Ceftibuten: A new expanded-spectrum oral cephalosporin

Annals of Pharmacotherapy

Volumn 31, Issue 9, 1997, Pages 1022-1033

  Guay, David R P ^a,b,c  

^a UNIVERSITY OF MINNESOTA   (United States)

^b REGIONS HOSPITAL   (United States)

^c Cedax (Ceftibuten Schering Corp)   (Germany)

Author keywords

Ceftibuten; Cephalosporin

Indexed keywords

AMOXICILLIN; AMOXICILLIN PLUS CLAVULANIC ACID; CEFACLOR; CEFADROXIL; CEFIXIME; CEFPODOXIME; CEFPROZIL; CEFTIBUTEN; CEFUROXIME; CIPROFLOXACIN; CLARITHROMYCIN; CLAVULANIC ACID; COTRIMOXAZOLE; PENICILLIN V;

ANTIBIOTIC THERAPY; ANTIMICROBIAL ACTIVITY; CLINICAL TRIAL; DRUG ABSORPTION; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG COST; DRUG DISTRIBUTION; DRUG EFFICACY; DRUG ELIMINATION; DRUG METABOLISM; DRUG PENETRATION; DRUG PROTEIN BINDING; DRUG SAFETY; DRUG TOLERANCE; GASTROINTESTINAL SYMPTOM; HUMAN; LIVER TOXICITY; NONHUMAN; ORAL DRUG ADMINISTRATION; PRIORITY JOURNAL; RESPIRATORY TRACT INFECTION; REVIEW; URINARY TRACT INFECTION;

EID: 0030880599     PISSN: 10600280     EISSN: None     Source Type: Journal    
DOI: 10.1177/106002809703100913     Document Type: Review

References (81)

