Ideal microbiological and pharmacological characteristics of a quality antimicrobial agent: Comparing original and generic molecules

Journal of Chemotherapy

Volumn 19, Issue 6, 2007, Pages 609-619

  Concia, E ^a   Novelli, A ^b   Schito, G C ^c   Marchese, A ^c  

^a UNIVERSITY OF VERONA   (Italy)

^b UNIVERSITY OF FLORENCE   (Italy)

^c UNIVERSITY OF GENOA   (Italy)

Author keywords

Bioequivalence; Brand name antibiotics; Generic antibiotics

Indexed keywords

'AXON'; AMIKACIN; AMINOGLYCOSIDE; AMOXICILLIN; AMOXICILLIN PLUS CLAVULANIC ACID; AMPICILLIN; ANTIINFECTIVE AGENT; BETA LACTAM ANTIBIOTIC; BROADCEF; CARBAPENEM; CEFACLOR; CEFAZOLIN; CEFIXIME; CEFONICID; CEFOTAXIME; CEFTAZIDIME; CEFTREX; CEFTRIAXONE; CEPHALOSPORIN; CERIXON; CHLORAMPHENICOL; CIPROFLOXACIN; CLARITHROMYCIN; CLINDAMYCIN; ELPICEF; ERYTHROMYCIN; FLUCLOXACILLIN; GENERIC DRUG; GENTAMICIN; KEPTRIX; MACROLIDE; MERCEFEX; NOVOCEF; OFRAMAX; QUINOLINE DERIVED ANTIINFECTIVE AGENT; TEICOPLANIN; TETRACYCLINE; TITAN; TRIJEC; UNCLASSIFIED DRUG; UNINDEXED DRUG; UNOCEF; VANCOMYCIN; VENTRAXIN; ZEFTROX;

BIOEQUIVALENCE; CONTINUOUS INFUSION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG COST; DRUG DETERMINATION; DRUG EFFICACY; DRUG FORMULATION; DRUG HALF LIFE; DRUG LEGISLATION; DRUG RESEARCH; DRUG SENSITIVITY; DRUG TOLERABILITY; HEALTH CARE COST; HOSPITAL INFECTION; HUMAN; INFECTION; NEPHROTOXICITY; NONHUMAN; OTOTOXICITY; PNEUMONIA; REVIEW; RISK FACTOR; SEPSIS; STREPTOCOCCUS INFECTION;

EID: 38949170924     PISSN: 1120009X     EISSN: None     Source Type: Journal    
DOI: 10.1179/joc.2007.19.6.609     Document Type: Review

References (59)

