Ceftibuten

Class: Third Generation Cephalosporins
Molecular Formula: C₁₅H₁₄N₄O₆S₂
CAS Number: 97519-39-6
Brands: Cedax

Introduction

Antibacterial; β-lactam antibiotic; third generation cephalosporin.^{1 3}

Uses for Ceftibuten

Otitis Media

Treatment of acute otitis media (AOM) caused by H. influenzae (including β-lactamase-producing strains), M. catarrhalis (including β-lactamase-producing strains), or S. pyogenes (group A β-hemolytic streptococci).^{1 2 3 5 7 8 42} (See Acute Otitis Media under Cautions.)

Management of otitis media with effusion†.³⁶ Use of anti-infectives controversial; they provide only limited benefit in enhancing resolution of effusion and may promote resistance.^{36 49 50 51 52 67 68}

Pharyngitis and Tonsillitis

Treatment of pharyngitis and tonsillitis caused by S. pyogenes (group A β-hemolytic streptococci).^{1 2 16} Generally effective in eradicating S. pyogenes from the nasopharynx, but efficacy in prevention of subsequent rheumatic fever has not been established to date.¹

CDC, AAP, IDSA, AHA, and others recommend oral penicillin V or IM penicillin G benzathine as treatments of choice;^{12 13 25 53} oral cephalosporins and oral macrolides considered alternatives.^{12 13 25 53} Amoxicillin sometimes used instead of penicillin V, especially for young children.^{13 53}

Respiratory Tract Infections

Treatment of acute bacterial exacerbations of chronic bronchitis caused by Streptococcus pneumoniae (penicillin-susceptible strains only), Haemophilus influenzae (including β-lactamase-producing strains), or Moraxella catarrhalis (including β-lactamase-producing strains).^{1 2 9 26 37}

Treatment of acute maxillary sinusitis† caused by susceptible S. pneumoniae, H. influenzae, or M. catarrhalis.^{3 45}

Treatment of acute bronchitis†,^{3 26 27 46} bronchiectasis†,⁴⁷ or pneumonia†^{3 46 47} caused by susceptible bacteria.

Urinary Tract Infections (UTIs)

Treatment of uncomplicated UTIs† caused by susceptible Escherichia coli, Klebsiella, Proteus mirabilis, Enterobacter, or staphylococci.^{3 63 64}

Treatment of complicated or recurrent UTIs† caused by susceptible E. coli, Klebsiella, P. mirabilis, Enterobacter, or staphylococci.^{3 63 64}

Ceftibuten Dosage and Administration

Administration

Oral Administration

Administer capsules orally without regard to meals.^{1 17}

Administer oral suspension at least 2 hours before or 1 hour after meals.^{1 2}

Reconstitution

Reconstitute oral suspension at time of dispensing by adding the amount of water specified on the container in 2 portions; invert bottle and shake after each addition.¹

Dosage

Available as ceftibuten dihydrate; dosage expressed in terms of anhydrous ceftibuten.¹

Pediatric Patients

Otitis Media

Acute Otitis Media (AOM)

Oral

Children 6 months through 11 years of age: 9 mg/kg (up to 400 mg) once daily for 10 days.¹

Children ≥12 years of age: 400 mg once daily for 10 days.^{1 3}

Pediatric Dosage of Ceftibuten Oral Suspension for AOM1

Weight (kg)	Daily Dosage
10	90 mg once daily1
20	180 mg once daily1
40	360 mg once daily1
>45	400 mg once daily1

Otitis Media with Effusion†

Oral

Children 7 months to 12 years of age: 9 mg/kg (up to 400 mg) once daily for 14 days.³⁶

Pharyngitis and Tonsillitis

Oral

Children 6 months through 11 years of age: 9 mg/kg (up to 400 mg) once daily for 10 days.¹

Children ≥12 years of age: 400 mg once daily for 10 days.¹

Pediatric Dosage of Ceftibuten Oral Suspension for Pharyngitis and Tonsillitis1

Weight (kg)	Daily Dosage
10	90 mg once daily1
20	180 mg once daily1
40	360 mg once daily1
>45	400 mg once daily1

Respiratory Tract Infections

Acute Exacerbations of Chronic Bronchitis

Oral

Children ≥12 years of age: 400 mg once daily for 10 days.^{1 3}

Adults

Acute Otitis Media (AOM)

