Drug: Cefizox

Cefizox® (ceftizoxime for injection, USP) FOR INTRAMUSCULAR OR INTRA VENOUS USE Cefizox® (ceftizoxime for injection, USP) is a sterile, semisynthetic, broad-spectrum, betalactamase resistant cephalosporin antibiotic for parenteral (IV, IM) administration. It is the sodium salt of [6R-[6a,7B(Z)]]-7-[(2,3-dihydro-2-imino-4-thiazolyl) (methoxyimino)acetyl]amino]- 8-oxo-5-thia-i-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid. Its sodium content is approximately 60 mg (2.6 mEq) per gram of ceftizoxime activity. It has the following molecular formula: C13H12N5NaO5S2 and its molecular weight is 405.38. Ceftizoxime for injection, USP is a white to pale yellow crystalline powder. Cefizox (ceftizoxime) 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.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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Cefizox® (ceftizoxime for injection, USP) is generally well tolerated. The most frequent adverse reactions (greater than 1 % but less than 5%) are:
Hypersensitivity: Rash, pruritus, fever.
Hepatic: Transient elevation in AST (SGOT), ALT (SGPT), and alkaline phosphatase.
Hematologic: Transienteosinophilia, thrombocytosis. Some individuals have developed a positive Coombs test.
Local†Injection site: Burning, cellulitis, phlebitis with IV administration, pain, induration, tenderness, paresthesia. The less frequent adverse reactions (less than 1%) are:
Hypersensitivity: Numbness and anaphylaxis have been reported rarely.
Hepatic: Elevation of bilirubin has been reported rarely.
Renal: Transient elevations of BUN and creatinine have been occasionally observed with Cefizox (ceftizoxime) .
Hematologic: Anemia, including hemolytic anemia with occasional fatal outcome, leukopenia, neutropenia, and thrombocytopenia have been reported rarely.
Urogenital: Vaginitis has occurred rarely.
Gastrointestinal: Diarrhea; nausea and vomiting have been reported occasionally.
Symptoms of pseudomembranous colitis can appear during or after antibiotic treatment (see WARNINGS). In addition to the adverse reactions listed above which have been observed in patients treated with ceftizoxime, the following adverse reactions and altered laboratory tests have been reported for cephalosporin-class antibiotics:
    Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, serum-sickness like reaction, toxic nephropathy, aplastic anemia, hemorrhage, prolonged prothrombin. Several cephalosporins have been implicated in triggering seizures, particularly in patients with renal impairment, when the dosage was not reduced. (See DOSAGE ANDADMINISTRATION.) If seizures associated with drug therapy occur, the drug should be discontinued.
Anticonvulsant therapy can be given if clinically indicated.
  Read the Cefizox (ceftizoxime) Side Effects Center for a complete guide to possible side effectsLearn More »

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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.
  General Guidelines for Dosage of Cefizox (ceftizoxime) Uncomplicated
Urinary Tract  1 500 mg qi 2h IM or IV Other Sites  2-3 1 gram q8-1 2h IM or IV  Severe or Refractory  3-6 1 gram q8h IM or IV 
2 grams q8-12h IMa or IV  PIDb 6 2 grams q8h IV  Life-Threateningc  9-12  3-4 grams q8h IV  a) When administering 2 gram IM doses, the dose should be divided and given in different large muscle masses.  b) If C. trachomatis is a suspected pathogen, appropriate antichlamydial coverage should be added, because ceftizoxime has no activity against this organism.  c) In life-threatening infections, dosages up to 2 grams every 4 hours have been given.
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.
  Pediatric Dosage Schedule   Unit Dose  Frequency Pediatric patients 6 months or older 50 mg/kg q6-8h 
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:
  Clcr † Weight (kg) x (140 - age) cr † 72 x serum creatinine
________________________________________
(mg/100 mL)
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.
  Dosage in Adults with Reduced Renal Function Creatinine Clearance mL/min Renal Function Less Severe Infections Life-Threatening Infections 79-50 Mild impairment 500 mg q8h  0.75-1.5 grams 
q8h 49-5 Moderate to severe impairment 250-500 mg 
ql2h  0.5-1 gram 
ql2h 4-0 Dialysis patients 500 mg q48h or 
250 mgq24h 0.5-1 gram q48h or 
0.5 gram q24h
Preparation of Parenteral Solution Reconstitution: IM Administration: Reconstitute with Sterile Water for Injection. SHAKE WELL.
  Vial Size  Diluent to
Be Added  Approx.
Avail. Vol.  Approx. Avg. 
Concentration  Room Temp.
Stability  500 mg  1.5 mL  1.8 mL  280 mg/mL  16 hours  1 gram  3.0 mL  3.7mL 270 mg/mL  16 hours  2 grams* 6.0 mL  7.4mL 270 mg/mL  16 hours  *When administering 2 gram IM doses, the dose should be divided and given in different large muscle masses.
IV Administration: Reconstitute with Sterile Water for Injection. SHAKE WELL.
  Vial Size  Diluent to
Be Added  Approx.
Avail. Vol.  Approx. Avg. 
Concentration  Room Temp.
Stability  500 mg  5 mL  5.3 mL  95 mg/mL  24 hours  1 gram  10 mL  10.7mL 95 mg/mL  24 hours  2 grams* 20 mL  21.4mL 95 mg/mL  24 hours 
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).

