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Ceftibuten

Pronunciation

(sef TYE byoo ten)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Cedax: 400 mg [contains butylparaben, edetate calcium disodium, methylparaben, propylparaben]

Generic: 400 mg

Suspension Reconstituted, Oral:

Cedax: 90 mg/5 mL (60 mL, 90 mL, 120 mL) [contains polysorbate 80, sodium benzoate; cherry flavor]

Cedax: 180 mg/5 mL (30 mL, 60 mL) [contains sodium benzoate; cherry flavor]

Generic: 180 mg/5 mL (60 mL)

Brand Names: U.S.

  • Cedax

Pharmacologic Category

  • Antibiotic, Cephalosporin (Third Generation)

Pharmacology

Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs) which in turn inhibits the final transpeptidation step of peptidoglycan synthesis in bacterial cell walls, thus inhibiting cell wall biosynthesis. Bacteria eventually lyse due to ongoing activity of cell wall autolytic enzymes (autolysins and murein hydrolases) while cell wall assembly is arrested.

Absorption

Rapid; food decreases peak concentrations, delays Tmax, and lowers AUC

Distribution

Distributes into middle ear fluid, bronchial secretions, and sputum; Vd: Children: 0.5 L/kg; Adults: 0.21 L/kg

Excretion

Urine (~56%); feces (39%)

Time to Peak

2 to 2.6 hours

Half-Life Elimination

Children: 2 hours; Adults: 2.4 hours; CrCl 30 to 49 mL/minute: 7.1 hours; CrCl 5 to 29 mL/minute: 13.4 hours; CrCl <5 mL/minute: 22.3 hours

Protein Binding

65%

Special Populations: Renal Function Impairment

Clearance is decreased and half-life is increased.

Use: Labeled Indications

Acute bacterial exacerbations of chronic bronchitis: Treatment of mild to moderate acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae (including beta-lactamase-producing strains), Moraxella catarrhalis (including beta-lactamase-producing strains), or Streptococcus pneumoniae (penicillin-susceptible strains only).

Limitations of use: In acute bacterial exacerbations of chronic bronchitis clinical trials where M. catarrhalis was isolated from infected sputum at baseline, ceftibuten clinical efficacy was 22% less than control.

Acute bacterial otitis media: Treatment of mild to moderate acute bacterial otitis media due to H. influenzae (including beta-lactamase-producing strains), M. catarrhalis (including beta-lactamase-producing strains), or Streptococcus pyogenes.

Limitations of use: Although ceftibuten used empirically was equivalent to comparators in the treatment of clinically and/or microbiologically documented acute otitis media, the efficacy against S. pneumoniae was 23% less than control. Therefore, ceftibuten should be given empirically only when adequate antimicrobial coverage against S. pneumoniae has been previously administered.

Pharyngitis/tonsillitis: Treatment of mild to moderate pharyngitis and tonsillitis due to S. pyogenes.

Contraindications

Hypersensitivity to ceftibuten, other cephalosporins, or any component of the formulation.

Dosing: Adult

Acute bacterial exacerbations of chronic bronchitis: Oral: 400 mg once daily for 10 days

Acute bacterial otitis media: Oral: 400 mg once daily for 10 days

Pharyngitis/tonsillitis: Oral: 400 mg once daily for 10 days

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Acute bacterial otitis media:

Infants and Children 6 months to <12 years: Oral: 9 mg/kg/dose once daily (maximum dose: 400 mg/day) for 10 days

Children ≥12 years and Adolescents: Oral: Refer to adult dosing.

Pharyngitis/tonsillitis:

Infants and Children 6 months to <12 years: Oral: 9 mg/kg/dose once daily (maximum dose: 400 mg/day) for 10 days

Children ≥12 years and Adolescents: Oral: Refer to adult dosing.

Dosing: Renal Impairment

CrCl ≥50 mL//minute: No dosage adjustment necessary.

CrCl 30 to 49 mL//minute: 4.5 mg/kg or 200 mg every 24 hours.

CrCl 5 to 29 mL/minute: 2.25 mg/kg or 100 mg every 24 hours.

End-stage renal disease (ESRD) on intermittent hemodialysis (IHD) (2 or 3 times weekly): 65% removed by a 2- to 4-hour hemodialysis session; administer 400 mg or 9 mg/kg/dose (maximum: 400 mg/dose) after each hemodialysis session

Dosing: Hepatic Impairment

There are no dosage adjustments provided in the manufacturer’s labeling.

