Cefoperazone Sterile Powder For Injection/ Cephalosporin Antibiotic
(Use for Infections caused by sensitive bacteria)
Western Medicine Cefoperazone for injection
Cefobid (sterile cefoperazone) is a cephalosporin antibiotic used
to treat infections caused by bacteria. Common side effects of
hypersensitivity skin reactions including rash, injection site
reactions (pain, swelling, or redness), or
Cefobid is administered by intravenous (IV) or intramuscular injection, as directed by your doctor. Cefobid may interact with
blood-thinning medications such as Coumadin or other antibiotics, like penicillin. Tell your doctor all medications and supplements you take. Avoid
alcoholic beverages. Consult your doctor before taking Cefobid if
you are pregnant or breastfeeding.
Our Cefobid (sterile cefoperazone) Side Effects Center provides a
comprehensive view of available drug information on the potential
side effects when taking this medication.
This is not a complete list of side effects and others may occur.
Call your doctor for medical advice about side effects. You may
report side effects to FDA at 1-800-FDA-1088.
Clinical Trials Experience
In clinical studies the following adverse effects were observed and
were considered to be related to CEFOBID therapy or of uncertain etiology:
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.
As with other beta-lactam antibacterial drugs, reversible neutropenia may occur with prolonged administration. Slight decreases in neutrophil count (1 patient in 50) have been reported. Decreased hemoglobins
(1 in 20) or hematocrits (1 in 20) have been reported, which is
consistent with published literature on other cephalosporins.
Transient eosinophilia has occurred in 1 patient in 10.
Of 1285 patients treated with cefoperazone in clinical trials, one
patient with a history of liver disease developed significantly elevated liver function enzymes during
CEFOBID therapy. Clinical signs and symptoms of nonspecific hepatitis accompanied these increases. After CEFOBID therapy was
discontinued, the patient's enzymes returned to pre-treatment
levels and the symptomatology resolved. As with other antibacterial
drugs that achieve high bile levels, mild transient elevations of liver function enzymes have
been observed in 5-10% of the patients receiving CEFOBID therapy.
The relevance of these findings, which were not accompanied by
overt signs or symptoms of hepatic dysfunction, has not been
Diarrhea or loose stools has been reported in 1 in 30 patients.
Most of these experiences have been mild or moderate in severity
and self-limiting in nature. In all cases, these symptoms responded
to symptomatic therapy or ceased when cefoperazone therapy was
stopped. Nausea and vomiting have been reported rarely.
Symptoms of pseudomembranous colitis can appear during or for several weeks subsequent to antibacterial
therapy (see WARNINGS).
Renal Function Tests
Transient elevations of the BUN (1 in 16) and serum creatinine (1 in 48) have been noted.
CEFOBID is well tolerated following intramuscular administration.
Occasionally, transient pain (1 in 140) may follow administration
by this route. When CEFOBID is administered by intravenous infusion
some patients may develop phlebitis (1 in 120) at the infusion site.
The following adverse reactions have been identified during
post-approval use of CEFOBID. Because these reactions are reported
voluntarily from a population of uncertain size, it is not always
possible to reliably estimate their frequency or establish a causal
relationship to drug exposure.
Blood and Lymphatic System Disorders: Thrombocytopenia, hypoprothrombinaemia (See PRECAUTIONS)
Immune System disorders: Anaphylactic reactions, including shock and fatal cases (See WARNINGS)
Hepatobiliary Disorders: Jaundice, hepatic dysfunction
Skin and Subcutaneous Tissue Disorders: Toxic epidermal necrolysis, Stevens Johnson syndrome, pruritus
To reduce the development of drug-resistant bacteria and maintain
the effectiveness of CEFOBID and other antibacterial drugs, CEFOBID should be used only to treat infections that are
proven or strongly suspected to be caused by susceptible bacteria.
When culture and susceptibility information are available, they
should be considered in selecting or modifying antibacterial
therapy. In the absence of such data, local epidemiology and
susceptibility patterns may contribute to the empiric selection of
CEFOBID is indicated for the treatment of the following infections
when caused by susceptible organisms:
Respiratory Tract Infections caused by S. pneumoniae, H.
influenzae, S. aureus (penicillinase and non-penicillinase
producing strains), S. pyogenes* (Group A beta-hemolytic streptococci), P. aeruginosa, Klebsiellapneumoniae, E. coli, Proteus mirabilis, and Enterobacter species.
Peritonitis and Other Intra-abdominal Infections caused by E. coli, P. aeruginosa,* and anaerobic gram-negative bacilli (including Bacteroides fragilis).
Bacterial Septicemia caused by S. pneumoniae, S. agalactiae,* S.
aureus,Pseudomonas aeruginosa,* E. coli, Klebsiella spp.,* Klebsiella pneumoniae,* Proteus
species* (indole-positive and indole-negative), Clostridium spp.* and anaerobic gram-positive cocci.*
Infections of the Skin and Skin Structures caused by S.
aureus(penicillinase and non-penicillinase producing strains), S.
pyogenes,* and P. aeruginosa.
Pelvic Inflammatory Disease, Endometritis, and Other Infections of
the Female Genital Tract caused by N. gonorrhoeae, S. epidermidis,*
S. agalactiae, E. coli, Clostridium spp.,* Bacteroides species
(includingBacteroides fragilis), and anaerobic gram-positive cocci.
Cefobid® has no activity against Chlamydia trachomatis. Therefore, when Cefobid is used in the treatment of
patients with pelvic inflammatory diseaseand C. trachomatis is one of the suspected pathogens, appropriate
anti-chlamydial coverage should be added.
Urinary Tract Infections caused by Escherichia coli and Pseudomonas
Enterococcal Infections: Although cefoperazone has been shown to be
clinically effective in the treatment of infections caused by
enterococci in cases of peritonitis and other intra-abdominal
infections, infections of the skin and skin structures, pelvic
inflammatory disease, endometritis and other infections of the
female genital tract, and urinary tract infections,* 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.
However, in vitro susceptibility testing may not correlate directly
with in vivo results. 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.
* Efficacy against this organism in this organ system was studied
in fewer than 10 infections.
Synergy between CEFOBID and aminoglycosides has been demonstrated
with many gram-negative bacilli. However, such enhanced activity of
these combinations is not predictable. If such therapy is
considered, in vitro susceptibility tests should be performed to
determine the activity of the drugs in combination, and renal
function should be monitored carefully. (SeePRECAUTIONS, and DOSAGE AND ADMINISTRATION sections.)
Store in a cool & dry place.
Protect from the light.
Keep out of the reach of the children.