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 mirabills; 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 morganil); 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 anti-chlamydial coverage should be added.

Intra-Abdominal Infections caused by Escherichia coli; Staphylococcus epidermidis; 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 mirabills; Serratia spp.; Enterobacterspp.; 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); Proteus mirabills; Bacteroides spp.; and anaerobic cocci, including Peptococcus spp. and Peptostreptococcus spp.

Meningitis caused by Haemophilus influenzae. Cefizox (ceftizoxime) has also been used successfully in the treatment of a limited number of pediatric and adult cases of meningitis caused by Streptococcus pneumoniae.

Cefizox (ceftizoxime) 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 (ceftizoxime) .

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 (ceftizoxime) , 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 (ceftizoxime) . Therapy with Cefizox (ceftizoxime) may be initiated pending results of the studies; however, treatment should be adjusted according to study findings. In serious infections, Cefizox (ceftizoxime) has been used concomitantly with aminoglycosides (see PRECAUTIONS). Before using Cefizox (ceftizoxime) 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.  

The usual adult dosage is 1 or 2 grams of Cefizox (ceftizoxime for injection, USP) every 8 to 12 hours. Proper dosage and route of administration should be determined by the condition of the patient, severity of the infection, and susceptibility of the causative organisms.
 

Because of the serious nature of urinary tract infections due to P. aeruginosa and because many strains of Pseudomonas species are only moderately susceptible to Cefizox (ceftizoxime) , higher dosage is recommended. Other therapy should be instituted if the response is not prompt.

A single, 1 gram IM dose is the usual dose for treatment of uncomplicated gonorrhea.

The IV route may be preferable for patients with bacterial septicemia, localized parenchymal abscesses (such as intra-abdominal abscess), peritonitis, or other severe or life-threatening infections.

In those with normal renal function, the IV dosage for such infections is 2 to 12 grams of Cefizox (ceftizoxime for injection, USP) daily. In conditions such as bacterial septicemia, 6 to 12 grams/day may be given initially by the IV route for several days, and the dosage may then be gradually reduced according to clinical response and laboratory findings.
 

Dosage maybe increased to atotal daily dose of 200 mg/kg (not to exceed the maximum adult dose for serious infection).

Impaired Renal Function

Modification of Cefizox (ceftizoxime) dosage is necessary in patients with impaired renal function. Following an initial loading dose of 500 mg-1 gram IM or IV, the maintenance dosing schedule shown below should be followed. Further dosing should be determined by therapeutic monitoring, severity of the infection, and susceptibility of the causative organisms.

When only the serum creatinine level is available, creatinine clearance may be calculated from the following formula. The serum creatinine level should represent current renal function at the steady state.

Males:
 

Females: Females are 0.85 of the calculated clearance values for males.

In patients undergoing hemodialysis, no additional supplemental dosing is required following hemodialysis; however, dosing should be timed so that the patient receives the dose (according to the table below) at the end of the dialysis.
 

Preparation of Parenteral Solution

Reconstitution:

IM Administration: Reconstitute with Sterile Water for Injection. SHAKE WELL.
 

IV Administration: Reconstitute with Sterile Water for Injection. SHAKE WELL.
 

These solutions of Cefizox (ceftizoxime) are stable 24 hours at room temperature or 96 hours if refrigerated (5°C).

Parenteral drug products should be inspected visually for particulate matter prior to administration. If particulate matter is evident in reconstituted fluids, then the drug solution should be discarded. Reconstituted solutions may range from yellow to amber without changes in potency.

Piggyback Vials: Reconstitute with 50 to 100 mL of Sodium Chloride Injection or any other IV solution listed below. SHAKE WELL.

Administer with primary IV fluids, as a single dose. These Piggyback vial solutions of Cefizox (ceftizoxime) are stable 24 hours at room ternperature or 96 hours if refrigerated (5°C).

A solution of 1 gram Cefizox (ceftizoxime) in 13 mL Sterile Water for Injection is isotonic.

IM Injection:

Inject well within the body of a relatively large muscle. Aspiration is necessary to avoid inadvertent injection into a blood vessel. When administering 2 gram IM doses, the dose should be divided and given in different large muscle masses.

IV Administration:

Direct (bolus) injection, slowly over 3 to 5 minutes, directly or through tubing for patients receiving parenteral fluids (see list below). Intermittent or continuous infusion, dilute reconstituted Cefizox (ceftizoxime) in 50 to 100 mL of one of the following solutions:

• Sodium Chloride Injection
• 5% or 10% Dextrose Injection
• 5% Dextrose and 0.9%, 0.45%, or 0.2% Sodium Chloride Injection
• Ringer†s Injection
• Lactated Ringer†s Injection
• Invert Sugar 10% in Sterile Water for Injection
• 5% Sodium Bicarbonate in Sterile Water for Injection
• 5% Dextrose in Lactated Ringer†s Injection (only when reconstituted with 4% Sodium Bicarbonate Injection)

In these fluids, Cefizox (ceftizoxime) is stable 24 hours at room temperature or 96 hours if refrigerated (5°C).

Cefizox® (ceftizoxime for injection, USP)

NDC 0469-7250-01 Product No. 725001 Equivalent to 500 mg ceftizoxime in 10 mL, single-dose, flip-top vials, individually packaged

NDC 0469-7251-01 Product No. 725101 Equivalent to 1 gram ceftizoxime in 20 mL, single-dose, flip-top vials, individually packaged

NDC 0469-7252-01 Product No. 725201 Equivalent to 1 gram ceftizoxime in 100 mL, single-dose, Piggyback, flip-top vials, packaged in tens

NDC 0469-7253-02 Product No. 725302 Equivalent to 2 grams ceftizoxime in 20 mL, single-dose, flip-top vials, individually packaged

NDC 0469-7254-02 Product No. 725402 Equivalent to 2 grams ceftizoxime in 100 mL, single-dose, Piggyback, flip-top vials, packaged in tens

Unreconstituted Cefizox (ceftizoxime) should be protected from excessive light, and stored at controlled room temperature (59°-86°F)in the original package until used.

Rx only

REFERENCES

1. National Committee for Clinical Laboratory Standards, Approved Standard. Performance Standards for Antimicrobial Disk Susceptibility Test, 4th Edition, Vol 10 (7): M2-A4. Villanova, PA, April 1990.

2. National Committee for Clinical Laboratory Standards, Approved Standard. Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically, 2nd Edition, Vol 10 (8): M7-A2. Villanova, PA, April 1990.

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