Note: All ceftibuten formulations (brand and generic) have been discontinued in the US for more than 1 year.
General dosing, susceptible infection; mild to moderate: Infants, Children, and Adolescents: Oral: 9 mg/kg/dose once daily; maximum dose: 400 mg/dose (Red Book [AAP 2015])
Bronchitis, chronic; acute bacterial exacerbations: Children ≥12 years and Adolescents: Oral: 400 mg once daily for 10 days
Otitis media, acute: Note: Ceftibuten is not a recommended treatment option in the AAP guidelines (Lieberthal 2013).
Infants ≥6 months and Children <12 years: Oral: 9 mg/kg/dose once daily for 10 days; maximum dose: 400 mg/dose
Children ≥12 years and Adolescents: Oral: 400 mg once daily for 10 days
Pharyngitis/tonsillitis: Note: Ceftibuten is not a recommended treatment option in the IDSA guidelines (Shulman 2012).
Infants ≥6 months and Children <12 years: Oral: 9 mg/kg/dose once daily for 10 days; maximum dose: 400 mg/dose
Children ≥12 years and Adolescents: Oral: 400 mg once daily for 10 days
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Infants ≥6 months, Children, and Adolescents:
CrCl ≥50 mL/minute: No adjustment needed.
CrCl 30 to 49 mL/minute: 4.5 mg/kg (maximum dose: 200 mg/dose) every 24 hours
CrCl 5 to 29 mL/minute: 2.25 mg/kg (maximum dose: 100 mg/dose) every 24 hours
End-stage renal disease on intermittent hemodialysis (2 or 3 times weekly): Dialyzable; 65% removed by a 2- to 4-hour hemodialysis session: Administer 9 mg/kg (maximum dose: 400 mg/dose) after hemodialysis
There are no dosage adjustments provided in the manufacturer’s labeling.
(For additional information see "Ceftibuten (United States: Not available): Drug information")
Note: All ceftibuten formulations (brand and generic) have been discontinued in the US for more than 1 year.
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.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
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
There are no dosage adjustments provided in the manufacturer’s labeling.
Yes
All ceftibuten formulations (brand and generic) have been discontinued in the US for more than 1 year.
Oral:
Capsule: Administer without regard to food.
Suspension: Shake suspension well before use. Administer 2 hours before or 1 hour after meals.
Capsule: Administer without regard to food.
Suspension: Administer at least 2 hours before or 1 hour after meals. Shake well before use.
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).
Treatment of acute bacterial otitis media and pharyngitis/tonsillitis due to susceptible organisms (FDA approved in ages ≥6 months and adults); treatment of acute exacerbations of chronic bronchitis (FDA approved in ages ≥12 years and adults)
Cedax may be confused with Cidex
Cedax [US and multiple international markets] may be confused with Codex brand name for acetaminophen/codeine [Brazil] and Saccharomyces boulardii [Italy]
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
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%, postmarketing, and/or case reports: 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
Hypersensitivity to ceftibuten, other cephalosporins, or any component of the formulation.
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.
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.
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer’s labeling.
• Sucrose: Some formulations may contain sucrose.
May cause diarrhea; incidence is higher in younger pediatric patients (8% in patients ≤2 years; 2% in patients >2 years).
Substrate of OAT1/3
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program
Aminoglycosides: Cephalosporins may enhance the nephrotoxic effect of Aminoglycosides. Cephalosporins may decrease the serum concentration of Aminoglycosides. Risk C: Monitor therapy
Bacillus clausii: Antibiotics may diminish the therapeutic effect of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider therapy modification
BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy
Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination
Furosemide: May enhance the nephrotoxic effect of Cephalosporins. Risk C: Monitor therapy
Immune Checkpoint Inhibitors: Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors. Risk C: Monitor therapy
Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy
Probenecid: May increase the serum concentration of Cephalosporins. Risk C: 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. Risk D: Consider therapy modification
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider therapy modification
Vitamin K Antagonists (eg, warfarin): Cephalosporins may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy
Suspension: Take 2 hours before or 1 hour after meals.
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).
Observe for signs and symptoms of anaphylaxis during first dose; with prolonged therapy, monitor renal, hepatic, and hematologic function periodically; number and type of stools/day for diarrhea
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
Protein binding: 65%
Bioavailability: 75% to 90% (Owens 1997)
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
Time to peak: 2 to 2.6 hours
Excretion: Urine (~56%); feces (39%)
Altered kidney function: Clearance is decreased and half-life is increased.
Capsules (Cedax Oral)
400 mg (20): $767.98
Capsules (Ceftibuten Oral)
400 mg (20): $656.16
Suspension (reconstituted) (Cedax Oral)
180 mg/5 mL (30 mL): $119.88
Suspension (reconstituted) (Ceftibuten Oral)
180 mg/5 mL (60 mL): $553.60
Disclaimer: The pricing data provide a representative AWP and/or AAWP price from a single manufacturer of the brand and/or generic product, respectively. The pricing data should be used for benchmarking purposes only, and as such should not be used to set or adjudicate any prices for reimbursement or purchasing functions. Pricing data is updated monthly.
