Skip to main content

Cefpodoxime Proxetil

A Review of its Use in the Management of Bacterial Infections in Paediatric Patients

Paediatric Drugs volume 3, pages 137–158 (2001)Cite this article

Abstract

Abstract

Cefpodoxime proxetil is an oral third generation cephalosporin with a broad spectrum of antibacterial activity. The drug has in vitro activity against many common Gram-positive and Gram-negative pathogens associated with common paediatric infections, making the drug a useful option for empirical therapy.

In randomised controlled trials conducted in children with acute otitis media, oral cefpodoxime proxetil 8 to 10 mg/kg/day (usually administered in 2 divided doses) for 5 to 10 days was at least as effective as standard regimens of amoxicillin/clavulanic acid, cefixime, cefuroxime axetil or cefaclor as assessed by either clinical or bacteriological criteria.

Cefpodoxime 8 to 10 mg/kg/day (administered in 2 divided doses) for 5 to 10 days was at least as effective as standard 10-day regimens of penicillin V in the treatment of children with pharyngitis and/or tonsillitis. Significant differences in favour of cefpodoxime proxetil were demonstrated in terms of clinical (1 study) and bacteriological (2 studies) criteria. The clinical efficacy of 5 days of treatment with cefpodoxime proxetil is similar to that of 10 days of treatment with penicillin V.

In children with lower respiratory tract infections (primarily pneumonia), clinical and bacteriological efficacy rates achieved with cefpodoxime proxetil treatment were similar to those produced by cefuroxime axetil or amoxicillin/clavulanic acid in randomised controlled trials. Cefpodoxime proxetil also demonstrated clinical efficacy in paediatric patients with skin and soft tissue infections. In randomised studies that included both adults and children with a variety of infections (e.g. abscess, atheroma, furuncle and carbuncle, infected wounds, cellulitis), cefpodoxime proxetil showed efficacy similar to that of cefuroxime axetil or cefaclor.

Cefpodoxime proxetil is well tolerated by paediatric patients, with adverse events (primarily gastrointestinal tract disturbances and skin rashes) that are consistent with those reported for other oral cephalosporins.

Conclusion: Cefpodoxime proxetil is a third generation cephalosporin with a broad spectrum of antibacterial activity and a favourable pharmacokinetic profile which allows twice-daily administration. It is generally well tolerated and demonstrates good bacteriological and clinical efficacy in paediatric patients with various infectious diseases, including acute otitis media, tonsillitis and/or pharyngitis. Based on these characteristics, cefpodoxime proxetil is a suitable option for the treatment of paediatric patients with various common bacterial infections.

Antibacterial Activity

Cefpodoxime is active against a broad range of Gram-positive and Gram-negative bacteria, including those that are frequently associated with common paediatric infections, such as acute otitis media, pharyngitis and lower respiratory tract infections e.g. bronchitis and pneumonia. The drug is active against penicillin-susceptible strains of Streptococcus pneumoniae and has modest activity against strains that are intermediately susceptible to penicillin. In a US study that evaluated the activity of various antibacterial agents against S. pneumoniae isolates (n = 4489, including 2849 penicillin-susceptible, 1059 intermediately susceptible and 581 penicillin-resistant strains), the overall activity of cefpodoxime was less than that of amoxicillin or amoxicillin/clavulanic acid but greater than that of cefaclor, cefuroxime, cefprozil, cefixime and loracarbef. Cefpodoxime shows good in vitro activity against S. pyogenes and S. agalactiae but only modest activity against Staphylococcus aureus (methicillin-susceptible strains). The drug also has good in vitro activity against a number of Gram-negative pathogens, such as Haemophilus influenzae (including β-lactamase-producing strains), Moraxella catarrhalis and Enterobacteriaceae (Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis).

Cefpodoxime shows good stability towards common plasmid-mediated β-lactamases, including the TEM-1 enzyme that is frequently found in H. influenzae. However, the drug appears to be susceptible to hydrolysis by most chromosomally-mediated β-lactamases.

Pharmacokinetic Properties

After oral administration of cefpodoxime proxetil, the drug is absorbed and deesterified, releasing cefpodoxime, the active moiety, into the plasma. In paediatric patients with bacterial infections, peak plasma cefpodoxime concentrations range from 3.7 to 5.5 mg/L and are achieved approximately 2 hours after single oral doses of cefpodoxime proxetil 6 mg/kg; plasma cefpodoxime concentrations remain above 0.5 mg/L for at least 8 hours after administration of the dose. Food has no effect on the extent of absorption of orally administered cefpodoxime proxetil. However, coadministration of cefpodoxime proxetil with agents that increase gastric pH significantly decreases cefpodoxime absorption.

Cefpodoxime is generally well distributed to relevant tissues and fluids. In adults, therapeutic cefpodoxime concentrations have been observed in lung, head and neck, tonsillar, and skin tissues, bronchial mucosa, and pleural and skin blister fluids. In children, single doses of cefpodoxime proxetil produced drug concentrations above the MIC90 in tonsillar tissue and in middle ear fluid. Mean concentrations of cefpodoxime in middle ear fluid were 0.87 mg/L at 2 hours, and 0.52 mg/L hours after administration of a single 4 mg/kg dose of cefpodoxime proxetil.

Excretion of unchanged cefpodoxime in the urine is the primary route of elimination of the drug. Clearance of cefpodoxime appears to be age-dependent, with mean clearance values higher (0.57 L/h/kg) in children less than 5 years of age than in older children (0.36 L/h/kg). The mean plasma elimination half-life of cefpodoxime ranges from 1.7 to 3.3 hours in paediatric patients.

