Classifications: beta-lactam antibiotic; third-generation cephalosporin; Therapeutic:antibiotic; cephalosporin
Prototype: Cefotaxime sodium
Pregnancy Category: B
400 mg capsules; 90 mg/5 mL, 180 mg/5 mL suspension
Ceftibuten is a broad-spectrum, third-generation beta-lactam antibiotic. Preferentially binds to one or more of the penicillin-binding
proteins located in the cell wall of susceptible organisms. This inhibits third and final stage of bacterial cell wall synthesis,
thus killing the bacterium. It is highly resistant to hydrolysis by most beta-lactamase bacteria.
It has antibacterial activity against both gram-negative and gram-positive bacteria.
Acute bacterial exacerbations of chronic bronchitis caused by H. influenzae, Moraxella catarrhalis, or S. pneumoniae; acute bacterial otitis media caused by H. influenzae, M. catarrhalis, or S. pyogenes; pharyngitis or tonsillitis caused by S. pyogenes.
Hypersensitivity to ceftibuten or cephalosporins.
Renal dysfunction, penicillin hypersensitivity, history of colitis or diabetes; GI disease; coagulopathy; pregnancy (category
B), lactation. Safety and efficacy in infants <6 mo not established.
Route & Dosage
|Mild to Moderate Infections
Adult: PO 400 mg once daily for 10 d
Clcr 3049 mL/min: 200 mg q24h; <30 mL/min: 100 mg q24h
Child (6 mo12 y): PO 9 mg/kg once daily (max: 400 mg) for 10 d
Clcr 3049 mL/min: 4.5 mg/kg q24h; <30 mL/min: 2.25 mg/kg q24h
- Give oral suspension 1 h before or 2 h after a meal.
- Children weighing more than 45 kg may receive maximum daily dose.
- Hemodialysis patients should receive drug at the end of dialysis.
- Store capsules at 2°25° C (36°77° F); keep container tightly closed. Reconstituted oral suspension
is stable for 14 d under refrigeration at 2°8° C (36°46° F).
Adverse Effects (≥1%)Body as a Whole:
Dyspnea, dysuria, fatigue
, moniliasis, urticaria, pruritus, rash, paresthesia, taste perversion. GI:
Nausea, vomiting, diarrhea, dyspepsia, abdominal pain, anorexia, constipation
, dry mouth, eructation, flatulence. CNS:
Headache, dizziness, nasal congestion, somnolence.
may increase risk of nephrotoxicity and have additive/synergistic effects. May decrease efficacy
of oral contraceptives
may increase levels.
Rapidly from GI tract. Peak:
Approx. 23 h. Distribution:
Bronchial mucosa levels are approx 37% of plasma levels, middle ear levels approx 50% of plasma levels. Elimination:
Primarily in urine. Half-Life:
Assessment & Drug Effects
- Determine history of hypersensitivity reactions to cephalosporins, penicillins, or other drugs, before therapy is initiated.
Monitor for S&S of hypersensitivity (see Appendix F); report their appearance promptly and discontinue drug.
- Lab tests: Perform culture and sensitivity tests before initiation of therapy. Dosage may be started pending test results.
- Monitor for S&S of superinfection or pseudomembranous colitis (see Appendix F); immediately report either to physician.
- Closely monitor patients with renal impairment; if seizures develop, discontinue drug and notify physician.
Patient & Family Education
- If on dialysis treatment, take this drug after dialysis.
- Report any S&S of hypersensitivity, superinfection, and pseudomembranous colitis promptly.