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This commonly used medicine called digestion and treatment stomach pain
domperidone
again asked to revise the instruction manual html again html
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On October 27, the website of National Medical Products Administration issued the "Announcement of the National Medical Products Administration on Revising the Instructions for Domperidone Preparation (No. 93 of 2022)". Among them, the revision of the prescription instructions for domperidone preparations requires "precautions" to include: children under 12 years old (especially infants), adolescents weighing less than 35 kg and adults, and closely monitor adverse reactions when taking the medicine. domperidone preparation over-the-counter drug instructions revision requirements "Precautions" should include: This product is not suitable for children under 12 years old (especially infants), adolescents and adults weighing less than 35 kg.
Domperidone is a gastrointestinal accelerator. It has been produced by many domestic companies. In the past two years, domperidone, represented by morphine, has become increasingly strict in clinical application. On October 28, Zhang Yatong, deputy director of the Pharmacy Department of Beijing Hospital, told the Health Times reporter, "Not any patient can use it at will, and it will only be used after passing the evaluation under certain premises. Now the overall dosage of drugs in each hospital is slowly decreasing. can be said that mutantilin has changed from the original common drugs to a drug that can be used reasonably after full evaluation. "
announced that according to the results of adverse drug reaction evaluation, in order to further ensure the safety of public drug use, National Drug Administration decided to uniformly revise the instructions for domperidone preparations (including domperidone tablets, domperidone dispersed tablets, domperidone oral disintegration tablets, domperidone capsules, domperidone suspension, domperidone maleate tablets)
As early as August 2016, the Health Times reported that "Metta-Dinlin actually became a regular medicine for Chinese people", and mentioned that in In 2015, the Canadian Ministry of Health was more confident in the risk correlation, saying that domperidone would slightly increase the risk of severe ventricular arrhythmia or sudden cardiac death. Health Canada recommends that the medication should be taken at the smallest dose possible in the beginning. In April 2014, the European Medicines Agency released a report, suggesting that its indications be restricted within the entire EU range, and is only used to relieve nausea and vomiting symptoms, and is no longer used to treat other indications such as bloating or heartburn.
In September 2016, the former State Food and Drug Administration issued the "Announcement on Revising the Instructions for Domperidone Preparation", which revised the instructions for Domperidone over-the-counter and prescription drugs. In the adverse reactions, the content related to heart disease has also been added.
"Dopestidone can be said to be an old drug. This time, it was re-emphasized and revised separately. Previously, many clinical evaluations have found that there are risks in children using , and children should be cautious when using dompestidone. This time, the prescription and over-the-counter drugs of morphine have been revised to varying degrees. Over-the-counter drugs limit children to improve the clinical safe use." Zhang Yatong explained that FDA previously pointed out that the serious adverse reactions of dompestidone include arrhythmia , cardiac arrest, and sudden death .
The marketing authorization holders of the above drugs shall submit the Drug Review Center of the State Drug Administration or the provincial drug supervision and administration department before January 24, 2023 in accordance with the relevant provisions of " Drug Registration Management Measures " and other relevant regulations, and in accordance with the revision requirements of domperidone preparations. Drugs produced from the date of filing shall not continue to be used in the original drug instructions.
Source: People's Daily Health Client