Therapeutic Efficacy

Cefpodoxime proxetil is an effective treatment for a variety of bacterial infections in paediatric patients. In children with acute otitis media, randomised controlled trials have shown 5- to 10-day regimens of cefpodoxime proxetil 8 to 10 mg/kg/day to be at least as effective as 5 to 10 days’ treatment with comparator β-lactam antibacterials (amoxicillin/clavulanic acid, cefixime, cefuroxime axetil or cefaclor) as assessed by either clinical or bacteriological criteria. Cefpodoxime produced a significantly higher clinical cure rate than amoxicillin/clavulanic acid both at the end of 8 days’ therapy and after follow-up (20 to 30 days after the completion of therapy) in a single trial.

In children with pharyngitis and/or tonsillitis caused by S. pyogenes, treatment with cefpodoxime proxetil 10 mg/kg/day for 10 days produced clinical cure rates (83 to 100%) broadly similar to those achieved with penicillin V 40 mg/kg/day for 10 days (76 to 100%). A statistically significant difference in favour of cefpodoxime proxetil in terms of clinical end-points was demonstrated in 1 study. In 2 other investigations, cefpodoxime proxetil produced significantly higher bacteriological response rates than penicillin V when assessed by bacteriological criteria. In 1 study, a 5-day course of cefpodoxime proxetil was at least as effective as a 10-day course of penicillin V.

In the treatment of lower respiratory tract infections (e.g. pneumonia, bronchitis) in children, cefpodoxime proxetil has demonstrated significant efficacy in a number of controlled trials. In comparative trials, cefpodoxime proxetil 8 mg/kg/day for 10 days produced rates of clinical cure or improvement (93 and 95%) that were similar to those obtained after 10 days of therapy with either cefuroxime axetil 30 mg/kg/day (93%) or amoxicillin/clavulanic acid 40/10 mg/kg/day (97%).

Cefpodoxime proxetil also appears to be an effective treatment for children with skin and soft tissue infections. In 2 controlled trials that included both children and adults with a variety of infections (abscess, atheroma, furuncle and carbuncle, infected wounds, cellulitis), cefpodoxime proxetil and comparators (cefuroxime axetil, cefaclor) produced similar rates of clinical cure (>80%) and bacteriological eradication (>90%).

Tolerability

Cefpodoxime proxetil has a tolerability profile similar to that of other oral cephalosporins, with gastrointestinal symptoms (e.g. diarrhoea, loose stools, nausea/vomiting, abdominal pain) and skin rashes being the most frequently reported adverse events. The incidence of diarrhoea is age-dependent, occurring more frequently in children aged 1 month to 2 years (12.8%) than in older children (6%). In clinical trials involving paediatric patients, the tolerability of cefpodoxime proxetil was similar to that of comparator antibacterial drugs in terms of incidences of adverse events, severe adverse events, laboratory abnormalities and treatment discontinuations.

Administration of multiple doses of the drug to adults resulted in significant decreases in the number of streptococci, E. coli, Klebsiella spp., and Gram-positive anaerobic bacteria, an increase in the growth of yeasts and enterococci, and the colonisation of Clostridium difficile in the gastrointestinal tract.

Dosage and Administration

The recommended dosage of cefpodoxime proxetil oral suspension is 8 mg/kg/day in the UK and 10 mg/kg/day in the US, administered in 2 divided doses; in the US, recommended durations of treatment are 5 days for acute otitis media and 5 to 10 days for pharyngitis and/or tonsillitis. In Japan, the normal dosage of the ‘dry syrup’ formulation is 3 mg/kg (administered as a suspension) 2 to 3 times daily; recommended indications include lower respiratory tract infections, skin and soft tissue infections, and otitis media. Although cefpodoxime proxetil tablets are better absorbed on a full than on an empty stomach, the absorption of the oral suspension and ‘dry syrup’ formulations is not affected by food; thus, these formulations can be administered without regard to meals. The dosage interval should be increased to 24 hours in patients with moderate renal impairment (creatinine clearance <30 to 40 ml/min/1.73m2) and to 48 hours in those with severe renal impairment (creatinine clearance <10 ml/min/1.73m2). Dosage adjustments in patients with hepatic impairment are not required.

This is a preview of subscription content, access via your institution.

Access options

Buy single article

Instant access to the full article PDF.

49,54 €

Price includes VAT (Finland)
Tax calculation will be finalised during checkout.

Fig. 1
Table I
Fig. 2
Table II
Fig. 3
Table III
Table IV
Fig. 4

References

  1. Frampton JE, Brogden RN, Langtry HD, et al. Cefpodoxime proxetil: A review of its antibacterial activity, pharmacokinetic properties and therapeutic potential. Drugs 1992 Nov; 44:889–917

    PubMed  CAS  Article  Google Scholar 

  2. Kayser FH. In vitro activity of cefpodoxime in comparison with other oral β-lactam antibiotics. Infection 1994 Sep–Oct; 22: 370–5

    PubMed  CAS  Article  Google Scholar 

  3. Liu Y-C, Huang W-K, Cheng D-L. Antibacterial activity of cefpodoxime in vitro. Chemotherapy 1997 Jan–Feb; 43: 21–6

    PubMed  CAS  Article  Google Scholar 

  4. Mason Jr EO, Lamberth LB, Kershaw NL, et al. Streptococcus pneumoniae in the USA: in vitro susceptibility and pharmacodynamic analysis. J Antimicrob Chemother 2000; 45: 623–31

    PubMed  CAS  Article  Google Scholar 

  5. Raymond N, Lang S. Activity of cefpodoxime, an oral 3rd generation cephalosporin [letter]. NZ Med J 1993 Feb 10; 106: 44

    CAS  Google Scholar 

  6. Sader HS, Jones RN, Washington JA, et al. In vitro activity of cefpodoxime compared with other oral cephalosporins tested against 5556 recent clinical isolates from five medical centers. Diagn Microbiol Infect Dis 1993 Aug–Sep; 17: 143–50

