Summary of content

Cefradine

Visa No.: 893110832324

Product: Doncef

API: Cefradin

Product Category: Antibiotics

Version approved leaflet: 607/QĐ-QLD_23/08/2024_208

 

INDICATIONS

Cefradine 500 mg is used in the treatment of infections of the respiratory tract, urinary tract, and skin and soft tissues, including:

  • Upper respiratory tract infections: sinusitis, tonsillitis, pharyngitis, pneumonia, and otitis media
  • Lower respiratory tract infections: acute and chronic bronchitis, pneumonia
  • Urinary tract infections: cystitis, urethritis, and pyelonephritis
  • Skin and soft tissue infections: boils, abscesses, cellulitis, impetigo

Cefradine 500 mg is also indicated for the prophylaxis of postoperative infections in patients undergoing surgical procedures.
Cefradine should be administered on the day of surgery, with the dose adjusted to ensure adequate drug levels at the time of incision and maintained during the postoperative period.

Where appropriate, bacteriological examination and susceptibility testing should be performed. Treatment may be initiated before results are available.
 

DOSAGE AND ADMINISTRATION

Method of administration: For oral use. Cefradine may be taken with or without food.
Dosage
Adult: 

Respiratory tract, urinary tract, and skin and soft tissue infections: The usual dose is 250 mg or 500 mg four times daily, or 500 mg twice daily.
Severe or chronic infections: The dose may be increased to 1 g four times daily, particularly in severe or persistent infections. Treatment duration depends on clinical response and severity. In infections caused by beta-haemolytic streptococci, treatment should be continued for at least 10 days to prevent complications. For urinary tract infections, bacteriological evaluation and clinical response should be reassessed. In recurrent infections, longer treatment durations may be required.The dose should not exceed the recommended maximum.
Elderly patients
The usual adult dosage may be used. However, in elderly patients with impaired renal function, dose adjustment may be necessary.
Children
The recommended dose is 25–50 mg/kg/day, pided into 2–4 doses. Otitis media: doses up to 75–100 mg/kg/day, pided every 6–12 hours.The maximum daily dose should not exceed 4 g
For severe or chronic infections, doses up to 1 g four times daily may be required. Treatment should be continued for 48–72 hours after clinical improvement to ensure eradication of infection.
In infections caused by beta-haemolytic streptococci, treatment should be continued for at least 10 days.
The dose in children should not exceed the recommended adult dose.
Use in patients with renal impairment
Patients not undergoing dialysis: Dosage should be adjusted according to creatinine clearance as follows:

Creatinine clearance (ml/min)DoseDosing interval
 > 20500 mgEvery 6 hours
 5- 20250 mgEvery 6 hours
 < 5250 mgEvery 50 -70 

hours Dose adjustment should be inpidualized based on the patient’s clinical condition.

Patients undergoing chronic haemodialysis : An initial dose of 250 mg should be administered at the start of dialysis.

DoseDosing interval after initiation
250 mg6–12 hours after initiation
250 mg36–48 hours after initiation
250 mgAdminister at the next dialysis session if >30 hours have elapsed since the previous dose. Dose interval adjustment may be required in children.

 

CONTRAINDICATIONS

Hypersensitivity to cefradine or to any excipients of the product

WARNINGS AND PRECAUTIONS

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