Ceftibuten  (PDF Version)

Antibiotic Class:

Third-Generation Cephalosporin

Antimicrobial Spectrum:

Staphylococcus aureus (methicillin susceptible), Coagulase negative Staphylococci, Streptococcus pneumoniae (penicillin susceptible), Streptococcus spp., Haemophilus influenzae, Moraxella catarrhalis, Neisseria meningitides, Neisseria gonorrhoeae, Enterobacteriaceae, E. coli

Mechanism of Action:

Cephalosporins exert bactericidal activity by interfering with bacterial cell wall synthesis and inhibiting cross-linking of the peptidoglycan. The cephalosporins are also thought to play a role in the activation of bacterical cell autolysins which may contribute to bacterial cell lysis.

Pharmacodynamics:

Cephalosporins exhibit time-dependent killing (T > MIC)

Pharmacokinetics:

Dose of 400mg: Cmax: 17 mcg/L; Tmax: 2.0 hour; Half-life: 2.3 hours; Table 10

Adverse Effects:

Hypersensitivity: Maculopapular rash, Urticaria, Pruritis, Anaphylaxis/angioedema, eosinophilia

Hematologic: Hypoprothrombinemia, Neutropenia, Leukopenia, Thrombocytopenia

GI: Diarrhea, C. difficile disease

Renal: Interstitial nephritis

Table 14

Dosage:

PO: 400mg tablets

Powder for Suspension: 90mg/5mL, 180mg/5mL

Dosing in adults:

Tonsillitis: 400 mg PO q24h x 10 days

Otitis media: 400 mg PO q24h x 10 days

Pharyngitis: 400 mg PO q24h x 10 days

Acute exacerbation of chronic bronchitis: 400mg PO q24h x 10 days

Dosing in pediatrics:

9mg/kg/day q24h

Table 12

Disease state based dosing:

Renal failure:  CrCl > 50 mL/min: Standard dosing

                        CrCl 30-49 mL/min: 200mg q24h OR 4.5mg/kg q24h

                        CrCl 5-29 mL/min: 100mg q24h OR 2.25mg/kg q24h

Hepatic failure:  No dosing changes recommended at this time.

Contraindications/Warnings/Precautions:

Precautions: hypersensitivity to penicillins, history of gastrointestinal disease, particularly colitis, renal impairment

Drug Interactions:

Cimetidine: an increased risk of ceftibuten adverse effects

Famotidine: an increased risk of ceftibuten adverse effects

Live Typhoid Vaccine: decreased immunological response to the typhoid vaccine

Nizatidine: an increased risk of ceftibuten adverse effects

Ranitidine: an increased risk of ceftibuten adverse effects

Pregnancy:

Category B: No evidence of risk in humans but studies inadequate.

Monitoring Requirements:

Therapeutic:  Culture and sensitivities, serum levels, signs and symptoms of infection, white blood cell count

Toxic:  Urinalysis, BUN, SCr, AST and ALT, skin rash, Neutropenia and leukopenia, Prothrombin time in patients with renal or hepatic impairment or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy.

Brand names/Manufacturer

Cedax /Schering