    PubMed  CAS  Article  Google Scholar 

  7. Wallrauch-Schwarz C, Milatovic D, Braveny I. Comparative antibacterial activity of cefpodoxime against Haemophilus influenzae, Streptococcus pyogenes, Streptococcus pneumoniae and Moraxella catarrhalis [in German]. Arzneimittel Forschung 1994 May; 44: 668–70

    PubMed  CAS  Google Scholar 

  8. Yamaji E, Nakayama I, Hirata H, et al. Comparative in vitro activity of cefpodoxime proxetil and other cephalosporin against Gram-positive bacterias [abstract]. 8th International Congress on Infectious Diseases. 1998 May 15–18; Boston, 16

  9. Vantin® Prescribing Information, USA: Pharmacia & Upjohn, December 1998

  10. National Committee for Clinical Laboratory Standards. Methods for dilution antimicrobial susceptibility tests for bacteria that grow aerobically [in NCCLS document M7-A4.] 4th ed. Wayne (PA): NCCLS, 1997

    Google Scholar 

  11. Focht J. An-vitro-aktivität von cefpodoxim im vergleich zu anderen oralen antibiotika. Arzneimitteltherapie 1999; 17(10): 305–11

    Google Scholar 

  12. Fernandes C, Gottlieb T, Cefpodoxime Study Group. In vitro activity of cefpodoxime proxetil: an Australian multi-centre study [abstract]. Can J Infect Dis 1995 Jul; 6 Suppl.: 474C

    Google Scholar 

  13. Kawada H, Kitayama A, Fukuoka T, et al. In vitro and in vivo activities of cefpodoxime proxetil against penicillin-resistant Streptococcus pneumoniae [in Japanese]. Jpn J Antibiot 1999 Aug; 52: 533–40

    PubMed  CAS  Google Scholar 

  14. Wiedemann B, Luhmer E, Zühlsdorf MT. Microbiological evaluation of cefpodoxime proxetil [see comments]. Drugs 1991; 42Suppl. 3:6–12

    PubMed  CAS  Article  Google Scholar 

  15. Wiedemann B, Luhmer E, Zühlsdorf MT. In vitro activity of cefpodoxime and ten other cephalosporins against Gram-positive cocci, Enterobacteriaceae and Pseudomonas aeruginosa, including β-lactamase producers. Infection 1991 Sep–Oct; 19: 363–9

    PubMed  CAS  Article  Google Scholar 

  16. Stobberingh EE, Houben AW, Philips JH. In vitro activity of cefpodoxime, a new oral cephalosporin. Eur J Clin Microbiol Infect Dis 1989; 8: 657–8

    Article  Google Scholar 

  17. Wise R, Andrews JM, Ashby JP, et al. The in-vitro activity of cefpodoxime: a comparison with other oral cephalosporins. J Antimicrob Chemother 1990; 25(4): 541–50

    PubMed  CAS  Article  Google Scholar 

  18. Cazzola M, Matera MG, Donner CF. Pharmacokinetics and pharmacodynamics of newer oral cephalosporins: implications for treatment of community-acquired lower respiratory tract infections. Clin Drug Invest 1998 Oct; 16: 335–46

    CAS  Article  Google Scholar 

  19. Cars O. Efficacy of beta-lactam antibiotics: integration of pharmacokinetics and pharmacodynamics. Diagn Microbiol Infect Dis 1997; 27: 29–33

    PubMed  CAS  Article  Google Scholar 

  20. Stoeckel K, Hayton WL, Edwards DJ, et al. Clinical pharmacokinetics of oral cephalosporins. Antibiot Chemother 1995; 47: 34–71

    PubMed  CAS  Google Scholar 

  21. Quintiliani R, Nightingale CH, Freeman CD. Pharmacokinetic and pharmacodynamic considerations in antibiotic selection with particular attention to oral cephalosporins. Infect Dis Clin Pract 1994; 3: 1–7

    Article  Google Scholar 

  22. Stein GE, Schooley S, Walker RD, et al. Pharmacodynamic activity of five oral cephalosporins against Haemophilus influenzae. Pharmacotherapy 1997 Mar-Apr; 17(2): 235–41

    PubMed  CAS  Google Scholar 

  23. Lemmen SW, Hauer T, Anding K, et al. Serum bactericidal activity against Moraxella catarrhalis and Streptococcus pneumoniae after administration of four oral cephalosporins in healthy volunteers [abstract]. J Antimicrob Chemother 1995 Jan; 35: 233–5

    PubMed  CAS  Article  Google Scholar 

  24. Borin MT. A review of the pharmacokinetics of cefpodoxime proxetil. Drugs 1991; 42Suppl. 3: 13–21

    PubMed  CAS  Article  Google Scholar 

  25. Fujii R. Clinical trials of cefpodoxime proxetil suspension in paediatrics. Drugs 1991; 42Suppl. 3: 57–60

    PubMed  Article  Google Scholar 

  26. Kearns GL, Darville T, Wells TG, et al. Single dose pharmacokinetics of cefpodoxime proxetil in infants and children. Drug Invest 1994; 7(5): 221–33

    CAS  Article  Google Scholar 

  27. Kearns GL, Abdel-Rahman SM, Jacobs RF, et al. Cefpodoxime pharmacokinetics in children: effect of food. Pediatr Infect Dis J 1998 Sep; 17: 799–804

    PubMed  CAS  Article  Google Scholar 

  28. Sakata H, Kakehashi H, Fujita K, et al. Clinical and pharmacokinetic evaluation of cefpodoxime proxetil in children [in Japanese]. Jpn J Antibiot 1989 Jul; 42: 1456–63

