Cefoperazone

What is Cefoperazone?

• Cefoperazone (Cefobid) is a semisynthetic, broad-spectrum cephalosporin antibacterial drug.
• It is one of few cephalosporin antibiotics effective in treating Pseudomonas bacterial infections which are otherwise resistant to these antibiotics.

Cefoperazone

Cefoperazone ball-and-stick

What are the uses of this medicine?

Cefoperazone (Cefobid) is used for the treatment of the following infections:

• 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.
• Urinary Tract Infections caused by Escherichia coli and Pseudomonas aeruginosa.
• Enterococcal Infections

Limitations of use:

• 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.

How does this medicine work?

• Cefoperazone, a third-generation cephalosporin, interferes with cell wall synthesis by binding to the penicillin-binding proteins (PBPs), thus preventing cross-linking of nascent peptidoglycan.
• Cefoperazone is stable to penicillinases and has a high degree of stability to many beta-lactamases produced by gram-negative bacteria.

Cefoperazone has been shown to be active against the following microorganisms:

Gram-positive aerobic bacteria:

• Staphylococcus aureus (methicillin-susceptible isolates only)
• Staphylococcus epidermidis (methicillin-susceptible isolates only)
• Streptococcus agalactiae (Group B beta-hemolytic streptococci)
• Streptococcus pneumoniae
• Streptococcus pyogenes (Group A beta-hemolytic streptococci)

Gram-negative aerobic bacteria:

• Citrobacter species
• Enterobacter species
• Escherichia coli
• Haemophilus influenzae
• Klebsiella species
• Morganella morganii
• Neisseria gonorrhoeae
• Proteus mirabilis
• Proteus vulgaris
• Providencia rettgeri
• Providencia stuartii
• Pseudomonas species
• Serratia marcescens

Anaerobic gram-positive bacteria:

• Gram-positive cocci (including Peptococcus and Peptostreptococcus spp.)
• Clostridium species (with the exception of C. difficile)

Anaerobic gram-negative bacteria:

• Bacteroides species

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with known allergy to the cephalosporin-class of antibacterial drugs.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• A false-positive reaction for glucose in the urine may occur with Benedict’s or Fehling’s solution.

Is this medicine FDA approved?

• It was patented in 1974 and approved for medical use in 1981.
• Cefoperazone/sulbactam (Sulperazon) is a co-formulation with sulbactam.

How should this medicine be used?

Recommended dosage:

• The usual adult daily dose of Cefobid is 2 to 4 grams per day administered in equally divided doses every 12 hours.
• 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.

Administration:

• Cefobid for intravenous or intramuscular use may be initially reconstituted with any compatible solution.
• Cefobid concentrations between 2 mg/mL and 50 mg/mL are recommended for intravenous administration.
• Solutions should be allowed to stand after reconstitution to allow any foaming to dissipate to permit visual inspection for complete solubilization.
• Solutions of Cefobid should be administered over a 15–30 minute time period.
• Cefobid can be used for continuous infusion after dilution to a final concentration of between 2 and 25 mg cefoperazone per mL.
• Any suitable solution 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Cefobid (sterile cefoperazone) is available in vials

This medicine is available in fallowing brand namesː Cefobid

What side effects can this medication cause?

The most common side effects of this medicine include:

• Hypersensitivity
• neutropenia
• Decreased hemoglobins or hematocrits
• elevated liver function enzymes
• Diarrhea
• Nausea and vomiting
• pseudomembranous colitis
• Transient elevations of the BUN and serum creatinine
• phlebitis

The less common side effects may include:

• Blood and Lymphatic System Disorders: Thrombocytopenia, hypoprothrombinaemia
• Immune System disorders: Anaphylactic reactions, including shock and fatal cases
• Hepatobiliary Disorders: Jaundice, hepatic dysfunction
• Skin and Subcutaneous Tissue Disorders: Toxic epidermal necrolysis, Stevens Johnson syndrome, pruritus
• Vascular Disorders: Hemorrhage

What special precautions should I follow?

• Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Cefobid, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
• If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.
• Serious hemorrhage cases, including fatalities, have been reported with cefoperazone. Monitor for signs of bleeding, thrombocytopenia, and coagulopathy. Discontinue Cefobid if there is persistent bleeding and no alternative explanations are identified.
• Prescribing Cefobid in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drugresistant bacteria.
• Concomitant administration of aminoglycosides and other cephalosporins has caused nephrotoxicity.
• Because renal excretion is not the main route of elimination of Cefobid, patients with renal failure require no adjustment in dosage when usual doses are administered.
• As with other antibacterial drugs, vitamin K deficiency has occurred rarely in patients treated with Cefobid. Prothrombin time should be monitored in these patients and exogenous vitamin K administered as indicated.
• A disulfiram-like reaction characterized by flushing, sweating, headache, and tachycardia has been reported when alcohol (beer, wine) was ingested within 72 hours after Cefobid administration. Patients should be cautioned about the ingestion of alcoholic beverages following the administration of Cefobid.
• Cefobid should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
• Patients should be counseled that antibacterial drugs including Cefobid should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold)
• Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treated by Cefobid or other antibacterial drugs in the future.
• Diarrhea is a common problem caused by antibacterial drugs which usually ends when the drug is discontinued. Sometimes after starting treatment with antibacterial drugs, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial drug. If this occurs, patients should contact their physician as soon as possible.
• Although Cefobid passes poorly into breast milk of nursing mothers, caution should be exercised when Cefobid is administered to a nursing woman.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Pregnancy Category B.
• There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Can this medicine be used in children?

• Safety and effectiveness in children have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• cefoperazone sodium

Inactive ingredients:

Who manufactures and distributes this medicine?

• Marketed by Pfizer under the name Cefobid.

What should I know about storage and disposal of this medication?

• 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.

• Dailymed label info on Cefoperazone
• FDA Cefoperazone

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