1. Cohen M.L. Changing patterns of infectious disease. Nature 2000; 406 (6797): 762-767.
2. Janssens JP, Krause KH. Pneumonia in very old. Lancet Infectious Diseases 4: 112-24, 2004.
3. th Edition, Elsevier/Churchill Livingstone, New York, NY 2005.
4. nd ed. Baltimore, Williams & Wilkins 1993: 512-555.
5. Novelli A, Adombri C, Livi P, Fallani S, Mazzei T, De Gaudio AR. Pharmacokinetic evaluation of meropenem and imipenem in critically ill patients with sepsis. Clin Pharmacokinet. 2005;44(5):539-49.
6. Roberts SJ, Bateman DN, Smith JM. Prescribing behaviour in general practice: the impact of promoting therapeutically equivalent cheaper medicines. Br J Gen Pract. 1997 Jan;47(414):13-8.
7. Magazzini L, Pammolli F, Riccaboni M. Dynamic competition in pharmaceuticals. Patent expiry, generic penetration, and industry structure. Eur J Health Econ. 2004 Jun;5(2):175-82.
8. Committee for Proprietary Medicinal Products (CPMP) of the European Agency for Evaluation of Medicinal Products (EMEA). Note for guidance for the investigation of bioavailability and bioequivalence. EMEA, London - 26 July, 2001. www.eudra-org/emea.html (last accessed January 2, 2006).
9. Fry DE. The importance of antibiotic pharmacokinetics in criticall illness. Am J Surg 1996;172(Suppl 6A):20S-25S.
10. De Paepe P, Belpaire FM, Buylaert WA. Pharmacokinetic and pharmacodynamic considerations when treating patients with sepsis and septic shock. Clin Pharmacokinet 2002;41(14):1135-1151.
11. Pinder M, Bellomo R, Lipman J. Pharmacological principles of antibiotic prescription in the critically ill. Anaesth Intensive Care 2002;30(2):134-144.
12. Roberts JA, Lipman J. Antibacterial dosing in intensive care: pharmacokinetics, degree of disease and pharmacodynamics of sepsis - Review. Clin Pharmacokinet. 2006; 45(8): 755-773.
13. Joukhadar C, Frossard M, Mayer BX, et al. Impaired target site penetration of beta-lactams may account for therapeutic failure in patients with septic shock. Crit Care Med 2001; 29(2): 385-391.
14. Pea F, Viale P, Furlanut M. Antimicrobial therapy in critically ill patients: a review of pathophysiological conditions responsible for altered disposition and pharmacokinetic variability - Review. Clin Pharmacokinet. 2005; 44(10): 1009-1034.
15. Bulfoni A, Concia E, Costantino S, et al. Orientamenti terapeutici per il trattamento delle sepsi e delle endocarditi in medicina interna.Giornale Ital Med Interna 2004; 3(1/2), Suppl.2: 1-102.
16. Pea F, Viale P, Candoni A, Pavan F, Pagani L, Damiani D, Casini M, Furlanut M. Teicoplanin in patients with acute leukaemia and febrile neutropenia: a special population benefiting from higher dosages. Clin Pharmacokinet. 2004;43(6):405-15.
17. Ogunbona FA, Akanni AO. Comparative bioavailability studies on some brands of ampicillin capsules. Pharmazie 1985; 40(7): 479.
18. Lohitnavy O, Lohitnavy M, Sareekan K, Polnok S, Taytiwat P. Average bioequivalence of generic clarithromycin tablets in healthy Thai male volunteers. Biopharm Drug Dispos 2003; 24(6): 229-231.
19. Ilupeju TO, Oladeinde FO, Olaniyi AA, Amosu MA. Bioequivalence study of three generic formulations of co-trimoxazole tablets in human urine. Afr J Med Med Sci 2004; 33(4): 341-345.
20. Semde R, Ouedraogo HW, Guissou IP, Amighi K. Bioequivalence in vitro evaluation of some antibacterial generic dosage forms. J Pharm Belg 2005; 60(2): 51-55.
21. Pineyro-Lopez A, Pineyro-Garza E, Torres-Alanis O, et al. Bioavailability of two oral formulations of loratadine 20 mg with concomitant ketoconazole: an open-label, randomized, two-period crossover comparison in healthy Mexican adult volunteers. Clin Ther 2006; 28(1): 110-115.
