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Indications - 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. Pharyngitis and Tonsillitis: Due to Streptococcus pyogenes.

Dosage & Administration - 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

Side Effects - Nausea, headache, diarrhea, dyspepsia, dizziness, abdominal pain, vomiting.

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

Others - Pregnancy & Lactation 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. Precautions & Warnings 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. Use in Special Populations 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. Reconstitution The small bottle contains purified water and large bottle contains granules Pour the purified water completely into large bottle Tighten the cap of large bottle and shake the bottle for at least one minute Use a measuring cup or dropper for reconstituted suspension Prepared suspension to be consumed within 14 days of preparation if kept in a refrigerator. Shake the bottle well each time before use. Storage Conditions 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.