Ceftibuten

Visa No.: 893110547824

Product: Cefidax 200mg

API: Ceftibuten

Product Category: Antibiotics

Version approved leaflet: 652/QĐ-QLD_23/10/2019_166

INDICATIONS

Treatment of infections caused by susceptible bacteria, including:

• Acute otitis media (with or without effusion)
• Pharyngitis and tonsillitis
• Respiratory tract infections, including acute exacerbations of chronic bronchitis and acute sinusitis
• Urinary tract infections
   

DOSAGE AND ADMINISTRATION

Method of administration: Oral use
Dosage: is determined based on ceftibuten (anhydrous) content.

Adults and adolescents ≥ 12 years: 
Usual dose: 400 mg once daily for 10 days
Mild urinary tract infections: 400 mg once daily for 7 days

Children 6 months to 11 years:
Usual dose: 9 mg/kg once daily for 10 days Maximum dose: 400 mg/day

Patients with renal or hepatic impairment

• CrCl ≥ 50 mL/min: 400 mg/day
• CrCl 30–49 mL/min: 4.5 mg/kg or 200 mg/day
• CrCl 5–29 mL/min: 2.25 mg/kg or 100 mg/day

As ceftibuten is removed by hemodialysis, a dose of 9 mg/kg (maximum 400 mg) should be administered after each dialysis session
 

CONTRAINDICATIONS

Hypersensitivity to cephalosporin antibiotics
Hypersensitivity to any excipient   of the product
History of severe hypersensitivity reactions to penicillins or other beta-lactam antibiotics
 

WARNINGS AND PRECAUTIONS

Prescription-only medicine
Read the instructions carefully before use
Consult a physician or pharmacist if needed
Keep out of reach of children.