1. Hamashima Y, Kuhota T, Minami K, Ishikura K, Konoike T, Yoshioka M, et al. Synthesis and biological properties of 7b-[(Z)-2-(2-amino-4-thiazolyl)-4-carboxy-2-butenoylamino]-3-cephem-4-carboxylic acid (7432-S), a new oral cephem antibiotic. J Antibiot 1987;40:1468-70.
2. Braga PC, Piatti G. Kinetics of filamentation of Escherichia coli induced by different sub-MICs of ceftibuten at different times. Chemotherapy 1993;39:272-7.
3. Kearns GL, Young RA. Ceftibuten pharmacokinetics and pharmacodynamics. Clin Pharmacokinet 1994;26:169-89.
4. Bauernfeind A. Comparative antimicrobial spectrum and activity of ceftibuten against clinical isolates from West Germany. Diagn Microbiol Infect Dis 1991;14:63-74.
5. Bauernfeind A, Jungwirth R. Antibacterial activity of cefpodoxime in comparison with cefixime, cefdinir, ceftamet, ceftibuten, loracarbef, cefprozil, BAY-3522, cefuroxime, cefaclor, and cefadroxil. Infection 1991; 19:353-62.
6. Jones RN, Barry AL, for the Collaborative Antimicrobial Susceptibility Testing Group. Ceftibuten (7432-S, SCH 39720): comparative antimicrobial activity against 4735 clinical isolates, β-lactamase stability and broth microdilution quality control guidelines. Eur J Clin Microbiol Infect Dis 1988;7:802-7.
7. Jones RN, Barry AL. Antimicrobial activity, spectrum, and recommendations for disk diffusion susceptibility testing of ceftibuten (7432-S; SCH 39720), a new orally administered cephalosporin. Antimicrob Agents Chemother 1988;32:1576-82.
8. Mazzulli T, Simor AE, Jaeger R, Fuller S, Low DE. Comparative in vitro activities of several new fluoroquinolones and β-lactam antimicrobial agents against community isolates of Streptococcus. Antimicrob Agents Chemother 1990;34:467-9.
9. Verbist L, Jacobs J, Hens K. Comparative antimicrobial activity of ceftibuten against multiply-resistant microorganisms from Belgium. Diagn Microbiol Infect Dis 1991;14:53-61.
10. Wise R, Andrews JM, Ashby JP, Thornber D. Ceftibuten: a new orally absorbed cephalosporin. In vitro activity against strains from the United Kingdom. Diagn Microbiol Infect Dis 1991;14:45-52.
11. Bragman SGL, Casewell MW. The in-vitro activity of ceftibuten against 475 clinical isolates of gram-negative bacilli, compared with cefuroxime and cefadroxil. J Antimicrob Chemother 1990;25:221-6.
12. Bannatyne RM, Cheung R. Susceptibility of Bordetella pertussis to cephalosporin derivatives and imipenem. Antimicrob Agents Chemother 1984;26:604-5.
13. Doern GV. In vitro activity of ceftibuten against Haemophilus influenzae and Branhamella catarrhalis. Diagn Microbiol Infect Dis 1991;14:75-7.
14. Hoppe JE, Muller J. In vitro susceptibilities of Bordetella pertussis and Bordetella parapertussis to six new oral cephalosporins. Antimicrob Agents Chemother 1990;34:1442-3.
15. Mendelman PM, Henritzy LL, Chaffm DO, Lent K, Smith AL, Stull TL, et al. In vitro activities and targets of three cephem antibiotics against Haemophilus influenzae. Antimicrob Agents Chemother 1989;33:1878-82.
16. Shawar R, LaRocco M, Cleary TG. Comparative in vitro activity of ceftibuten (SCH 39720) against bacterial enteropathogens. Antimicrob Agents Chemother 1989;33:781-4.
17. Westblom TU, Gudipati S, Midkiff BR. In vitro susceptibility of Helicobacter pylori to the new oral cephalosporins cefpodoxime, ceftibuten and cefixime. Eur J Clin Microbiol Infect Dis 1990;9:691-3.
18. Debbia EA, Schito GC, Pesce A. Antibacterial activity of ceftibuten, a new oral third-generation cephalosporin. J Chemother 1991;3:209-25.
19. Bauerafeind A, Jungwirth R, Eberlein E, Kiesel N, Adam F, Isert D, et al. RU 29246, the active compound of the cephalosporin-prodrug-ester HR 916.1. Antibacterial activity in vitro. J Antibiot 1992;45:505-20.
20. Rodriguez WJ, Schwartz RH, Akram S, Khan WN. Streptococcus resistant to penicillin: incidence and potential therapeutic options. Laryngoscope 1995;105:300-4.