Oral

400 mg once daily for 10 days.^{1 3}

Pharyngitis and Tonsillitis

Oral

400 mg once daily for 10 days.^{1 3}

Respiratory Tract Infections

Acute Exacerbations of Chronic Bronchitis

Oral

400 mg once daily for 10 days.^{1 3}

Uncomplicated UTIs†

Oral

400 mg once daily for 7 days.⁶⁴

Prescribing Limits

Pediatric Patients

Oral

Maximum 400 mg once daily for children 6 months through 11 years of age.¹

Adults

Oral

Maximum 400 mg once daily.¹

Special Populations

Hepatic Impairment

No dosage adjustments required.¹

Renal Impairment

Dosage for Renal Impairment1

Clcr (mL/min)	Daily Dosage
>50	9 mg/kg or 400 mg once every 24 hours1
30–49	4.5 mg/kg or 200 mg once every 24 hours1 4
5–29	2.25 mg/kg or 100 mg once every 24 hours1 4

For patients undergoing hemodialysis 2 or 3 times weekly, a single 400-mg dose (given as a capsule) or 9 mg/kg (up to 400 mg; given as the oral suspension) may be given at the end of each dialysis period.^{1 5}

Geriatric Patients

No dosage adjustments required other than those related to renal impairment.¹ (See Renal Impairment under Dosage and Administration.)

Cautions for Ceftibuten

Contraindications

• 
  

  Known hypersensitivity to ceftibuten or other cephalosporins.¹

  
  

Warnings/Precautions

Warnings

Superinfection/Clostridium difficile-associated Diarrhea and Colitis

Possible emergence and overgrowth of nonsusceptible organisms (e.g., Enterobacter, Pseudomonas, enterococci, Candida) with prolonged use.^a Careful observation of the patient is essential.¹ Institute appropriate therapy if superinfection occurs.^{1 a}

Treatment with anti-infectives may permit overgrowth of Clostridium difficile.¹ C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) has been reported with nearly all anti-infectives, including ceftibuten, and may range in severity from mild diarrhea to fatal colitis.¹

Consider CDAD if diarrhea develops during or after therapy and manage accordingly.¹ Careful medical history is necessary since CDAD has been reported to occur as late as 2 months or longer after anti-infective therapy is discontinued.

If CDAD is suspected or confirmed, the anti-infective may need to be discontinued. Some mild cases may respond to discontinuance alone.¹ Manage moderate to severe cases with fluid, electrolyte, and protein supplementation, anti-infective therapy active against C. difficile (e.g., oral metronidazole or vancomycin), and surgical evaluation when clinically indicated.¹

Sensitivity Reactions

Hypersensitivity Reactions

Possible hypersensitivity reactions such as urticaria, pruritus, rash (maculopapular, erythematous, morbilliform), fever and chills, eosinophilia, joint pain or inflammation, edema, erythema, genital and anal pruritus, angioedema, shock, hypotension, vasodilatation, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, exfoliative dermatitis, and anaphylaxis.^a

If hypersensitivity reaction occurs, discontinue ceftibuten and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway and oxygen).¹

Cross-hypersensitivity

Partial cross-sensitivity among cephalosporins and other β-lactam antibiotics, including penicillins and cephamycins.^{1 43}

Prior to initiation of therapy, make careful inquiry concerning previous hypersensitivity reactions to any cephalosporins or penicillins.¹ Cautious use recommended in individuals hypersensitive to penicillins:^a avoid use in those who have had an immediate-type (anaphylactic) hypersensitivity reaction^{1 43 44} and administer with caution to those who have had a delayed-type (e.g., rash, fever, eosinophilia) reaction.^a

General Precautions

Diabetes Mellitus

Reconstituted oral suspension contains 1 g of sucrose per 5 mL.¹

Acute Otitis Media

Possibly less effective than some other β-lactam antibiotics for the treatment of AOM caused by S. pneumoniae.^{1 2 7} Use for empiric therapy only when adequate antimicrobial coverage against S. pneumoniae has been previously administered.^{1 2}

History of GI Disease

Use with caution in patients with a history of GI disease, particularly colitis.¹ (See Superinfection/Clostridium difficile-associated Colitis under Cautions.)

