CFDA revised domperidone drug instructions will be affected by the domestic market of domperidone 下北glory days

CFDA revised domperidone drug instructions domestic market will be affected by the CFDA of domperidone domperidone revised drug instructions Xi’an Yang Sen core product "exam" with the after each intern reporter Xie Xin and domperidone (Motilium known to every family because of advertising) in the United States was barred from the city, in the European Union, Canada also restricted, and now in Chinese by relevant regulatory. The "daily economic news" reporter noted that recently, the State Food and Drug Administration (CFDA) issued "on the revision of domperidone preparation instructions notice", (including preparation of domperidone domperidone maleate preparation) non prescription drugs and prescription drug adverse reaction of [], [] taboo, [notice], [usage the amount of items were revised]. And modify the instructions in the CFDA hand, there are people in the industry in September 21st of the "daily economic news" reporter said, sales of domperidone in the domestic market will greatly affect the domestic manufacturers of Xi’an Janssen Pharmaceutical Ltd said its effect on domperidone sales, there is no data. A number of changes in Domperidone 1 months ago, the media widely reported domperidone in the United States and the EU because there are security risks and bans and restrictions, CFDA finally shot. Daily economic news reporter saw from the CFDA announcement, the specification of the main changes in the amount of medication, medication time and medication groups. The dosage, preparation of domperidone prescription drug new: 3 times a day for adult 10mg every time, every day should not exceed 40mg. Children under 35kg take up to three times a day, each time 0.25mg kg, weight of 35kg or more children daily oral up to three times, each time 10mg. While in non prescription drugs, recommended treatment instructions is domperidone "without consulting physician under the condition of not more than 14 days." The new specification [note] is a column: the drug for three days, symptoms are not alleviated, you need to consult a doctor or pharmacist. The drug should not be used for more than one week. In addition to the above several, the new version of the specification also increased in patients with moderate and severe liver dysfunction patients with severe vomiting, acute abdominal pain patients should be admitted to the hospital". Other modifications also include the adverse reaction of the original is revised as follows: "there are reports of more than 30 mg daily dose and associated with heart disease, or cancer patients undergoing chemotherapy, electrolyte disorders such as severe organic disease, patients older than 60 years, the occurrence of serious ventricular arrhythmias and risk of sudden cardiac death may be increased." Taboo: mechanical obstruction, gastrointestinal bleeding, perforation of gastrointestinal tract in patients with disabling "to" mechanical obstruction of the digestive tract, gastrointestinal bleeding and perforation were disabled "," forbidden combination "and" CYP3A4 ketoconazole oral formulations modified as potent inhibitors of enzyme preparations, and the prohibition of ketoconazole oral erythromycin or other may prolonged QTc interval (for example: fluconazole, voriconazole, clarithromycin, amiodarone, telithromycin) combined with." Sales will be affected by the "daily economic theory相关的主题文章: