Summary of content

Ceftizoxim

Visa No.: 893110907424

Product: Zoximcef 1 g

API: Ceftizoxime

Product Category: Antibiotics

Version approved leaflet: 4244e/QLD-ĐK_26/03/2026

 

INDICATIONS

Ceftizoxime is indicated for the treatment of infections caused by susceptible strains of microorganisms in the following conditions:
- Respiratory Tract Infections: Bronchitis, infected bronchiectasis, secondary infections in chronic respiratory diseases, pneumonia, lung abscess, and empyema.
- Cholangitis, cholecystitis, and peritonitis.
- Urinary Tract Infections: Pyelonephritis, cystitis, and prostatitis. Uncomplicated Gonorrhea.
- Pelvic inflammatory disease (PID), adnexitis, and endometritis.
- Secondary infections associated with trauma or burns; bone and joint infections.
- Septicemia, endocarditis, and pyogenic meningitis (excluding cases caused by Listeria monocytogenes).
 

DOSAGE AND ADMINISTRATION

a. Dosage

Adults:
Standard dose: 1 – 2 g every 8 – 12 hours, via intramuscular or intravenous injection. Dosage varies depending on age and severity of infection.
- Uncomplicated urinary tract infections: 500 mg every 12 hours. The dose should be increased for urinary tract infections caused by Pseudomonas aeruginosa.
- Other infections: 1 g every 8 – 12 hours.
- Severe or complicated infections: 1 g every 8 hours or 2 g every 8 – 12 hours.
- Life-threatening infections: 3 – 4 g intravenously every 8 hours. An increased dose up to 2 g every 4 hours may also be used if necessary.
- Septicemia: 6 – 12 g per day, via intravenous injection. Gradually reduce the dose based on the patient's clinical response and bacteriological evaluation.
- Uncomplicated gonorrhea: a single dose of 1 g via intramuscular injection.
- Pelvic inflammatory disease caused by Neisseria gonorrhoeae, E.coli, Streptococcus agalactiae: 2 g every 8 hours (6 g per day), via intravenous injection.
Children: Children ≥ 6 months: Standard dose 50 mg/kg every 6 – 8 hours. For life-threatening infections, when necessary, the total dose may be increased up to 200 mg/kg/day and must be pided into small doses. The total dose must not exceed 12 g/day.
Renal Impairment: Dosage adjustment is required.

Creatinine clearance (mL/min)Life-threatening infectionsLess severe infections
50 - 79750 mg – 1,5 g every 8 hours500 mg every 8 hours
5 - 49500 mg – 1 g every 8 hours250–500 mg every 12 hours
< 5500 mg – 1 g every 48 hours or 500 mg every 24 hours500 mg every 48 hours or 250 mg every 24 hours

Patients undergoing hemodialysis, no supplemental dose is required after dialysis; however, dosing should be scheduled so that the dose is administered at the end of the dialysis session.

b. Method of preparation and administration

Intramuscular injection: 500 mg, 1 g, or 2 g of ceftizoxime powder for injection is reconstituted in 1.5 ml, 3 ml, or 6 ml of corresponding Water for Injection, respectively, creating solutions with concentrations of approximately 280, 270, or 270 mg/ml. The reconstituted solution is stable for 16 hours at room temperature. Inject deeply into a large muscle mass. When using a 2 g intramuscular dose, the dose must be pided and injected into two different large muscle masses. 

Intravenous injection: 500 mg, 1 g, or 2 g of ceftizoxime powder for injection is reconstituted in 5 ml, 10 ml, or 20 ml of corresponding Water for Injection, respectively, creating solutions with a concentration of approximately 95 mg/ml. The reconstituted solution is stable for 24 hours at room temperature and for 96 hours at 5°C. Inject slowly intravenously over 3 – 5 minutes or inject slowly into the tubing of a parenteral infusion system with compatible solutions (0.9% NaCl solution, 5% or 10% Dextrose solution, Ringer's injection, Lactated Ringer's, etc.).

Intermittent or continuous intravenous infusion: 1 g or 2 g of ceftizoxime powder for injection is reconstituted in 50 – 100 ml of 0.9% NaCl solution, 5% Dextrose solution, or other compatible intravenous infusion solutions. Infuse over a period of 15 – 30 minutes.

CONTRAINDICATIONS

Patients with known hypersensitivity to ceftizoxime, any of the excipients, or other cephalosporins.
Patients with a history of hypersensitivity to amide-type local anesthetics, such as lidocaine (in cases where lidocaine is used as a diluent to reduce pain during intramuscular injection).
 

WARNINGS AND PRECAUTIONS

This medication is available by prescription only. Read the package insert carefully before use. Consult your doctor or pharmacist if further information is required. Keep out of reach of children.