Specific Populations

Pregnancy

Category B.¹

Lactation

Not known whether distributed into milk;¹ use with caution.¹

Pediatric Use

Safety and efficacy not established in children <6 months of age.¹

Increased incidence of diarrhea in pediatric patients ≤2 years of age compared with older pediatric patients.¹

Geriatric Use

Increased peak plasma concentrations and half-life may be due to age-related changes in renal function.^{1 3 5 17} Adjust dosage based on the degree of renal impairment.¹ (See Renal Impairment under Dosage and Administration.)

Hepatic Impairment

Pharmacokinetics not altered; dosage adjustments not required.^{1 3}

Renal Impairment

Increased plasma half-life and decreased total body clearance.^{1 4}

Use with caution and reduce dosage.^a (See Renal Impairment under Dosage and Administration.)

Careful clinical observation and renal function tests recommended prior to and during cephalosporin therapy.^a

Common Adverse Effects

GI effects (e.g., nausea, diarrhea, dyspepsia, vomiting, abdominal pain), headache, dizziness, increased BUN concentrations, eosinophilia.^{1 3 5 34}

Interactions for Ceftibuten

Specific Drugs

Drug	Interaction
Antacids	No known pharmacokinetic interaction1
Histamine H2-receptor antagonists (ranitidine)	Potential for increased ceftibuten concentrations1
Theophylline	No evidence of pharmacokinetic interaction with IV theophylline;1 effects of concomitant oral theophylline unknown

Ceftibuten Pharmacokinetics

Absorption

Bioavailability

Rapidly and almost completely absorbed following oral administration.^{1 5 28 29 31} Oral bioavailability is 75–90%.⁵

In adults, a 400-mg ceftibuten dose given as the oral suspension is bioequivalent to a 400-mg dose given as 400-mg capsules.⁴⁰

Food

Food decreases rate and extent of absorption of ceftibuten; this effect is more pronounced with the oral suspension than with capsules.^{1 2 31}

Distribution

Extent

Distributed into blister fluid,³¹ bronchial secretions,^{1 31 33} nasal secretions,³¹ sputum,¹ middle ear fluid,^{1 31 32} tracheal secretions,³¹ and tonsillar tissue.⁴¹

Not known whether the drug crosses the placenta or is distributed into milk.^{1 66}

Plasma Protein Binding

Approximately 65%.¹

Elimination

Metabolism

Ceftibuten is present in plasma and urine principally as cis-ceftibuten; about 10% of a dose is converted in vivo to trans-ceftibuten.^{1 29} The trans-isomer has only about 12% of the antibacterial activity of the cis-isomer.^{1 30}

Elimination Route

The cis- and trans-isomers of ceftibuten eliminated principally in urine.^{1 29 30} Approximately 56% of a dose eliminated in urine and 39% excreted in feces within 24 hours.¹

Half-life

Adults with normal renal function: 2–2.6 hours.^{1 29 30 31}

Children 6 months to 16 years of age: 1.9–2.5 hours.^{31 35}

Special Populations

In renal impairment, plasma half-life averages 7.1–22.3 hours depending on creatinine clearance.¹

Stability

Storage

Oral

Capsules

Tight container at 2–25°C.¹

For Suspension

2–25°C.¹ Following reconstitution, store suspension at 2–8°C for up to 14 days.¹

Actions and SpectrumActions

• 
  

  Third generation cephalosporin with an expanded spectrum of activity against aerobic gram-negative bacteria compared with first and second generation cephalosporins.^{3 5}

  
  


• 
  

  Usually bactericidal.^a

  
  


• 
  

  Like other β-lactam antibiotics, antibacterial activity results from inhibition of bacterial cell wall synthesis.^a

  
  


• 
  

  In vitro spectrum of activity includes some gram-positive aerobic bacteria and some gram-negative aerobic bacteria; inactive against most anaerobes; inactive against fungi and viruses.^{3 19 a}

  
  


• 
  

  Gram-positive aerobes: active in vitro and in clinical infections against Streptococcus pneumoniae (penicillin-susceptible strains only) and S. pyogenes (group A β-hemolytic streptococci).¹ Inactive against other streptococci, staphylococci, and enterococci (e.g., Enterococcus faecalis).^{3 19 a}

  
  


