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Cefobid

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Cefobid

Indications
Dosage
How Supplied

INDICATIONS

CEFOBID (sterile cefoperazone) 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® (sterile cefoperazone) , like other cephalosporins, has no activity against Chlamydia trachomatis. Therefore, when cephalosporins are 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.

Susceptibility Testing

Before instituting treatment with CEFOBID (sterile cefoperazone) , appropriate specimens should be obtained for isolation of the causative organism and for determination of its susceptibility to the drug. Treatment may be started before results of susceptibility testing are available.

Combination Therapy

Synergy between CEFOBID (sterile cefoperazone) 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.)

* Efficacy of this organism in this organ system was studied in fewer than 10 infections.

DOSAGE AND ADMINISTRATION

Sterile cefoperazone sodium can be administered by IM or IV injection (following dilution). However, the intent of this pharmacy bulk package is for the preparation of solutions for IV infusion only.

The usual adult daily dose of CEFOBID (sterile cefoperazone) is 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.

If C. trachomatis is a suspected pathogen, appropriate anti-chlamydial coverage should be added, because cefoperazone has no activity against this organism.

Solutions of CEFOBID (sterile cefoperazone) and aminoglycoside should not be directly mixed, since there is a physical incompatibility between them. If combination therapy with CEFOBID (sterile cefoperazone) and an aminoglycoside is contemplated (see INDICATIONS) this can be accomplished by sequential intermittent intravenous infusion provided that separate secondary intravenous tubing is used, and that the primary intravenous tubing is adequately irrigated with an approved diluent between doses. It is also suggested that CEFOBID (sterile cefoperazone) be administered prior to the aminoglycoside. In vitro testing of the effectiveness of drug combination(s) is recommended.

In a pharmacokinetic study, a total daily dose of 16 grams was administered to severely immunocompromised patients by constant infusion without complications. Steady-state serum concentrations were approximately 150 mcg/mL in these patients.

Reconstitution

The following solutions may be used for the initial reconstitution of CEFOBID (sterile cefoperazone) sterile powder:

Table 1. Solutions for Initial Reconstitution

5% Dextrose Injection (USP)
5% Dextrose and 0.9% Sodium Chloride Injection (USP)
5% Dextrose and 0.2% Sodium Chloride Injection (USP)
10% Dextrose Injection (USP)
Bacteriostatic Water for Injection [Benzyl Alcohol or Parabens] (USP)*
0.9% Sodium Chloride Injection (USP)
Normosol® M and 5% Dextrose
Injection
Normosol® R
Sterile Water for Injection*
* Not to be used as a vehicle for intravenous infusion.
Preparations containing Benzyl Alcohol should not be used in neonates.

General Reconstitution Procedures

CEFOBID (sterile cefoperazone) sterile powder 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 (sterile cefoperazone) in higher concentrations (above 333 mg cefoperazone/mL). The maximum solubility of CEFOBID (sterile cefoperazone) sterile powder is approximately 475 mg cefoperazone/mL of compatible diluent.

Preparation for Intravenous Use

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

Table 2. Vehicles for Intravenous Infusion

5% Dextrose Injection (USP)
5% Dextrose and Lactated Ringer's Injection
5% Dextrose and 0.9% Sodium Chloride Injection (USP)
5% Dextrose and 0.2% Sodium Chloride Injection (USP)
10% Dextrose Injection (USP)
Lactated Ringer's Injection (USP)
0.9% Sodium Chloride Injection (USP)
Normosol® M and 5% Dextrose Injection
Normosol® R

Directions For Proper Use of Pharmacy Bulk Package

The 10 gram vial should be reconstituted with 95 mL of sterile water for injection in two separate aliquots in a suitable work area such as a laminar flow hood. Add 45 mL of solution, shake to dissolve and add 50 mL, shake for final solution. The resulting solution will contain 100 mg/mL of cefoperazone. This closure may be penetrated only one time after reconstitution, if needed, using a suitable sterile transfer device or dispensing set which allows measured dispensing of the contents.

Discard unused solution within 24 hours of initial entry.

Reconstituted Bulk Solutions Should Not Be Used For Direct Infusion.

Although after reconstitution of the Pharmacy Bulk Package, no significant loss of potency occurs for 24 hours at room temperature and for 5 days if refrigerated, transfer individual dose to appropriate intravenous infusion solutions as soon as possible following reconstitution of the bulk package. Discard unused portions of solution held longer than these recommended periods at room temperature or under refrigeration. The stability of the solution which has been transferred into a container varies according to diluent and concentration. (See Storage And Stability.)

