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Basic Drug Info
Drug Name:Cefizox
Manufacturer:Fujisawa Healthcare, Inc.
Other Info:Manufactured for Fujisawa Healthcare, Inc.Deerfield, IL 60015-2548 by GlaxoSmithKline, Philadelphia, PA 19101



Clinical Trials:


Indications and Usage

Cefizox (ceftizoxime for injection, USP) 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 ampicillin?resistant strains; Staphylococcus aureus (penicillinase­ and nonpenicillinase?producing); Serratia spp.; Enterobacter spp.; Bacteroides spp.; and Streptococcus spp.

including S.

pneumoniae, but excluding enterococci.Urinary Tract Infections caused by Staphylococcus aureus (penicillinase? and nonpenicillinase?producing); 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.

including S.

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.Intra?Abdominal Infections caused by Escherichia coli; Staphylococcusepidermidis; Streptococcus spp.

(excluding enterococci); Enterobacter spp.; Klebsiella spp.; Bacteroides spp.

including B.

fragilis; and anaerobic cocci, including Peptococcus spp.

and Peptostreptococcus spp.Septicemia caused by Streptococcus spp.

including S.

pneumoniae (but excluding enterococci); Staphylococcus aureus (penicillinase? and nonpenicillinase?producing); Escherichia coli; Bacteroides spp.

including B.

fragilis; Klebsiella spp.; and Serratia spp.Skin and Skin Structure Infections caused by Staphylococcus aureus (penicillinase? and nonpenicillinase?producing); Staphylococcus epidermidis; Escherichia coli; Klebsiella spp.; Streptococcus spp.

including Streptococcus pyogenes (but excluding enterococci); Proteus mirabilis; Serratia spp.; Enterobacter spp.; Bacteroides spp.

including B.

fragilis; and anaerobic cocci, including Peptococcus spp.

and Peptostreptococcus spp.Bone and Joint Infections caused by Staphylococcus aureus (penicillinase? and nonpenicillinase?producing); 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 gram?negative 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.
Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

Lower respiratory tract infection --

Pneumonia -- Inflammation of any part, segment or lobe, of the lung parenchyma.

Urinary tract infection -- Inflammatory responses of the epithelium of the URINARY TRACT to microbial invasions. They are often bacterial infections with associated BACTERIURIA and PYURIA.

Gonorrhea -- Acute infectious disease characterized by primary invasion of the urogenital tract. The etiologic agent, NEISSERIA GONORRHOEAE, was isolated by Neisser in 1879.

Pelvic Inflammatory Disease -- A spectrum of inflammation involving the female upper genital tract and the supporting tissues. It is usually caused by an ascending infection of organisms from the endocervix. Infection may be confined to the uterus (ENDOMETRITIS), the FALLOPIAN TUBES; (SALPINGITIS); the ovaries (OOPHORITIS), the supporting ligaments (PARAMETRITIS), or may involve several of the above uterine appendages. Such inflammation can lead to functional impairment and infertility.

Abdominal Infection --

Septicemia -- systemic disease associated with presence and persistance of pathogenic microorganisms or their toxins in the blood.

skin infection -- Skin diseases caused by bacteria, fungi, parasites, or viruses.

Arthropathy associated with infection --

Meningitis -- Inflammation of the coverings of the brain and/or spinal cord, which consist of the PIA MATER; ARACHNOID; and DURA MATER. Infections (viral, bacterial, and fungal) are the most common causes of this condition, but subarachnoid hemorrhage (HEMORRHAGES, SUBARACHNOID), chemical irritation (chemical MENINGITIS), granulomatous conditions, neoplastic conditions (CARCINOMATOUS MENINGITIS), and other inflammatory conditions may produce this syndrome. (From Joynt, Clinical Neurology, 1994, Ch24, p6)

Contraindications
Cefizox (ceftizoxime for injection, USP) is contraindicated in patients who have known allergy to the drug.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Immediate hypersensitivity -- Hypersensitivity reactions which occur within minutes of exposure to challenging antigen due to the release of histamine which follows the antigen-antibody reaction and causes smooth muscle contraction and increased vascular permeability.

Warnings

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 BETA?LACTAM 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 “antibiotic?associated” 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.

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