Cefoperazone Sodium
Indications
Cefoperazone is indicated for the treatment
of the following infections when caused by susceptible organisms:
Respiratory Tract Infections, Peritonitis & Other Intra-abdominal
Infections, Bacterial Septicemia, Skin and Skin Structures Infections,
Pelvic Inflammatory Disease, Endometritis & Other Infections of the
Female Genital Tract, Urinary Tract Infections, Enterococcal Infections
etc.
Pharmacology
Cefoperazone is a bactericidal
Cephalosporin antibiotic which is resistant to most beta-lactamases and
active against a wide range of aerobic & anaerobic, Gram positive
& Gram negative bacteria. The bactericidal action of Cefoperazone
results from the inhibition of bacterial cell wall synthesis.
Cefoperazone has a high degree of stability in the presence of
beta-lactamases produced by most Gram negative pathogens. Cefoperazone
is usually active against organisms which are resistant to other
beta-lactam antibiotics because of beta-lactamase production.
Dosage & Administration
Sterile Cefoperazone Sodium can be administered by IM or IV injection (following dilution).
Adult: 2 to 4 grams per day administered in equally divided doses every 12 hours. In severe infections or infections caused by less sensitive organisms, the total daily dose and/or frequency may be increased. Patients have been successfully treated with a total daily dosage of 6-12 grams divided into 2,3, or 4 administrations ranging from 1.5 to 4 grams per dose. When treating infections caused by Streptococcus pyogenes, therapy should be continued for at least 10 days.
Adult: 2 to 4 grams per day administered in equally divided doses every 12 hours. In severe infections or infections caused by less sensitive organisms, the total daily dose and/or frequency may be increased. Patients have been successfully treated with a total daily dosage of 6-12 grams divided into 2,3, or 4 administrations ranging from 1.5 to 4 grams per dose. When treating infections caused by Streptococcus pyogenes, therapy should be continued for at least 10 days.
Contraindications
Cefoperazone is contraindicated in patients with known allergy to the Cephalosporin-class of antibiotics.
Side Effects
Hypersensitivity: As with all
Cephalosporins, hypersensitivity manifested by skin reactions (1 patient
in 45), drug fever (1 in 260), or a change in Coombs’ test (1 in 60)
has been reported. These reactions are more likely to occur in patients
with a history of allergies, particularly to Penicillin.
Pregnancy & Lactation
Pregnancy Category B.This drug should be
used during pregnancy only if clearly needed. Only low concentrations of
Cefoperazone is excreted in human milk. Although Cefoperazone passes
poorly into breast milk of nursing mothers, caution should be exercised
when Cefoperazone is administered to a nursing woman.
Precautions & Warnings
Cefoperazone is extensively excreted in
bile. The serum half-life of Cefoperazone is increased 2-4 fold in
patients with hepatic disease and/or biliary obstruction. In general,
total daily dosage above 4 gm should not be necessary in such patients.
If higher dosages are used, serum concentrations should be monitored.
Use in Special Populations
Children use: Safety and effectiveness in children have not been established.
Geriatric use: Reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Geriatric use: Reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Therapeutic Class
Third generation Cephalosporins
Reconstitution
Cefoperazone for intravenous or
intramuscular use may be initially reconstituted with compatible
solution. Solutions should be allowed to stand after reconstitution to
allow any foaming to dissipate to permit visual inspection for complete
solubilization. Vigorous and prolonged agitation may be necessary to
solubilize Cefoperazone in higher concentrations (above 333 mg
Cefoperazone/ml). The maximum solubility of Cefoperazone is
approximately 475 mg Cefoperazone/ml of compatible diluent.
Storage Conditions
Cefoperazone is to be stored in a dry
place, below 25°C and protected from light prior to reconstitution. The
reconstituted solution may be stored for 24 hours if kept in room
temperature (below 25°C).
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