echemi logo
Product
  • Product
  • Supplier
  • Inquiry
    Home > Medical News > Latest Medical News > The State Food and Drug Administration revises the instructions for systemic fluoroquinolones

    The State Food and Drug Administration revises the instructions for systemic fluoroquinolones

    • Last Update: 2021-03-26
    • Source: Internet
    • Author: User
    Search more information of high quality chemicals, good prices and reliable suppliers, visit www.echemi.com
    Medical Network, March 24 News On March 23, the State Food and Drug Administration issued the "Announcement on Revising the Instructions for Fluoroquinolones for Systemic Use (No.
    44 of 2021)", [Adverse Reactions] and [Attention] Matters] and [Medications for the Elderly] have been revised.
    Among them, [Adverse Reaction] increases the risk of aortic aneurysm and aortic dissection.
     
    annex
     
    Revised requirements for the package insert of fluoroquinolones for systemic use
     
    1.
    General requirements for manual revision
     
    1.
    This revision of the manual is only for systemic fluoroquinolone drugs (oral preparations and injection preparations), and the specific revision opinions are applicable to each specific category of systemic fluoroquinolone drugs.
     
    2.
    This revision of the instructions for systemic fluoroquinolone drugs (oral preparations and injection preparations) is mainly aimed at the three parts of [ Adverse Reactions ], [Precautions], and [Medications for the Elderly], and the following principles should be followed: If the relevant content approved by the State Drug Administration is more stringent and comprehensive, the instructions should be revised in accordance with this revision.
    The relevant content approved by the State Drug Administration shall not be deleted in principle.
    If the original approved content is more comprehensive or stricter than this revision, the original approved content should be retained.
     
    2.
    The following content should be added under [Adverse Reaction]
     
    1.
    Serious and other important adverse reactions
     
    Risk of aortic aneurysm and aortic dissection
     
    3.
    Add the following content under [Notes]
     
    Risk of aortic aneurysm and aortic dissection
     
    Epidemiological studies report an increase in the incidence of aortic aneurysm and aortic dissection within two months after the use of fluoroquinolones, especially in elderly patients.
    The reason for the increased risk has not yet been determined.
    For patients who are known to have aortic aneurysms or a high-risk aortic aneurysm, use XXXX only if no other antibacterial treatment is available.
     
    4.
    Add the following content under [Medications for the Elderly]:
     
    Epidemiological studies report an increase in the incidence of aortic aneurysm and aortic dissection within two months after the use of fluoroquinolones, especially in elderly patients.
    (See 【Notes】).
     
      (Note: If the other contents of the manual are inconsistent with the above revision requirements, they should be revised together.
    )
      Medical Network, March 24 News On March 23, the State Food and Drug Administration issued the "Announcement on Revising the Instructions for Fluoroquinolones for Systemic Use (No.
    44 of 2021)", [Adverse Reactions] and [Attention] Matters] and [Medications for the Elderly] have been revised.
    Among them, [Adverse Reaction] increases the risk of aortic aneurysm and aortic dissection.
     
      annex
     
      Revised requirements for the package insert of fluoroquinolones for systemic use
     
      1.
    General requirements for manual revision
     
      1.
    This revision of the manual is only for systemic fluoroquinolone drugs (oral preparations and injection preparations), and the specific revision opinions are applicable to each specific category of systemic fluoroquinolone drugs.
     
      2.
    This revision of the instructions for systemic fluoroquinolone drugs (oral preparations and injection preparations) is mainly aimed at the three parts of [ Adverse Reactions ], [Precautions], and [Medications for the Elderly], and the following principles should be followed: If the relevant content approved by the State Drug Administration is more stringent and comprehensive, the instructions should be revised in accordance with this revision.
    The relevant content approved by the State Drug Administration shall not be deleted in principle.
    If the original approved content is more comprehensive or stricter than this revision, the original approved content should be retained.
     
      2.
    The following content should be added under [Adverse Reaction]
     
      1.
    Serious and other important adverse reactions
     
      Risk of aortic aneurysm and aortic dissection
     
      3.
    Add the following content under [Notes]
     
      Risk of aortic aneurysm and aortic dissection
     
      Epidemiological studies report an increase in the incidence of aortic aneurysm and aortic dissection within two months after the use of fluoroquinolones, especially in elderly patients.
    The reason for the increased risk has not yet been determined.
    For patients who are known to have aortic aneurysms or a high-risk aortic aneurysm, use XXXX only if no other antibacterial treatment is available.
     
      4.
    Add the following content under [Medications for the Elderly]:
     
      Epidemiological studies report an increase in the incidence of aortic aneurysm and aortic dissection within two months after the use of fluoroquinolones, especially in elderly patients.
    (See 【Notes】).
     
      (Note: If the other contents of the manual are inconsistent with the above revision requirements, they should be revised together.
    )
      Medical Network, March 24 News On March 23, the State Food and Drug Administration issued the "Announcement on Revising the Instructions for Fluoroquinolones for Systemic Use (No.
    44 of 2021)", [Adverse Reactions] and [Attention] Matters] and [Medications for the Elderly] have been revised.
    Among them, [Adverse Reaction] increases the risk of aortic aneurysm and aortic dissection.
     
      annex
      annex
     
      Revised requirements for the package insert of fluoroquinolones for systemic use
      Revised requirements for the package insert of fluoroquinolones for systemic use
     
      1.
    General requirements for manual revision
      1.
    General requirements for manual revision
     
      1.
    This revision of the manual is only for systemic fluoroquinolone drugs (oral preparations and injection preparations), and the specific revision opinions are applicable to each specific category of systemic fluoroquinolone drugs.
    Medicine, medicine, medicine
     
      2.
    This revision of the instructions for systemic fluoroquinolone drugs (oral preparations and injection preparations) is mainly aimed at the three parts of [ Adverse Reactions ], [Precautions], and [Medications for the Elderly], and the following principles should be followed: If the relevant content approved by the State Drug Administration is more stringent and comprehensive, the instructions should be revised in accordance with this revision.
    The relevant content approved by the State Drug Administration shall not be deleted in principle.
    If the original approved content is more comprehensive or stricter than this revision, the original approved content should be retained.
    Adverse reactions adverse reactions adverse reactions
     
      2.
    The following content should be added under [Adverse Reaction]
      2.
    The following content should be added under [Adverse Reaction]
     
      1.
    Serious and other important adverse reactions
     
      Risk of aortic aneurysm and aortic dissection
     
      3.
    Add the following content under [Notes]
      3.
    Add the following content under [Notes]
     
      Risk of aortic aneurysm and aortic dissection
     
      Epidemiological studies report an increase in the incidence of aortic aneurysm and aortic dissection within two months after the use of fluoroquinolones, especially in elderly patients.
    The reason for the increased risk has not yet been determined.
    For patients who are known to have aortic aneurysms or a high-risk aortic aneurysm, use XXXX only if no other antibacterial treatment is available.
     
      4.
    Add the following content under [Medications for the Elderly]:
      4.
    Add the following content under [Medications for the Elderly]:
     
      Epidemiological studies report an increase in the incidence of aortic aneurysm and aortic dissection within two months after the use of fluoroquinolones, especially in elderly patients.
    (See 【Notes】).
     
      (Note: If the other contents of the manual are inconsistent with the above revision requirements, they should be revised together.
    )
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

    Related Articles

    Contact Us

    The source of this page with content of products and services is from Internet, which doesn't represent ECHEMI's opinion. If you have any queries, please write to service@echemi.com. It will be replied within 5 days.

    Moreover, if you find any instances of plagiarism from the page, please send email to service@echemi.com with relevant evidence.