Cefaten

• Acute Bacterial Exacerbation of Chronic Bronchitis (ABECB):
  Caused by susceptible strains of Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae.
• Otitis Media:
  Acute bacterial otitis media in pediatric patients caused by susceptible bacteria.
• Pharyngitis and Tonsillitis:
  Caused by Streptococcus pyogenes (Group A β-hemolytic streptococci).
• Uncomplicated Urinary Tract Infections (UTIs):
  Including cystitis caused by susceptible Escherichia coli, Klebsiella pneumoniae, and Proteus mirabilis.
• Other Off-Label Uses:
  May be used for respiratory tract infections and other infections caused by susceptible Gram-negative and Gram-positive bacteria based on clinical judgment.

Adults and Adolescents (≥12 years):

• Dose: 400 mg orally once daily.
• Duration: Usually 7–14 days depending on infection type and severity.

Pediatrics (<12 years):

• Safety and efficacy not established in children under 12 years; dosing should be guided by a physician based on clinical experience.

Renal Impairment:

• Mild to Moderate Renal Impairment (CrCl 30–59 mL/min): No dosage adjustment necessary.
• Severe Renal Impairment (CrCl <30 mL/min): Use with caution; no established dose adjustment, consider alternative therapy or clinical monitoring.

Administration:

• Administer orally with or without food.
• Capsules should be swallowed whole with water.

Ceftibuten is an orally active third-generation cephalosporin antibiotic. It exerts bactericidal activity by inhibiting bacterial cell wall synthesis. It binds specifically to penicillin-binding proteins (PBPs) in susceptible bacteria, thereby interfering with the final transpeptidation step of peptidoglycan synthesis. This disruption weakens the bacterial cell wall, leading to osmotic instability and cell lysis. Ceftibuten is particularly effective against Gram-negative bacteria due to its enhanced stability against certain β-lactamases.

• Absorption:
  Rapidly absorbed from the gastrointestinal tract with an oral bioavailability of approximately 75–85%.
• Distribution:
  Widely distributed in body tissues and fluids, including respiratory tract secretions and urine.
• Protein Binding:
  Approximately 60–70%.
• Metabolism:
  Minimal hepatic metabolism; primarily excreted unchanged.
• Elimination:
  Mainly eliminated unchanged by renal excretion through glomerular filtration.
• Half-life:
  Approximately 2.5 to 4 hours in healthy adults; prolonged in renal impairment.
• Onset of Action:
  Achieves peak plasma concentration within 2 to 3 hours post oral administration.

• Pregnancy:
  Classified as FDA Pregnancy Category B. Animal studies show no evidence of harm to the fetus. Human data are limited; use only if clearly needed and after assessing benefit-risk.
• Lactation:
  Excreted in small amounts into breast milk. Caution advised when administered to breastfeeding women; monitor infants for possible adverse reactions.

• Primary Class: Third-generation cephalosporin antibiotic
• Subclass: Oral cephalosporin

• Known hypersensitivity to ceftibuten, other cephalosporins, or beta-lactam antibiotics.
• History of severe allergic reactions to penicillins or other β-lactams.

• Hypersensitivity: Potential for serious allergic reactions including anaphylaxis. Patients with penicillin allergy may be at increased risk.
• Clostridioides difficile-associated diarrhea: May occur during or after antibiotic therapy; monitor for persistent diarrhea.
• Renal Impairment: Use cautiously; dose adjustments may be necessary in severe renal dysfunction.
• Superinfection: Prolonged use may result in overgrowth of non-susceptible organisms including fungi.

Common:

• Gastrointestinal: Diarrhea, nausea, abdominal pain, vomiting
• Dermatologic: Rash, pruritus
• General: Headache, dizziness

Serious/Rare:

• Hypersensitivity reactions (anaphylaxis, Stevens-Johnson syndrome)
• Clostridioides difficile colitis
• Hematologic: Eosinophilia, neutropenia (rare)

• Antacids: May reduce absorption; administer ceftibuten 2 hours before or after antacids.
• Probenecid: May increase serum concentrations by reducing renal clearance.
• Other antibiotics: No significant CYP450 interactions; low potential for metabolic drug interactions.
• Live oral typhoid vaccine: Effectiveness may be reduced when administered concurrently.

• Continued recommendation for uncomplicated urinary and respiratory tract infections caused by susceptible bacteria.
• No significant changes in dosing or safety profile reported in recent clinical guidelines.
• Not recommended for severe renal impairment without close monitoring.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from moisture and light.
• Keep capsules in tightly closed containers.
• Do not freeze.
• Keep out of reach of children.