Ceftibuten is prescribed for the management of mild to moderate infections caused by susceptible bacteria, in the conditions listed below:

• Acute Bacterial Exacerbations of Chronic Bronchitis: Caused by Haemophilus influenzae (including β-lactamase producing strains), Moraxella catarrhalis (including β-lactamase producing strains), or Streptococcus pneumoniae (only penicillin-sensitive strains).
• Acute Bacterial Otitis Media: Caused by Haemophilus influenzae (including β-lactamase producing strains), Moraxella catarrhalis (including β-lactamase producing strains), or Streptococcus pyogenes.
• Pharyngitis and Tonsillitis: Caused by Streptococcus pyogenes.

Ceftibuten, in its dihydrate form, is a semi-synthetic Cephalosporin antibiotic intended for oral use. It works by attaching to specific proteins in the bacterial cell wall, which inhibits the formation of the cell wall and ultimately results in bacterial cell death.

Otitis Media-

• Adult Dosage: 400 mg orally every 24 hours for 10 days
• Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days

Tonsillitis/Pharyngitis-

• Adult Dosage: 400 mg orally every 24 hours for 10 days
• Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days

Bronchitis-

• Adult Dosage: 400 mg orally every 24 hours for 10 days
• Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 10 days

Cystitis-

• Adult Dosage: 400 mg orally every 24 hours for 7 days
• Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 7 days

Pneumonia-

• Adult Dosage: 200 mg orally every 12 hours for 7 to 14 days
• Pediatric Dosage: >12 years: 200 mg orally every 12 hours for 7 to 14 days

Sinusitis-

• Adult Dosage: 400 mg orally every 24 hours for 10 to 14 days
• Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 10 to 14 days

Urinary tract Infection-

• Adult Dosage: 400 mg orally every 24 hours for 10 days
• Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days

Theophylline and antacids do not significantly affect the pharmacokinetics of Ceftibuten. However, Ranitidine may increase the peak concentration (Cmax) and overall exposure (AUC) of Ceftibuten.

Ceftibuten should not be used in patients with a known hypersensitivity to cephalosporin antibiotics.

Nausea, headache, diarrhea, dyspepsia, dizziness, abdominal pain, vomiting.

Pregnancy Category B. There are no adequate and well-controlled studies of Ceftibuten use in pregnant women. It should be used during pregnancy only if the expected benefit outweighs the potential risk. It is not known whether Ceftibuten is excreted in human breast milk. Since many drugs are excreted in breast milk, caution should be exercised when administered to nursing mothers.

As with other broad-spectrum antibiotics, prolonged use may lead to the overgrowth of non-susceptible organisms. Careful monitoring of the patient is necessary. Dose adjustment may be required in patients with renal impairment. Caution is advised in patients with a history of gastrointestinal disorders, especially colitis.

Renal Impairment:

• CrCl 5 to 29 ml/min: 2.25 mg/kg or 100 mg orally once daily
• CrCl 30 to 49 ml/min: 4.5 mg/kg or 200 mg orally once daily

Hepatic Impairment: Dose adjustment is not required.

Third generation Cephalosporins

Store below 25°C, protected from light and moisture. For suspension: after reconstitution, it can be used for up to 14 days if stored at 2° to 8°C. Keep out of reach of children.