    PubMed  CAS  Google Scholar 

  29. Toyonaga Y, Koizumi M, Imai H, et al. Bacteriological, pharmacokinetic and clinical studies on cefpodoxime proxetil in the pediatric field [in Japanese]. Jpn J Antibiot 1989 Jul; 42: 1519–46

    PubMed  CAS  Google Scholar 

  30. Tremblay D, Dupront A, Ho C, et al. Pharmacokinetics of cefpodoxime in young and elderly volunteers after single doses. J Antimicrob Chemother 1990; 26Suppl. E: 21–8

    PubMed  CAS  Article  Google Scholar 

  31. Iwai N, Taneda Y, Nakamura H, et al. Pharmacokinetic, bacteriological and clinical evaluation of cefpodoxime proxetil in pediatrics [in Japanese]. Jpn J Antibiot 1989 Jul; 42: 1571–92

    PubMed  CAS  Google Scholar 

  32. Kimura H, Takeuchi H, Ishikawa H, et al. Bacteriological, pharmacokinetic and clinical studies on cefpodoxime proxetil in the pediatric field [in Japanese]. Jpn J Antibiot 1989 Jul; 42: 1593–606

    PubMed  CAS  Article  Google Scholar 

  33. Hughes GS, Heald DL, Barker KB, et al. The effects of gastric pH and food on the pharmacokinetics of a new oral cephalosporin, cefpodoxime proxetil. Clin Pharmacol Ther 1989 Dec; 46: 674–85

    PubMed  CAS  Article  Google Scholar 

  34. Borin MT, Driver MR, Forbes KK. Effect of timing of food on absorption of cefpodoxime proxetil. J Clin Pharmacol 1995 May; 35: 505–9

    PubMed  CAS  Google Scholar 

  35. Fujii R, Meguro H, Arimasu O, et al. Overall clinical evaluation of cefpodoxime proxetil against infections in pediatric fields [in Japanese]. Jpn J Antibiot 1989 Jul; 42: 1439–55

    PubMed  CAS  Google Scholar 

  36. Borin MT, Forbes KK, Hughes GS. The bioavailability of cefpodoxime proxetil tablets relative to an oral solution. Biopharm Drug Dispos 1995 May; 16: 295–302

    PubMed  CAS  Article  Google Scholar 

  37. Saathoff N, Lode H, Neider K, et al. Pharmacokinetics of cefpodoxime proxetil and interactions with an antacid and an H2 receptor antagonist. Antimicrob Agents Chemother 1992 Apr; 36: 796–800

    PubMed  CAS  Article  Google Scholar 

  38. Hughes Jr GS, Heald DL, Patel R, et al. Gastric emptying and the pharmacokinetics of the cephalosporin antibiotic, cefpodoxime proxetil. Methods Find Exp Clin Pharmacol 1990 Apr; 12: 197–204

    PubMed  CAS  Google Scholar 

  39. Kees F, Wellenhofer M, Bröhl K, etal. Bioavailability of cefpodoxime proxetil with co-administered acetylcysteine. Arzneimittel Forschung 1996 Apr; 46: 435–8

    PubMed  CAS  Google Scholar 

  40. Deslandes A, Camus F, Lacroix C, et al. Effects of nifedipine and diltiazem on pharmacokinetics of cefpodoxime following its oral administration. Antimicrob Agents Chemother 1996 Dec; 40: 2879–81

    PubMed  CAS  Google Scholar 

  41. Couraud L, Andrews JM, Lecoeur H, et al. Concentrations of cefpodoxime in plasma and lung tissue after a single oral dose of cefpodoxime proxetil. J Antimicrob Chemother 1990 Dec; 26Suppl. E: 35–40

    PubMed  Article  Google Scholar 

  42. Muller-Serieys C, Bancal C, Dombret MC, et al. Penetration of cefpodoxime proxetil in lung parenchyma and epithelial lining fluid of noninfected patients. Antimicrob Agents Chemother 1992 Oct; 36: 2099–103

    PubMed  CAS  Article  Google Scholar 

  43. Baldwin DR, Wise R, Andrews JM, et al. Concentrations of cefpodoxime in serum and bronchial mucosal biopsies. J Antimicrob Chemother 1992 Jul; 30: 67–71

    PubMed  CAS  Article  Google Scholar 

  44. Dumont R, Guetat F, Andrews JM, et al. Concentrations of cefpodoxime in plasma and pleural fluid after a single oral dose of cefpodoxime proxetil. J Antimicrob Chemother 1990 Dec; 26Suppl. E: 41–6

    PubMed  Article  Google Scholar 

  45. Theopold HM, Matthias C, Adam D. Cefpodoxime proxetil concentrations in head and neck tissues. Infection 1991 Jan–Feb; 19:41–3

    PubMed  CAS  Article  Google Scholar 

  46. Gehanno P, Andrews JM, Ichou F, et al. Concentrations of cefpodoxime in plasma and tonsillar tissue after a single oral dose of cefpodoxime proxetil. J Antimicrob Chemother 1990 Dec; 26Suppl. E: 47–51

    PubMed  Article  Google Scholar 

  47. Bairamis TN, Nikolopoulos TP, Kafetzis DA, et al. Concentrations of cefpodoxime in plasma, adenoid, and tonsillar tissue after repeated administrations of cefpodoxime proxetil in children. J Antimicrob Chemother 1996 Apr; 37: 821–4

    PubMed  CAS  Article  Google Scholar 

  48. van Dyk JC, Terespolsky SA, Meyer CS, et al. Penetration of cefpodoxime into middle ear fluid in pediatric patients with acute otitis media. Pediatr Infect Dis J 1997 Jan; 16(1): 79

    PubMed  Article  Google Scholar 

  49. Borin MT, Hughes GS, Spillers CR, et al. Pharmacokinetics of cefpodoxime in plasma and skin blister fluid following oral dosing of cefpodoxime proxetil. Antimicrob Agents Chemother 1990 Jun; 34: 1094–9

