dosage will be modified to: "adults and children over 12 years of age 1 pack 1 pack at a time, if continuous fever or pain, every 8 hours, 24 hours no more than 3 times." "
addition of acetaminophen under "Adverse Reactions" can cause serious liver damage "
add "Add" strictly according to the instructions Adults or children who overdose should seek medical attention immediately, regardless of whether they experience symptoms of discomfort or not "And" N-acetylcysteine is an antagonistic drug for acetaminophen poisoning, should be applied as early as possible, within 12 hours of the drug treatment is satisfactory, more than 24 hours of poor efficacy "
four, ammonia chlorpyrifos pseudo-hemp release tablets "indications" under the removal of "seasonal allergic rhinitis" "drug overdose" under the "drug overdose" under the "acetaminophen" segment increase "N-acetyl cysteine is acetaminophen poisoning resistance drugs, should be applied as soon as possible, within 12 hours of the drug treatment is satisfactory, more than 24 hours of poor efficacy ,"
," chloracean hypoxapolium hypoxeletatonics removed "seasonal allergic rhinitis" under "indications" "adverse reactions" under the "adverse reactions" under the "acetaminophen" segment increase "long-term use, short-term overdosing use of acetaminophen can cause serious liver damage." "
"" added under the "severe liver injury: over-dose use of acetaminophen can cause serious liver damage, so the amount of this product should be strictly applied in accordance with the instructions; During the drug use, if abnormal liver biochemical indicators or the appearance of systemic fatigue, loss of appetite, anorexia oil, nausea, upper abdominal swelling pain, urine yellow, ojainization, skin yellowing and other clinical manifestations may be related to liver damage, should immediately stop the drug and seek medical treatment N-acetylcysteine is an antagonistic drug of acetaminophen poisoning, should be applied as early as possible, within 12 hours of the drug treatment is satisfactory, more than 24 hours of poor efficacy (Note: If the rest of the specification is inconsistent with the above revision requirements, it shall be revised together.) annex: compound licorice tablet specification revision requirements "warning note": this product contains opioid powder, athletes use with caution I "Adverse Reactions" itemshould include the following after the listing of adverse reactions monitoring data show that the following adverse reactions are visible: gastrointestinal system: nausea, vomiting, dry mouth, abdominal pain, diarrhea, constipation, etc.
; systemic damage: allergic reactions, chills, fever, edema, fatigue, etc., cases of anaphylactic shock reported; respiratory system: chest tightness, breathing difficulties, cough aggravation, asthma, etc.; cardiovascular system: elevated blood pressure, flush, cyanosis, heart palpitations, arrhythmia, etc.; urinary system: urinary frequency, urination difficulty, uri nation, etc second, "taboo" item should contain the following
1 Do not allow anyone who is allergic to this product and the ingredients contained 2 Patients with increased growth of aldosterone are prohibited three, "Precautions" item should contain the following
1 Athletes are careful to use During the period of taking the drug and within 3 to 4 days after discontinuation, the urine morphine test has a positive effect 2 This product should not be taken for a long time, such as taking 3-7 days symptoms have not alleviated, please seek medical attention promptly strictly master the dose, and overdosing is prohibited 4 Patients with hypertension should pay attention to monitor blood pressure during taking this product 5 Use with caution in pregnant and lactating women 6 Patients with gastritis and gastric ulcers are treated with caution Long-term use can cause dependence IV, "Drug Interaction" should include the following: take this product, care to avoid taking strong cough medicine at the same time (Note: If the other contents of the specification are inconsistent with the above amendment requirements, they shall be revised together.) original title: Heavy! This commonly used drug modification instruction manual, involving thousands of approvals!