The State Food and Drug Administration revised the instructions of yanyanning preparation, Yinzhihuang oral preparation and other drugs
2022-05-25
Drug instructions are an important basis for guiding clinical correct drug use, and play an important role in the safe and rational use of drugs. According to the official website of the State Food and drug administration, recently, the State Food and Drug Administration announced that according to the adverse drug reaction evaluation results, in order to further ensure the safety of public medication, it decided to uniformly revise the drug instructions of yanyanning preparation, yanyanning preparation over-the-counter drugs, Yinzhihuang oral preparation and ginkgolide injection. According to the announcement, the revision involves adverse reactions, contraindications and precautions. Among them, the taboo items of prescription drugs of yanyanning preparation, over-the-counter drugs of yanyanning preparation and Yinzhihuang oral preparation should be added "forbidden for those who are allergic to this product and its ingredients". The "warning words" in the manual of ginkgolide injection shall be revised to "Warning: the adverse reactions of this product, including anaphylactic shock, should be used in medical institutions with rescue conditions. The user should be a doctor with the qualification to treat severe anaphylactic reactions such as anaphylactic shock or who has received anaphylactic shock rescue training. Pay close attention to observation during medication. Those with severe adverse reactions such as anaphylactic reaction should stop the drug immediately and treat in time!" The adverse reactions of prescription drugs of yanyanning preparation and over-the-counter drug instructions of yanyanning preparation shall include: according to the monitoring data, yanyanning preparation can see the following adverse reactions: nausea, vomiting, constipation, dry mouth, stomach discomfort, rash, pruritus, dizziness, headache, allergic reaction, etc. The precautions in the prescription drug Manual of yanyanning preparation should include: during the medication, the diet should be light, and avoid spicy, cold and greasy food This product should not be used for cold dampness diarrhea; People with allergic constitution should use it with caution. The precautions in the over-the-counter drug Manual of yanyanning preparation should include: Patients with severe symptoms or severe internal urgency and purulent and bloody stool should go to the hospital in time; This product should not be used for cold dampness diarrhea. It is mainly manifested in clear and sparse diarrhea, even such as water sample, bowel ringing, abdominal pain, thin white or greasy tongue coating; Take it according to the usage and dosage. If abdominal pain, diarrhea and other aggravation occur during the medication, stop the medication and go to the hospital in time. The adverse reactions in the manual of Yinzhihuang oral preparation are revised as follows: the monitoring data show that Yinzhihuang oral preparation has reported adverse reactions such as diarrhea, vomiting, rash, pruritus, fever, dizziness and so on. There were reports of severe diarrhea and bloody stool in newborns after using Yinzhihuang oral preparation. Precautions should be added: the usage and dosage of this product is for adults; Jaundice belongs to Yin Yellow, which should not be used; This product is a prescription drug and should be used under the guidance of a doctor. In the course of taking medicine, pay attention to the characteristics of stool. In case of diarrhea, inform the doctor in time. In case of diarrhea, watery stool, egg soup like stool, mucus stool, bloody stool, bloody stool and perianal redness and swelling, stop taking medicine and seek medical treatment in time. The instructions of ginkgolide injection shall add allergic reaction, skin and subcutaneous tissue, neuropsychiatric system, gastrointestinal system and other adverse reactions and details, including skin rash, pruritus, allergic dermatitis, dyspnea and other allergic reactions; Fever, chills, fatigue and pain all over the body; Dizziness, headache, dizziness, etc; Phlebitis, pain, redness, swelling, heat and pain at the infusion site and other reactions at the injection site. The State Food and Drug Administration said that the marketing license holders of the above drugs should submit a supplementary application for revising the instructions in accordance with the relevant provisions of the measures for the administration of drug registration and other requirements, and submit it to the provincial drug regulatory department for the record before August 19, 2022. If the revised contents involve drug labels, they shall be revised at the same time; Other contents of the instructions and labels shall be consistent with the original approved contents. Drugs produced since the date of filing the case shall not continue to use the original drug instructions. The holder of a drug marketing license shall replace the instructions and labels of the drugs that have left the factory within 9 months after filing. In addition, clinicians and pharmacists should carefully read the revised contents of the above drug instructions. When selecting drugs, they should conduct a full benefit / risk analysis according to the newly revised instructions. Patients should carefully read the drug instructions before taking drugs, and those who use prescription drugs should strictly follow the doctor's advice. (outlook new era)
Edit：Yuanqi Tang Responsible editor：Xiao Yu
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