No

Antibiotic, Cephalosporin (Third Generation)

Oral cephalosporin for 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

B

In patients with known allergy to the cephalosporin group of antibiotics

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

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, diaper rash, dry mouth, dyspnea, dysuria, fatigue, candidiasis, rash, urticaria, irritability, paresthesia, nasal congestion, insomnia, rigors, increased transaminases, increased creatinine, leukopenia

Other reactions with 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, seizures, serum-sickness reactions, renal dysfunction, interstitial nephritis, toxic nephropathy, cholestasis, aplastic anemia, hemolytic anemia, pancytopenia, agranulocytosis, colitis, prolonged PT, hemorrhage, superinfection

After acute overdose, most agents cause only nausea, vomiting, and diarrhea, although neuromuscular hypersensitivity and seizures are possible, especially in patients with renal insufficiency; many beta-lactam antibiotics have the potential to cause neuromuscular hyperirritability or seizures

Hemodialysis may be helpful to aid in the removal of the drug from the blood but not usually indicated, otherwise most treatment is supportive or symptom directed following GI decontamination

Increased effect: High-dose probenecid decreases clearance

Increased toxicity: Aminoglycosides increase nephrotoxic potential

Reconstituted suspension is stable for 14 days in the refrigerator

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 (T_max: 2-3 hours); food decreases peak concentrations, delays T_max and lowers the AUC (total amount of drug absorbed)

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

Half-life: 2 hours

Elimination: In urine

Oral:

Children greater than or equal to 12 years and Adults: 400 mg once daily for 10 days; maximum: 400 mg

Dosage adjustment in renal impairment:

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

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

Take without regard to food

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

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

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

May rarely cause neutropenia; use caution with clozapine and carbamazepine

No information available to require special precautions

No effects or complications reported

Take as directed, at regular intervals around-the-clock (with or without food). Chilling oral suspension improves flavor (do not freeze). Complete full course of medication, even if you feel better. Drink 2-3 L fluid/day. If diarrhea occurs, yogurt or buttermilk may help. May cause false-positive test with Clinitest®; use another form of testing. May interfere with oral contraceptives; additional contraceptive measures are necessary. Report severe, unresolved diarrhea; vaginal itching or drainage; sores in mouth; blood, pus, or mucus in stool or urine; easy bleeding or bruising; unusual fever or chills; rash; or respiratory difficulty. Breast-feeding precautions: Consult prescriber if breast-feeding.

After mixing suspension, may be kept for 14 days if stored in refrigerator; discard any unused portion after 14 days; must be administered at least 2 hours before meals or 1 hour after a meal; shake suspension well before use

Capsule: 400 mg

Powder for oral suspension (cherry flavor): 90 mg/5 mL (30 mL, 60 mL, 120 mL); 180 mg/5 mL (30 mL, 60 mL, 120 mL)

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.