Summary of content

Cefuroxime

Visa No.: 893110549824

Product: Negacef 500

API: Cefuroxime

Product Category: Antibiotics

Version approved leaflet: 3539/QLD-ĐK_20/03/2019

 

INDICATIONS

Mild to moderate lower respiratory tract infections, such as acute and chronic bronchitis.
Upper respiratory tract infections, including otitis media, sinusitis, tonsillitis, and pharyngitis.
Uncomplicated genitourinary infections, including pyelonephritis, cystitis, and urethritis.
Uncomplicated skin and soft tissue infections, including impetigo, cellulitis, and abscesses.
Uncomplicated gonorrhea and acute pelvic inflammatory disease due to gonococci.
Early-stage Lyme disease.
 

DOSAGE AND ADMINISTRATION

Adults
Bronchitis: 500 mg twice daily for 7 days (may range from 5–10 days).
Other indications: 250 mg or 500 mg twice daily for 7 days (may range from 5–10 days).
Cystitis: 250 mg twice daily. Pyelonephritis: 250 mg twice daily.
Uncomplicated skin and soft tissue infections: 250 mg twice daily. Uncomplicated gonorrhea: a single dose of 1 g is recommended.
Lyme disease: 500 mg twice daily for 14 days (range: 10–21 days).

Pediatric population: 
General dosing: 125 mg twice daily or 10 mg/kg twice daily; maximum 250 mg/day.
Children ≥ 2 age with otitis media: 250 mg twice daily or 15 mg/kg twice daily; maximum 500 mg/day.
For doses below 500 mg per dose, cefuroxime 250 mg tablets or other suitable formulations may be used.

Patients with renal impairment
Recommended dose adjustment based on creatinine clearance:

  • ≥ 30 ml/min: No dose adjustment required; usual dose 125–500 mg twice daily.
  • 10–29 ml/min: Usual single daily dose.
  • < 10 ml/min: Usual dose once daily.
  • Patients on hemodialysis: Administer the usual dose at the end of each dialysis session.
     

CONTRAINDICATIONS

Hypersensitivity to cefuroxime, other cephalosporins, or any excipient of the product.

 

WARNINGS AND PRECAUTIONS

 

Prescription-only medicine.

Read the instructions for use carefully before administration.

Consult a physician or pharmacist if additional information is required.

Keep out of reach of children.