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Cefizox

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Cefizox

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(Generic versions may still be available.)

Cefizox

CLINICAL PHARMACOLOGY

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.
 

Serum Concentrations After Intramuscular Administration Serum Concentration (mcg/mL)

Dose

1/ 2hr

1 hr

2hr

4hr

6hr

8hr

500mg

13.3

13.7

9.2

4.8

1.9

0.7

1 gm

36.0

39.0

31.0

15.0

6.0

3.0


Following IV administration of 1,2, and 3 gram doses of Cefizox (ceftizoxime) to normal volunteers, the following serum levels were obtained.
 

Serum Concentrations After Intra Serum Concentration venous Adm (mcg/mL) inistration

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 

2grams

131.8

110.9

77.5

53.6 

33.1

12.1

2.0

3grams

221.1

174.0

112.7

83.9

47.4 

26.2 

4.8

ND=Not Done

A serum half-life of approximately 1.7 hours was observed after IV or IM administration.

Cefizox (ceftizoxime) is 30% protein bound.

Cefizox (ceftizoxime) is not metabolized, and is excreted virtually unchanged by the kidneys in 24 hours. This provides a high urinary concentration.

Concentrations greater than 6000 mcg/mL have been achieved in the urine by 2 hours after a 1 gram dose of Cefizox (ceftizoxime) intravenously. Probenecid slows tubular secretion and produces even higher serum levels, increasing the duration of measurable serum concentrations. Cefizox (ceftizoxime) achieves therapeutic levels in various bodyfluids, 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 bodytissues: heart, gallbladder, bone, biliary, peritoneal, prostatic, and uterine.

In clinical experience to date, no disulfiram-like reactions have been reported with Cefizox (ceftizoxime) .

Microbiology

The bactericidal action of Cefizox (ceftizoxime for injection, USP) results from inhibition of cell-wall synthesis. Cefizox (ceftizoxime) is highly resistant to a broad spectrum of beta-lactamases (penicillinase and cephalosporinase), including Richmond types I, II, III, TEM, and IV, produced by both aerobic and anaerobic gram-positive and gram-negative organisms. Cefizox (ceftizoxime) is active against a wide range of gram-positive and gram-negative organisms, and is usually active against the following organisms in vitro and in clinical situations (see NDICATIONS AND USAGE).

Gram-Positive Aerobes

NOTE: Ceftizoxime is usually inactive against most strains of Enterococcus faecalis (formerly S. faecalis).

Gram-Negative Aerobes

Anaerobes

    Bacteroides spp.
    Peptococcus spp.
    Peptostreptococcus spp.

Ceftizoxime is usually active against the following organisms in vitro, but the clinical significance of these data is unknown.

Gram-Positive Aerobes

    Cotynebacterium diphtheriae

Gram-Negative Aerobes

Anaerobes

    Actinomyces spp.
    Bifidobacterium spp.
    Clostridium spp.
    NOTE: Most strains of Clostridium difficile are resistant.
    Eubacterium spp.
    Fusobacterium spp.
    Propionibacterium spp.
    Veillonella spp.

Susceptibility Testing

Diffusion Techniques: Quantitative methods that require measurement of zone diameters give the most precise estimate of the susceptibility of bacteria to antimicrobial agents. One such standard procedure1 has been recommended for use with disks to test susceptibility of organisms to ceftizoxime. Interpretation involves the correlation of the diameters obtained in the disk test with the minimum inhibitory concentration (MIC) for ceftizoxime.

Organisms should be tested with the ceftizoxime disk, since ceftizoxime has been shown by in vitro tests to be active against certain strains found resistant when other beta-lactam disks are used.

Reports from the laboratory giving results of the standard single-disk susceptibility test with a 30 mcg ceftizoxime disk should be interpreted according to the following criteria (with the exception of Pseudomonas aeruginosa).
 

Zone Diameter (mm)

Interpretation

20

(S) Susceptible 

15-19

(MS) Moderately Susceptible

14 

(R) Resistant 


A report of †Susceptible† indicates that the pathogen is likely to be inhibited by generally achievable blood levels. A report of †Moderately Susceptible† suggests that the organism would be susceptible if high dosage is used or if the infection is confined to tissue and fluids (e.g., urine) in which high antibiotic levels are attained. A report of †Resistant† indicates that achievable concentrations of the antibiotic are unlikely to be inhibitory and other therapy should be selected.

Standardized procedures require the use of laboratory control organisms. The 30 mcg ceftizoxime disk should give the following zone diameters.
 

Organism

ATCC Zone

Diameter (mm)

Escherichia coli 

25922

30-36

Pseudomonas aeruginosa 

27853

12-17 

Staphylococcus aureus

25923

27-35


Susceptibility Testing for Pseudomonas in Urinary Tract Infections: Most strains of Pseudomonasaeruginosa are moderately susceptible to ceftizoxime. Ceftizoxime achieves high levels in the urine (greater than 6000 mcg/mL at 2 hours with 1 gram IV) and therefore, the following zone sizes should be used when testing ceftizoxime for treatment of urinary tract infections caused by Pseudomonas aeruginosa.

Susceptible organisms produce zones of 20 mm or greater, indicating that the test organism is likely to respond to therapy.

Organisms that producezones of 11 to 19 mm are expected to be susceptible when the infection is confined to the urinary tract (in which high antibiotic levels are attained).

Resistant organisms produce zones of 10 mm or less, indicating that other therapy should be selected.

Dilution Techniques: When using the NCCLS agar dilution or broth dilution (including microdilution) method 2 or equivalent, the following MIC data should be used for interpretation.
 

MIC (mcg/mL) 

Interpretation

(S) Susceptible 

16-32 

(MS) Moderately Susceptible

64 

(R) Resistant 


As with standard disk diffusion methods, dilution procedures require the use of laboratory control organisms. Standard ceftizoxime powder should give MIC values in the following ranges.
 

Organism

ATCC 

MIC (mcg/mL) 

Escherichia coli 

25922

0.03-0.12 

Pseudomonas aeruginosa 

27853

16-64

Staphylococcus aureus

25923

2-8

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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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.


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