    PubMed  CAS  Article  Google Scholar 

  50. O’Neill P, Nye K, Douce G, et al. Pharmacokinetics and inflammatory fluid penetration of cefpodoxime proxetil in volunteers. Antimicrob Agents Chemother 1990 Feb; 34: 232–4

    PubMed  Article  Google Scholar 

  51. Zolfino I, Senesi S, Campa M, et al. Human skin disposition of cefpodoxime after oral administration of its proxetil ester [letter]. J Antimicrob Chemother 1992 Nov; 30: 731–3

    PubMed  CAS  Article  Google Scholar 

  52. Del Tacca- M, Danesi R, Blandizzi C, et al. Periodontal tissue distribution of cefpodoxime proxetil and efficacy in acute odontogenic infections. Drug Invest 1993; 5(6): 313–9

    Article  Google Scholar 

  53. Abdel-Rahman SM, Maxson S, Teo C, et al. Cerebrospinal fluid pharmacokinetics of cefpodoxime proxetil in piglets. J Clin Pharmacol 2000 Mar; 40: 290–5

    PubMed  CAS  Article  Google Scholar 

  54. St.-Peter JV, Borin MT, Hughes GS, et al. Disposition of cefpodoxime proxetil in healthy volunteers and patients with impaired renal function. Antimicrob Agents Chemother 1992 Jan; 36: 126–31

    PubMed  CAS  Article  Google Scholar 

  55. Borin MT, Hughes GS, Kelloway JS, et al. Disposition of cefpodoxime proxetil in hemodialysis patients. J Clin Pharmacol 1992 Nov; 32: 1038–44

    PubMed  CAS  Google Scholar 

  56. Johnson CA, Ateshkadi A, Zimmerman SW, et al. Pharmacokinetics and ex vivo susceptibility of cefpodoxime proxetil in patients receiving continuous ambulatory peritoneal dialysis. Antimicrob Agents Chemother 1993 Dec; 37: 2650–5

    PubMed  CAS  Article  Google Scholar 

  57. Pichichero ME. Therapeutic considerations for management of otitis media, sinusitis, and tonsillopharyngitis. Pediatr Asthma Allergy Immunol 1992; 6(3): 167–74

    Article  Google Scholar 

  58. Block SL. Management of acute otitis media in the 1990s: the decade of resistant pneumococcus. Paediatr Drugs 1999 Jan–Mar; 1: 31–50

    PubMed  CAS  Article  Google Scholar 

  59. Marchant CD, Carlin SA, Johnson CE, et al. Measuring the comparative efficacy of antibacterial agents for acute otitis media: the ‘Pollyanna phenomenon’. J Pediatr 1992; 120:72–7

    PubMed  CAS  Article  Google Scholar 

  60. Cohen R, De la-Rocque F, Boucherat M, et al. Randomized trial comparing 5-day cefpodoxime proxetil and 8-day amoxicillin-clavulanate treatment of acute otitis media in children [in French]. Med Mal Infect 1997; 27(5): 596–602

    Article  Google Scholar 

  61. Gehanno P, Barry B, Bobin S, et al. Twice daily cefpodoxime proxetil compared with thrice daily amoxicillin/clavulanic acid for treatment of acute otitis media in children. Scand J Infect Dis 1994; 26: 577–84

    PubMed  CAS  Article  Google Scholar 

  62. Graham-Zapata LF, Mexican SG. Efficacy and safety of cefpodoxime proxetil (8 mg/kg/day) for 5 days vs. amoxicillin/clavulanic acid (40 mg/kd/day) for 8 days in the treatment of acute otitis media in children [abstract]. 37th Interscience Conference on Antimicrobial Agents and Chemotherapy. 1997 Sep 28-Oct 1; Toronto, 370

  63. Mendelman PM, Del Beccaro MA, McLinn SE, et al. Cefpodoxime proxetil compared with amoxicillin-clavulanate for the treatment of otitis media [published erratum appears in J Pediatr 1993 Mar;122(3):502] [see comments]. J Pediatr 1992 Sep; 121:459–65

    PubMed  CAS  Article  Google Scholar 

  64. Asmar BI, Dajani AS, Del Beccaro MA, et al. Comparison of cefpodoxime proxetil and cefixime in the treatment of acute otitis media in infants and children. Otitis Study Group. Pediatrics 1994 Dec; 94(6 Pt 1): 847–52

    PubMed  CAS  Google Scholar 

  65. Cohen R, De La-Rocque F, Boucherat M, et al. Cefpodoxime proxetil vs. cefixime for painful febrile acute otitis media in children [in French]. Med Mal Infect 1994; 24(8–9): 844–51

    Article  Google Scholar 

  66. MacLoughlin GJ, Barreto DG, de la Torre C, et al. Cefpodoxime proxetil suspension compared with cefaclor suspension for treatment of acute otitis media in paediatric patients. J Antimicrob Chemother 1996 Mar; 37: 565–73

    PubMed  CAS  Article  Google Scholar 

  67. Tsai HY, Huang LM, Chiu HH, et al. Comparison of once daily cefpodoxime proxetil suspension and thrice daily cefaclor suspension in the treatment of acute otitis media in children. Chung Hua Min Kuo Wei Sheng Wu Chi Mien I Hsueh Tsa Chih 1998 Sep; 31: 165–70

    CAS  Google Scholar 

  68. Triglia JM, Gaudelus J, Riebbels V, et al. Treatment of acute otitis media (AOM) in pediatric patients: comparison of cefuroxime axetil (CAE) with cefpodoxime proxetil (CPD) [abstract]. 9th International Congress on Infectious Diseases; 2000 Apr 10–13; Buenos Aires, 99–100