21. Kelloway JS, Awni WM, Lin CC, Lim J, Affrime MB, Keane WF, et al. Pharmacokinetics of ceftibuten-cis and its trans metabolite in healthy volunteers and in patients with chronic renal insufficiency. Antimicrob Agents Chemother 1991;35:2267-74.
22. Barry AL, Fuchs PC, Pfaller MA. Susceptibilities of β-lactamase-producing and -nonproducing ampicillin-resistant strains of Haemophilus influenzae to ceftibuten, cefaclor, cefuroxime, cefixime, cefotaxime, and amoxicillin-clavulanic acid. Antimicrob Agents Chemother 1993;37:14-8.
23. Chin N-X, Huang HB, Neu HC. Post-antibiotic effect of ceftibuten on respiratory pathogens. Pediatr Infect Dis J 1995;14(suppl):S84-7.
24. Guerillot F, Carret G, Flandrois JP. A statistical evaluation of the bactericidal effects of ceftibuten in combination with aminoglycosides and ciprofloxacin. J Antimicrob Chemother 1993;32:685-94.
25. Adam D. Do we still need new oral antibiotics for community-acquired infections in pediatrics? Introduction. Pediatr Infect Dis J 1995;14 (suppl):S5-6.
26. Papanicolaou GA, Medeiros AA, Jacoby GA. Novel plasmid-mediated β-lactamase (MIR-1) conferring resistance to oxyimino- and α-methoxy β-lactams in clinical isolates of Klebsiella. Antimicrob Agents Chemother 1990;34:2200-9.
27. Kitzis M-D, Liassine N, Ferre B, Gutmann L, Acar JF, Goldstein F. In vitro activities of 15 oral β-lactams against Klebsiella harboring new extended-spectrum β-lactamases. Antimicrob Agents Chemother 1990;34: 1783-6.
28. Jacoby GA, Carreras I. Activities of β-lactam antibiotics against Escherichia coli strains producing extended-spectrum β-lactamases. Antimicrob Agents Chemother 1990;34:858-62.
29. Thabaut A, Meyran M, Sofer L, Morand A, Labia R. Interactions of ceftibuten with extended-spectrum β-lactamases: a bacteriological and enzymatic analysis. Drugs Exp Clin Res 1994;20:49-54.
30. Papanicolaou GA, Medeiros AA. Ability of ceftibuten to induce class-I β-lactamases of Enterobacter cloacae, Serratia marcescens, and Enterobacter aerogenes. Diagn Microbiol Infect Dis 1991;14:85-7.
31. Nakashima M, Uematsu T, Takiguchi Y, Mizuno A, Iida M, Yoshida T, et al. Phase I clinical studies of 7432-S, a new oral cephalosporin: safety and pharmacokinetics. J Clin Pharmacol 1988;28:246-52.
32. Gismondo MR, Drago L, Lombardi A, Fassina C. Effect of ceftibuten on intestinal microflora: in vitro and in vivo studies. Drugs Exp Clin Res 1994;20:55-9.
33. Brismar B, Edlund C, Nord CE. Effect of ceftibuten on the normal intestinal microflora. Infection 1993;21:373-5.
34. Bale MJ, Jones RN, Erwin ME, Koontz FP, Gerlach EH, Murray PR, et al. MIC quality control guidelines for Haemophilus susceptibility tests using cefdinir (FK 482), cefepime, cefetamet, cefpirome, ceftibuten, fleroxacin, temafloxacin, clarithromycin, RP59500, and trospectomycin. J Clin Microbiol 1992;30:225-6.
35. Barry AL, Jones RN, for the Collaborative Antimicrobial Susceptibility Testing Group. Interpretive criteria and quality control limits for ceftibuten disk susceptibility tests. J Clin Microbiol 1990;28:605-7.
36. Wise R, Nye K, O'Neill P, Wostenholme M, Andrews J. Pharmacokinetics and tissue penetration of ceftibuten. Antimicrob Agents Chemother 1990;34:1053-5.
37. Pan H-T, Kumari P, DeSilva JAF, Lin C-C. Determination of ceftibuten in sputum by column-switching high-performance liquid chromatography on-line with thermospray mass spectrometry. J Pharm Sci 1993;82:52-5.
38. Lim JM, Kim H, Marco A, Mojaverian P, Lin C-C. Liquid Chromatographic determination of ceftibuten, a new oral cephalosporin, in human plasma and urine. J Pharm Biomed Anal 1994;12:699-703.
39. Kinowski JM, Bressolle F, Fabre D, Goncalves F, Rouzier-Panis R, Galtier M. High-performance liquid Chromatographic determination of ceftibuten and its metabolite in biological fluids: applications in pharmacokinetic studies. J Pharm Sci 1994;83:736-41.
