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Ceftibuten (United States: Not available): Pediatric drug information

Ceftibuten (United States: Not available): Pediatric drug information
(For additional information see "Ceftibuten (United States: Not available): Drug information" and see "Ceftibuten (United States: Not available): Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Therapeutic Category
  • Antibiotic, Cephalosporin (Third Generation)
Dosing: Pediatric

Note: All ceftibuten formulations (brand and generic) have been discontinued in the United States for >1 year.

General dosing: Infants, Children, and Adolescents: Oral: 9 mg/kg/dose once daily; maximum dose: 400 mg/dose (Ref).

Chronic bronchitis, acute bacterial exacerbation

Chronic bronchitis, acute bacterial exacerbation: Children ≥12 years and Adolescents: Oral: 400 mg once daily for 10 days.

Otitis media, acute

Otitis media, acute: Note: Ceftibuten is not included in the AAP acute otitis media guidelines (Ref).

Infants ≥6 months and Children <12 years: Oral: 9 mg/kg/dose once daily for 10 days; maximum dose: 400 mg/dose.

Children ≥12 years and Adolescents: Oral: 400 mg once daily for 10 days.

Streptococcus, group A; pharyngitis/tonsillitis

Streptococcus, group A; pharyngitis/tonsillitis: Note: Narrow-spectrum cephalosporins (eg, cephalexin) are preferred over broad-spectrum cephalosporins such as ceftibuten (Ref).

Infants ≥6 months and Children <12 years: Oral: 9 mg/kg/dose once daily for 10 days; maximum dose: 400 mg/dose.

Children ≥12 years and Adolescents: Oral: 400 mg once daily for 10 days.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Infants ≥6 months, Children, and Adolescents:

CrCl ≥50 mL/minute: No adjustment needed.

CrCl 30 to 49 mL/minute: Oral: 4.5 mg/kg/dose every 24 hours; maximum dose: 200 mg/dose.

CrCl 5 to 29 mL/minute: Oral: 2.25 mg/kg/dose every 24 hours; maximum dose: 100 mg/dose.

End-stage renal disease on intermittent hemodialysis (2 or 3 times weekly): Dialyzable; 65% removed by a 2- to 4-hour hemodialysis session:

Oral: 9 mg/kg/dose (maximum dose: 400 mg/dose) after each hemodialysis session.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Adult

(For additional information see "Ceftibuten (United States: Not available): Drug information")

Note: All ceftibuten formulations (brand and generic) have been discontinued in the US for more than 1 year.

Chronic bronchitis, acute bacterial exacerbation

Chronic bronchitis, acute bacterial exacerbation: Oral: 400 mg once daily for 10 days.

Otitis media, acute bacterial

Otitis media, acute bacterial: Oral: 400 mg once daily for 10 days.

Pharyngitis/tonsillitis

Pharyngitis/tonsillitis: Oral: 400 mg once daily for 10 days.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

CrCl ≥50 mL/minute: No dosage adjustment necessary.

CrCl 30 to 49 mL/minute: 4.5 mg/kg or 200 mg every 24 hours.

CrCl 5 to 29 mL/minute: 2.25 mg/kg or 100 mg every 24 hours.

End-stage renal disease (ESRD) on intermittent hemodialysis (IHD) (2 or 3 times weekly): 65% removed by a 2- to 4-hour hemodialysis session; administer 400 mg or 9 mg/kg/dose (maximum: 400 mg/dose) after each hemodialysis session

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

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 & oncologic: Eosinophilia (3%), decreased hemoglobin (1% to 2%), change in platelet count (increase: ≤1%)

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

Renal: Increased blood urea nitrogen (2% to 4%)

<1%, postmarketing, and/or case reports: Agitation, anorexia, aphasia, candidiasis, constipation, dehydration, diaper rash, drowsiness, dysgeusia, dyspnea, dysuria, eructation, fatigue, fever, flatulence, hematuria, hyperkinesia, increased serum alkaline phosphatase, increased serum AST, increased serum creatinine, insomnia, irritability, jaundice, leukopenia, melena, nasal congestion, paresthesia, pruritus, pseudomembranous colitis, psychosis, rigors, serum sickness, skin rash, Stevens-Johnson syndrome, stridor, thrombocytopenia, toxic epidermal necrolysis, urticaria, vaginitis, xerostomia

Contraindications

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

Warnings/Precautions

Concerns related to adverse effects:

• Penicillin allergy: Use with caution in patients with a history of penicillin allergy; if a hypersensitivity reaction occurs, discontinue therapy and institute supportive emergency measures.