  69. Spencer R, Hannington J, Fraser S, et al. UK Study Group in General Practice. Cefpodoxime proxetil vs co-amoxiclav in the treatment of acute infections of the ear, nose and throat in children-a multicentre randomized study [abstract no. 851]. 18th International Congress of Chemotherapy; 1993 Jun 27–Jul 2; Stockholm, 264

  70. Cohen R, Levy C, Boucherat M, et al. Five vs. ten days of antibiotic therapy for acute otitis media in young children. Pediatr Infect Dis J 2000 May; 19: 458–63

    PubMed  CAS  Article  Google Scholar 

  71. Guillot M, Groupe Pédiatrique National Étude. Multicenter open-label trial of cefodoxime proxetil in febrile and painful acute otitis media in infants and children [abstract]. Can J Infect Dis 1995 Jul; 6Suppl. C: 358C

    Google Scholar 

  72. Kawabata I, Nomura Y, Mizuno M, et al. The clinical efficacy of Banan dry syrup on children with otorhinolaryngological infections [in Japanese]. Jibi to Rinsho 1995; 41(4): 660–9

    Google Scholar 

  73. Tamaki K, Sakai T, Murata K, et al. Effect of CPDX-PR on pediatric infections [in Japanese]. Pract Otol 1994; 87(1): 141–9

    Article  Google Scholar 

  74. Tanaka O, Matsunaga T, Miyahara H. Comparative study of the efficacy of cefpodoxime proxetil (CPDX-PR) dry syrup at two doses in pediatric otorhinolaryngology [in Japanese]. Pract Otol 1995; 88(11): 1513–20

    Article  Google Scholar 

  75. Wiese K. Efficacy and safety of cefpodoxime proxetil (Orelox® Junior) in children with RTI [abstract]. 20th International Congress on Chemotherapy; 1997 Jun 29–Jul 3: Sydney, 102–3

  76. Dajani AS, Kessler SL, Mendelson R, et al. Cefpodoxime proxetil vs. penicillin V in pediatric streptococcal pharyngitis /tonsillitis. Pediatr Infect Dis J 1993 Apr; 12: 275–9

    PubMed  CAS  Article  Google Scholar 

  77. Kline NE, Kline MW. Cefpodoxime proxetil versus penicillin V in the treatment of streptococcal pharyngitis in children. Curr Ther Res Clin Exp 1991; 49(5): 807–13

    Google Scholar 

  78. Pichichero ME, Gooch WM, Rodriguez W, et al. Effective short-course treatment of acute group A β-hemolytic streptococcal tonsillopharyngitis. Ten days of penicillin V vs 5 days or 10 days of cefpodoxime therapy in children. Arch Pediatr Adolesc Med 1994 Oct; 148: 1053–60

    PubMed  CAS  Article  Google Scholar 

  79. Portier H, Chavanet P, Waldner-Combernoux A, et al. Five versus ten days treatment of streptococcal pharyngotonsillitis: a randomized controlled trial comparing cefpodoxime proxetil and phenoxymethyl penicillin. Scand J Infect Dis 1994; 26: 59–66

    PubMed  CAS  Article  Google Scholar 

  80. Imanaka H, Kitahara T, Yoshinaga M, et al. A multi-institutional study on clinical effectiveness of cefpodoxime proxetil dry syrup in childhood infections. J Chemother 1995 Nov; 7Suppl. 4: 131–3

    PubMed  Google Scholar 

  81. Kasagi T, Tanimoto K, Ogihara Y, et al. The clinical study of cefpodoxime proxetil dry syrup preparation in the pediatric field [in Japanese]. Jpn J Antibiot 1994 Sep; 47: 1202–9

    PubMed  CAS  Article  Google Scholar 

  82. Muranaka H, Yokoyama M. Evaluation of cefpodoxime proxetil dry syrup in pediatric patients with various infections. J Chemother 1995 Nov; 7Suppl. 4: 127–30

    PubMed  Google Scholar 

  83. Boulesteix J, Olivier C, Mselati JC, et al. Treatment of community-acquired pneumonia in paediatric patients: comparison of cefuroxime axetil with cefpodoxime proxetil [abstract]. 9th International Congress on Infectious Diseases; 2000 Apr 10–13; Buenos Aires, 100

  84. Klein M. Multicentertrial of cefpodoxime proxetil vs. amoxicillin-clavulanate in acute lower respiratory tract infections in childhood. International Study Group. Pediatr Infect Dis J 1995 Apr; 14(4 Suppl.): S19–22

    PubMed  CAS  Google Scholar 

  85. Yokoyama M. Evaluation of cefpodoxime proxetil in the patient with various pediatric infections [abstract]. 9th Mediterranean Congress on Chemotherapy; 1994 Jun 12–17; Milan, 94

  86. Nakayama I, Yamaji E, Hirata H, et al. Comparative effectiveness and safety of cefpodoxime proxetil versus cefuroxime axetil for the treatment of skin and soft-tissue infections [abstract]. 8th International Congress on Infectious Diseases; 1998 May 15–18; Boston, 130

  87. Stevens DL, Pien F, Drehobl M. Comparison of oral cefpodoxime proxetil and cefaclor in the treatment of skin and soft tissue infections. Diagn Microbiol Infect Dis 1993 Feb; 16: 123–9

    PubMed  CAS  Article  Google Scholar 

  88. Ito K, Ito M. Microbiological and clinical studies on cefpodoxime proxetil for bacterial skin and soft tissue infections in pediatric patients. J Chemother 1995 Nov; 7Suppl. 4: 124–6

    PubMed  Google Scholar 

  89. Ito K, Kazama T, Ito M, et al. Microbiological and clinical studies on cefpodoxime proxetil in pediatric patients with bacterial skin and soft tissue infections [in Japanese]. Rinsho Iyaku 1994; 10(11): 2555–74

