Roin90 mg/5 ml

Ceftibuten is indicated for the treatment of individuals with mild-to-moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. 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). ... Read moreCeftibuten is indicated for the treatment of individuals with mild-to-moderate infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below. 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.

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.

Otitis Media- Adult Dosage: 400 mg orally every 24 hours for 10 days Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days Tonsillitis/Pharyngitis- Adult Dosage: 400 mg orally every 24 hours for 10 days Pediatric Dosage: >6 months: 9 mg/kg/day (maximum 400 mg) every 24 hours for 10 days Bronchitis- Adult Dosage: 400 mg orally every 24 hours for 10 days Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 10 days Cystitis- Adult Dosage: 400 mg orally every 24 hours for 7 days Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 7 days Pneumonia- Adult Dosage: 200 mg orally every 12 hours for 7 to 14 days Pediatric Dosage: >12 years: 200 mg orally every 12 hours for 7 to 14 days Sinusitis- Adult Dosage: 400 mg orally every 24 hours for 10 to 14 days Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 10 to 14 days Urinary tract Infection- Adult Dosage: 400 mg orally every 24 hours for 10 days Pediatric Dosage: >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.

Ceftibuten is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.

Nausea, headache, diarrhea, dyspepsia, dizziness, abdominal pain, vomiting.

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.

As with other broad-spectrum antibiotics, prolonged treatment may result in the possible emergence and overgrowth of resistant organisms. Careful observation of the patient is essential. The dose of Ceftibuten may require adjustment in patients with varying degrees of renal insufficiency. Ceftibuten should be prescribed with caution to individuals with a history of gastrointestinal disease, particularly colitis.

Overdose symptoms may include seizure (convulsions).

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.

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.

Third generation Cephalosporins

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.

Pregnancy Category B. There are no controlled data on the use of Ceftibuten in pregnant women. Ceftibuten should be used in pregnancy only when the benefit clearly outweighs the risk. It is not known whether Ceftibuten (recommended dosage) is excreted in human milk. Because many drugs are excreted in human milk, caution should be excercised when Ceftibuten is administered to nursing women.

Renal Impairment- CrCl 5 to 29 ml/min: 2.25 mg/kg or 100 mg orally once a day CrCl 30 to 49 ml/min: 4.5 mg/kg or 200 mg orally once a day Hepatic Impairment: Dose adjustment is not necessary.