40. Product information. Cedax (ceftibuten). Kenilworth, NJ: Schering Corporation, November 1995.
41. Shiba K. Pharmacokinetic evaluation of ceftibuten (7432-S) in humans (abstract). Presented at the 28th Interscience Conference on Antimicrobial Agents and Chemotherapy, Los Angeles, CA, October 23-26, 1988.
42. Bressolle F, Galtier M, Kinowski JM, Goncalves F, Edno L, Panis R, et al. Multiple-dose pharmacokinetics of ceftibuten after oral administration to healthy volunteers. J Pharm Sci 1994;83:1236-40.
43. Lin C, Lim J, Radwanski E, Marco A, Affrime M. Pharmacokinetics and dose proportionality of ceftibuten in man. Antimicrob Agents Chemother 1995;39:359-61.
44. Lin C, Radwanski E, Affrime M, Cayen MN. Multiple-dose pharmacokinetics of ceftibuten in healthy volunteers. Antimicrob Agents Chemother 1995;39:356-8.
45. Barr WH, Affrime M, Lin C-C, Barta V. Pharmacokinetics of ceftibuten in children. Pediatr Infect Dis J 1995;14(suppl):S93-101.
46. Barr WH, Lin C-C, Radwanski E, Lim J, Symchowicz S, Affrime M. The pharmacokinetics of ceftibuten in humans. Diagn Microbiol Infect Dis 1991;14:93-100.
47. Colucci RD, Elliott M, Affrime MB, Zampaglione N. Ceftibuten in paediatrics. Clin Pharmacokinet 1994;27:166-8.
48. Hirano K, Yoshida T, Matsubara T, Mizojiri K, Kobayashi F. 7432-S, a new oral cephem: animal pharmacology (abstract). Presented at the 26th Interscience Conference on Antimicrobial Agents and Chemotherapy, New Orleans, LA, September 28-October 1, 1986.
49. Shimada J, Hori S, Oguma T, Yoshikawa T, Yamamoto S, Nishikawa T, et al. Effects of protein binding on the isomerization of ceftibuten. J Pharm Sci 1993;83:461-5.
50. Scaglione F, Triscari F, Demartini G, Arcidiacono M, Cocuzza C, Fraschini F. Concentrations of ceftibuten in bronchial secretions. Chemotherapy 1995;41:229-33.
51. Lin C, Kumari P, Perrotta RJ, Reidenberg BE. Penetration of ceftibuten into middle ear fluid. Antimicrob Agents Chemother 1996;40:1394-6.
52. Kearns GL, Reed MD, Jacobs RF, Ardite M, Yogev RD, Blumer JL. Single-dose pharmacokinetics of ceftibuten (SCH 39720) in infants and children. Antimicrob Agents Chemother 1991;35:2078-84.
53. Craig WA, Andes D. Pharmacokinetics and pharmacodynamics of antibiotics in acute otitis media. Pediatr Infect Dis J 1996;15:255-9.
54. Kumazawa J. Phase I open clinical trials of ceftibuten (7432-S), a new oral cephem (abstract). Presented at the 28th Interscience Conference on Antimicrobial Agents and Chemotherapy, Los Angeles, CA, October 23-26, 1988.
55. Suzuki K, Nagata Y, Horiba M. Clinical studies on ceftibuten in the urinary field infection. Jpn J Antibiot 1990;43:2003-10.
56. Mizutani S, Nishimura K, Yoshimura K, Miyoshi S, Iwao N, Highashimoto J, et al. Clinical experience with ceftibuten in complicated urinary tract infections. Jpn J Antibiot 1990;43:779-89.
57. Watanabe A, Oizumi K, Motomiya M, Yoshida T, Ito T, Kanayama H, et al. Therapeutic efficacy of ceftibuten in chronic respiratory tract infections. Jpn J Antibiot 1990;43:768-78.
58. Hashimoto H, Yamaguchi S, Yachiku S. Clinical studies of ceftibuten in the field of urology. Jpn J Antibiot 1990;43:355-61.
59. Hayashi I, Onuma K, Hasuike M, Ishii T. Clinical examination of ceftibuten in acute bronchitis. Jpn J Antibiot 1990;43:761-7.
60. Kammer RB, Ress R. Randomized comparative study of ceftibuten versus cefaclor in the treatment of acute lower respiratory tract infections. Diagn Microbiol Infect Dis 1991;14:101-5.
61. DeAbate CA, Perrotta RJ, Dennington ML, Ziering RM. The efficacy and safety of once-daily ceftibuten compared with co-amoxiclav in the treatment of acute bacterial sinusitis. J Chemother 1992;4:358-63,
62. McCabe R, Rumans L, Perrotta R, Mogabgab W. Comparison of the efficacy and safety of ceftibuten and cefaclor in the treatment of pneumonia and bronchiectasis. J Chemother 1993;5:124-32.
