IBN SINA PHARMACEUTICALS LTD.
Ceftibuten is indicated for the treatment of: Upper respiratory tract infections, including acute sinusitis; otitis media, pharyngitis, tonsillitis and scarlet fever. Lower respiratory tract infections including acute bronchitis, acute exacerbations of chronic bronchitis and acute pneumonia in patients appropriately considered for oral therapy ie, those with primary community-acquired infections. Urinary tract infections: Both complicated and uncomplicated infections. Enteritis and gastroenteritis caused by Salmonella, Shigella or E. coli.
Third generation Cephalosporins
As with most beta-lactam antibiotics, the bactericidal activity of ceftibuten results from the inhibition of bacterial cell wall synthesis. Due to its chemical structure, ceftibuten is highly stable to beta-lactamases. Many beta-lactamase-producing microorganisms, which are resistant to penicillins or other cephalosporins, may be inhibited by ceftibuten.
As with other oral antibiotics, duration of treatment generally ranges from 5-10 days. For treatment of infections due to Streptococcus pyogenes, a therapeutic dose of Ceftibuten should be administered for at least 10 days. Adults: Recommended Dose: 400 mg daily. Ceftibuten capsules may be taken without regard to mealtime. For treatment in the following indications, this may be administered as 400 mg once daily: Acute bacterial sinusitis, acute bronchitis, acute exacerbations of chronic bronchitis, and complicated or uncomplicated urinary tract infections. For the treatment of community-acquired pneumonia in patients in whom oral therapy is appropriate, the recommended dose is 200 mg every 12 hrs. Children: Recommended Dose: 9 mg/kg/day (maximum of 400 mg daily) of the oral suspension. This may be administered as a single daily dose for treatment in the following indications: Pharyngitis with or without tonsillitis, acute otitis media with effusion and complicated or uncomplicated urinary tract infections. For the treatment of acute bacterial enteritis in children, the total daily dosage may be administered in 2 divided doses of 4.5 mg/kg every 12 hrs. Children weighing >45 kg or >10 years may receive the recommended adult dose. Ceftibuten suspension may be taken approximately 1 or 2 hrs before or after mealtime. Shake bottle well before measuring each dose.
High-dose aluminium-magnesium hydroxide antacid, ranitidine, and single dose intravenous theophylline. No significant drug interaction occurred. The effect of Ceftibuten on the plasma levels or pharmacokinetics of theophylline administered orally is not known. No other significant drug interactions have been reported to date.
Ceftibuten is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
Ceftibuten was generally safe and well tolerated. The most frequently reported adverse effects were gastrointestinal, including nausea (<3%) and diarrhea (3%), and headache (2%). Rarely reported adverse effects included dyspepsia, gastritis, vomiting, abdominal pain, dizziness and serum-sickness like disorders.
Ceftibuten has been assigned to pregnancy category B by the FDA. Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. Ceftibuten should be only given during pregnancy when need has been clearly established. Ceftibuten is acceptable to use during breastfeeding. Limited information indicates that single maternal doses of ceftibuten up to 200 mg produce low levels in milk that are not expected to cause adverse effects in breastfed infants.
Overdose symptoms may include seizure (convulsions).
Special precaution should be taken before use in Penicillin-allergic patients; patients with impaired renal function, history of complicated GI disease, particularly chronic colitis. Use in pregnancy & lactation: Pregnancy category B. There are no adequate and controlled studies in pregnant women or during labor and delivery. Because animal reproduction studies are not always predictive of human response, administration of Ceftibuten during such clinical situations should be weighed in terms of potential risk and benefit to both mother and fetus. Ceftibuten has not been detected in the milk of nursing mothers.
Store in a cool (below 308 C) dry place, away from light and children. Store in a cool (below 308 C) dry place, away from light and children.