The instruction of bromocriptine mesylate tablets was revised, and the indication of "postpartum mastitis" was deleted

On May 8, the State Food and Drug Administration issued a notice to revise the instructions of bromocriptine mesylate tablets [indications] and [contraindications] The indication of postpartum mastitis should be deleted In order to further ensure the safety of public drug use, the State Drug Administration decided to revise the instructions of bromocriptine mesylate tablets [indications], [contraindications], etc The relevant matters are hereby announced as follows: 1 All manufacturers of bromocriptine mesylate tablets shall, in accordance with the measures for the administration of drug registration and other relevant regulations, put forward supplementary applications for the revision of the instructions of bromocriptine mesylate tablets (see Annex), and report to the national drug regulatory authority for the record before June 29, 2019 If the revised contents involve drug labels, they shall be revised together; the instructions and other contents of the labels shall be consistent with the original approved contents Replace all drug instructions and labels that have been delivered within 6 months after the supplementary application is filed Each bromocriptine mesylate tablet manufacturer shall conduct in-depth research on the mechanism of new adverse reactions, take effective measures to do a good job in the publicity and training of the use and safety issues, and immediately notify the drug dealers and users in an appropriate way of changes in the content related to the safety of drug use, and guide doctors and pharmacists in the rational use of drugs 2、 Clinicians and pharmacists should carefully read the revised contents of the instructions of bromocriptine mesylate tablets, and make full benefit / risk analysis according to the newly revised instructions when choosing drugs 3、 Patients should strictly follow the doctor's instructions and read the instructions carefully before using the medicine It is hereby announced Appendix: requirements for the revision of the specification of bromocriptine mesylate tablets issued by the State Food and Drug Administration on April 29, 2019 requirements for the revision of the specification of bromocriptine mesylate tablets I indications 1 From "inhibiting lactation" or "inhibiting physiological lactation" to "inhibiting physiological lactation: only used for medical reasons but not for lactation, such as stillbirth, neonatal death, mother's infection with human immunodeficiency virus (HIV), etc." 2 Delete the indication of "postpartum mastitis" 2、 [contraindications] [contraindications] are revised as: 1 Those who are known to be allergic to bromoergotin and any component of this product or other ergot base 2 Poor control of hypertension, pregnancy hypertension related diseases (including eclampsia, preeclampsia or pregnancy hypertension syndrome), post delivery and puerperal hypertension, coronary artery disease or other serious cardiovascular diseases 3 Patients with symptoms and / or history of serious mental illness 4 Patients with valvular disease (Note: if other contents of the manual are inconsistent with the above revision requirements, they shall be revised together.)