BUTICEF
CEFTIBUTEN INN
| NAME | STRENGTH | PACK SIZE | DOSAGE FORM |
|---|---|---|---|
| BUTICEF 400 MG | 400 MG | 10 S | CAPSULE |
| BUTICEF 90 MG/5 ML | 90 MG/5 ML | 60 ML | POS |
Buticef powder for suspension: Each 5 ml contains Ceftibuten 90 mg as Ceftibuten Dihydrate INN.
Butacef 400 mg capsule: Each film coated tablet contains Ceftibuten 400 mg as Ceftibuten Dihydrate INN.
Ceftibuten is a third-generation Cephalosporin antibiotic. 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.
Acute Bacterial Exacerbations of Chronic Bronchitis due to Haemophilus influenzae(including ß-lactamase-producing strains), Moraxella catarrhalis (including ß-lactamase-producing strains), or Streptococcus pneumoniae (penicillin-susceptible strains only). Acute Bacterial Otitis Media due to Haemophilus influenzae (including ß-lactamase-producing strains), Moraxella catarrhalis (including ß-lactamase-producing strains), or Streptococcus pyogenes.
Pharyngitis and Tonsillitis due to Streptococcus pyogenes.
Adults (12 years of age and older): 400 mg once daily for 10 days.
Pediatric (<12 years of age): 9 mg/kg once daily for 10 days.
Maximum daily dose is 400 mg.
Suspension should be taken on an empty stomach (take 2 hr before or 1 hr after meals.);
Capsule may be taken with or without food.
Ceftibuten is contraindicated in patients with known allergy to the Cephalosporin group of antibiotics.
Ceftibuten is readily dialyzable. Dialysis patients 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.
Nausea, Diarrhea, Headache, Increased eosinophils, Decreased hemoglobin, Dyspepsia, Thrombocytosis, Abdominal pain, Dizziness, Increased bilirubin,Vomiting.
Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Lactation: 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
Ceftibuten with Antacids or H2-receptor antagonists may increase the Ceftibuten Cmax.
Overdosage of Cephalosporins can cause cerebral irritation leading to convulsions. Ceftibuten is readily dialyzable and significant quantities (65% of plasma concentrations) can be removed from the circulation by a single hemodialysis session. Information does not exist with regard to removal of Ceftibuten by peritoneal dialysis.
Store the capsules between 2° to 25°C. Protect from light and moisture.
Buticef 400 mg capsule: Each box contains 2×4 capsuls in blister pack.
Buticef powder for suspension: Bottle contains dry powder to make 60 ml suspension with a bottle contains 45 ml diluent.