Cefaten 90 mg/5 ml (Powder for Suspension)
Medicine Details
Category | Details |
---|---|
Generic | Ceftibuten dihydrate |
Company | Eskayef pharmaceuticals ltd |
Also available as |
Indications
- Acute Bacterial Exacerbations of Chronic Bronchitis
- Acute Bacterial Otitis Media
- Pharyngitis and Tonsillitis
Pharmacology
Ceftibuten exerts its bactericidal action by binding to essential target proteins of the bacterial cell wall, leading to inhibition of cell-wall synthesis.
Dosage & Administration
- Otitis Media:
- Adult Dosage: 400 mg orally every 24 hours for 10 days
- Pediatric Dosage: 9 mg/kg/day (max 400 mg) every 24 hours for 10 days
- Tonsillitis/Pharyngitis:
- Adult Dosage: 400 mg orally every 24 hours for 10 days
- Pediatric Dosage: 9 mg/kg/day (max 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 7-14 days
- Pediatric Dosage: >12 years: 200 mg orally every 12 hours for 7-14 days
- Sinusitis:
- Adult Dosage: 400 mg orally every 24 hours for 10-14 days
- Pediatric Dosage: >12 years: 400 mg orally every 24 hours for 10-14 days
- Urinary tract Infection:
- Adult Dosage: 400 mg orally every 24 hours for 10 days
- Pediatric Dosage: 9 mg/kg/day (max 400 mg) every 24 hours for 10 days
Interaction
Theophylline & Antacid do not alter the pharmacokinetic profile of Cefaten. Ranitidine increases the Cmax & AUC of Cefaten.
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. Caution should be exercised when Ceftibuten is administered to nursing women.
Precautions & Warnings
Prolonged treatment may result in the possible emergence and overgrowth of resistant organisms. Careful observation of the patient is essential. Dose of Cefaten may require adjustment in patients with varying degrees of renal insufficiency. Cefaten should be prescribed with caution to individuals with a history of gastrointestinal disease, particularly colitis.
Use in Special Populations
- Renal Impairment:
- CrCl 5-29 ml/min: 2.25 mg/kg or 100 mg orally once a day
- CrCl 30-49 ml/min: 4.5 mg/kg or 200 mg orally once a day
- Hepatic Impairment: Dose adjustment is not necessary.
Therapeutic Class
Third generation Cephalosporins
Reconstitution
- The small bottle contains purified water and large bottle contains granules
- Prepared suspension to be consumed within 14 days of preparation if kept in a refrigerator
Storage Conditions
Store below 25°C, protected from light and moisture. After reconstitution, the suspension may be used for 14 days while stored at 2°-8°C. Keep out of reach of children.