Generic

Ceftibuten Dihydrate

Indications

Ceftibuten is used to treat people who have mild-to-moderate infections caused by susceptible strains of the designated microorganisms in the situations listed below.

• Bacterial Exacerbations of Chronic Bronchitis: Haemophilus influenzae (including -lactamase producing strains), Moraxella catarrhalis (including -lactamase producing strains), or Streptococcus pneumoniae (penicillin-susceptible strains only).
• Haemophilus influenzae (including -lactamase generating strains), Moraxella catarrhalis (including -lactamase producing strains), or Streptococcus pyogenes cause acute bacterial otitis media.
• Streptococcus pyo causes pharyngitis and tonsillitis.

Pharmacology

Ceftibuten dihydrate, a semi-synthetic Cephalosporin antibiotic for oral administration, is the dihydrate salt of Ceftibuten. Ceftibuten works as a bactericide by binding to key bacterial cell wall target proteins. The suppression of cell-wall production occurs as a result of this interaction.

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

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

Interaction

Ceftibuten's pharmacokinetic profile is unaffected by theophylline or antacid. Ceftibuten's Cmax and AUC are increased by ranitidine.

Contraindications

Ceftibuten is not recommended for those who have a known allergy to cephalosporin drugs.

Side Effects

Nausea, headaches, diarrhea, dyspepsia, dizziness, abdominal discomfort, and vomiting are all symptoms of dyspepsia.

Pregnancy & Lactation

Pregnancy Classification B. On the usage of Ceftibuten in pregnant women, there is no controlled data. Only use ceftibuten during pregnancy if the benefit clearly outweighs the danger. Ceftibuten (recommended dosage) is not known to be excreted in human milk. Because many medicines are excreted in human milk, Ceftibuten should be provided with caution to nursing mothers.

Precautions & Warnings

Prolonged use of broad-spectrum antibiotics, like other antibiotics, can lead to the formation and spread of resistant bacteria. It is critical to keep a close eye on the patient. In patients with varied degrees of renal impairment, the dose of Ceftibuten may need to be adjusted. Individuals with a history of gastrointestinal disease, particularly colitis, should be taken ceftibuten with caution.

Therapeutic Class

Third generation Cephalosporins

Storage Conditions

Store at a temperature below 25°C, away from light and moisture. Suspension: After reconstitution, the suspension can be stored at 2° to 8°C for 14 days. Keep out of children's reach.

Pharmaceutical Name

Incepta Pharmaceuticals Ltd.