• 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.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.

• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer’s labeling.

• Sucrose: Some formulations may contain sucrose.

Warnings: Additional Pediatric Considerations

May cause diarrhea; incidence is higher in younger pediatric patients (8% in patients ≤2 years of age; 2% in patients >2 years of age).

Product Availability

All ceftibuten formulations (brand and generic) have been discontinued in the US for more than 1 year.

Generic Equivalent Available: US

Yes

Pricing: US

Capsules (Cedax Oral)

400 mg (20): $767.98

Capsules (Ceftibuten Oral)

400 mg (20): $656.16

Suspension (reconstituted) (Cedax Oral)

180 mg/5 mL (30 mL): $119.88

Suspension (reconstituted) (Ceftibuten Oral)

180 mg/5 mL (60 mL): $553.60

Disclaimer: The pricing data provide a representative AWP and/or AAWP price from a single manufacturer of the brand and/or generic product, respectively. The pricing data should be used for benchmarking purposes only, and as such should not be used to set or adjudicate any prices for reimbursement or purchasing functions. Pricing data is updated monthly.

Administration: Pediatric

Oral:

Capsule: Administer without regard to food.

Suspension: Shake suspension well before use. Administer 2 hours before or 1 hour after meals.

Administration: Adult

Capsule: Administer without regard to food.

Suspension: Administer at least 2 hours before or 1 hour after meals. Shake well before use.

Storage/Stability

Store 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).

Use

Treatment of acute bacterial otitis media and pharyngitis/tonsillitis due to susceptible organisms (FDA approved in ages ≥6 months and adults); treatment of acute exacerbations of chronic bronchitis (FDA approved in ages ≥12 years and adults).

Medication Safety Issues
Sound-alike/look-alike issues:

Cedax may be confused with Cidex

International issues:

Cedax [US and multiple international markets] may be confused with Codex brand name for acetaminophen/codeine [Brazil] and Saccharomyces boulardii [Italy]

Metabolism/Transport Effects

Substrate of OAT1/3

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Aminoglycosides: Cephalosporins may enhance the nephrotoxic effect of Aminoglycosides. Cephalosporins may decrease the serum concentration of Aminoglycosides. Risk C: Monitor therapy

Bacillus clausii: Antibiotics may diminish the therapeutic effect of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider therapy modification

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy

Cholera Vaccine: Antibiotics may diminish the therapeutic effect of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid combination

Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination

Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination

Furosemide: May enhance the nephrotoxic effect of Cephalosporins. Risk C: Monitor therapy

Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy

Probenecid: May increase the serum concentration of Cephalosporins. Risk C: Monitor therapy

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider therapy modification

Typhoid Vaccine: Antibiotics may diminish the therapeutic effect of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider therapy modification

Vitamin K Antagonists (eg, warfarin): Cephalosporins may enhance the anticoagulant effect of Vitamin K Antagonists. Risk C: Monitor therapy

Dietary Considerations

Suspension: Take 2 hours before or 1 hour after meals.

Pregnancy Considerations

Adverse events have not been observed in animal reproduction studies. An increase in most types of birth defects was not found following first trimester exposure to cephalosporins (Crider 2009).

Monitoring Parameters

Observe for signs and symptoms of anaphylaxis; with prolonged therapy, monitor renal, hepatic, and hematologic function periodically; number and type of stools/day for diarrhea.

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.

Pharmacokinetics (Adult Data Unless Noted)

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

Distribution: Distributes into middle ear fluid, bronchial secretions, and sputum; Vd: Children: 0.5 L/kg; Adults: 0.21 L/kg

Protein binding: 65%

Bioavailability: 75% to 90% (Owens 1997)

Half-life elimination: Children: 2 hours; Adults: 2.4 hours; CrCl 30 to 49 mL/minute: 7.1 hours; CrCl 5 to 29 mL/minute: 13.4 hours; CrCl <5 mL/minute: 22.3 hours

Time to peak: 2 to 2.6 hours

Excretion: Urine (~56%); feces (39%)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: Clearance is decreased and half-life is increased.

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