Description
Ceftibuten Dihydrate is a semisynthetic cephalosporin antibiotic for oral administration.
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.
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.
Therapeutic Class
Third generation Cephalosporins
Pharmacology
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.
Dosage & Administration
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.
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.
Interaction
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.
Contraindications
Ceftibuten is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
Side Effects
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.
Pregnancy & Lactation
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.
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.
Precautions
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.
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.
Overdose Effects
Overdose symptoms may include seizure (convulsions).
Use in Special Population
Use in children: Safety and efficacy of Ceftibuten in infants <6 months have not been established.
Adult Patients with Renal Impairment: Ceftibuten pharmacokinetics are not affected sufficiently to require dosage modifications unless creatinine clearance values are <50 mL/min. If creatinine clearance is from 49 to 30 mL/min, the daily dose should be decreased to 200 mg. With creatinine clearance values of 29 to 5 mL/min, the recommended daily dose is 100 mg.
If alteration of dosing frequency is preferred, a 400-mg dose of Ceftibuten may be administered every 48 hrs (every 2 days) to a patient with a creatinine clearance of 30-49 mL/min, and every 96 hrs (every 4 days) if creatinine clearance is 5-29 mL/min.
In patients undergoing hemodialysis 2 or 3 times weekly, a single dose of Ceftibuten 400 mg may be administered at the end of each hemodialysis session.
Adult Patients with Renal Impairment: Ceftibuten pharmacokinetics are not affected sufficiently to require dosage modifications unless creatinine clearance values are <50 mL/min. If creatinine clearance is from 49 to 30 mL/min, the daily dose should be decreased to 200 mg. With creatinine clearance values of 29 to 5 mL/min, the recommended daily dose is 100 mg.
If alteration of dosing frequency is preferred, a 400-mg dose of Ceftibuten may be administered every 48 hrs (every 2 days) to a patient with a creatinine clearance of 30-49 mL/min, and every 96 hrs (every 4 days) if creatinine clearance is 5-29 mL/min.
In patients undergoing hemodialysis 2 or 3 times weekly, a single dose of Ceftibuten 400 mg may be administered at the end of each hemodialysis session.
Storage Conditions
Store in a cool (below 30º C) dry place,
away from light and children. Store in a cool (below 30º C) dry place,
away from light and children.
Supply:
Zoventa 200: Each box contains 2 x 6's capsules in Alu-Alu blister pack. Unit Price : ৳ 70.00
Zoventa 400: Each box contains 1 x 6's capsules in Alu-Alu blister pack. Unit Price : ৳ 120.00
Zoventa Powder for Suspension: Each bottle contains Ceftibuten dry powder to reconstitute 60 ml suspension. Unit Price : ৳ 480.00
Zoventa DS Powder for Suspension: Each bottle contains Ceftibuten dry powder to reconstitute 60 ml suspension. Unit Price : ৳ 800.00
Manufacture
Healthcare Pharmacuticals Ltd.
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