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Pronunciation:

(sef TYE byoo ten)

U.S. Brand Names:

Cedax®

Generic Available:

Use:

Oral cephalosporin for treatment of bronchitis, otitis media, and pharyngitis/tonsillitis due to H. influenzae and M. catarrhalis, both beta-lactamase-producing and nonproducing strains, as well as S. pneumoniae (weak) and S. pyogenes

Pregnancy Risk Factor:

Lactation:

Excretion in breast milk unknown/use caution

Contraindications:

Hypersensitivity to ceftibuten, any component of the formulation, or other cephalosporins

Warnings/Precautions:

Modify dosage in patients with severe renal impairment, prolonged use may result in superinfection; use with caution in patients with a history of penicillin allergy, especially IgE-mediated reactions (eg, anaphylaxis, urticaria). May cause antibiotic-associated colitis or colitis secondary to C. difficile.

Adverse Reactions:

1% to 10%:

Central nervous system: Headache (3%), dizziness (1%)

Gastrointestinal: Nausea (4%), diarrhea (3%), dyspepsia (2%), vomiting (1%), abdominal pain (1%)

Hematologic: Increased eosinophils (3%), decreased hemoglobin (2%), thrombocytosis

Hepatic: Increased ALT (1%), increased bilirubin (1%)

Renal: Increased BUN (4%)

<1%: Anorexia, agitation, constipation, creatinine increased, diaper rash, dry mouth, dyspnea, dysuria, fatigue, candidiasis, rash, urticaria, irritability, paresthesia, nasal congestion, insomnia, rigors, transaminases increased, leukopenia

Reactions reported with other cephalosporins include anaphylaxis, fever, paresthesia, pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, angioedema, pseudomembranous colitis, hemolytic anemia, candidiasis, vaginitis, encephalopathy, asterixis, neuromuscular excitability, seizure, serum-sickness reactions, renal dysfunction, interstitial nephritis, toxic nephropathy, cholestasis, aplastic anemia, hemolytic anemia, pancytopenia, agranulocytosis, colitis, prolonged PT, hemorrhage, superinfection

Overdosage/Toxicology:

Symptoms of overdose include neuromuscular hypersensitivity and convulsions. Many beta-lactam containing antibiotics have the potential to cause neuromuscular hyperirritability or convulsive seizures. Hemodialysis may be helpful to aid in the removal of drug from blood; otherwise, treatment is supportive or symptom-directed.

Drug Interactions:

Increased effect: High-dose probenecid decreases clearance

Increased toxicity: Aminoglycosides may increase nephrotoxic potential

Stability:

Reconstituted suspension is stable for 14 days in the refrigerator

Mechanism of Action:

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.

Pharmacodynamics/Kinetics:

Absorption: Rapid; food decreases peak concentrations, delays Tmax, and lowers AUC

Distribution: Vd: Children: 0.5 L/kg; Adults: 0.21 L/kg

Half-life elimination: 2 hours

Time to peak: 2-3 hours

Excretion: Urine

Dosage:

Oral:

Children <12 years: 9 mg/kg/day for 10 days; maximum daily dose: 400 mg

Children 12 years and Adults: 400 mg once daily for 10 days; maximum: 400 mg

Dosage adjustment in renal impairment:

Clcr 30-49 mL//minute: Administer 4.5 mg/kg or 200 mg every 24 hours

Clcr<29 mL/minute: Administer 2.25 mg/kg or 100 mg every 24 hours

Administration:

Shake suspension well before use.

Monitoring Parameters:

Observe for signs and symptoms of anaphylaxis during first dose; with prolonged therapy, monitor renal, hepatic, and hematologic function periodically

Test Interactions:

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

Dietary Considerations:

Capsule: Take without regard to food.

Suspension: Take 2 hours before or 1 hour after meals; contains 1 g of sucrose per 5 mL

Patient Education:

Inform prescriber of all prescriptions, OTC medications, or herbal products you are taking, and any allergies you have. Do not take any new medication during therapy unless approved by prescriber. Take as directed, at regular intervals around-the-clock (with or without food). Chilling oral suspension improves flavor (do not freeze). Maintain adequate hydration (2-3 L/day of fluids) unless instructed to restrict fluid intake. Complete full course of medication, even if you feel better. May cause false test results with Clinitest®; use of another type of testing is preferable. May cause headache or dizziness (use caution when driving or engaging in potentially hazardous tasks until response to drug is known); nausea or vomiting (small, frequent meals, frequent mouth care, sucking lozenges, or chewing gum may help); or diarrhea (yogurt, boiled milk, or buttermilk may help). Report changes in urinary pattern (decreased output); unresolved diarrhea; opportunistic infection (vaginal itching or drainage, sores in mouth; blood in urine or stool); or rash. Breast-feeding precaution: Consult prescriber if breast-feeding.

Dental Health: Effects on Dental Treatment:

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

May cause nervousness; case reports of euphoria, delusion, illusions, and depersonalization with cephalosporins

Mental Health: Effects on Psychiatric Treatment:

May rarely cause neutropenia; use caution with clozapine and carbamazepine

Dosage Forms:

Capsule: 400 mg

Powder for oral suspension: 90 mg/5 mL (30 mL, 60 mL, 120 mL) [contains sodium benzoate; cherry flavor]

International Brand Names:

Biocef® (ES); Cedax® (AR, BD, CH, CR, DO, EC, ES, GB, GT, HN, HR, HU, ID, IL, IT, MX, NL, PA, PL, RO, RU, SE, SG, SI, SV, TH, YU); Cepifran® (ES); Isocef® (IT); Keimax® (DE); Procadax® (IN); Seftem® (JP); Sepexin® (CL)

References

Guay DR, "Ceftibuten: A New Expanded-Spectrum Oral Cephalosporin,"Ann Pharmacother, 1997, 31(9):1022-33.

Marshall WF and Blair JE, "The Cephalosporins,"Mayo Clin Proc, 1999, 74(2):187-95.

Owens RC Jr, Nightingale CH, and Nicolau DP, "Ceftibuten: An Overview,"Pharmacotherapy, 1997, 17(4):707-20.

Schatz BS, Karavokiros KT, Taeubel MA, et al, "Comparison of Cefprozil, Cefpodoxime Proxetil, Loracarbef, Cefixime, and Ceftibuten,"Ann Pharmacother, 1996, 30(3):258-68.

Wiseman LR and Balfour JA, "Ceftibuten: A Review of Its Antibacterial Activity Pharmacokinetic Properties and Clinical Efficacy,"Drugs, 1994, 47(5):784-808.

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