Ceftibuten is used to treat acute bacterial exacerbations of chronic bronchitis (ABECB), acute bacterial otitis media, pharyngitis, and tonsilitis. It is also indicated for pneumonia, infections of the urinary tract, enteritis, and gastroenteritis.
Ceftibuten is the dihydrate salt of Ceftibuten, is a semi-synthetic Cephalosporin antibiotic for oral administration. 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.
Usual Adult Dose for Otitis Media 400 mg orally every 24 hours for 10 days Usual Adult Dose for Tonsillitis/Pharyngitis 400 mg orally every 24 hours for 10 days Usual Adult Dose for Bronchitis 400 mg orally every 24 hours for 10 days Usual Adult Dose for Cystitis 400 mg orally every 24 hours for 7 days Usual Adult Dose for Pneumonia 200 mg orally every 12 hours for 7 to 14 days Usual Adult Dose for Sinusitis 400 mg orally every 24 hours for 10 to 14 days Usual Pediatric Dose for Bronchitis >12 years: 400 mg orally every 24 hours for 10 days Usual Pediatric Dose for Cystitis >12 years: 400 mg orally every 24 hours for 7 days Usual Pediatric Dose for Pneumonia >12 years: 200 mg orally every 12 hours for 7 to 14 days Usual Pediatric Dose for Sinusitis >12 years: 400 mg orally every 24 hours for 10 to 14 days Usual Pediatric Dose for Otitis Media >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days Usual Pediatric Dose for Tonsillitis/Pharyngitis >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days
Theophylline & Antacid do not alter the pharmacokinetic profile of Ceftibuten. Ranitidine increases the Cmax & AUC of Ceftibuten.
Colitis, diarrhea, GI disease, inflammatory bowel disease, pseudomembranous colitis, ulcerative colitis, Cephalosporin hypersensitivity, penicillin hypersensitivity,Dialysis, renal failure, renal impairment, Coagulopathy, vitamin K deficiency, Pregnancy, Breast-feeding.
nausea, vomiting, stomach pain, upset stomach, belching, constipation, mild diarrhea, stiff, tight muscles, numbness, tingly feeling, headache, dizziness, drowsiness, tired feeling, feeling agitated, irritable, restless, hyperactive, dry mouth.
Pregnancy Ceftibuten is classified in FDA pregnancy risk category B. Animal data reveal no teratogenic or embryocidal effects. There are, however, no adequate and well-controlled studies of ceftibuten use in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Ceftibuten has not been studied for use during labor and delivery. Treatment should be given only if clearly needed. Breast-feeding It is not known if ceftibuten is excreted in human milk. Because many cephalosporins are excreted in human milk at low concentrations, the manufacturer recommends that caution should be exercised when ceftibuten is administered to breast-feeding women. In general, unless the infant is allergic to cephalosporins, breast-feeding is generally safe during maternal cephalosporin therapy; the infant should be observed for potential effects. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.
Store below 25°C, protected from light and moisture. For Suspension: After reconstitution, the suspension may be used for 14 days while stored at 2° to 8°C. Keep out of reach of children.
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