INDICATIONS
Ceftibuten (Logibac) is indicated for the treatment of individuals with mild to moderate infections caused by susceptible strains of the
designeted 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
Adults : 400 mg once daily for 10 days.
Child : 9 mg/kg once daily for 10 days.
OR AS DIRECTED BY PHYSICIAN.
SIDE EFFECTS
The following adverse experiences have been reported during worldwide post-marketing surveillance : aphasia, jaundice, melena,
psychosis, serum sickness-like reactions, stridor, and toxic epidermal necrolysis.
CONTRAINDICATIONS
Ceftibuten is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
PRECAUTIONS
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 to patients with varying degrees of renal
insufficiency, particularly in patients with Creatinine clearance less than 50 mL/min or undergoing hemodialysis. Ceftibuten is readily
dialyzable. Dialysis should be monitored carefully, and administration of Ceftibuten should occur immediately following dialysis. Ceftibuten
should be prescribed with caution to individuals with a history of gastrointestinal disease, particularly colitis.
USE IN PREGNANCY & LACTATION
Ceftibuten has revealed no evidence of harm to the fetus. There are no adequate and well-controlled studies in pregnant women. Because
animal reproduction is not always predictive of human response, this drug should be used during pregnancy only if clearly needed. It is not
known whether Ceftibuten (recommended dosages) is excreted in human milk. Though many drugs are excreted in human milk, caution
should be exercised when Ceftibuten is administered to nursing women.
DRUG INTERACTIONS
Theophylline & Antacid: Do not alter the pharmacokinetic profile of Ceftibuten.
Ranitidine: Increases the Cmax & AUC of Ceftibuten.
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