22. Leelarasamee A, Tatong W, Kasattut N, Sriboonruang T, Ayudhya DP. Bioequivalence study of clindamycin phosphate injection (Clinott-P) in Thai healthy volunteers. J Med Assoc Thai 2006; 89(5): 683-689.
23. Nightingale CH A survey of the quality of generic clarithromycin products manufactured in Slovenia and Israel. Adv Ther 2000; 17(3): 167-178
24. Henwood SQ, De Villiers MM, Liebenger W, et al. Solubility and dissolution properties of generic rifampicin raw materials. Drug Develop and industrial Pharmacy 2000; 26(4): 403-408.
25. Cuadrado A, Gascon AR, Solinis MA et al. Bioequivalence of two oral ciprofloxacin tablets formulations. Int J Clin Pharmacol Ther 2004; 42(6): 336-341.
26. Weir RE, Zaidi FH, Charteris DG, Bunce C, Soltani M, Lovering AM. Variability in the content of Indian generic ciprofloxacin eye drops. Br J Ophthalmol 2005; 89(9): 1094-1096.
27. Conte JE Jr. Comparative antibacterial activity of Vancocin and generic vancomycin. Antimicrob Agents Chemother 1987; 31(2): 333-334.
28. Kirst HA, Thompson DG, Nicas TI. Historical yearly usage of vancomycin. Antimicrob Agents Chemother 1998; 42(5): 1303-1304.
29. Finch RG, Eliopoulos GM. Safety and efficacy of glycopeptide antibiotics. J Antimicrob Chemother 2005; 55 Suppl 2: ii5-13.
30. Marchese A, Debbia EA, Bacca D, Balistreri G, Musolino B, Schito GC. Multidrug-resistant gram-positive pathogens. An update on current microbiological patterns. Drugs 1997; 54 Suppl 6: 11-20.
31. Grundmann H, Aires-de-Sousa M, Boyce J, Tiemersma E. Emergence and resurgence of meticillin-resistant Staphylococcus aureus as a public-health threat. Lancet 2006; 368(9538): 874-885.
32. Pace JL, Yang G. Glycopeptides: Update on an old successful antibiotic class. Biochem Pharmacol 2006; 71(7): 968-980.
33. Rice LB. Antimicrobial resistance in gram-positive bacteria. Am J Med 2006;119(6 Suppl 1): S11-S19.
34. Courvalin P. Vancomycin resistance in gram-positive cocci. Clin Infect Dis 2006; 42 Suppl 1: S25-S34.
35. Kaplan SL. Community-acquired methicillin-resistant Staphylococcus aureus infections in children. Semin Pediatr Infect Dis 2006; 17(3): 113-119
36. Cosgrove SE, Sakoulas G, Perencevich EN, Schwaber MJ, Karchmer AW, Carmeli Y. Comparison of mortality associated with methicillin-resistant and methicillin-susceptible Staphylococcus aureus bacteraemia: a meta-analysis. Clin Infect Dis 2003; 36(1): 53-59.
37. Leclercq R, Derlot E, Duval J, Courvalin P. Plasmid-mediated resistance to vancomycin and teicoplanin in Enterococcus faecium. N Engl J Med 1988; 319(3): 157-161.
38. Uttley AH, Collins CH, Naidoo J, George RC. Vancomycin-resistant enterococci. Lancet 1988; 1(8575-6): 57-58.
39. Frieden TR, Munsiff SS, Low DE et al. Emergence of vancomycin-resistant enterococci in New York City. Lancet. 1993; 342(8863): 76-79.
40. Marchese A, Balistreri G, Tonoli E, Debbia EA, Schito GC. Heterogeneous vancomycin resistance in methicillin-resistant Staphylococcus aureus strains isolated in a large Italian hospital. J Clin Microbiol 2000; 38(2): 866-869.
41. Jones RN. Microbiological features of vancomycin in the 21st century: minimum inhibitory concentration creep, bactericidal/static activity, and applied breakpoints to predict clinical outcomes or detect resistant strains. Clin Infect Dis 2006; 42 Suppl 1: S13-S24.
42. Howden BP, Johnson PD, Ward PB, Stinear TP, Davies JK. Isolates with low-level vancomycin resistance associated with persistent methicillin-resistant Staphylococcus aureus bacteremia. Antimicrob Agents Chemother. 2006; 50(9): 3039-3047.
43. Appelbaum PC. The emergence of vancomycin-intermediate and vancomycin-resistant Staphylococcus aureus. Clin Microbiol Infect. 2006; 12 Suppl 1: 16-23.
