Recommended Topic Related To:

Cefobid

"The food service industry can help prevent norovirus outbreaks.

Most norovirus outbreaks from contaminated food occur in food service settings, according to a Vital Signs (http://www.cdc.gov/vitalsigns) report by the Centers fo"...

Cefobid

Indications
Dosage
How Supplied

INDICATIONS

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.)

DOSAGE AND ADMINISTRATION

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 and aminoglycoside should not be directly mixed, since there is a physical incompatibility between them. If combination therapy with CEFOBID 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 be administered prior to the aminoglycoside. In vitro testing of the effectiveness of drug combination(s) is recommended.

Reconstitution

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

Table 1: Solutions for Initial Reconstitution

5% Dextrose Injection (USP) 0.9% Sodium Chloride Injection (USP)
5% Dextrose and 0.9% Sodium Chloride Injection (USP) Normosol® M and 5% Dextrose Injection
5% Dextrose and 0.2% Sodium Chloride Injection (USP) Normosol® R
10% Dextrose Injection (USP) Sterile Water for Injection*
Bacteriostatic Water for Injection [Benzyl Alcohol or Parabens] (USP)*†  
* 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) 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

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

Preparation of Vials: 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:

Table 2: Vehicles for Intravenous Infusion

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

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.

  Final Cefoperazone Concentration Step 1 Volume of Sterile Water Step 2 Volume of 2% Lidoeaine Withdrawable Volume*†
1 g vial 333 mg/mL 2.0 mL 0.6 mL 3 mL
250 mg/mL 2.8 mL 1.0 mL 4 mL
2 g vial 333 mg/mL 3.8 mL 1.2 mL 6 mL
250 mg/mL 5.4 mL 1.8 mL 8 mL
* There is sufficient excess present to allow for withdrawal of the stated volume.
† Final lidocaine concentration will approximate that obtained if a 0.5% Lidocaine Hydrochloride Solution is used as diluent.

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

  Cefoperazone Concentration Volume of Diluent to be Added Withdrawable Volume*
1 g vial 333 mg/mL 2.6 mL 3 mL
250 mg/mL 3.8 mL 4 mL
2 g vial 333 mg/mL 5.0 mL 6 mL
250 mg/mL 7.2 mL 8 mL
* There is sufficient excess present to allow for withdrawal of the stated volume.

Storage And Stability

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

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 300 mg/mL
Reconstituted CEFOBID 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 300 mg/mL
Reconstituted CEFOBID solutions may be stored in glass or plastic syringes, or in plastic parenteral solution containers. glass or flexible
Reconstituted CEFOBID 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)

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
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) 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.

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

Distributed by: Roerig, Division of Pfizer Inc., NY, NY 10017. Revised March 2015

Last reviewed on RxList: 3/30/2015
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.