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|NAME||STRENGTH||PACK SIZE||DOSAGE FORM|
|Buticef Powder for suspension||90 mg/5 ml||60 ml||Powder for suspension|
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.
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.
Indications And Uses
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 And Administration
Adults- 400 mg once a day for 10 days. Children 6 months up to 12 years of age- Usually 9 mg/kg of body weight a day for 10 days. Renal Impairment: Cetibuten Capsules may be administered at normal doses in the presence of impaired renal function with Creatinine Clearance (CrCl) of 50 mL/min or greater. CrCl: 30-49 mL/min recommended dose is 4.5 mg/kg or 200 mg Q24h; CrCl: 5-29 mg/kg recommended dose is 2.25g/kg or 100 mg Q24h.
Nausea, Diarrhea, Headache, Increased eosinophils, Decreased hemoglobin, Dyspepsia, Thrombocytosis, Abdominal pain, Dizziness, Increased bilirubin,Vomiting.
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.
Use In Pregnancy Lactation
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.
Ceftibuten is contraindicated in patients with known allergy to the Cephalosporin group of antibiotics.
Buticef 400 mg capsule: Each box contains 10 capsuls in blister pack. Buticef powder for suspension: Each bottle contains dry powder to make 60 ml suspension.