Comparative Analysis of the Instructions of Original and Domestic Generic Levofloxacin Injections
10.6039/j.issn.1001-0408.2016.25.43
- VernacularTitle:原研与国产仿制左氧氟沙星注射液说明书的对比分析
- Author:
Guidan LI
;
Xin HE
- Publication Type:Journal Article
- Keywords:
Levofloxacin;
Instructions;
Original drug;
Generic drug;
Comparative analysis
- From:
China Pharmacy
2016;27(25):3598-3600
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To provide suggestions for improving the quality of the instructions of domestic generic Levofloxacin injections. METHODS:A set of instructions of original Levofloxacin injection and 20 sets of instructions of domestic generic Levo-floxacin injections(with three kinds of acid radicals)were compared and analyzed in warning,indications,dosage and administra-tion,medication for children,drug interactions,toxicology,pharmacokinetics,etc. RESULTS & CONCLUSIONS:The rate of re-cording indications,dosage and administration and pharmacokinetics among the 21 sets of instructions is high,up to 100%. Among the instructions of domestic generic Levofloxacin hydrochloride injection,Levofloxacin lactate injection and Levofloxacin mesylate injection,the rates of mentioning a tendon injury in the warning section are 30.00%,0 and 33.33% respectively;those of recording antibacterial spectrum in the indications section are 10.00%,0 and 33.33% respectively;those of recording the specif-ic results of drug interactions are 10.00%,0 and 66.67% respectively;and those of recording toxicological information are 70.00%,85.71% and 33.33% respectively,all of which are lower than the recording rates of 100% for the instructions of original one. In the instructions of domestic generic Levofloxacin injection,there is a lack of clinical trial data in the sections of dosage and administration,medication for children and toxicology and of pharmacokinetic parameters for patients with impaired liver/kidney function and special population in the pharmacokinetics section. It is suggested that the manufacturers of domestic generic Levoflox-acin injections should improve the specific contents of the instructions;the instructions regulatory authorities should improve the ad-ministration of instructions examination and approval;and doctors and pharmacists should strictly follow the instructions.
