Therapeutic equivalence of generic imipenem/cilastatin for therapy of infections at Siriraj Hospital

Journal of the Medical Association of Thailand

Volumn 93, Issue SUPPL 1, 2010, Pages

  Piyasirisilp, Sukij ^a   Premprawat, Wanna ^a   Thamlikitkul, Visanu ^a  

^a MAHIDOL UNIVERSITY   (Thailand)

Author keywords

Generic Drug; Imipenem Cilastatin; Therapeutic Equivalence

Indexed keywords

ANTIINFECTIVE AGENT; CILASTATIN; GENERIC DRUG; IMIPENEM;

ADULT; AGED; ARTICLE; BACTERIAL INFECTION; COMPARATIVE STUDY; CROSS INFECTION; FEMALE; HOSPITALIZATION; HUMAN; MALE; MEDICAL RECORD; MIDDLE AGED; PHARMACOKINETICS; THAILAND; TREATMENT OUTCOME; UNIVERSITY HOSPITAL;

ADULT; AGED; AGED, 80 AND OVER; ANTI-BACTERIAL AGENTS; BACTERIAL INFECTIONS; CILASTATIN; CROSS INFECTION; DRUGS, GENERIC; FEMALE; HOSPITALIZATION; HOSPITALS, UNIVERSITY; HUMANS; IMIPENEM; MALE; MEDICAL RECORDS; MIDDLE AGED; THAILAND; THERAPEUTIC EQUIVALENCY; TREATMENT OUTCOME;

EID: 77951897013     PISSN: 01252208     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (25)

1. Rodloff AC, Goldstein EJ, Torres A. Two decades of imipenem therapy. J Antimicrob Chemother 2006; 58: 916-29.
2. Zhanel GG, Wiebe R, Dilay L, Thomson K, Rubinstein E, Hoban DJ, et al. Comparative review of the carbapenems. Drugs 2007; 67: 1027-52.
3. Mouton JW, Touzw DJ, Horrevorts AM, Vinks AA. Comparative pharmacokinetics of the carbapenems: clinical implications. Clin Pharmacokinet 2000; 39: 185-201.
4. Raw AS, Furness MS, Gill DS, Adams RC, Holcombe FO Jr, Yu LX. Regulatory considerations of pharmaceutical solid polymorphism in Abbreviated New Drug Applications (ANDAs). Adv Drug Deliv Rev 2004; 56: 397-414.
5. Jones RN, Fritsche TR, Moet GJ. In vitro potency evaluations of various piperacillin/tazobactam generic products compared with the contemporary branded (Zosyn, Wyeth) formulation. Diagn Microbiol Infect Dis 2008; 61: 76-9.
6. Lambert PA, Conway BR. Pharmaceutical quality of ceftriaxone generic drug products compared with Rocephin. J Chemother 2003; 15: 357-68.
7. Schito GC, Keenan MH. Predicting the clinical efficacy of generic formulations of ceftriaxone. J Chemother 2005; 17 (Suppl 2): 33-40.
8. Wetterich U, Mutschler E. Quality of cefotaxime sodium preparations. Arzneimittelforschung 1995; 45: 74-80.
9. Zuluaga AF, Agudelo M, Rodriguez CA, Vesga O. Application of microbiological assay to determine pharmaceutical equivalence of generic intravenous antibiotics. BMC Clin Pharmacol 2009; 9: 1.
10. Rodriguez CA, Zuluaga AF, Salazar BE, Agudelo M, Vesga O. Experimental comparison of 11 generic products of oxacillin with the original compound (OC) in terms of concentration of active principle, in vitro activity, and in vivo efficacy, using the neutropenic murine thigh infection model [abstract A-1305]; The 44th Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), Washington, D.C.; Oct. 30-Nov. 2, 2004.
11. Ye Y, Lee J, Chen Y, Lin S, Chien S. A comparative study of the clinical efficacy of two piperacillin/ tazobactam products. Poster 27th Annual Conference of Taiwan Society of Health System Pharmacists, Taiwan, 2006.
12. Zuluaga AF, Salazar BE, Loaiza SA, Agudelo M, Vesga O. Therapeutic equivalence with the original compound of 8 genetic products of ampicillin determined in the neutropenic murine thigh infection model [abstract E-2033]. The 44th International Conference on Antimicrobial Agents and Chemotherapy (ICAAC), Washington, D.C.; Oct. 30-Nov. 2, 2004.
13. Pasqualotto AC, Denning DW. Generic substitution of itraconazole resulting in sub-therapeutic levels and resistance. Int J Antimicrob Agents 2007; 30: 93-4.
14. Mastoraki E, Michalopoulos A, Kriaras I, Mouchtouri E, Falagas ME, Karatza D, et al. Incidence of postoperative infections in patients undergoing coronary artery bypass grafting surgery receiving antimicrobial prophylaxis with original and generic cefuroxime. J Infect 2008; 56: 35-9.
15. Kesselheim AS, Misono AS, Lee JL, Stedman MR, Brookhart MA, Choudhry NK, et al. Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis. JAMA 2008; 300: 2514-26.
16. Berg MJ, Gross RA, Tomaszewski KJ, Zingaro WM, Haskins LS. Generic substitution in the treatment of epilepsy: case evidence of breakthrough seizures. Neurology 2008; 71: 525-30.
17. Deaney NB, Tate H. A meta-analysis of clinical studies of imipenem-cilastatin for empirically treating febrile neutropenic patients. J Antimicrob Chemother 1996; 37: 975-86.
18. Chang DC, Wilson SE. Meta-analysis of the clinical outcome of carbapenem monotherapy in the adjunctive treatment of intra-abdominal infections. Am J Surg 1997; 174: 284-90.
19. Zanetti G, Bally F, Greub G, Garbino J, Kinge T, Lew D, et al. Cefepime versus imipenem-cilastatin for treatment of nosocomial pneumonia in intensive care unit patients: a multicenter, evaluator-blind, prospective, randomized study. Antimicrob Agents Chemother 2003; 47: 3442-7.
20. Edwards SJ, Emmas CE, Campbell HE. Systematic review comparing meropenem with imipenem plus cilastatin in the treatment of severe infections. Curr Med Res Opin 2005; 21: 785-94.
21. Embil JM, Soto NE, Melnick DA. A post hoc subgroup analysis of meropenem versus imipenem/ cilastatin in a multicenter, double-blind, randomized study of complicated skin and skin-structure infections in patients with diabetes mellitus. Clin Ther 2006; 28: 1164-74.
22. Schmitt DV, Leitner E, Welte T, Lode H. Piperacillin/ tazobactam vs imipenem/cilastatin in the treatment of nosocomial pneumonia-a double blind prospective multicentre study. Infection 2006; 34: 127-34.
23. Garbino J, Villiger P, Caviezel A, Matulionyte R, Uckay I, Morel P, et al. A randomized prospective study of cefepime plus metronidazole with imipenem-cilastatin in the treatment of intra-abdominal infections. Infection 2007; 35: 161-6.
24. Chastre J, Wunderink R, Prokocimer P, Lee M, Kaniga K, Friedland I. Efficacy and safety of intravenous infusion of doripenem versus imipenem in ventilator-associated pneumonia: a multicenter, randomized study. Crit Care Med 2008; 36: 1089-96.
25. Jaruratanasirikul S, Sudsai T. Comparison of the pharmacodynamics of imipenem in patients with ventilator-associated pneumonia following administration by 2 or 0.5 h infusion. J Antimicrob Chemother 2009; 63: 560-3.