CEFIZOX- ceftizoxime sodium injection, powder, lyophilized, for solution
Fujisawa Healthcare, Inc.
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 bacteria.
OR INTRAVENOUS USE
Cefizox® (ceftizoxime for injection, USP) is a sterile, semisynthetic, broadspectrum, betalactamase resistant cephalosporin antibiotic for parenteral (IV, IM) administration. It is the sodium salt of [6R[6a,7β(Z)]]7[[(2,3dihydro2imino4 thiazolyl) (methoxyimino) acetyl] amino]8oxo5thia1azabicyclo [4.2.0] oct2ene2carboxylic acid. Its sodium content is approximately 60 mg (2.6 mEq) per gram of ceftizoxime activity.
It has the following structural formula:
C12 H12 N5 NaO5 S2 405.38
Ceftizoxime for injection, USP is a white to pale yellow crystalline powder.
Cefizox is supplied in vials equivalent to 500 mg, 1 gram or 2 grams of ceftizoxime, and in Piggyback Vials for IV admixture equivalent to 1 gram or 2 grams of ceftizoxime.
The table below demonstrates the serum levels and duration of Cefizox (ceftizoxime for injection, USP) following IM administration of 500 mg and 1 gram doses, respectively, to normal volunteers.
|Dose||½ hr||1 hr||2 hr||4 hr||6 hr||8hr|
Following IV administration of 1, 2, and 3 gram doses of Cefizox to normal volunteers, the following serum levels were obtained.
|Dose||5 min||10 min||30 min||1 hr||2 hr||4 hr||8 hr|
|1 gram||ND *||ND *||60.5||38.9||21.5||8.4||1.4|
A serum halflife of approximately 1.7 hours was observed after IV or IM administration.
Cefizox is 30% protein bound.
Cefizox is not metabolized, and is excreted virtually unchanged by the kidneys in 24 hours. This provides a high urinary concentration. Concentrations greater than 6000 μg/mL have been achieved in the urine by 2 hours after a 1 gram dose of Cefizox intravenously. Probenecid slows tubular secretion and produces even higher serum levels, increasing the duration of measurable serum concentrations.
Cefizox achieves therapeutic levels in various body fluids, e.g., cerebrospinal fluid (in patients with inflamed meninges), bile, surgical wound fluid, pleural fluid, aqueous humor, ascitic fluid, peritoneal fluid, prostatic fluid and saliva, and in the following body tissues: heart, gallbladder, bone, biliary, peritoneal, prostatic, and uterine.
In clinical experience to date, no disulfiramlike reactions have been reported with Cefizox.
The bactericidal action of ceftizoxime results from inhibition of cellwall synthesis. Ceftizoxime is highly resistant to a broad spectrum of betalactamases (penicillinase and cephalosporinase), including Richmond types I, II, III, TEM, and IV, produced by both aerobic and anaerobic grampositive and gramnegative organisms. Ceftizoxime has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections described in the INDICATIONS AND USAGE section:
Aerobic Gram-Positive Microorganisms
Staphylococcus aureus (including penicillinase producing strains)
NOTE: Methicillinresistant staphylococci are resistant to cephalosporins, including ceftizoxime.
Staphylococcus epidermidis (including penicillinase producing strains)
NOTE: A streptococcal isolate that is susceptible to penicillin can be considered susceptible to ceftizoxime 4.
NOTE: Ceftizoxime is usually inactive against most strains of Enterococcus faecalis.
Aerobic Gram-Negative Microorganisms
Haemophilus influenzae (including ampicillinresistant strains)
The following in vitro data are available, but their clinical significance is unknown. At least 90% of the following microorganisms exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoint for ceftizoxime. However, the safety and effectiveness of ceftizoxime in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials.
Aerobic Gram-Negative Microorganisms
Susceptibility Testing Methods:
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