Reconstitution

Refer to manufacturer’s product labeling for reconstitution instructions. Shake well.

Administration

Capsule: Administer without regard to food.

Suspension: Administer at least 2 hours before or 1 hour after meals. Shake well before use.

Dietary Considerations

Capsule: Take without regard to food.

Suspension: Take 2 hours before or 1 hour after meals.

Storage

Store at 2°C to 25°C (36°F to 77°F). Reconstituted suspension is stable for 14 days when refrigerated at 2°C to 8°C (36°F to 46°F).

Drug Interactions

Aminoglycosides: Cephalosporins (3rd Generation) may enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Monitor therapy

Multivitamins/Minerals (with ADEK, Folate, Iron): May decrease the serum concentration of Ceftibuten. Specifically, the zinc contained in many multivitamins may decrease ceftibuten absorption. Management: Consider administering oral zinc-containing multivitamins at least 3 hours after ceftibuten. Consider therapy modification

Multivitamins/Minerals (with AE, No Iron): May decrease the serum concentration of Ceftibuten. Specifically, the zinc contained in many multivitamins may decrease ceftibuten absorption. Management: Consider administering oral zinc-containing multivitamins at least 3 hours after ceftibuten. Consider therapy modification

Probenecid: May increase the serum concentration of Cephalosporins. Monitor therapy

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Consider therapy modification

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Vaccination with live attenuated typhoid vaccine (Ty21a) should be avoided in patients being treated with systemic antibacterial agents. Use of this vaccine should be postponed until at least 3 days after cessation of antibacterial agents. Consider therapy modification

Vitamin K Antagonists (eg, warfarin): Cephalosporins may enhance the anticoagulant effect of Vitamin K Antagonists. Monitor therapy

Zinc Salts: May decrease the serum concentration of Ceftibuten. Management: Consider administering oral zinc salts at least 3 hours after ceftibuten. Exceptions: Zinc Chloride. Consider therapy modification

Test Interactions

Positive direct Coombs', false-positive urinary glucose test using cupric sulfate (Benedict's solution, Clinitest®, Fehling's solution), false-positive serum or urine creatinine with Jaffé reaction

Adverse Reactions

1% to 10%:

Central nervous system: Headache (≤3%), dizziness (≤1%)

Gastrointestinal: Nausea (≤4%), diarrhea (3% to 4%), dyspepsia (≤2%), loose stools (≤2%), abdominal pain (1% to 2%), vomiting (1% to 2%)

Hematologic & oncologic: Eosinophilia (3%), decreased hemoglobin (1% to 2%), change in platelet count (increase: ≤1%)

Hepatic: Increased serum ALT (≤1%), increased serum bilirubin (≤1%)

Renal: Increased blood urea nitrogen (2% to 4%)

<1% (Limited to important or life-threatening): Agitation, anorexia, aphasia, candidiasis, constipation, dehydration, diaper rash, drowsiness, dysgeusia, dyspnea, dysuria, eructation, fatigue, fever, flatulence, hematuria, hyperkinesia, increased serum alkaline phosphatase, increased serum AST, increased serum creatinine, insomnia, irritability, jaundice, leukopenia, melena, nasal congestion, paresthesia, pruritus, pseudomembranous colitis, psychosis, rigors, serum sickness, skin rash, Stevens-Johnson syndrome, stridor, thrombocytopenia, toxic epidermal necrolysis, urticaria, vaginitis, xerostomia

Warnings/Precautions

Concerns related to adverse effects:

• Penicillin allergy: Use with caution in patients with a history of penicillin allergy; if a hypersensitivity reaction occurs, discontinue therapy and institute supportive emergency measures.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

Disease-related concerns:

• Colitis: Use with caution in patients with a history of colitis and other gastrointestinal diseases.

• Renal impairment: Use with caution in patients with renal impairment; modify dosage in moderate to severe impairment and in hemodialysis patients.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.

• Sucrose: Some formulations may contain sucrose.

Monitoring Parameters

Monitor renal, hepatic, and hematologic function periodically with prolonged therapy. Observe for signs and symptoms of anaphylaxis during first dose.

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies. An increase in most types of birth defects was not found following first trimester exposure to cephalosporins (Crider 2009).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea or diarrhea. Have patient report immediately to prescriber bruising, bleeding, urinary retention, change in amount of urine passed, chills, pharyngitis, seizures, severe loss of strength and energy, vaginitis, or signs of Clostridium difficile (C. diff)-associated diarrhea (stomach pain or cramps, very loose or watery stools, or bloody stools) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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