Dosing and uses of Cedax (ceftibuten)
Adult dosage forms and strengths
capsule
- 400mg
oral suspension
- 90mg/5mL
- 180mg/5mL
Infections
400 mg PO qDay for 10 days
Renal Impairment
CrCl 30-49 mL/min: 200 mg PO qDay or 4.5 mg/kg qDay
CrCl 5-29 mL/min: 100 mg PO qDay or 2.25 mg/kg qDay
Supplement following hemodialysis
Other Indications & Uses
Mild to moderate respiratory tract infections (ie, acute exacerbation of chronic bronchitis) caused by susceptible bacteria
AOM caused by susceptible bacteria & pharyngitis/tonsillitis caused by Streptococcus pyogenes (group A beta-hemolytic streptococci)
Off-label: UTI caused by susceptible bacteria
Pediatric dosage forms and strengths
capsule
- 400mg
oral suspension
- 90mg/5mL
- 180mg/5mL
Infections
<6 months: Safety and efficacy not established
6-12 years old or <45 kg: 9 mg/kg PO qDay; 400 mg/day PO for 10 days maximum
>12 years old or >45 kg: As in adults
Cedax (ceftibuten) adverse (side) effects
1-10%
Increased BUN (4%)
Nausea (4%)
Diarrhea (3%)
Headache (3%)
Increased eosinophils (3%)
Decreased hemoglobin (2%)
Dyspepsia (2%)
Thrombocytosis (2%)
Abdominal pain (1%)
Dizziness (1%)
Increased ALT (1%)
Increased bilirubin (1%)
Vomiting (1%)
<1%
Anorexia
Candidiasis
Constipation
Dysuria
Agitation
Fatigue
Insomnia
Irritability
Paresthesia
Rigors
Diaper rash
Urticaria
Dry mouth
Dyspnea
Nasal congestion
Increased transaminases
Increased creatinine
Leukopenia
Warnings
Contraindications
Documented hypersensitivity
Cautions
Diabetics: oral suspension contains 1 g sucrose/tsp
Modify dosage in severe renal impairment; prolonged use may result in superinfection; caution in seizure disorder; may cause antibiotic associated colitis
Pregnancy and lactation
Pregnancy category: B
Lactation: excretion in milk unknown; use with caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Cedax (ceftibuten)
Half-Life: 2.4 hr
Peak Plasma Time: 2-3 hr
Absorption: rapid; food decreases peak concentrations, delays Tmax, & lowers AUC
Vd: children: 0.5 L/kg; adults: 0.21 L/kg
Excretion: urine (56%); feces (39%)
Mechanism of action
Third-generation cephalosporin that is bactericidal. Inhibits cell wall mucopeptide synthesis.
Inhibits bacterial cell wall synthesis by binding to one or more of the penicillin-binding proteins (PBPs)
