Ceftibuten Dihydrate
Indications
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).
- 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.
Pharmacology
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.
Dosage & Administration
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
- 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
- Adult Dosage: 400 mg orally every 24 hours for 10 days
- Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 10 days
- Adult Dosage: 400 mg orally every 24 hours for 7 days
- Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 7 days
- 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
- 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
- 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
Interaction
Theophylline & Antacid do not alter the
pharmacokinetic profile of Ceftibuten. Ranitidine increases the Cmax
& AUC of Ceftibuten.
Contraindications
Ceftibuten is contraindicated in patients with known allergy to the cephalosporin group of antibiotics.
Side Effects
Nausea, headache, diarrhea, dyspepsia, dizziness, abdominal pain, vomiting.
Pregnancy & Lactation
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.
Precautions & Warnings
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.
Use in Special Populations
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
Therapeutic Class
Third generation Cephalosporins
Reconstitution
- The small bottle contains purified water and large bottle contains granules
- Pour the purified water completely into large bottle
- Tighten the cap of large bottle and shake the bottle for at least one minute
- Use a measuring cup or dropper for reconstituted suspension
Storage Conditions
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.