• 
  

  Gram-negative aerobes: active in vitro and in clinical infections against Haemophilus influenzae (including β-lactamase-producing strains) and Moraxella catarrhalis (including β-lactamase-producing strains).¹ Inactive against Pseudomonas aeruginosa.^{1 3 5 19 22 23}

  
  


• 
  

  Stable in the presence of a variety of plasmid-mediated β-lactamases produced by gram-positive and gram-negative bacteria;^{1 2 3 5 7 8 19 20 21 22 23} more active in vitro than other currently available oral third generation cephalosporins against Enterobacteriaceae that produce plasmid-mediated β-lactamases.^{3 5 7 19 20 21 22 23} Unstable in the presence of chromosomally-mediated cephalosporinases.¹

  
  


• 
  

  Strains of staphylococci resistant to penicillinase-resistant penicillins (oxacillin-resistant [methicillin-resistant] staphylococci) should be considered resistant to ceftibuten, although results of in vitro susceptibility tests may indicate that the organisms are susceptible to the drug.²⁴

  
  

Advice to Patients

• 
  

  Importance of administering oral suspension at least 2 hours before or 1 hour after meals.^{1 2} Capsules may be administered without regard to meals.^{1 17}

  
  


• 
  

  Importance of completing full course of therapy.¹

  
  


• 
  

  Advise patients that diarrhea is a common problem caused by anti-infectives and usually ends when the drug is discontinued. Importance of contacting a clinician if watery and bloody stools (with or without stomach cramps and fever) occur during or as late as 2 months or longer after the last dose.

  
  


• 
  

  Importance of discontinuing ceftibuten and informing clinician if an allergic reaction occurs.¹

  
  


• 
  

  For patients with diabetes, importance of being informed of sucrose content of oral suspension.¹

  
  


• 
  

  Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

  
  


• 
  

  Importance of advising patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Ceftibuten Dihydrate

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Capsules	400 mg (of anhydrous ceftibuten)	Cedax	Shionogi
	For suspension	90 mg (of anhydrous ceftibuten) per 5 mL	Cedax	Shionogi

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Cedax 400MG Capsules (PERNIX THERAPEUTICS): 20/$299.99 or 60/$859.97

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions February 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Shionogi USA. Cedax (ceftibuten) capsules and oral suspension prescribing information. Florham Park, NJ; 2004 Aug.

2. Schering Corporation. Cedax profile. Kenilworth, NJ.

3. Wiseman LR, Balfour JA. Ceftibuten: a review of its antibacterial activity, pharmacokinetic properties and clinical efficacy. Drugs. 1994; 47:784-808. [PubMed 7520858]

4. Kelloway JS, Awni WM, Lin CC 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. [IDIS 295994] [PubMed 1803999]

5. Spector S. Review of the properties and features of ceftibuten: a new orally active antibiotic. Infect Dis Clinical Pract. 1995; 4(Suppl 2): S113-23.

6. Klein JO. Selection of oral antimicrobial agents for otitis media and pharyngitis. Infect Dis Clin Pract. 1995; 4(Suppl 2):S88-94.

7. Blumer JL, McLinn SE, Deabate CA et al. Multinational multicenter controlled trial comparing ceftibuten with cefaclor for the treatment of acute otitis media. Pediatr Infect Dis J. 1995; 14(Suppl):S115-20. [IDIS 349762] [PubMed 7567311]

8. McLinn SE, McCarty JM, Perrotta R et al. Multicenter controlled trial comparing ceftibuten with amoxicillin/clavulanate in the empiric treatment of acute otitis media. Pediatr Infect Dis J. 1995; 14(Suppl):S108-14.

9. Bensch GW, Klaustermeyer WB, McCarty J et al. 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.

10. Chin NX, Huang HB, Neu HC. Postantibiotic effect of ceftibuten on respiratory pathogens. Pediatr Infect Dis J. 1995; 14(Suppl):S84-7.

11. Neu HC. Ceftibuten: minimal inhibitory concentration, postantibiotic effect and beta-lactamase stability—a rationale for dosing programs. Pediatr Infect Dis J. 1995; 14:S88-92.