63. Chirurgi VA, Edelstein H, Oster SE, Karp R, Cassano KB, Aiken S, et al. Ceftibuten versus cefaclor for the treatment of bronchitis. J Antimicrob Chemother 1991;28:577-80.
64. Perrotta R, McCabe R, Rumans L, Nolen T. Comparison of the efficacy and safety of ceftibuten and cefaclor in the treatment of acute bacterial bronchitis. Infect Dis Clin Pract 1994;3:270-6.
65. Bensch GW, Klaustermeyer WB, McCarty J, Schworer PB, Taglietti MA. Efficacy and safety of once-daily ceftibuten vs twice-daily ciprofloxacin in the treatment of acute exacerbation of chronic bronchitis. Infect Dis Clin Pract 1995;4(suppl 2):S80-7.
66. Data on file. Kenilworth, NJ: Schering Corporation, 1995.
67. Ziering W, McElvaine P, Taglietti M. Ceftibuten in the treatment of acute exacerbation of chronic bronchitis (abstract). Presented at the 35th Interscience Conference on Antimicrobial Agents and Chemotherapy, San Francisco, CA, September 17-20, 1995.
68. Stein GE, Christensen S, Mummaw N. Treatment of acute uncomplicated urinary tract infection with ceftibuten. Infection 1991;19:124-6.
69. Pichichero ME, McLinn SE, Gooch WM III, Rodriguez W, Goldfarb J, Reidenberg BE, for the Ceftibuten Pharyngitis International Study Group. Ceftibuten vs. penicillin V in group A β-hemolytic streptococcal pharyngitis. Pediatr Infect Dis J 1995;14(suppl):S102-7.
70. Blumer JL, McLinn SE, DeAbate CA, Kafetzis DA, Perrotta RJ, for the Ceftibuten Otitis Media International Study Group. Multinational multicenter controlled trial comparing ceftibuten with cefaclor for the treatment of acute otitis media. Pediatr Infect Dis J 1995;14(suppl):S115-20.
71. Blumer JL, Forti WP, Summerhouse TL. Comparison of the efficacy and tolerability of once-daily ceftibuten and twice-daily cefprozil in the treatment of children with acute otitis media. Clin Ther 1996;18:811-20.
72. McLinn SE, McCarty JM, Perrotta R, Pichichero ME, Reidenberg BE, for the Ceftibuten Otitis Media United States Study Group. Multicenter controlled trial comparing ceftibuten with amoxicillin/clavulanate for the treatment of acute otitis media. Pediatr Infect Dis J 1995;14(suppl):S108-14.
73. Mandel EM, Casselbrant ML, Kurs-Lasky M, Bluestone CD. Efficacy of ceftibuten compared with amoxicillin for otitis media with effusion in infants and children. Pediatr Infect Dis J 1996;15:409-14.
74. Banfi A, Gabriele G, Hill-Juarez JM, Kaufman A, Moens E, for the Ceftibuten Urinary Tract Infection International Study Group. Multinational comparative trial of ceftibuten and trimethoprim-sulfamethoxazole in the treatment of children with complicated or recurrent urinary tract infections. Pediatr Infect Dis J 1993;12(suppl):S84-91.
75. Prado D, Lopez E, Liu H, Devoto S, Woloj M, Contrini M, et al. Ceftibuten and trimethoprim-sulfamethoxazole for treatment of Shigella and enteroinvasive Escherichia coli disease. Pediatr Infect Dis J 1992;11: 644-7.
76. Reidenberg BE. Worldwide safety experience with ceftibuten pediatric suspension. Pediatr Infect Dis J 1995; 14(suppl):S130-3.
77. Nakashima M, Uematsu T, Takiguchi Y, Mizuno A, Uchida K, Matsubara T. Phase I clinical studies of 7432-S: effect of 7432-S on platelet aggregation and blood coagulation. J Clin Pharmacol 1988;28:253-8.
78. Braga PC, Piatti G, DalSasso M, Maci S, Blasi F. The in vitro effects of ceftibuten on the host defense mechanism. Chemotherapy 1994;40:37-41.
79. Bachmann K, Schwartz J, Jaregui L, Martin M, Nunlee M. Failure of ceftibuten to alter single dose theophylline clearance. J Clin Pharmacol 1990;30:444-8.
80. 1996 Drug topics red book. Montvale, NJ: Medical Economics Company, Inc., 1996.
81. Gutierrez Ortiz B, Saltigeral Simental P, Hernandez Porras M, Reyes Berlanga M, Gomez Garcia P, Martinez Zuniga R, et al. Comparison of the smell, body, taste, and aftertaste produced by 15 oral pediatric antibiotic liquid formulations. Presented at the 19th International Congress of Chemotherapy, Montreal, Canada, July 16-21, 1995.