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Medication Safety Issues
Sound-alike/look-alike issues:
Cedax® may be confused with Cidex®
International issues:
Cedax® may be confused with Codex which is a brand name for Saccharomyces boulardii in Italy
Pronunciation
(sef TYE byoo ten)
U.S. Brand Names
Generic Available
No
Pharmacologic Category
Pharmacologic Category Synonyms
Use: Labeled Indications
Treatment of acute exacerbations of chronic bronchitis, acute bacterial otitis media, and pharyngitis/tonsillitis
Pregnancy Risk Factor
B
Pregnancy Considerations
Teratogenic effects were not observed in animal studies; therefore, ceftibuten is classified as pregnancy category B. It is not know if ceftibuten crosses the placenta; other cephalosporins cross the placenta and are considered safe for use during pregnancy. Adequate and well-controlled studies have not been completed in pregnant women.
Lactation
Excretion in breast milk unknown/use caution
Breast-Feeding Considerations
Ceftibuten was not detectable in milk after a single 200 mg dose (limit of detection: 1 mcg/mL). It is not known if it would be detectable after a 400 mg dose or multiple doses. The manufacturer recommends that caution be exercised when administering ceftibuten to nursing women. If ceftibuten does reach the human milk, nondose-related effects could include modification of bowel flora.
Contraindications
Hypersensitivity to ceftibuten, any component of the formulation, or other cephalosporins
Warnings/Precautions
Concerns related to adverse effects:
• Penicillin allergy: Use with caution in patients with a history of penicillin allergy, especially IgE-mediated reactions (eg, anaphylaxis, angioedema, urticaria).
• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.
Disease-related concerns:
• Colitis: Use with caution in patients with a history of colitis and other gastrointestinal diseases.
• Renal impairment: Use with caution in patients with renal impairment; modify dosage in moderate-to-severe impairment and in hemodialysis patients. In 2-4 hours of hemodialysis, 65% of ceftibuten is removed.
Special populations:
• Pediatrics: Safety and efficacy not established in children <6 months of age.
Dosage form specific issues:
Sucrose: Oral suspension formulation contains sucrose.
Adverse Reactions
1% to 10%:
Central nervous system: Headache (?3%), dizziness (?1%)
Gastrointestinal: Nausea (?4%), diarrhea (3% to 4%), dyspepsia (?2%), loose stools (?2%), abdominal pain (1% to 2%), vomiting (1% to 2%)
Hematologic: Eosinophils increased (3%), hemoglobin decreased (1% to 2%), platelets increased (?1%)
Hepatic: ALT increased (?1%), bilirubin increased (?1%)
Renal: BUN increased (2% to 4%)
<1%, postmarketing, and/or case reports: Agitation, alkaline phosphatase increased, anorexia, aphasia, AST increased, constipation, creatinine increased, dehydration, diaper rash, dyspnea, dysuria, eructation, fatigue, fever, flatulence, hematuria, hyperkinesia, insomnia, irritability, jaundice, leukopenia, melena, moniliasis, nasal congestion, paresthesia, platelets increased, pruritus, pseudomembranous colitis, psychosis, rash, rigors, serum-sickness reactions, somnolence, Stevens-Johnson syndrome, stridor, taste perversion, thrombocytopenia, toxic epidermal necrolysis, urticaria, vaginitis, xerostomia
Additional reactions reported with other cephalosporins: Allergic reaction, agranulocytosis, angioedema, aplastic anemia, anaphylaxis, asterixis, cholestasis, drug fever, encephalopathy, erythema multiforme, hemolytic anemia, hemorrhage, interstitial nephritis, neuromuscular excitability, neutropenia, pancytopenia, prolonged PT, renal dysfunction, seizure, superinfection, toxic nephropathy
Drug Interactions
BCG: Antibiotics may diminish the therapeutic effect of BCG. Risk X: Avoid combination
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Risk D: Consider therapy modification
Uricosuric Agents: May decrease the excretion of Cephalosporins. Risk C: Monitor therapy
Storage
Store capsules and powder for suspension at 2°C to 25°C (36°F to 77°F). Reconstituted suspension is stable for 14 days when refrigerated at 2°C to 8°C (36°F to 46°F).
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
Protein binding: 65%
Half-life elimination: 2 hours; Clcr 30-49 mL/minute: 7 hours; Clcr 5-29 mL/minute: 13 hours; Clcr <5 mL/minute: 22 hours
Time to peak: 2-3 hours
Excretion: Urine (~56%); feces (39%)
Dosage
Usual dosage range:
Children 6 months to <12 years: Oral: 9 mg/kg/day for 10 days (maximum dose: 400 mg/day)
Children ?12 years and Adults: Oral: 400 mg once daily for 10 days
Dosage adjustment in renal impairment:
Clcr ?50 mL//minute: No adjustment needed
Clcr 30-49 mL//minute: Administer 4.5 mg/kg or 200 mg every 24 hours
Clcr 5-29 mL/minute: Administer 2.25 mg/kg or 100 mg every 24 hours.
Hemodialysis: Administer 400 mg or 9 mg/kg (maximum: 400 mg) after each hemodialysis session
Administration: Oral
Capsule: Administer without regard to food.
Suspension: Administer 2 hours before or 1 hour after meals. Shake 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
Some products may contain sucrose.
Capsule: Take without regard to food.
Suspension: Take 2 hours before or 1 hour after meals.
Patient Education
Do not take any new medication during therapy unless approved by prescriber. Take as directed, at regular intervals around-the-clock (take capsules with or without food; take suspension 2 hours before or 1 hour after meals). Chilling oral suspension improves flavor (do not freeze). Maintain adequate hydration 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. Report rash; breathing or swallowing difficulty; persistent diarrhea, nausea, vomiting, or abdominal pain; changes in urinary pattern or pain on urination; opportunistic infection (eg, vaginal itching or drainage, sores in mouth, blood in stool or urine, unusual fever or chills); CNS changes (eg, irritability, agitation, nervousness, insomnia, hallucinations); or other adverse reactions. Breast-feeding precaution: Consult prescriber if breast-feeding.
Geriatric Considerations
Has not been studied specifically in the elderly. Adjust dose for renal function.
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
Nursing: Physical Assessment/Monitoring
Assess results of culture/sensitivity tests and patient's allergy history prior to therapy. Assess other pharmacological or herbal products patient may be taking for potential interactions (eg, nephrotoxicity). Assess results of laboratory tests, therapeutic response, and adverse effects (eg, hemolytic anemia, hypoprothrombinemia, and bleeding) regularly during therapy. Advise patients with diabetes about use of Clinitest® (may cause false-positive test). Teach patient possible side effects/appropriate interventions and adverse symptoms to report (eg, opportunistic infection, hypersensitivity reaction).
Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule:
Cedax®: 400 mg
Powder for oral suspension:
Cedax®: 90 mg/5 mL (60 mL, 90 mL, 120 mL) [contains sucrose 1g/5 mL and sodium benzoate; cherry flavor]
Pricing: U.S. (www.drugstore.com)
Capsules (Cedax)
400 mg (20): $298.80
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.
International Brand Names
Lexi-Comp.com
Last full review/revision December 2009
Content last modified December 2009
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