Cefixime

Visa No.: VD-35469-21

Product: Cefixime STADA 200 mg

API: Cefixime

Product Category: Antibiotics

Version approved leaflet: 641/QĐ-QLD_01/11/2021_172

INDICATIONS

Cefixime STADA is indicated for the treatment of the following infections caused by susceptible microorganisms:

• Upper and lower respiratory tract infections, including pneumonia, bronchitis, sinusitis, and otitis media.
• Acute uncomplicated urinary tract infections, including acute cystitis.

Typhoid fever caused by Salmonella typhi.

• Shigellosis, including infections caused by ampicillin-resistant strains.
• Other infections caused by cefixime-susceptible bacteria, as determined by clinical and microbiological assessment.
   

DOSAGE AND ADMINISTRATION

Adults and adolescents ≥ 12 years
The usual recommended dose is 400 mg per day, administered as a single daily dose or pided into two doses of 200 mg every 12 hours.
For the treatment of gonococcal urinary tract infection, the recommended dose is 400 mg once daily
Children from 6 months old to 12 years old: The recommended dose is 8 mg/kg/day administered as an oral suspension, given as a single daily dose or pided into two doses every 12 hours.
The safety of cefixime in children under 6 months of age has not been established.

Patients with renal impairment: No dose adjustment is required in patients with creatinine clearance > 60 mL/min. In patients with creatinine clearance < 60 mL/min, the dose and dosing frequency should be adjusted according to the degree of renal impairment, as follows: Creatinine clearance 21–60 mL/min: 300 mg once daily. Creatinine clearance < 20 mL/min: 200 mg once daily.
As cefixime is not significantly removed by hemodialysis, patients undergoing hemodialysis or peritoneal dialysis do not require supplemental dosing.

Elderly patients: may receive the same dosage as adults. Renal function should be assessed, and in cases of severe renal impairment, dose adjustment is required.
 

CONTRAINDICATIONS

Do not use in patients with hypersensitivity to cephalosporin antibiotics, beta-lactam antibiotics, or to any component of the product.

WARNINGS AND PRECAUTIONS

This medicine is available only on prescription.
Read the instructions carefully before use.
If further information is required, consult a physician or pharmacist.
Keep out of reach of children.