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Detailed Product Description
Composition:
Each vial contains:
Cefoperazone sodium equivalent to cefoperazonee 1g
Indication
Cefoperazone is used in the treatment of serious infections
caused by susceptible Gram-negative and Gram-positive bacteria
which are resistant to common beta-lactam antibiotics.
Cefoperazone is indicated for the treatment of the following
infections: mainly for biliary tract infections; upper and lower
respiratory tract infections; skin and skin structure infections;
bone and joint infections; urinary tract and renal infections;
pelvic inflammatory disease and gynecological infections;
peritonitis and other intra-abdominal infections; peritonitis and
other intra-abdominal infections; bacterial septicemia;
gonorrhea.
Cefoperazone should generally not be used in the treatment of
infections caused by Gram-positive bacteria when a penicillin or a
first-generation cephalosporin could be used.
The majority of clinical isolates of Enterococci tested are not
susceptible to cefoperazone but fall just at or in the intermediate
zone of susceptibility and are moderately resistant to
cefoperazone. Despite this, cefoperazone therapy has resulted in
clinical cures of enterococcal infections chiefly in polymicrobial
infections. Cefoperazone should be used in enterococcal infections
with care and at doses that achieve satisfactory serum levels of
cefoperazone.
Cefoperazone may be used as an effective alternative to an
extended-spectrum penicillin with or without an aminoglucoside for
the treatment of pseudomonal infections in patients who are
hypersensitive to penicillins. An aminoglucoside should be used in
conjunction with cefoperazone in the treatment of infections caused
by P.aeruginosa.
Note: Culture and susceptibility tests should be initiated prior
to and during therapy.
Dosage and Administration
Cefoperazone is administered as the sodium salt by deep IM
injection or intravenously by intermittent (over 15-30 minutes) or
continuous infusion. Although cefoperazone has been injected
directly into a vein over a 3 to 5 minute period, the manufacturer
does not recommend rapid, direct IV injection of the drug.
Dissolution at concentrations exceeding 333 mg/ml may require
vigorous and prolonged agitation. Maximum solubility is
approximately 475 mg/ml.
Adults: In mild to moderate infections, the usual dose is
1-2g/dose every 12 hours. In severe infections, up to 12 g/24 hours
divided into 2-4 doses may be given. In general, the dose should
not exceed 4 g daily in patients with liver disease or biliary
obstruction or 2 g daily in those with both liver and kidney
impairment; if higher doses are used, plasma concentration of
cefoperazone should be monitored.
Patients with renal failure are required no adjustment in
cefoperazone dosage if usual doses are administered. If evidence of
accumulation exists, dosage should be decreased accordingly.
Therapy should be continued for at least 10 days in group A
beta-hemolytic streptococcal infections to help prevent the
occurrence of acute rheumatic fever or glomerulonephritis.
In patients who are receiving hemodialysis treatment, a dose
should be scheduled to follow hemodialysis.
Pediatric dosage: Although safe use of cefoperazone in children
under 12 years has not been definitely established, the drug has
been administered IV to neonates and children in a dosage of
25-100mg/kg every 12 hours.
Because of toxicity of benzyl alcohol in neonates, IM injections
of cefoperazone prepared using bacteriostatic water for injection
containing benzyl alcohol should not be used in neonates.
Contraindications
Cefoperazone is contraindicated in patients with known allergy
to cephalosporins.
Drug Interactions
Storage
Cefoperazone is to be stored at cold place (210) and protected
airtight.
Manufacturer: CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co.,
Ltd
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