(sef TYE byoo ten)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
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.
- Antibiotic, Cephalosporin (Third Generation)
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.
Rapid; food decreases peak concentrations, delays Tmax, and lowers AUC
Vd: Children: 0.5 L/kg; Adults: 0.21 L/kg; distributes into middle ear fluid, bronchial secretions, sputum, tonsillar tissue, and blister fluid
Urine (~56%); feces (39%)
Time to Peak
2 to 3 hours
Children: 1.9 to 2.5 hours; Adults: 2 to 3 hours; CrCl 30 to 49 mL/minute: 7 hours; CrCl 5 to 29 mL/minute: 13 hours; CrCl <5 mL/minute: 22 hours
Special Populations: Renal Function Impairment
Clearance is decreased.
Use: Labeled Indications
Treatment of acute exacerbations of chronic bronchitis, acute bacterial otitis media, and pharyngitis/tonsillitis
Hypersensitivity to ceftibuten, any component of the formulation, or other cephalosporins
Usual dosage range:
Children 6 months to <12 years: Oral: 9 mg/kg/day for 10 days (maximum dose: 400 mg/day)
Children ≥12 years and Adults: Oral: 400 mg once daily for 10 days
Dosage adjustment in renal impairment:
CrCl ≥50 mL//minute: No adjustment needed
CrCl 30-49 mL//minute: Administer 4.5 mg/kg or 200 mg every 24 hours
CrCl 5-29 mL/minute: Administer 2.25 mg/kg or 100 mg every 24 hours.
Hemodialysis: Administer 400 mg or 9 mg/kg (maximum: 400 mg) after each hemodialysis session
Dosage adjustment in hepatic impairment: No dosage adjustment provided in manufacturer’s labeling.
Capsule: Administer without regard to food.
Suspension: Administer 2 hours before or 1 hour after meals. Shake well before use.
Capsule: Take without regard to food.
Suspension: Take 2 hours before or 1 hour after meals.
Store capsules and powder for suspension 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).
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
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
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: Eosinophils increased (3%), hemoglobin decreased (1% to 2%), platelets increased (≤1%)
Hepatic: ALT increased (≤1%), bilirubin increased (≤1%)
Renal: BUN increased (2% to 4%)
<1% (Limited to important or life-threatening): Agitation, alkaline phosphatase increased, anorexia, aphasia, AST increased, constipation, creatinine increased, dehydration, diaper rash, dyspnea, dysuria, eructation, fatigue, fever, flatulence, hematuria, hyperkinesia, insomnia, irritability, jaundice, leukopenia, melena, moniliasis, nasal congestion, paresthesia, platelets increased, pruritus, pseudomembranous colitis, psychosis, rash, rigors, serum-sickness reactions, somnolence, Stevens-Johnson syndrome, stridor, taste perversion, thrombocytopenia, toxic epidermal necrolysis, urticaria, vaginitis, xerostomia
Additional reactions reported with other cephalosporins: Allergic reaction, agranulocytosis, angioedema, aplastic anemia, anaphylaxis, asterixis, cholestasis, drug fever, encephalopathy, erythema multiforme, hemolytic anemia, hemorrhage, interstitial nephritis, neuromuscular excitability, neutropenia, pancytopenia, prolonged PT, renal dysfunction, seizure, superinfection, toxic nephropathy
Concerns related to adverse effects:
• Penicillin allergy: Use with caution in patients with a history of penicillin allergy, especially IgE-mediated reactions (eg, anaphylaxis, angioedema, urticaria).
• 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.
• 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. In 2-4 hours of hemodialysis, 65% of ceftibuten is removed.
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: Oral suspension formulation contains sucrose.
Monitor renal, hepatic, and hematologic function periodically with prolonged therapy. Observe for signs and symptoms of anaphylaxis during first dose.
Pregnancy Risk Factor
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).
• 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 dyspepsia or diarrhea. Have patient report immediately to prescriber ecchymosis, hemorrhaging, urinary retention, oliguria, chills, pharyngitis, considerable asthenia, vaginitis, or signs of pseudomembranous colitis (rare) (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.
More about ceftibuten
- Other brands: Cedax