    Google Scholar 

  90. Kurokawa I, Nishijima S, Asada Y, et al. Clinical evaluation of cefpodoxime proxetil (Banan) dry syrup in patients with bacterial skin infection in children [in Japanese]. Skin Res 1995; 37(1): 193–200

    Google Scholar 

  91. Matsuo S, Ishida-Yamamoto A, Iizuka H. Microbiological and clinical studies on cefpodoxime proxetil in bacterial skin and soft tissue infections [abstract]. 9th Mediterranean Congress on Chemotherapy; 1994 Jun 12–17; Milan, 93

  92. Miyachi Y, Ishikawa T, Furuse Y, et al. Clinical evaluation of cefpodoxime proxetil in various superficial infectious skin diseases [abstract]. 9th Mediterranean Congress on Chemotherapy; 1994 Jun 12–17; Milan, 94

  93. Motohiro T, Oda K, Aramaki M, et al. Clinical study of cefpodoxime proxetil dry syrup for skin and soft tissue infections in the field of pediatrics [in Japanese] J Antibiot 1989 Jul; 42: 1685–704

    CAS  Google Scholar 

  94. Nakagawa K, Fukai K, Kobayashi H, et al. Bacteriological and clinical evaluation of cefpodoxime proxetil (Banan registered dry syrup) against impetigo contagiosa. Skin Res 1993; 35(3): 417–30

    Google Scholar 

  95. Tack KJ, Wilks NE, Semerdjian G, et al. Cefpodoxime proxetil in the treatment of skin and soft tissue infections. Drugs 1991; 42Suppl. 3:51–6

    PubMed  Article  Google Scholar 

  96. Terui T, Tagami H. Clinical evaluation of cefpodoxime proxetil dry syrup in pediatric cutaneous bacterial infection. J Chemother 1995 Nov; 7Suppl. 4: 119–21

    PubMed  Google Scholar 

  97. Orelox Prescribing Information. ABPI Compendium of Data Sheets. London: Datapharm Publications Ltd, 1999–2000

    Google Scholar 

  98. Sankyo Co. Ltd. Banan® Dry Syrup prescribing information (Japan). Tokyo, Jun 1998

    Google Scholar 

  99. Autret E, Dubois C, Eladan G, et al. The overall safety of cefpodoxime proxetil (CPD) suspension in paediatric clinical studies [abstract]. 33rd Interscience Conference on Antimicrobial Agents and Chemotherapy; 1993 Oct 17–20; New Orleans, 155

  100. Edlund C, Stark C, Nord CE. The relationship between an increase in β-lactamase activity after oral administration of three new cephalosporins and protection against intestinal ecological disturbances. J Antimicrob Chemother 1994 Jul; 34: 127–38

    PubMed  CAS  Article  Google Scholar 

  101. Brismar B, Edlund C, Nord CE. Impact of cefpodoxime proxetil and amoxicillin on the normal oral and intestinal microflora. Eur J Clin Microbiol Infect Dis 1993 Sep; 12: 714–9

    PubMed  CAS  Article  Google Scholar 

  102. Edlund C, Brismar B, Nord CE. Effect of cefpodoxime proxetil and amoxicillin on the normal oropharyngeal and intestinal microflora [abstract]. 33rd Interscience Conference on Antimicrobial Agents and Chemotherapy; 1993 Oct 17–20; New Orleans, 196

  103. Chachaty E, Depitre C, Mario N, et al. Presence of Clostridium difficile and antibiotic and β-lactamase activities in feces of volunteers treated with oral cefixime, oral cefpodoxime proxetil, or placebo. Antimicrob Agents Chemother 1992 Sep; 36: 2009–13

    PubMed  CAS  Article  Google Scholar 

  104. Hamacher J, Luepke J, Reidenberg BE, et al. Changes in fecal flora and comparative multiple-dose pharmacokinetics of ceftibuten, cefpodoxime proxetil and amoxycillin/clavulanate. Clin Microbiol Infect 1999; 5(6): 339–54

    PubMed  CAS  Article  Google Scholar 

  105. Iwata S, Yamada K, Kin Y, et al. The influence of cefpodoxime proxetil on the intestinal bacterial flora [in Japanese]. Jpn J Antibiot 1989 Jul; 42: 1667–84

    PubMed  CAS  Google Scholar 

  106. Guggenbichler JP, Titz B, Uzun A. Beeinflussung der körpereigenen flora durch verschiedene oral verabreichte antibiotika und chemotherapeutika. Antibiotika Monitor 1995; XI(3): 38–43

    Google Scholar 

  107. Klugman KP, Feldman C. Penicillin- and cephalosporin-resistant Streptococcus pneumoniae: emerging treatment for an emerging problem. Drugs 1999 Jul; 58: 1–4

    PubMed  CAS  Article  Google Scholar 

  108. Bradley JS, Kaplan SL, Klugman KP, et al. Consensus: management of infections in children caused by Streptococcus pneumoniae with decreased susceptibility to penicillin. Pediatr Infect Dis J 1995 Dec; 14: 1037–41

    PubMed  CAS  Google Scholar 

  109. Jacobsson S, Fogh A, Larsson P, et al. Evaluation of amoxicillin clavulanate twice daily versus thrice daily in the treatment of otitis media in children. Eur J Clin Microbiol Infect Dis 1993; 12(5): 319

    PubMed  CAS  Article  Google Scholar 

  110. Pichichero M. Empiric antibiotic selection criteria for respiratory infections in pediatric practice. Pediatr Infect Dis J 1997; 16: S60–4

    PubMed  CAS  Article  Google Scholar 

  111. Steele RW, Estrada B, Begue RE, et al. A double-blind taste comparison of pediatric antibiotic suspensions. Clin Pediatr 1997; 36(4): 193–9

