Ceftibuten Dihydrate

Ceftibuten is indicated for the treatment of individuals with mild-to-moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below.

• Acute Bacterial Exacerbations of Chronic Bronchitis: Due to Haemophilus influenzae (including β-lactamase producing strains), Moraxella catarrhalis (including (β-lactamase producing strains), or Streptococcus pneumoniae (penicillin-susceptible strains only).
• Acute Bacterial Otitis Media: Due to Haemophilus influenzae (including β-lactamase producing strains), Moraxella catarrhalis (including β-lactamase producing strains) or Streptococcus pyogenes.

Ceftibuten is the dihydrate salt of Ceftibuten, is a semi-synthetic Cephalosporin antibiotic for oral administration. Ceftibuten exerts its bactericidal action by binding to essential target proteins of the bacterial cell wall. This binding leads to inhibition of cell-wall synthesis.

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 & Antacid do not alter the pharmacokinetic profile of Ceftibuten. Ranitidine increases the Cmax & AUC of Ceftibuten.

Ceftibuten is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

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

Pregnancy Category B. There are no controlled data on the use of Ceftibuten in pregnant women. Ceftibuten should be used in pregnancy only when the benefit clearly outweighs the risk. It is not known whether Ceftibuten (recommended dosage) is excreted in human milk. Because many drugs are excreted in human milk, caution should be excercised when Ceftibuten is administered to nursing women.

As with other broad-spectrum antibiotics, prolonged treatment may result in the possible emergence and overgrowth of resistant organisms. Careful observation of the patient is essential. The dose of Ceftibuten may require adjustment in patients with varying degrees of renal insufficiency. Ceftibuten should be prescribed with caution to individuals with a history of gastrointestinal disease, particularly colitis.

Third generation Cephalosporins

Renal Impairment-

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

Hepatic Impairment: Dose adjustment is not necessary.

Store below 25°C, protected from light and moisture. For Suspension: After reconstitution, the suspension may be used for 14 days while stored at 2° to 8°C. Keep out of reach of children.