The 10 gram vials may be further diluted with the parenteral diluents listed under Table 2. Vehicles for Intravenous Infusion. The parenteral diluents and approximate concentrations of CEFOBID (sterile cefoperazone) that provide stable solutions are presented under STORAGE AND STABILITY.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Storage And Stability

CEFOBID (sterile cefoperazone) sterile powder is to be stored at or below 25°C (77°F) and protected from light prior to reconstitution. After reconstitution, protection from light is not necessary.

The following parenteral diluents and approximate concentrations of CEFOBID (sterile cefoperazone) provide stable solutions under the following conditions for the indicated time periods. (After the indicated time periods, unused portions of solutions should be discarded.)

Controlled Room Temperature (15°–25°C/59°–77°F) 24 Hours Approximate Concentrations
Bacteriostatic Water for Injection [Benzyl Alcohol or Parabens] (USP) 300 mg/mL
5% Dextrose Injection (USP) 2 mg to 50 mg/mL
5% Dextrose and Lactated Ringer′s Injection 2 mg to 50 mg/mL
5% Dextrose and 0.9% Sodium Chloride Injection (USP) 2 mg to 50 mg/mL
5% Dextrose and 0.2% Sodium Chloride Injection (USP) 2 mg to 50 mg/mL
10% Dextrose Injection (USP) 2 mg to 50 mg/mL
Lactated Ringer′s Injection (USP) 2 mg/mL
0.5% Lidocaine Hydrochloride Injection (USP) 300 mg/mL
0.9% Sodium Chloride Injection (USP) 2 mg to 300 mg/mL
Normosol® M and 5% Dextrose Injection 2 mg to 50 mg/mL
Normosol® R 2 mg to 50 mg/mL
Sterile Water for Injection 100 mg to 300 mg/mL

Reconstituted CEFOBID (sterile cefoperazone) solutions may be stored in glass or plastic syringes, or in glass or flexible plastic parenteral solution containers.

Refrigerator Temperature (2°–8°C/36°–46°F) 5 Days Approximate Concentrations
Bacteriostatic Water for Injection [Benzyl Alcohol or Parabens] (USP) 300 mg/mL
5% Dextrose Injection (USP) 2 mg to 50 mg/mL
5% Dextrose and 0.9% Sodium Chloride Injection (USP) 2 mg to 50 mg/mL
5% Dextrose and 0.2% Sodium Chloride Injection (USP) 2 mg to 50 mg/mL
Lactated Ringer's Injection (USP) 2 mg/mL
0.5% Lidocaine Hydrochloride Injection (USP) 300 mg/mL
0.9% Sodium Chloride Injection (USP) 2 mg to 300 mg/mL
Normosol® M and 5% Dextrose Injection  2 mg to 50 mg/mL
Normosol® R 2 mg to 50 mg/mL
Sterile Water for Injection 100 mg to 300 mg/mL

Reconstituted CEFOBID (sterile cefoperazone) solutions may be stored in glass or plastic syringes, or in glass or flexible plastic parenteral solution containers.

Freezer Temperature (–20° to –10°C/–4° to 14°F) 3 Weeks Approximate Concentrations
5% Dextrose Injection (USP) 50 mg/mL
5% Dextrose and 0.9% Sodium Chloride Injection (USP) 2 mg/mL
5% Dextrose and 0.2% Sodium Chloride Injection (USP) 2 mg/mL
5 Weeks
0.9% Sodium Chloride Injection (USP) 300 mg/mL
Sterile Water for Injection 300 mg/mL

Reconstituted CEFOBID (sterile cefoperazone) solutions may be stored in plastic syringes, or in flexible plastic parenteral solution containers.

Frozen samples should be thawed at room temperature before use. After thawing, unused portions should be discarded. Do not refreeze.

HOW SUPPLIED

CEFOBID® (sterile cefoperazone) sterile powder is available in Pharmacy Bulk Package containing cefoperazone sodium equivalent to 10 g cefoperazone x 1 (NDC 0049-1219-28).

Other Size Packages Available

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

Distributed by: Roerig. Division of Pfizer Inc, NY, NY 10017. Revised January 2006.

Last reviewed on RxList: 8/24/2009
This monograph has been modified to include the generic and brand name in many instances.

Indications
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