Cefoperazone
Visa No.: VD-35594-22
Product: Ceraapix 2g
API: Cefoperazon
Product Category: Antibiotics
Version approved leaflet: 26204e_31/07/2025
INDICATIONS
Monotherapy
Cefoperazone is indicated for the treatment of the following infections caused by susceptible organisms:
- Upper and lower respiratory tract infections
- Upper and lower urinary tract infections
- Peritonitis, cholecystitis, cholangitis, and other intra-abdominal infections
- Septicaemia
- Skin and soft tissue infections
- Skin and soft tissue infections
- Bone and joint infections
- Pelvic inflammatory disease, endometritis, gonorrhoea, and other genital tract infections
Prophylaxis
- Cefoperazone may be used for the prevention of postoperative infections in patients undergoing abdominal, gynaecological, cardiovascular, and orthopaedic surgery.
Combination therapy
- Due to its broad spectrum of activity, cefoperazone used as monotherapy may be sufficient for the treatment of many infections.
- However, combination therapy with other antibiotics may be considered when clinically indicated.
- When cefoperazone is used in combination with an aminoglycoside, renal function should be monitored during treatment.
DOSAGE AND ADMINISTRATION
Dosage
Adult
The usual daily dose for adults is 2–4 g per day, administered in two pided doses (every 12 hours).
In severe infections, the dose may be increased to 8 g per day, administered in two pided doses (every 12 hours). Doses of 12 g per day, administered in three pided doses (every 8 hours), and doses of up to 16 g per day given in multiple pided doses have been used without reported complications. Treatment may be initiated before the results of susceptibility testing are available.
The recommended dose for uncomplicated gonococcal urethritis is a single intramuscular injection of 500 mg. Intramuscular injections should be administered deeply into a large muscle mass, such as the gluteal muscle or the anterior thigh.
Use in patients with hepatic impairment
Dose adjustment is required in cases of severe biliary obstruction, severe hepatic disease, or concomitant hepatic and renal impairment. In such cases, the dose should not exceed 2 g per day unless serum cefoperazone concentrations are closely monitored.
Use in patients with renal impairment
As the kidney is not the primary route of elimination of cefoperazone, dose adjustment is not required in patients with renal impairment receiving usual doses of 2–4 g per day. In patients with a glomerular filtration rate < 18 ml/min or serum creatinine > 3.5 mg/dL, the maximum daily dose should not exceed 4 g.
The elimination half-life of cefoperazone is slightly reduced during haemodialysis; therefore, dosing should be adjusted according to the dialysis schedule
Use in patients with combined hepatic and renal impairment
In patients with hepatic impairment accompanied by renal insufficiency, serum cefoperazone concentrations should be monitored, and the dose adjusted as necessary. The dose should not exceed 2 g per day unless serum concentrations are closely monitored.
Infants and young children
In infants and young children, cefoperazone should be administered at a dose of 50–200 mg/kg/day, pided into 2–3 doses (every 8–12 hours). The maximum daily dose must not exceed 12 g (see section Warnings and precautions).
Use in neonates
In neonates less than 8 days of age, dosing should be administered every 12 hours.
Surgical prophylaxis
For surgical prophylaxis, 1–2 g should be administered by intravenous infusion 30–90 minutes before surgery. In most cases, this dose may be repeated every 12 hours for no longer than 24 hours. In surgical procedures with a higher risk of infection (e.g. colorectal surgery), or where infection may have particularly serious consequences (e.g. open-heart surgery or joint replacement surgery), prophylactic administration of cefoperazone should be continued for up to 72 hours after completion of surgery.
Method of administration
Intravenous administration in adults and children
Intermittent intravenous infusion, Each vial should be reconstituted and further diluted with a suitable diluent to obtain a final concentration of 2–50 mg/ml, and infused over 15 minutes to 1 hour.
If sterile water for injection is used as the diluent, the volume added should not exceed 20 ml.
Continuous intravenous infusion, Each gram of cefoperazone should be reconstituted and diluted in compatible solutions to achieve a final concentration of 2–25 mg/ml.
Direct intravenous injection: The maximum dose for direct intravenous injection is 2 g in adults and 50 mg/kg in children. Each vial should be reconstituted and diluted to obtain a final concentration of 100 mg/ml, and injected over a period of at least 3–5 minutes.
Preparation
Initially, each vial should be reconstituted at a ratio of 1 g cefoperazone in at least 2.8 ml of one of the following compatible solutions (for ease of preparation, 5 ml per 1 g cefoperazone is recommended):
- Dextrose 5% solution for injection
- Dextrose 10% solution for injection
- Sodium chloride 0.9% solution for injection
- Sterile water for injection
The entire volume of the reconstituted solution should then be further diluted using one of the following diluents:
- Dextrose 5% solution for injection
- Dextrose 10% solution for injection
- Sodium chloride 0.9% solution for injection
Intramuscular administration:
For intramuscular injection, sterile water for injection should be used as the diluent. When concentrations of ≥ 250 mg/ml are required, a lidocaine solution should be used. Such solutions are prepared by combining sterile water for injection with lidocaine hydrochloride 2% solution to achieve a final concentration of lidocaine hydrochloride 0.5%. A two-step dilution process is recommended:
first, add the required amount of sterile water for injection to the vial and shake until the cefoperazone powder is completely dissolved then add the appropriate amount of 2% lidocaine solution and mix thoroughly.
| Final concentration of cefoperazone | Step 1: Volume of sterile water for injection | Step 2: Volume of lidocaine 2% | Withdrawable volume | |
| Cefoperazone 2 g vial | 250 mg/ml 333 mg/ml | 5,2 ml 3,7 ml | 1,8 ml 1,2 ml | 8,0 ml 6,0 ml |
CONTRAINDICATIONS
Cefoperazone is contraindicated in patients with a known hypersensitivity to cephalosporin antibiotics.
WARNINGS AND PRECAUTIONS
This medicinal product is for prescription use only. Read the instructions for use carefully before use. If further information is required, consult a physician or pharmacist. Keep out of the reach of children.
