Ceftibuten Dihydrate is a semisynthetic cephalosporin antibiotic intended for oral administration.
Renal Impairment:
CrCl 5–29 ml/min: 2.25 mg/kg or 100 mg orally once a day.
CrCl 30–49 ml/min: 4.5 mg/kg or 200 mg orally once a day.
Hepatic Impairment: No dose adjustment necessary.
Reconstitution of Suspension
Shake the bottle to loosen the powder.
Open the bottle cap carefully.
Withdraw 5 ml of boiled and cooled water using the oral dispenser.
Slowly add 5 ml of water into the bottle.
Repeat steps 3 and 4 eight times to add a total of 40 ml of water (5 ml × 8 = 40 ml).
Shake well for 1–2 minutes to obtain a homogeneous suspension.
Reported side effects include:
General: Aphasia, jaundice, melena, psychosis, stridor.
Severe: Toxic epidermal necrolysis, serum sickness-like reactions, Stevens-Johnson syndrome.
Prolonged treatment with broad-spectrum antibiotics, including Ceftibuten, may result in the emergence and overgrowth of resistant organisms. Patients should be carefully observed during therapy. If superinfection occurs, appropriate measures must be taken.
Dose adjustment is required for patients with varying degrees of renal insufficiency, particularly those with creatinine clearance less than 50 ml/min or undergoing hemodialysis. Dialysis patients should be monitored carefully, and Ceftibuten should be administered immediately following dialysis.
Pregnancy: Category B. There are no controlled studies on the use of Ceftibuten in pregnant women. It should be used during pregnancy only when the potential benefit clearly outweighs the risks.
Lactation: It is unknown if Ceftibuten is excreted in human milk. Since many drugs are excreted in human milk, caution is advised when administering Ceftibuten to nursing women.
Ceftibuten is contraindicated in patients with a known allergy to cephalosporins.
Theophylline and Antacids: Do not alter the pharmacokinetics of Ceftibuten.
H2-receptor antagonists: Ranitidine increases the Cmax and AUC of Ceftibuten.
Overdosing on cephalosporins can cause cerebral irritation, potentially leading to convulsions. Ceftibuten is readily dialyzable, with significant quantities (65% of plasma concentration) removable through a single hemodialysis session. No data is available on the removal of Ceftibuten via peritoneal dialysis.
Store at a temperature not exceeding 30°C in a dry place. Protect from light and moisture.
Caution: Keep out of reach of children.