12. Dajani A, Taubert K, Ferrieri P et al and the American Heart Association Committee on Rheumatic Fever et al. Treatment of acute streptococcal pharyngitis and prevention of rheumatic fever: a statement for health professionals. Pediatrics. 1995; 96:758-64. [IDIS 355409] [PubMed 7567345]

13. American Academy of Pediatrics. 2006 Red Book: Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2006:755.

14. Bisno AL. Streptococcus pyogenes. In: Mandell GL, Bennett JE, Dolin R, eds. Principles and practice of infectious diseases. 4th ed. New York: Churchill Livingstone; 1995:1786-99.

15. Anon. Choice of antibacterial drugs. Med Lett Treat Guid. 2004; 2:15-16.

16. Pichichero ME, McLinn SE, Gocch WM III et al. Ceftibuten vs. penicillin V in group A beta-hemolytic streptococcal pharyngitis. Pediatr Infect Dis J. 1995; 14(Suppl):S102-7.

17. Schering Corporation, Kenilworth, NJ: Personal communication.

19. Bauernfeind A, Jungwirth R. Antibacterial activity of cefpodoxime in comparison with cefixime, cefdinir, cefetamet, ceftibuten, loracarbef, cefprozil, BAY 3522, cefuroxime, cefaclor, and cefadroxil. Infection. 1991; 19:353-62. [PubMed 1800377]

20. Bauernfeind A. Ceftibuten and bactericidal kinetics: comparative in vitro activity against Enterobacteriaceae producing extended spectrum beta-lactamases. Diagn Microbiol Infect Dis. 1991; 14:89-92. [PubMed 2013215]

21. Bauernfeind A. Comparative antimicrobial spectrum and activity of ceftibuten against clinical isolates from West Germany. Diagn Microbiol Infect Dis. 1991; 14:63-74. [PubMed 2013211]

22. Jones RN. Ceftibuten: a review of antimicrobial activity, spectrum and other microbiologic features. Pediatr Infect Dis J. 1995; 14:S77-83. [IDIS 349756] [PubMed 7567314]

23. 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. [IDIS 246913] [PubMed 3190185]

24. Clinical and Laboratory Standards Institute. Performance standards for antimicrobial susceptibility testing; sixteenth informational supplement. CLSI document M100-S16. Wayne, PA; 2006.

25. Cooper RJ, Hoffman JR, Bartlett JG et al. Principles of appropriate antibiotic use for acute pharyngitis in adults: background. Ann Intern Med. 2001; 134:509-17. [IDIS 460578] [PubMed 11255530]

26. Perotta R, McCabe R, Rumans L et al. 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.

27. Chirurgi VA, Edelstein H, Oster SE et al. Ceftibuten versus cefaclor for the treatment of bronchitis. J Antimicrob Chemother. 1991; 28:577-80. [PubMed 1761452]

28. Bressolle F, Galtier M, Kinowski JM et al. Multiple-dose pharmacokinetics of ceftibuten after oral administration to healthy volunteers. J Pharm Sci. 1994; 83:1236-40. [IDIS 334891] [PubMed 7830237]

29. Lin C, Lim J, Radwanski E et al. Pharmacokinetics and dose proportionality of ceftibuten in men. Antimicrob Agents Chemother. 1995; 39:359-61. [IDIS 341970] [PubMed 7726498]

30. Lin C, Radwanski E, Affrime M et al. Multiple-dose pharmacokinetics of ceftibuten in healthy volunteers. Antimicrob Agents Chemother. 1995; 39:356-8. [IDIS 341969] [PubMed 7726497]

31. Barr WH, Affrime M, Lin CC et al. Pharmacokinetics of ceftibuten in children. Pediatr Infect Dis J. 1995; 14(Suppl):S93-101. [IDIS 349759] [PubMed 7567317]

32. Lin C, Kumari P, Perrotta RJ et al. Penetration of ceftibuten into middle ear fluid. Antimicrob Agents Chemother. 1996; 40:1394-6. [IDIS 368420] [PubMed 8726007]

33. Scaglione F, Triscari F, Demartini G et al. Concentrations of ceftibuten in bronchial secretions. Chemotherapy. 1995; 41:229-33. [IDIS 352360] [PubMed 7555201]

34. Reidenberg BE. Worldwide safety experience with ceftibuten pediatric suspension. Pediatr Infect Dis J. 1995; 14(Suppl):S130-3.

