|Manufacturer:||Astellas Pharma US, Inc.|
|Other Info:||Cefizox®(ceftizoxime injection) in Galaxy® plastic container is to be administered either as a continuous or intermittent infusion over 15 to 30 min.|
Cefizox (ceftizoxime injection) is indicated in the treatment of infections due to susceptible strains of the microorganisms listed below.Lower Respiratory Tract Infections caused by Klebsiella spp.; Proteus mirabilis; Escherichia coli; Haemophilus influenzae including ampicillinresistant strains; Staphylococcus aureus (penicillinase and nonpenicillinaseproducing); Serratia spp.; Enterobacter spp.; Bacteroides spp.; and Streptococcus spp.
pneumoniae, but excluding enterococci.Urinary Tract Infections caused by Staphylococcus aureus (penicillinase and nonpenicillinaseproducing); Escherichia coli; Pseudomonas spp.
including P.aeruginosa; Proteus mirabilis; P.
vulgaris; Providencia rettgeri (formerly Proteus rettgeri) and Morganella morganii (formerly Proteus morganii); Klebsiella spp.; Serratia spp.
marcescens; and Enterobacter spp.Gonorrhea including uncomplicated cervical and urethral gonorrhea caused by Neisseria gonorrhoeae.Pelvic Inflammatory Disease caused by Neisseria gonorrhoeae, Escherichia coli or Streptococcus agalactiae.
NOTE: Ceftizoxime, 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 antichlamydial coverage should be added.IntraAbdominal Infections caused by Escherichia coli; Staphylococcusepidermidis; Streptococcus spp.
(excluding enterococci); Enterobacter spp.; Klebsiella spp.; Bacteroides spp.
fragilis; and anaerobic cocci, including Peptococcus spp.
and Peptostreptococcus spp.Septicemia caused by Streptococcus spp.
pneumoniae (but excluding enterococci); Staphylococcus aureus (penicillinase and nonpenicillinaseproducing); Escherichia coli; Bacteroides spp.
fragilis; Klebsiella spp.; and Serratia spp.Skin and Skin Structure Infections caused by Staphylococcus aureus (penicillinase and nonpenicillinaseproducing); Staphylococcus epidermidis; Escherichia coli; Klebsiella spp.; Streptococcus spp.
including Streptococcus pyogenes (but excluding enterococci); Proteus mirabilis; Serratia spp.; Enterobacter spp.; Bacteroides spp.
fragilis; and anaerobic cocci, including Peptococcus spp.
and Peptostreptococcus spp.Bone and Joint Infections caused by Staphylococcus aureus (penicillinase and nonpenicillinaseproducing); Streptococcus spp.
(excluding enterococci); Proteusmirabilis; Bacteroides spp.; and anaerobic cocci, including Peptococcus spp.
and Peptostreptococcus spp.Meningitis caused by Haemophilus influenzae.
Cefizox has also been used successfully in the treatment of a limited number of pediatric and adult cases of meningitis caused by Streptococcus pneumoniae.Cefizox has been effective in the treatment of seriously ill, compromised patients, including those who were debilitated, immunosuppressed, or neutropenic.
Infections caused by aerobic gramnegative and by mixtures of organisms resistant to other cephalosporins, aminoglycosides, or penicillins have responded to treatment with Cefizox.Because of the serious nature of some urinary tract infections due to P.
aeruginosa and because many strains of Pseudomonas species are only moderately susceptible to Cefizox, higher dosage is recommended.
Other therapy should be instituted if the response is not prompt.Susceptibility studies on specimens obtained prior to therapy should be used to determine the response of causative organisms to Cefizox.
Therapy with Cefizox may be initiated pending results of the studies; however, treatment should be adjusted according to study findings.
In serious infections, Cefizox has been used concomitantly with aminoglycosides (see PRECAUTIONS).
Before using Cefizox concomitantly with other antibiotics, the prescribing information for those agents should be reviewed for contraindications, warnings, precautions, and adverse reactions.
Renal function should be carefully monitored.To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefizox and other antibacterial drugs, Cefizox should be used only to treat or prevent 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.
BEFORE THERAPY WITH CEFIZOX IS INSTITUTED, CAREFUL INQUIRY SHOULD BE MADE TO DETERMINE WHETHER THE PATIENT HAS HAD PREVIOUS HYPERSENSITIVITY REACTIONS TO CEFIZOX, OTHER CEPHALOSPORINS, PENICILLINS, OR OTHER DRUGS.
IF THIS PRODUCT IS TO BE GIVEN TO PENICILLINSENSITIVE PATIENTS, CAUTION SHOULD BE EXERCISED BECAUSE CROSS HYPERSENSITIVITY AMONG BETALACTAM ANTIBIOTICS HAS BEEN CLEARLY DOCUMENTED AND MAY OCCUR IN UP TO 10% OF PATIENTS WITH A HISTORY OF PENICILLIN ALLERGY.
IF AN ALLERGIC REACTION TO CEFIZOX OCCURS, DISCONTINUE THE DRUG.
SERIOUS ACUTE HYPERSENSITIVITY REACTIONS MAY REQUIRE TREATMENT WITH EPINEPHRINE AND OTHER EMERGENCY MEASURES, INCLUDING OXYGEN, IV FLUIDS, IV ANTIHISTAMINES, CORTICOSTEROIDS, PRESSOR AMINES, AND AIRWAY MANAGEMENT, AS CLINICALLY INDICATED.Pseudomembranous colitis has been reported with nearly all antibacterial agents, including ceftizoxime, and may range in severity from mild to life threatening.
Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of antibacterial agents.Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia.
Studies indicate that a toxin produced by Clostridium difficile is a primary cause of “antibioticassociated” colitis.After the diagnosis of pseudomembranous colitis has been established, appropriate therapeutic measures should be initiated.
Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone.In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridium difficile colitis.