    CAS  Article  Google Scholar 

  112. Schwartz RH. Enhancing children’s satisfaction with antibiotic therapy: a taste study of several antibiotic suspensions. Curr Ther Res 2000 Aug; 61(8): 570–81

    Article  Google Scholar 

  113. Rosenfeld RM, Vertrees JE, Carr J, et al. Clinical efficacy of antimicrobial drugs for acute otitis media: metaanalysis of 5400 children from thirty-three randomized trials. J Pediatr 1994; 124(3): 355–67

    PubMed  CAS  Article  Google Scholar 

  114. Del Mar C, Glasziou P, Hayem M, et al. Are antibiotics indicated as initial treatment for children with acute otitis media? A meta-analysis. BMJ 1997; 314(7093): 1526–9

    PubMed  Article  Google Scholar 

  115. Damoiseaux R, Van Balen FAM, Hoes AW, et al. Antibiotic treatment of acute otitis media in children under two years of age: evidence based? Br J Gen Pract 1998 Dec; 48: 1861–4

    PubMed  CAS  Google Scholar 

  116. Damoiseaux RA, van Balen FA, Hoes AW, et al. Primary care based randomised, double blind trial of amoxicillin versus placebo for acute otitis media in children aged under 2 years. BMJ 2000; 320: 350–4

    PubMed  CAS  Article  Google Scholar 

  117. O’Neill P. Acute otitis media. BMJ 1999 Sep 25; 319: 833–5

    PubMed  Article  Google Scholar 

  118. Aronovitz GH. Antimicrobial therapy of acute otitis media: review of treatment recommendations. Clin Ther 2000 Jan; 22: 29–39

    PubMed  CAS  Article  Google Scholar 

  119. Dowell SF, Butler JC, Giebink GS, et al. Acute otitis media: management and surveillance in an era of pneumococcal resistance — a report from the Drug-resistant Streptococcus pneumoniae Therapeutic Working Group. Pediatr Infect Dis J 1999 Jan; 18: 1–9

    PubMed  CAS  Google Scholar 

  120. Kotschwar TR, Landholt TF. A pharmacoeconomic comparison of amoxicillin/clavulanate potassium and cefpodoxime proxetil in the treatment of acute otitis media [abstract]. Pharmacotherapy 1994 May–Jun; 14: 370

    Google Scholar 

  121. Kozyrskyj AL, Hildes-Ripstein GE, Longstaffe SE, et al. Treatment of acute otitis media with a shortened course of antibiotics: a meta-analysis [see comments]. JAMA 1998 Jun 3; 279: 1736–42

    PubMed  CAS  Article  Google Scholar 

  122. Hoberman A, Paradise JL, Cohen R. Duration of therapy for acute otitis media. Pediatr Infect Dis J 2000; 19(5): 471–3

    PubMed  CAS  Article  Google Scholar 

Download references

Author information

Affiliations

  1. Adis International Limited, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, Auckland 10, New Zealand

    Bret Fulton & Caroline M. Perry

Authors
  1. Bret Fulton
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Caroline M. Perry
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Caroline M. Perry.

Additional information

Various sections of the manuscript reviewed by: S.L. Block, Kentucky Pediatric Research, Incorporated, Bardstown, Kentucky, USA; R.A. Damoiseaux, Department of General Practice, University Medical Centre, Universiteitsweg 100, Utrecht, The Netherlands; J.J. Haddad, Babies Hospital North 501, New York, New York, USA; D.A. Kafetzis, P&A Kyriakou Children’s Hospital, Thibon and Lebadias, Athens, Greece; G.L. Kearns, Division of Pediatric Pharmacology & Medical Toxicology, Children’s Mercy Hospital, University of Missouri, Kansas City, Missouri, USA; Y-C Liu, Section of Infectious Diseases, Department of Medicine, Veterans General Hospital-Kaohsiung, Kaohsiung, Taiwan; T. Terui, Department of Dermatology, Tohoku University School of Medicine, Sendai, Japan.

Data Selection

Sources: Medical literature published in any language since 1966 on cefpodoxime-proxetil, identified using Medline and EMBASE, supplemented by AdisBase (a proprietary database of Adis International, Auckland, New Zealand). Additional references were identified from the reference lists of published articles. Bibliographical information, including contributory unpublished data, was also requested from the company developing the drug.

Search strategy: Medline search terms were ‘cefpodoxime proxetil’ or ‘CPDX PR’ or ‘CS 807’ or ‘U 76252’ and (‘pediatrics’ or ‘children’). EMBASE search terms were ‘cefpodoxime proxetil’ or ‘CPDX PR’ or ‘CS 807’ or ‘U 7652’ and (‘pediatrics’ or ‘children’). AdisBase search terms were ‘cefpodoxime-proxetil’ or ‘CS 807’ and (‘pediatrics’ or ‘children’). Searches were last updated 30 Jan 2001.

Selection: Studies in children with infectious diseases who received cefpodoxime proxetil. Inclusion of studies was based mainly on the methods section of the trials. When available, large, well controlled trials with appropriate statistical methodology were preferred. Relevant pharmacodynamic and pharmacokinetic data are also included.

Index terms: Cefpodoxime proxetil, antibiotic, cephalosporin, infectious diseases, paediatric, pharmacodynamics, pharmacokinetics, therapeutic use.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

Fulton, B., Perry, C.M. Cefpodoxime Proxetil. Paediatr Drugs 3, 137–158 (2001). https://doi.org/10.2165/00128072-200103020-00006

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.2165/00128072-200103020-00006

Keywords

  • Acute Otitis Medium
  • Lower Respiratory Tract Infection
  • Cefaclor
  • Cefixime
  • Tonsillitis