35. Kearns GL, Reed MD, Jacobs RF et al. Single-dose pharmacokinetics of ceftibuten (SCH 39720) in infants and children. Antimicrob Agents Chemother. 1991; 35:2078-84. [IDIS 288658] [PubMed 1759830]

36. Mandel EM, Casselbrant ML, Kurs-Lasky M et al. Efficacy of ceftibuten compared with amoxicillin for otitis media with effusion in infants and children. Pediatr Infect Dis J. 1996; 15:409-14. [IDIS 366219] [PubMed 8724062]

37. McAdoo MA, Rice K, Gordon GR et al. Comparison of ceftibuten once daily and amoxicillin-clavulanate three times daily in the treatment of acute exacerbations of chronic bronchitis. Clin Ther. 1998; 20:88-100. [IDIS 402073] [PubMed 9522107]

38. Ziering W, McElvaine P. Randomized comparison of once-daily ceftibuten and twice-daily clarithromycin in the treatment of acute exacerbation of chronic bronchitis. Infection. 1998; 26:68-75. [PubMed 9505188]

39. Aubier MA. Comparison of ceftibuten versus amoxicillin/clavulanate in the treatment of acute exacerbations of chronic bronchitis. Chemotherapy. 1997; 43:297-302. [IDIS 389325] [PubMed 9209787]

40. Lin CC, Affrime M, Radwanski E et al. Comparative bioavailability of ceftibuten in capsule and suspension forms. Clin Ther. 1996; 18:1139-49. [IDIS 380772] [PubMed 9001830]

41. Scaglione F, Pintucci JP, Demartini G et al. Ceftibuten concentrations in human tonsillar tissue. Eur J Clin Microbiol Infect Dis. 1996; 15:940-3. [PubMed 9031878]

42. 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. [IDIS 376625] [PubMed 8930425]

43. Kishiyam JL, Adelman DC. The cross-reactivity and immunology of β-lactam antibiotics. Drug Saf. 1994; 10:318-27. [PubMed 8018304]

44. Thompson JW, Jacobs RF. Adverse effects of newer cephalosporins: an update. Drug Saf. 1993; 9:132-42. [PubMed 8397890]

45. De Abate CA, Perrotta RJ, Dennington ML et al. The efficacy and safety of once-daily ceftibuten compared with co-amoxiclav in the treatment of acute sinusitis. J Chemother. 1992; 4:358-63. [PubMed 1287138]

46. 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. [PubMed 2013204]

47. McCabe R, Rumans L, Perrotta R et al. Comparison and efficacy and safety of ceftibuten and cefaclor in the treatment of pneumonia and bronchiectasis. J Chemother. 1993; 5:124-32. [PubMed 8515295]

48. Stool SE, Gerg AO, Berman S et al. Otitis media with effusion in young children. Clinical practice guideline No 12. AHCPR publication No. 94-0622. Rockville, MD: Agency for Health Care Policy and Research, Public Health Service, US Department of Health and Human Services; 1994 Jul.

49. Williams RL, Chalmers TC, Stange KC et al. Use of antibiotics in preventing recurrent acute otitis media and in treating otitis media with effusion: a meta-analytic attempt to resolve the brouhaha. JAMA. 1993; 270:1344-51. [IDIS 319598] [PubMed 8141875]

50. Paradise JL. Treatment guidelines for otitis media: the need for breadth and flexibility. Pediatr Infect Dis J. 1995; 14:429-35. [IDIS 348106] [PubMed 7638033]

51. Berman S. Otitis media in children. N Engl J Med. 1995; 332:1560-5. [IDIS 348227] [PubMed 7739711]

52. The Otitis Media Guideline Panel. Managing otitis media with effusion in young children. Pediatrics. 1994; 94:766-73. [IDIS 337882] [PubMed 7936917]

53. Bisno AL, Gerber MA, Gwaltney JM. Practice guidelines for the diagnosis and management of group A streptococcal pharyngitis. Clin Infect Dis. 2002; 35:113-25. [IDIS 484228] [PubMed 12087516]

54. Klein JO. Management of streptococcal pharyngitis. Pediatr Infect Dis J. 1994; 13:572-5. [IDIS 331902] [PubMed 8078757]