44. Parenti F, Schito GC, Courvalin P. Teicoplanin Chemistry and Microbiology. J Chemother 2000; 12 Suppl 5: 5-14.
45. Sakoulas G, Moellering RC Jr, Eliopoulos GM. Adaptation of methicillin-resistant Staphylococcus aureus in the face of vancomycin therapy. Clin Infect Dis 2006; 42 Suppl 1: S40-S50.
46. Martinez JL, Baquero F. Mutation frequencies and antibiotic resistance. Antimicrob Agents Chemother 2000; 44(7): 1771-1777.
47. Muoghalu BU, Lattimer GL. Delayed red neck syndrome with generic vancomycin. Drug Intell Clin Pharm 1988; 22(2): 173.
48. Bednarek M, Majda-Stanislawska E. Incidence of methicillin-resistant Staphylococcus aureus strains (MRSA) and difficulties in treatment. Own experience Przegl Epidemiol 2006; 60(1): 49-52.
49. Lambert PA, Conway BR. Pharmaceutical quality of ceftriaxone generic drug products compared with Rocephin. J Chemother 2003; 15(4): 357-368.
50. Schito GC, Keenan MH Predicting the clinical efficacy of generic formulations of ceftriaxone. J Chemother 2005;17 Suppl 2: 33-40.
51. Tam VH, McKinnon PS, Akins RL, Rybak MJ, Drusano GL. Pharmacodynamics of cefepime in patients with Gram-negative infections. J Antimicrob Chemother 2002; 50: 425-428.
52. Sádaba B, Azanza JR, Campanero MA, Garcia-Quetglas E. Relationship between pharmacokinetics and pharmacodynamics of β-lactams and outcome. Clin Microbiol Infect 2004; 10: 990-998.
53. Odenholt I, Gustafsson I, Lowdin E, Cars O. Suboptimal antibiotic dosage as a risk factor for selection of penicillin-resistant Streptococcus pneumoniae: in vitro kinetic model. Antimicrob Agents Chemother 2003; 47(2): 518-523.
54. Levy SB, Marshall B. Antibacterial resistance worldwide: causes, challenges and responses. Nat Med 2004;10(12 Suppl): S122-S129.
55. Agudelo M, Zuluaga AF, Rodriguez C, Salazar BE, Vesga O. Determination of therapeutic equivalence (TE) for 5 generic products (GP) of penicillin G (PEN) using the neutropenic murine thigh infection model (NMTIM). [Abstract A-1877]. In Abstracts of the 44th Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington DC, Oct 30-Nov 2, 2004: p 40.
56. Rodriguez C, Zuluaga AF, Salazar BE, Agudelo M, Vesga O. Experimental comparison of 11 generic products (GP) of oxacillin (OXA) with the original compound (OC) in terms of concentration of active principle (CAP), in vitro activity, and in vivo efficacy, using the neutropenic murine thigh infection model (NMTIM). [Abstract A-1305]. In Abstracts of the 44th Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington DC, Oct 30-Nov 2, 2004: p 28.
57. Salazar BE, Zuluaga AF, Rodriguez C, Agudelo M, Vesga O. Experimental comparison of 7 generic products (GP) of lincomycin (LIN) with the original compound (OC) in terms of concentration of active priciple (CAP), in vitro activity, and in vivo efficacy, using the neutropenic murine thigh infection model (NMTIM). [Abstract A-1879]. In Abstracts of the 44th Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington DC, Oct 30-Nov 2, 2004: p 41
58. Zuluaga AF, Salazar BE, Loaiza SA, Agudelo M, Vesga O. Therapeutic equivalence (TE) with the original compound (OC) of 8 generic products (GP) of ampicillin (AMP) determined in the neutropenic murine thigh infection model (NMTIM). [Abstract E-2033]. In Abstracts of the 44th Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington DC, Oct 30-Nov 2, 2004: p 180.
59. Zuluaga AF, Salazar BE, Galvis W, Agudelo M, Vesga O. In vivo bactericidal efficacy of 10 generic products (GP) of amikacin (AMK) compared with the original compound (OC) in the neutropenic murine thigh model (NMTIM). [Abstract A-1878]. In Abstracts of the 44th Interscience Conference on Antimicrobial Agents and Chemotherapy, Washington DC, Oct 30-Nov 2, 2004: p 41.