国内外含可待因和羟考酮复方制剂说明书的比较

Comparison of the Drug Package Inserts of Domestic and Foreign Compound Preparations Containing Narcotic Drugs

目的规范国内含麻醉药品复方制剂说明书,指导安全合理用药。方法从安全用药的角度,如药物滥用与依赖、禁忌、注意事项等方面,对国内外的说明书进行比较。结果国内该类制剂说明书中警示信息不足;国内和国外说明书大多禁忌描述不全;中、英文说明书不对应。结论可以参照麻醉药品单方制剂和国外含麻醉药品复方制剂的说明书来修订国内的该类制剂说明书。

Objective To regulate the drug package inserts of domestic compound preparations containing narcotic drugs and improve rational use of these drugs. Methods From the safe medication＇s angle, choose drug abuse and dependence, contraindications, precautions and so on from the drug package inserts, and then contrastively analyse the domestic and foreign part. Results The domestic drug package inserts are lack of warnings. Both the domestic and the foreign ones are not all-inclusive about contraindications. The Chinese and English drug package inserts do not correspond. Conclusion We can reference package inserts of the narcotic drugs unilaterally preparations and foreign compound preparations containing narcotic drugs to revise domestic ones.