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Cedax

Generic Name: Ceftibuten
Class: Third Generation Cephalosporins
Molecular Formula: C15H14N4O6S2
CAS Number: 97519-39-6

Introduction

Antibacterial; β-lactam antibiotic; aminothiazolyl third generation cephalosporin.1 3

Uses for Cedax

Acute Otitis Media (AOM)

Treatment of AOM caused by Haemophilus influenzae (including β-lactamase-producing strains), Moraxella catarrhalis (including β-lactamase-producing strains), or Streptococcus pyogenes (group A β-hemolytic streptococci).1 3 5 7 8 48 (See Acute Otitis Media under Cautions.)

When anti-infectives indicated, AAP recommends high-dose amoxicillin or amoxicillin and clavulanate as drugs of choice for initial treatment of AOM; certain cephalosporins (cefdinir, cefpodoxime, cefuroxime, ceftriaxone) recommended as alternatives for initial treatment in penicillin-allergic patients without a history of severe and/or recent penicillin-allergic reactions.37

Pharyngitis and Tonsillitis

Treatment of pharyngitis and tonsillitis caused by S. pyogenes (group A β-hemolytic streptococci).1 14 Generally effective in eradicating S. pyogenes from nasopharynx; efficacy in prevention of subsequent rheumatic fever not established to date.1

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AAP, IDSA, AHA, and others recommend a penicillin regimen (10 days of oral penicillin V or oral amoxicillin or single dose of IM penicillin G benzathine) as treatment of choice for S. pyogenes pharyngitis and tonsillitis;10 16 17 other anti-infectives (oral cephalosporins, oral macrolides, oral clindamycin) recommended as alternatives in penicillin-allergic patients.10 11 16 17

If an oral cephalosporin used, 10-day regimen of first generation cephalosporin (cefadroxil, cephalexin) preferred instead of other cephalosporins with broader spectrums of activity (e.g., cefaclor, cefdinir, cefixime, cefpodoxime, cefuroxime).10 16 17

Respiratory Tract Infections

Treatment of acute bacterial exacerbations of chronic bronchitis caused by Streptococcus pneumoniae (penicillin-susceptible strains only), H. influenzae (including β-lactamase-producing strains), or M. catarrhalis (including β-lactamase-producing strains).1 9 12 26

Treatment of acute maxillary sinusitis caused by susceptible S. pneumoniae, H. influenzae, or M. catarrhalis.3 45 Because of variable activity against S. pneumoniae and H. influenzae, IDSA no longer recommends second or third generation oral cephalosporins for empiric monotherapy of acute bacterial sinusitis.43 Oral amoxicillin or amoxicillin and clavulanate usually recommended for empiric treatment.43 44 If an oral cephalosporin used as an alternative in children (e.g., in penicillin-allergic individuals), combination regimen that includes a third generation cephalosporin (cefixime or cefpodoxime) and clindamycin (or linezolid) recommended.43 44

Treatment of acute bronchitis,3 26 27 46 bronchiectasis,47 or pneumonia3 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

Some clinicians suggest that certain oral third generation cephalosporins (cefdinir, cefpodoxime, ceftibuten) are one of several alternatives for outpatient treatment of recurrent UTIs or UTIs that occur in patients who have indwelling urinary catheters or acquired the infections in hospitals or nursing homes; these infections likely to be caused by multidrug-resistant gram-negative bacilli.11

Cedax Dosage and Administration

Administration

Oral Administration

Administer capsules orally without regard to meals.1 15

Administer oral suspension at least 2 hours before or 1 hour after meals.1 (See Food under Pharmacokinetics.)

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

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

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

Dosage adjustments not 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 except those related to renal impairment.1 (See Renal Impairment under Dosage and Administration.)

Cautions for Cedax

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 alters normal colon flora and may permit overgrowth of Clostridium difficile.1 42 C. difficile infection (CDI) and C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis) reported with nearly all anti-infectives, including ceftibuten, and may range in severity from mild diarrhea to fatal colitis.1 42 C. difficile produces toxins A and B which contribute to development of CDAD.42

Consider CDAD if diarrhea develops during or after therapy and manage accordingly.1 42 Obtain careful medical history since CDAD has been reported to occur as late as 2 months or longer after anti-infective therapy is discontinued.42

If CDAD is suspected or confirmed, discontinue anti-infectives not directed against C. difficile whenever possible.42 Initiate appropriate supportive therapy (e.g., fluid and electrolyte management, protein supplementation), anti-infective therapy directed against C. difficile (e.g., metronidazole, vancomycin), and surgical evaluation as clinically indicated.1 42

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 49

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 reaction1 49 50 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 7 Use for empiric therapy only when adequate antimicrobial coverage against S. pneumoniae has been previously administered.1

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 neonates and infants <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 15 Adjust dosage based on 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 Cedax

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

Cedax 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 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

2–25°C in tight container.1

For Suspension

2–25°C.1 Following reconstitution, store suspension at 2–8°C; discard after 14 days.1

Actions and Spectrum

  • 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 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 (methicillin-resistant [oxacillin-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 Capsules may be administered without regard to meals.1 15

  • 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.1

  • 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

Pernix

For suspension

90 mg (of anhydrous ceftibuten) per 5 mL

Cedax

Pernix

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. 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

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions September 30, 2013. 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. Pernix. Cedax (ceftibuten dihydrate) capsules and oral suspension prescribing information. Gonzales, LA; 2010 Apr.

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.

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. American Academy of Pediatrics. Red Book: 2012 Report of the Committee on Infectious Diseases. 29th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2012.

11. Anon. Drugs for bacterial infections. Med Lett Treat Guid. 2010; 8:43-52.

12. 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]

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

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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]

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48. 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]

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

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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]

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]

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.

66. Schering, Kenilworth, NJ: Personal communication.

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

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