Composition

Each vial contains:
Cefoperazone (as sodium salt) ..........................................................................
500 mg, 1 g, or 2 g

Therapeutic Indications

Treatment of the following systemic and/or local infections caused by cefoperazone-susceptible microorganisms:
Upper and lower respiratory tract infections, e.g.
pneumonia, acute and chronic bronchitis.

Upper and lower urinary tract infections, e.g.
pyelonephritis, urethritis.

Peritonitis, cholecystitis, cholangitis, and other intraabdominal infections.

Septicemia.

Skin and soft tissue infections, e.g.
cellulitis.

Bone and joint infections, e.g.
osteomyelitis.

Infections of Bones and Joints.

Pelvic infections, such as endometritis and other infections of the genital tract including gonorrhea, in combination with other broad spectrum antibiotics, if necessary and prophylaxis of postoperative infections in connection with abdominal surgery, gynecological, cardioc and vascular as well as orthopedic surgery.

National and international recommendations for proper use of antimicrobial substances have to be considered when using CEFOZON 2 g vials.


Dosage and Administration

Dosage:
Adults:
The usual adult daily dose is 2-4 g, divided in two equal doses every 12 hours; in severe infections, the dose may be increased to 8 g daily in divided doses.
Even daily doses of up to 16 g (2 x 8 g) have been tolerated without complications.

The recommended dosage for uncomplicated gonococcal urethritis is 500 mg I.M.
as a single dose.

For perioperative prophylaxis, 1-2 g CEFOZON should be administered I.V.
approximately 0.5-
1.5 hrs prior to the start of surgery.
The dose may be repeated every 12 hours.
Prophylactic administration should be restricted to a maximum of 72 hours.

Infants and Children (1 month-11 years):
The recommended dosage in infants and children is 50-200 mg/kg body weight/day in divided doses every 8-12 hours.
The maximum dose should not exceed 12 grams/day.

Use in renal dysfunction:
Daily doses of 2x1 g or 2x2 g CEFOZON may be administered irrespective of the degree of renal dysfunction.

For patients whose glomerular filtration rate is less than 18 ml/min or whose serum creatinine level is greater than
3.5 mg/ dl, the maximum dosage is 4 g per day.

Serum half-life of cefoperazone is slightly reduced during hemodialysis.
Dosage should be adjusted according to dialysis requirements.

Use in patients with hepatic dysfunction or coexisting renal and hepatic dysfunction:
In patients with hepatic dysfunction and/or biliary obstruction, serum half-life is usually prolonged and renal excretion of cefoperazone is increased.

Dosage adjustment may be necessary in cases of severe biliary obstruction, severe hepatic dysfunction or coexisting renal dysfunction.

In patients with both severe renal and hepatic disease, plasma concentrations of cefoperazone should be monitored regularly and dosage adjusted as necessary.
In these patients, the dosage should not exceed 2 g daily without close monitoring of serum concentrations.
(see also Warnings and Precautions).

Elderly patients:
There are no special data available on pharmacokinetic parameters in elderly patients.

Duration of treatment:
The duration of treatment depends on the course of the disease.
CEFOZON therapy should be continued for at least 3 days after the patient's temperature has returned to normal.

Combination therapy:
In patients with severe, life-threatening infections, combination therapy with CEFOZON and an aminoglycoside may be indicated.
Because of physical incompatibility, the two drugs must not be mixed nor injected at the same time or at the same site.
The solutions should be prepared shortly before injection.
(see also Drug Interactions and Incompatibilities).

In case of a combination therapy with aminoglycosides, renal function must be carefully monitored (see also Warnings and Precautions).
In these cases also the contraindications of the aminoglycoside have to be considered