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Side Effects & Adverse Reactions
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 BETALACTAM 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 “antibioticassociated” 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.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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 ampicillinresistant strains; Staphylococcus aureus (penicillinase and nonpenicillinaseproducing); Serratia spp.; Enterobacter spp.; Bacteroides spp.; and Streptococcus spp. including S. pneumoniae, but excluding enterococci.
Urinary Tract Infections caused by Staphylococcus aureus (penicillinase and nonpenicillinaseproducing); 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.
IntraAbdominal 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 nonpenicillinaseproducing); Escherichia coli; Bacteroides spp. including B. fragilis; Klebsiella spp.; and Serratia spp.
Skin and Skin Structure Infections caused by Staphylococcus aureus (penicillinase and nonpenicillinaseproducing); 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 nonpenicillinaseproducing); 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 gramnegative 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.
History
There is currently no drug history available for this drug.
Other Information
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:
C12H12N5NaO5S2 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.
Sources
Cefizox Manufacturers
-
Fujisawa Healthcare, Inc.
Cefizox | Fujisawa Healthcare, Inc.
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 CefizoxType of
InfectionDaily Dose
(Grams)Frequency
and Route * When administering 2 gram IM doses, the dose should be divided and given in different large muscle masses. † If C. trachomatis is a suspected pathogen, appropriate antichlamydial coverage should be added, because ceftizoxime has no activity against this organism. ‡ In lifethreatening infections, dosages up to 2 grams every 4 hours have been given.Uncomplicated
Urinary Tract 1 500 mg q12h IM or IV Other Sites 2-3 1 gram q8-12h IM or IVSevere or
Refractory 3-61 gram q8h IM or IV
2 grams q8-12h IM* or IV PID† 6 2 grams q8h IV Life-Threatening‡ 9-12 3-4 grams q8h IV______________________________________________________________________________
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, 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 intraabdominal abscess), peritonitis, or other severe or lifethreatening 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 FrequencyPediatric patients
6 months or older 50 mg/kg q6-8hDosage may be increased to a total daily dose of 200 mg/kg (not to exceed the maximum adult dose for serious infection).
Impaired Renal FunctionModification of Cefizox 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)
72 x serum creatinine
(mg/100 mL)
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 79-50Mild
Impairment 500 mg q8h0.75-1.5 grams
q8h 49-5Moderate
to severe
impairment250-500 mg
q12h0.5-1 gram
q12h 4-0Dialysis
Patients500 mg q48h
or
250 mg q24h0.5-1 gram
q48h
or
0.5 gram q24h Preparation of Parenteral SolutionRECONSTITUTION
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 * When administering 2 gram IM doses, the dose should be divided and given in different large muscle masses. 500 mg 1.5 mL 1.8 mL 280 mg/mL 16 hours 1 gram 3.0 mL 3.7 mL 270 mg/mL 16 hours 2 grams* 6.0 mL 7.4 mL 270 mg/mL 16 hoursIV 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 10.7 mL 95 mg/mL 24 hours 2 grams 20 mL 21.4 mL 95 mg/mL 24 hoursThese solutions of Cefizox are stable 24 hours at room temperature or 96 hours if refrigerated (5ºC).
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 are stable 24 hours at room temperature or 96 hours if refrigerated (5ºC).
A solution of 1 gram Cefizox 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 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 is stable 24 hours at room temperature or 96 hours if refrigerated (5ºC).
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