FDA发布咀嚼片关键质量属性指导原则

Ifspace permits, it is recommended that the following statement be displayed withlesser prominence to reinforce the importance of chewing the tablets:

如果空间允许，则建议下面的语句稍突出显示，以加强咀嚼片剂的重要性： Donot swallow tablets whole. 不要整个吞服药片。

Additionally,language similar to the previously mentioned statements

should appear in the professionallabeling (Highlights of Prescribing Information; Section 2 Dosage andAdministration, and Section 17 Patient Counseling

Information), as well as inany accompanying patient information or Medication Guide, if applicable.

此外，类似于前面声明的语言应该出现在专业说明书（处方信息的要点；第2部分剂量和用法，第17部分患者咨询资料），任何附带的患者信息或用药指南（若适用）。