Microbiology: 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. Ceftibuten is stable in the presence of most plasmid-mediated beta-lactamases. Ceftibuten has been shown to be active against most strains of the following organisms both in vitro and in clinical infections- Gram-positive aerobes: Streptococcus pneumoniae (penicillin-susceptible strains only) Streptococcus pyogenes. Gramnegative aerobes: Haemophilus influenzae (including beta-lactamase-producing strains) Moraxella catarrhalis (including beta-lactamase-producing strains). Pharmacokinetics: Ceftibuten is generally absorbed after oral administration. Plasma protein binding of ceftibuten is 65% which is independent of plasma ceftibuten concentration. It shows good concentration in different tissues: of plasma concentration, 15% in epithelial lining fluid, 37% in bronchial mucosa, 7% in sputum, 70% in mid-ear fluid of the plasma concentration. Cis-ceftibuten is the predominant component of ceftibuten in both plasma and urine. About 10% of ceftibuten is converted to the trans-isomer. Approximately 56% of the administered dose of ceftibuten is recovered from urine & 39% from feces within 24 hours.

Ceftibuten is indicated for infections caused by susceptible microorganisms: 1) Acute Bacterial Exacerbations of Chronic Bronchitis 2) Pharyngitis and Tonsillitis 3) Acute Bacterial Otitis Media. Ceftibuten is also effective in treating urinary tract infection, pneumonia, enteric fever, gastroenteritis etc.

For Adult (12 years and older): The recommended dose of ceftibuten is 400 mg once daily for 10 days.

For children: The dose is 9 mg/kg body weight once daily for 10 days. For renal impairment: For the patients with creatinine clearance of 50 mL/min or greater normal dose should be administered. The recommended dose for renal insufficiency patients is given in the following table.

Ceftibuten is contraindicated to patients with the history of hypersensitivity reactions to ceftibuten, other cephalosporins & penicillins.

If superinfection occurs during therapy, appropriate measures should be taken. The dose may require adjustment, particularly in patients with creatinine clearance less than 50 mL/min or undergoing hemodialysis.

Theophylline: The pharmacokinetics of theophylline was not altered during coadministration with ceftibuten. Antacids or H2-receptor antagonists: A single dose of liquid antacid did not affect the Cmax or AUC of ceftibuten; however, 150 mg of ranitidine q12h for 3 days increased the Cmax of ceftibuten by 23% and AUC by 16%.

Use in pregnancy: Pregnancy category B. This drug should be used during pregnancy only if clearly needed. Use in nursing mothers: It is not known whether ceftibuten (at recommended dosages) is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ceftibuten is administered to a nursing woman. Use in pediatric patients: The safety and efficacy of ceftibuten in infants less than 6 months of age have not been established. Use in geriatric patients: The usual adult dosage is recommended. However if renal function is hampered, dosage adjustment may be required.

Orbuten 400 Capsule: Each box contains 8 capsules in Alu-Alu blister in Alu-Alu pillow pack.