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Ceftibuten

Medically reviewed by Drugs.com. Last updated on May 3, 2020.

Pronunciation

(sef TYE byoo ten)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral:

Cedax: 400 mg [DSC] [contains butylparaben, edetate (edta) calcium disodium, methylparaben, propylparaben]

Generic: 400 mg [DSC]

Suspension Reconstituted, Oral:

Cedax: 180 mg/5 mL (30 mL [DSC], 60 mL [DSC]) [contains sodium benzoate; cherry flavor]

Generic: 180 mg/5 mL (60 mL [DSC])

Brand Names: U.S.

  • Cedax [DSC]

Pharmacologic Category

  • Antibiotic, Cephalosporin (Third Generation)

Pharmacology

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; 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

Excretion

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

Time to Peak

2 to 2.6 hours

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

Protein Binding

65%

Special Populations: Renal Function Impairment

Clearance is decreased and half-life is increased.

Use: Labeled Indications

Acute bacterial exacerbations of chronic bronchitis: Treatment of mild to moderate acute bacterial exacerbations of chronic bronchitis due to Haemophilus influenzae (including beta-lactamase-producing strains), Moraxella catarrhalis (including beta-lactamase-producing strains), or Streptococcus pneumoniae (penicillin-susceptible strains only).

Limitations of use: In acute bacterial exacerbations of chronic bronchitis clinical trials where M. catarrhalis was isolated from infected sputum at baseline, ceftibuten clinical efficacy was 22% less than control.

Acute bacterial otitis media: Treatment of mild to moderate acute bacterial otitis media due to H. influenzae (including beta-lactamase-producing strains), M. catarrhalis (including beta-lactamase-producing strains), or Streptococcus pyogenes.

Limitations of use: Although ceftibuten used empirically was equivalent to comparators in the treatment of clinically and/or microbiologically documented acute otitis media, the efficacy against S. pneumoniae was 23% less than control. Therefore, ceftibuten should be given empirically only when adequate antimicrobial coverage against S. pneumoniae has been previously administered.

Pharyngitis/tonsillitis: Treatment of mild to moderate pharyngitis and tonsillitis due to S. pyogenes.

Contraindications

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

Dosing: Adult

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

Acute bacterial exacerbations of chronic bronchitis: Oral: 400 mg once daily for 10 days

Acute bacterial otitis media: Oral: 400 mg once daily for 10 days

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: Geriatric

Refer to adult dosing.

Dosing: Pediatric

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

General dosing, susceptible infection; mild to moderate: Infants, Children, and Adolescents: Oral: 9 mg/kg/dose once daily; maximum dose: 400 mg/dose (Red Book [AAP 2015])

Bronchitis, chronic; acute bacterial exacerbations: Children ≥12 years and Adolescents: Oral: 400 mg once daily for 10 days

Otitis media, acute: Note: Ceftibuten is not a recommended treatment option in the AAP guidelines (Lieberthal 2013).

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

Pharyngitis/tonsillitis: Note: Ceftibuten is not a recommended treatment option in the IDSA guidelines (Shulman 2012).

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.

Reconstitution

Refer to manufacturer’s product labeling for reconstitution instructions. Shake well.

Administration

Capsule: Administer without regard to food.

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

Dietary Considerations

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

Storage

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).

Drug Interactions

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

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

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). 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. Avoid combination

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

Multivitamins/Minerals (with ADEK, Folate, Iron): May decrease the serum concentration of Ceftibuten. Specifically, the zinc contained in many multivitamins may decrease ceftibuten absorption. Management: Consider administering oral zinc-containing multivitamins at least 3 hours after ceftibuten. Consider therapy modification

Multivitamins/Minerals (with AE, No Iron): May decrease the serum concentration of Ceftibuten. Specifically, the zinc contained in many multivitamins may decrease ceftibuten absorption. Management: Consider administering oral zinc-containing multivitamins at least 3 hours after ceftibuten. Consider therapy modification

Probenecid: May increase the serum concentration of Cephalosporins. 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. 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. Consider therapy modification

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

Zinc Salts: May decrease the serum concentration of Ceftibuten. Management: Consider administering oral zinc salts at least 3 hours after ceftibuten. Consider therapy modification

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

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

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.

Monitoring Parameters

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

Pregnancy Risk Factor

B

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).

Patient Education

What is this drug used for?

• It is used to treat bacterial infections.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Nausea

• Diarrhea

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Bruising

• Bleeding

• Unable to pass urine

• Change in amount of urine passed

• Chills

• Sore throat

• Seizures

• Severe loss of strength and energy

• Vaginal pain, itching, and discharge

Clostridioides (formerly Clostridium) difficile-associated diarrhea like abdominal pain or cramps, severe diarrhea or watery stools, or bloody stools

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.