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Although the occurrence has not been reported with Cefizox (ceftizoxime) , nephrotoxicity has been reported following concomitant administration of other cephalosporins and aminoglycosides. Read the Cefizox Drug Interactions Center for a complete guide to possible interactions Learn More »

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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.  

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Cefizox (ceftizoxime for injection, USP) is contraindicated in patients who have known allergy to the drug.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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No information provided.

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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.

Source: http://www.rxlist.com

General As with all broad-spectrum antibiotics, Cefizox (ceftizoxime for injection, USP) should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis. Although Cefizox (ceftizoxime) has not been shown to produce an alteration in renal function, renal status should be evaluated, especially in seriously ill patients receiving
maximum dose therapy. As with any antibiotic, prolonged use may result in overgrowth of nonsusceptible organisms. Careful observation is essential; appropriate
measures should be taken if superinfection occurs. Drug Interactions Althoughthe occurrence has not been reported with Cefizox (ceftizoxime) , nephrotoxicity has been reported following concomitant administration of other cephalosporins and
aminoglycosides. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals to evaluate the carcinogenic potential of ceftizoxime have not been conducted.
In an in vitro bacterial cell assay (i.e., Ames test), there was no evidence of mutagenicity at ceftizoxime concentrations of 0.001-0.5 mcg/plate. Ceftizoxime did not produce increases in micronuclei in the in vivo mouse micronucleus test when given to animals at doses up to 7500 mg/kg, approximately six times greater than the maximum human daily dose on a mg/M 2 basis.
Ceftizoxime had no effect on fertility when administered subcutaneously to rats at daily doses of up to 1000 mg/kg/day, approximately two times the maximum human daily dose on a mg/M2 basis.
Ceftizoxime produced no histological changes in the sexual organs of male and female dogs when given intravenously for thirteen weeks at a dose of 1000 mg/kg/day, approximately five times greater than the maximum human daily dose on a mg/M2 basis. Pregnancy Teratogenic Effects: Pregnancy Category B. Reproduction studies performed in rats and rabbits have revealed no evidence of impaired fertility or harm to the fetus due to Cefizox (ceftizoxime) . There are, however, no adequate and wellcontrolled studies in pregnant women. Because animal reproduction studies are not always predictive of human effects, this drug should be used
during pregnancy only if clearly needed. Labor and Delivery Safety of Cefizox (ceftizoxime) use during labor and delivery has not been established. Nursing Mothers Cefizox (ceftizoxime) is excreted in human milk in low concentrations. Caution should be exercised when Cefizox (ceftizoxime) is administered to a nursing woman. Pediatric Use Safety and efficacy in pediatric patients from birth to six months of age have not been established. In pediatric patients six months of age and older, treatment with Cefizox (ceftizoxime) has been associated with transient elevated levels of eosinophils, AST (SGOT), ALT (SGPT), and CPK (creatine phosphokinase). The CPKelevation may be related to IM administration. The potential for the toxic effect in pediatric patients from chemicalsthat may leachfrom the single-dose IV preparation in plastic has not been determined. 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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