Description

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.

Presentation

    Orbuten 400 Capsule: Each capsule contains Ceftibuten Dihydrate INN equivalent to Ceftibuten 400 mg.
    Orbten Suspension: Each 5ml suspension contains Ceftibuten Dihydrate INN equivalent to Ceftibuten 90 mg

Indications

    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.

Dosage & Administration

    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.

Contrainidications

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

Warning & Precautions

    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.

Side effects

    Nausea, headache, diarrhea, abdominal pain, dyspepsia etc. may occur.

Drug interaction

    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 special groups

    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.

Packing

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

    Orbten Powder for Suspension: Bottle containing dry powder for preparation of 60 ml suspension.