55. Pichichero ME, Cohen R. Shortened course of antibiotic therapy for acute otitis media, sinusitis and tonsillopharyngitis. Pediatr Infect Dis J. 1997; 16:680-95. [IDIS 390075] [PubMed 9239773]

56. Tack KJ, Henry DC, Gooch WM et al et al. Five-day cefdinir treatment for streptococcal pharyngitis. Antimicrob Agents Chemother. 1998; 42:1073-5. [IDIS 404900] [PubMed 9593129]

57. Milatovic D, Adam D, Hamilton H et al. Cefprozil versus penicillin V in treatment of streptococcal tonsillopharyngitis. Antimicrob Agents Chemother. 1993; 37:1620-3. [IDIS 318765] [PubMed 8215273]

58. Aujard Y, Boucot I, Brahimi N et al. Comparative efficacy and safety of four-day cefuroxime axetil and ten-day penicillin treatment of group A beta-hemolytic streptococcal pharyngitis in children. Pediatr Infect Dis J. 1995; 14:295-300. [IDIS 345876] [PubMed 7603811]

59. Mehra S, Van Moerkerke M, Welck J et al. Short course therapy with cefuroxime axetil for group A streptococcal tonsillopharyngitis in children. Pediatr Infect Dis J. 1998; 17:452-7. [IDIS 408830] [PubMed 9655533]

60. Dajani AS, Kessler SL, Mendelson R et al. Cefpodoxime proxetil vs. penicillin V in pediatric streptococcal pharyngitis/tonsillitis. Pediatr Infect Dis J. 1993; 12:275-9. [PubMed 8483620]

61. Pichichero ME. Cephalosporins are superior to penicillin for treatment of streptococcal tonsillopharyngitis: is the difference worth it? Pediatr Infect Dis. 1993; 12:268-74.

62. Milatovic D. Evaluation of cefadroxil, penicillin and erythromycin in the treatment of streptococcal tonsillopharyngitis. Pediatr Infect Dis J. 1991; 10:S61-3. [PubMed 1945599]

63. Banfi A, Gabriele G, Hill-Juarez MJ et al. 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:S84-91.

64. Stein GE, Christensen S, Mummaw N. Treatment of acute uncomplicated urinary tract infection with ceftibuten. Infection. 1991; 19:125-7.

65. Reviewers’s comments (personal observations).

66. Schering, Kenilworth, NJ: Personal communication.

67. Dowell SF, Marcy SM, Phillips WR et al. Otitis media—principles of judicious use of antimicrobial agents. Pediatrics. 1998; 101:165-71.

68. Stool SE, Berg AO, Berman S et al for the Otitis Media Guideline Panel. Otitis media with effusion in young children. Clinical practice guideline. Number 12. AHCPR Publication No. 94-0622. Rockville, MD: Agency for Health Care Policy and Research, Public Health Service, US Department of Health and Human Resources. July 1994.

69. American Academy of Pediatrics and American Academy of Family Physicians Subcommittee on Management of Acute Otitis Media. Diagnosis and management of acute otitis media. Pediatrics. 2004: 113:1451-65.

70. American Academy of Pediatrics, American Academy of Family Physicians, American Academy of Otolaryngology-Head and Neck Surgery, and American Academy of Pediatrics Subcommittee on Otitis Media with Effusion. Otitis media with effusion. Pediatrics. 2004: 113:1412-29.

a. AHFS Drug Information 2003. McEvoy GK, ed. Cephalosporins General Statement. American Society of Health-System Pharmacists; 2003:125-39.

More Ceftibuten resources

• Ceftibuten Side Effects (in more detail)
• Ceftibuten Use in Pregnancy & Breastfeeding
• Ceftibuten Drug Interactions
• Ceftibuten Support Group
• 3 Reviews for Ceftibuten - Add your own review/rating

• Ceftibuten Professional Patient Advice (Wolters Kluwer)


• Ceftibuten MedFacts Consumer Leaflet (Wolters Kluwer)


• ceftibuten Concise Consumer Information (Cerner Multum)


• ceftibuten Advanced Consumer (Micromedex) - Includes Dosage Information


• Cedax Prescribing Information (FDA)

Compare Ceftibuten with other medications

• Bladder Infection
• Bronchitis
• Otitis Media
• Pneumonia
• Sinusitis
• Strep Throat
• Tonsillitis/Pharyngitis