Cefobid

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 therapy.

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, Klebsiella pneumoniae, 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 (including Bacteroides 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 disease and C. trachomatis is one of the suspected pathogens, appropriate anti-chlamydial coverage should be added.

Urinary Tract Infections caused by Escherichia coli and Pseudomonas aeruginosa.

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.

Combination Therapy

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. (See PRECAUTIONS, and DOSAGE AND ADMINISTRATION sections.)

No information provided.

• E. coli (0157:H7) (Symptoms, Treatment, Prevention)
• Pelvic Inflammatory Disease

© Cefobid Patient Information is supplied by Cerner Multum, Inc. and Cefobid Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

The following solutions may be used for the initial reconstitution of Cefobid (sterile cefoperazone).

General Reconstitution Procedures

Cefobid (sterile cefoperazone) for intravenous or intramuscular use may be initially reconstituted with any compatible solution mentioned above in Table 1. 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 Cefobid in higher concentrations (above 333 mg cefoperazone/mL). The maximum solubility of Cefobid (sterile cefoperazone) is approximately 475 mg cefoperazone/mL of compatible diluent.

Preparation for Intravenous Use

Cefobid (sterile cefoperazone) concentrations between 2 mg/mL and 50 mg/mL are recommended for intravenous administration.

Vials of Cefobid (sterile cefoperazone) may be initially reconstituted with a minimum of 2.8 mL per gram of cefoperazone of any compatible reconstituting solution appropriate for intravenous administration listed above in Table 1. For ease of reconstitution the use of 5 mL of compatible solution per gram of Cefobid is recommended. The entire quantity of the resulting solution should then be withdrawn for further dilution and administration using any of the following vehicles for intravenous infusion:

The resulting intravenous solution should be administered in one of the following manners:

Intermittent Infusion

Solutions of Cefobid should be administered over a 15–30 minute time period.

Continuous Infusion

Cefobid can be used for continuous infusion after dilution to a final concentration of between 2 and 25 mg cefoperazone per mL.

Preparation for Intramuscular Injection

Any suitable solution listed above may be used to prepare Cefobid (sterile cefoperazone) for intramuscular injection. When concentrations of 250 mg/mL or more are to be administered, a lidocaine solution should be used. These solutions should be prepared using a combination of Sterile Water for Injection and 2% Lidocaine Hydrochloride Injection (USP) that approximates a 0.5% Lidocaine Hydrochloride Solution. A two-step dilution process as follows is recommended: First, add the required amount of Sterile Water for Injection and agitate until Cefobid powder is completely dissolved. Second, add the required amount of 2% lidocaine and mix.

When a diluent other than Lidocaine HCl Injection (USP) is used reconstitute as follows:

Cefobid (sterile cefoperazone) is available in vials containing cefoperazone sodium equivalent to 1 g cefoperazone × 10 (NDC 0049-1201-83) and 2 g cefoperazone × 10 (NDC 0049-1202-83) for intramuscular and intravenous administration.

Cefobid (sterile cefoperazone) is available in 10 g (NDC 0049-1219-28) Pharmacy Bulk Package for intravenous administration.

Rx only

LAB-0033-5.0

Cefoperazone has been assigned to pregnancy category B by the FDA. Animal studies failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. Cefoperazone should only be given during pregnancy when need has been clearly established.

Cefoperazone is excreted into human milk in small amounts. Adverse effects in the nursing infant are unlikely. Other cephalosporins have been classified as compatible with breast-feeding by the American Academy of Pediatrics.

Substance Name

Cefoperazone

CAS Registry Number

62893-19-0

Drug Class

Antiinfective Agents

Antibacterial Agents

Cephalosporins